DETAILED ACTION
Primary Examiner acknowledges Claims 1-7 are pending in this application, as originally filed on March 25, 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 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 1-7 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 1, Line 19 recites the word “and”; however, the breadth and scope of this limitation is unclear. It appears on Claim 1, Line 16, Applicant is attempting to recite a Markush or Markush-style claim by the use of “at least one of”. However, the proper format for a Markush or Markush-style claim requires a listing in the “alternative”; thus, it appears the conjunction utilized in Claim 1, Line 19 should be “or”. From a review of the original specification as filed, the “connection inlet port” can only be connected to one “rigidizer arm” OR one “conduit headgear” at a time. There is no configuration disclosed whereby the “connection inlet port” receives both the “rigidizer arm” AND the “conduit headgear” at the same time. Rather, as disclosed and claimed in dependent claim 6, the “connection inlet port” is interchangeable to receive either the “rigidizer arm” OR one “conduit headgear”. Thus, the recitation of “and” is unsupported and a mischaracterization of the disclosed invention. Dependent claims, Claims 2-7 incorporate the indefinite subject matter from which they depend. Explicitly, Claim 7, Lines 4-5, 8, and 11 each recite a similar recitation of a Markush or Markush-style claim by the use of “one of” and include the improper “and”. Each instance in Claim 7, Lines 4-5, 8, and 11 should be changed to “or”. For purposes of rejection, Primary Examiner will presume Applicant intents to refer to the subject matter in the alternative where only one component is required to meet the limitations of the claims. 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.
Claim 1, 4, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Ackerman et al. (4,774,946) in view of Collazo et al. (2013/0019870).
As to Claim 1, Ackerman discloses a patient interface (Figures 1, 3, and 7), comprising: a plenum chamber (16, “Apparatus 10 includes an elongated hollow tube 14 having a rigid hollow middle connecting portion 16 positioned proximately below the nose 18 of infant 12 and first and second flexible tube portions 20 and 22, respectively. First flexible tube portion 20 has opposed ends 24 and 26, with one end 24 attached to connecting portion 16 on the right side of the nose 18 and the other end 26 attached to one side 34 of the continuous positive airway pressure, or CPAP unit 28, which is shown in FIG. 7.” Column 3, Lines 5-20) pressuriziable to a therapeutic pressure (via 28, “the continuous positive airway pressure, or CPAP unit 28” Column 3, Lines 5-20), said plenum chamber (16) including a plenum chamber inlet port (one of 24/30 as connected to 16, wherein 24 – “First flexible tube portion 20 has opposed ends 24 and 26, with one end 24 attached to connecting portion 16 on the right side of the nose 18 and the other end 26 attached to one side 34 of the continuous positive airway pressure, or CPAP unit 28, which is shown in FIG. 7.” Column 3, Lines 5-20; and wherein 30 – “The second flexible tube portion 22 has opposed ends 30 and 32, with one end 30 attached to connecting portion 16 on the left side of nose 18 and the other end 32 attached to the other side 27 of the CPAP unit 28.” Column 3, Lines 15-25) sized and structured to receive a flow of air at therapeutic pressure (via 28) for breathing by a patient, and a connection inlet (other of 24/30 as connected to 16, wherein 24 – “First flexible tube portion 20 has opposed ends 24 and 26, with one end 24 attached to connecting portion 16 on the right side of the nose 18 and the other end 26 attached to one side 34 of the continuous positive airway pressure, or CPAP unit 28, which is shown in FIG. 7.” Column 3, Lines 5-20; and wherein 30 – “The second flexible tube portion 22 has opposed ends 30 and 32, with one end 30 attached to connecting portion 16 on the left side of nose 18 and the other end 32 attached to the other side 27 of the CPAP unit 28.” Column 3, Lines 15-25) sized and structured to receive a flow of air at therapeutic pressure (via 28) for breathing by a patient; a seal forming structure (44/46, “First and second nasal cannulae 36 and 38 have first and second globular, or bulbous, portions 44 and 46, respectively, which are seated against the inner walls of the first and second nares 40 and 42, respectively. Bulbous portions 44 and 46 are seated within the nares so as to seatingly and sealingly engage first and second nasal cannulae 36 and 38 in the nares of the nose. … First and second bulbous portions 44 and 46 also act to seat nasal cannulae 36 and 38 in the nares of the nose, since the bulbous portions are preferably slightly larger than the openings to the nares, which will spread slightly upon entry of the bulbous portions. Bulbous portions 44 and 46 act not only to seal off the nares between the walls of the nose and outside surfaces of nasal cannulae 36 and 38 as explained above, but also to tend to inhibit the nasal cannulae from sliding out of the nares. Thus, both a sealing action and a securing action result.” Column 3, Lines 25-60) constructed and arranged to form a seal with a region of a patient’s face surrounding an entrance to the patient’s airways, said feal forming structure (44/46) having a hole therein (via lumens in 37/39 to permit the passage of air from the plenum chamber 16 into the nares of the patient via 36/38, “First nasal cannula 36 is connected to middle connecting portion 16 proximate to end 24 of first tube portion 20 via a rigid connector tube 37, extending perpendicularly upward from connector 16, and second nasal cannula 38 is connected to middle connecting portion 16 proximate to end 30 of second tube portion 22 via a rigid connector tube 39 also extending perpendicularly upward from connector 16.” Column 3, Lines 25-50) such that the flow of air at said therapeutic pressure (via 28) is delivered to at least an entrance of the patient’s nares (via 36/38, “sealingly engage … seal off the nares” Column 3, Lines 25-60), the seal forming structure (44/46) constructed and arranged to maintain said therapeutic pressure (via 28) in the plenum chamber (16) throughout the patient’s respiratory cycle in use; and wherein the connection inlet port (other of 24/30 as connected to 16) is configured to removably receive a positioning and stabilizing structure (via 20/22 of other of 24/30, respectively, “Apparatus 10 includes an elongated hollow tube 14 having a rigid hollow middle connecting portion 16 positioned proximately below the nose 18 of infant 12 and first and second flexible tube portions 20 and 22, respectively.” Column 3, Lines 5-20) to provide a force to hold the seal forming structure (44/46) in a therapeutically effective position on the patient’s head, the positioning and stabilizing structure (via 20/22 of other of 24/30, respectively) comprising: a conduit headgear (20/22 of other of 24/30, respectively, “first and second flexible tube portions 20 and 22” Column 3, Lines 5-20) configured to convey the flow of air through the connection inlet port (other of 24/30) to the patient.
Yet, does not expressly disclose the specific therapeutic pressure to be “at least 6 cm of water above ambient pressure”.
Collazo teaches a patient interface suitable for operating as a CPAP device (“The ventilation interface for sleep apnea therapy interfaces a ventilation device which provides positive airway pressure (either continuous, bilevel, or intermittent) with the patient's airways.” Para 0017) to convey air to a patient.
Regarding the remaining limitation of the claims, Collazo teaches the known operational parameters of the CPAP device are “between five and fifteen centimeters of water” (Para 0042; 0047; 0050) to provide sleep apnea treatment to the patient. Hence, Collazo teaches the claimed “at least 6 cm of water”.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the operational parameters of the CPAP device of Ackerman to operate at the claimed “at least 6 cm of water” as taught by Collazo to be a known operating parameter for CPAP devices suitable for the treatment of sleep apnea in a patient.
As to Claim 4, the modified Ackerman, specifically Ackerman discloses the conduit headgear (20/22 of other of 24/30, respectively) is coupled to the connection inlet port (other of 24/30), the conduit headgear (20/22 of other of 24/30, respectively) comprising: an inlet (via 34/27 of other of 24/30) configured to receive the flow of air (via 28), the inlet (via 34/27 of other of 24/30) disclosed on a superior portion of the patient’s head (best seen Figure 1) in use; and a hollow tube (lumen of 20/22 of other of 24/30, respectively) configured to convey the flow of air (via 28) to the plenum chamber (16).
As to Claim 7, the modified Ackerman, specifically Ackerman discloses the patient interface (Figures 1, 3, and 7) utilizing the method comprising: providing the seal forming structure (44/46); selecting the positioning and stabilizing structure (via 20/22 of other of 24/30, respectively) from the conduit headgear (20/22 of other of 24/30, respectively); connecting the positioning and stabilizing structure (via 20/22 of other of 24/30, respectively) to the connection inlet port (other of 24/30 as connected to 16); connecting an air circuit (via 28 of 20/22 of one of 24/30, respectively) to the plenum chamber inlet (one of 24/30); and providing a flow of air through the positioning and stabilizing structure (via 20/22 of other of 24/30, respectively) or the air circuit (via 28 of 20/22 of one of 24/30, respectively), and limiting the flow of air using the positioning and stabilizing structure (via 20/22 of other of 24/30, respectively).
Claims 2, 3, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ackerman et al. (4,774,946) in view of Collazo et al. (2013/0019870), and further in view of Gunaratnam et al. (2004/0226566).
As to Claim 5, the modified Ackerman, specifically Ackerman discloses the conduit headgear (20/22 of other of 24/30, respectively) is coupled to the connection inlet port (other of 24/30), the conduit headgear (20/22 of other of 24/30, respectively) comprising: an inlet (via 34/27 of other of 24/30) configured to receive the flow of air (via 28), the inlet (via 34/27 of other of 24/30) disclosed on a superior portion of the patient’s head (best seen Figure 1) in use; and a hollow tube (lumen of 20/22 of other of 24/30, respectively) configured to convey the flow of air (via 28) to the plenum chamber (16).
Yet, does not expressly disclose “a cover removably received within the plenum chamber inlet port while the conduit headgear is coupled to the connection inlet port, the cover limiting fluid flow through the plenum chamber inlet port.”
Gunaratnam teaches a patient interface (Figures 108 and 60, “FIGS. 108-113 illustrate yet another preferred embodiment of the present invention. As shown in FIG. 108, a mask assembly 600 includes headgear 602 and a cushion assembly 604, each of which is substantially similar to the headgear and cushion assembly shown, e.g., in FIGS. 60 and 61, respectively.” Para 0376), similar to the modified Ackerman, suitable for imparting CPAP therapy to patient (Para 0002). Gunaratnam teaches the construction of the patient interface (Figures 108 and 60) including a plenum chamber (defined by the combination of 516 and 518 of Figure 60, “FIGS. 59-85 illustrate another embodiment of a nasal assembly, indicated as 510. The nasal assembly 510 includes a frame 516 and a nozzle assembly 518 that is removably coupled to the frame 516. As best seen in FIG. 61, the frame 516 includes a pair of first connector portions 524. Referring back to FIG. 59, a pair of inlet conduits 574 are structured to deliver breathable gas into the frame 516 and nozzle assembly 518 for breathing by the patient. The breathable gas is transported from the inlet conduits 574 to the frame 516 and nozzle assembly 518, e.g., via a pair of second connector portions 526 and a pair of angle connectors 542.” Para 0289) having a plenum chamber inlet port (one of 524/524, “As best seen in FIG. 61, the frame 516 includes a pair of first connector portions 524.” Para 0289) sized and structured to receive a flow of air at therapeutic pressure, a connection inlet port (other of 524/524, “As best seen in FIG. 61, the frame 516 includes a pair of first connector portions 524.” Para 0289) sized and structured to receive a flow of air at therapeutic pressure; a seal forming structure (550, “As shown in FIGS. 61-65, the nozzle assembly 518 includes a gusset or base portion 548 and a pair of nozzles 550 attached thereto. The nozzle assembly 518 is coupled with the frame 516 with the pair of nozzles 550 structured to sealingly engage with nasal passages of a patient's nose in use and provide a seal between the nasal assembly 510 and the patient's nasal passages. The nozzles 550 may be designed and structured in a similar manner to the nozzles 50 described above.” Para 0291); wherein the connection inlet port (other of 524/524) is configured to removably receive a positioning and stabilizing structure (the combination of 610 and 614 as engaging with 618 to receive 612, best seen Figure 110B, wherein 610 – “As with the fifth main illustrated embodiment, the yoke 608 may include a yoke ring 610. As shown in FIG. 109, the cushion assembly may be adjustably rotated with respect to headgear, to a position which best fits the patient. In FIG. 109, the ring 610 of the yoke 608 of the headgear includes an alignment marker 611a and the cushion includes a plurality of alignment markers 611b that can be selectively aligned with marker 611a.” Para 0379; wherein 614 – “The seal ring 614 may include first and second protrusions 624, 626, as described above.” Para 0383 and “In addition, the seal ring 614 may be connected to the ring 610 of the yoke 608.” Para 0390; wherein 618 – “The frame 616 includes a first connector portion 618 provided to each end of the frame 616 and/or cushion 617. Each first connector portion 618 is provided with or to a seal ring 614.” Para 0380; wherein 612 – “ In the embodiment of FIG. 108, one end of the cushion assembly 604 is provided with a plug 622 and the other end is provided with a swivel elbow 612. The positions of the swivel elbow 612 and the plug 622 may be interchanged, according to preference, e.g., the typical sleeping position of the patient. An air delivery tube 606 is joined to the swivel elbow 612. The air delivery tube 606 may include a swivel connector 607 and includes an end 609 which also may be provided with a swivel connector. The end 609 is provided with a source of pressurized gas.” Para 0377), the positioning and stabilizing structure (the combination of 610 and 614 as engaging with 618 to receive 612 to provide for conveyance of gas) comprising: a conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618, “An air delivery tube 606 is joined to the swivel elbow 612. The air delivery tube 606 may include a swivel connector 607 and includes an end 609 which also may be provided with a swivel connector. The end 609 is provided with a source of pressurized gas.” Para 0377) configured to convey the flow of air through the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110).
Regarding the remaining limitation of the claims, Gunaratnam teaches a cover (622, “In the embodiment of FIG. 108, one end of the cushion assembly 604 is provided with a plug 622 and the other end is provided with a swivel elbow 612. The positions of the swivel elbow 612 and the plug 622 may be interchanged, according to preference, e.g., the typical sleeping position of the patient.” Para 0377) removably received within the plenum chamber inlet port (one of 524/524 as shown in Figure 60 or one of 618/618 as shown in Figure 110) while the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618) is coupled to the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110), the cover (622) limiting flow through the plenum chamber inlet port (one of 524/524 as shown in Figure 60 or one of 618/618 as shown in Figure 110).
The resultant effect of this configuration is the ability to interchangeably choose whether the plenum chamber inlet port or the connection inlet port will receive the conduit headgear to accommodate the sleeping position of the patient. (Para 0377).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the conduit headgear as coupled to the connection inlet port and the plenum chamber inlet port of the modified Ackerman to include the cover, as taught by Gunaratnam to interchangeably choose whether the plenum chamber inlet port or the connection inlet port will receive the conduit headgear to accommodate the sleeping position of the patient.
As to Claim 2, the modified Ackerman, specifically Ackerman discloses the conduit headgear (20/22 of other of 24/30, respectively) is coupled to the connection inlet port (other of 24/30), the conduit headgear (20/22 of other of 24/30, respectively) comprising: an inlet (via 34/27 of other of 24/30) configured to receive the flow of air (via 28), the inlet (via 34/27 of other of 24/30) disclosed on a superior portion of the patient’s head (best seen Figure 1) in use; and a hollow tube (lumen of 20/22 of other of 24/30, respectively) configured to convey the flow of air (via 28) to the plenum chamber (16).
Yet, does not expressly disclose “a rigidized arm configured to limit fluid flow through the connection inlet port, and the rigidized arm configured to be positioned along the patient’s cheek while in use” (Claim 1) and further “where the rigidized arm is coupled to the connection inlet port, the rigidized arm comprises: a plug removably received within the connection inlet port and configured to limit the flow of air through the connection inlet port; and an arm portion configured to be positioned adjacent to a cheek of the patient.” (Claim 2).
Gunaratnam teaches a patient interface (Figures 108 and 60, “FIGS. 108-113 illustrate yet another preferred embodiment of the present invention. As shown in FIG. 108, a mask assembly 600 includes headgear 602 and a cushion assembly 604, each of which is substantially similar to the headgear and cushion assembly shown, e.g., in FIGS. 60 and 61, respectively.” Para 0376), similar to the modified Gusky, suitable for imparting CPAP therapy to patient (Para 0002). Gunaratnam teaches the construction of the patient interface (Figures 108 and 60) including a plenum chamber (defined by the combination of 516 and 518 of Figure 60, “FIGS. 59-85 illustrate another embodiment of a nasal assembly, indicated as 510. The nasal assembly 510 includes a frame 516 and a nozzle assembly 518 that is removably coupled to the frame 516. As best seen in FIG. 61, the frame 516 includes a pair of first connector portions 524. Referring back to FIG. 59, a pair of inlet conduits 574 are structured to deliver breathable gas into the frame 516 and nozzle assembly 518 for breathing by the patient. The breathable gas is transported from the inlet conduits 574 to the frame 516 and nozzle assembly 518, e.g., via a pair of second connector portions 526 and a pair of angle connectors 542.” Para 0289) having a plenum chamber inlet port (one of 524/524, “As best seen in FIG. 61, the frame 516 includes a pair of first connector portions 524.” Para 0289) sized and structured to receive a flow of air at therapeutic pressure, a connection inlet port (other of 524/524, “As best seen in FIG. 61, the frame 516 includes a pair of first connector portions 524.” Para 0289) sized and structured to receive a flow of air at therapeutic pressure; a seal forming structure (550, “As shown in FIGS. 61-65, the nozzle assembly 518 includes a gusset or base portion 548 and a pair of nozzles 550 attached thereto. The nozzle assembly 518 is coupled with the frame 516 with the pair of nozzles 550 structured to sealingly engage with nasal passages of a patient's nose in use and provide a seal between the nasal assembly 510 and the patient's nasal passages. The nozzles 550 may be designed and structured in a similar manner to the nozzles 50 described above.” Para 0291); wherein the connection inlet port (other of 524/524) is configured to removably receive a positioning and stabilizing structure (the combination of 610 and 614 as engaging with 618 to receive 612, best seen Figure 110B, wherein 610 – “As with the fifth main illustrated embodiment, the yoke 608 may include a yoke ring 610. As shown in FIG. 109, the cushion assembly may be adjustably rotated with respect to headgear, to a position which best fits the patient. In FIG. 109, the ring 610 of the yoke 608 of the headgear includes an alignment marker 611a and the cushion includes a plurality of alignment markers 611b that can be selectively aligned with marker 611a.” Para 0379; wherein 614 – “The seal ring 614 may include first and second protrusions 624, 626, as described above.” Para 0383 and “In addition, the seal ring 614 may be connected to the ring 610 of the yoke 608.” Para 0390; wherein 618 – “The frame 616 includes a first connector portion 618 provided to each end of the frame 616 and/or cushion 617. Each first connector portion 618 is provided with or to a seal ring 614.” Para 0380; wherein 612 – “ In the embodiment of FIG. 108, one end of the cushion assembly 604 is provided with a plug 622 and the other end is provided with a swivel elbow 612. The positions of the swivel elbow 612 and the plug 622 may be interchanged, according to preference, e.g., the typical sleeping position of the patient. An air delivery tube 606 is joined to the swivel elbow 612. The air delivery tube 606 may include a swivel connector 607 and includes an end 609 which also may be provided with a swivel connector. The end 609 is provided with a source of pressurized gas.” Para 0377), the positioning and stabilizing structure (the combination of 610 and 614 as engaging with 618 to receive 612 to provide for conveyance of gas) comprising: a conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618, “An air delivery tube 606 is joined to the swivel elbow 612. The air delivery tube 606 may include a swivel connector 607 and includes an end 609 which also may be provided with a swivel connector. The end 609 is provided with a source of pressurized gas.” Para 0377) configured to convey the flow of air through the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110).
Regarding the remaining limitation of the claims, Gunaratnam teaches a rigidized arm (via 610 of 608 as connected with plug 622, wherein 610 of 608 – “As with the fifth main illustrated embodiment, the yoke 608 may include a yoke ring 610. As shown in FIG. 109, the cushion assembly may be adjustably rotated with respect to headgear, to a position which best fits the patient. In FIG. 109, the ring 610 of the yoke 608 of the headgear includes an alignment marker 611a and the cushion includes a plurality of alignment markers 611b that can be selectively aligned with marker 611a.” Para 0379 and wherein 622 – “In the embodiment of FIG. 108, one end of the cushion assembly 604 is provided with a plug 622 and the other end is provided with a swivel elbow 612. The positions of the swivel elbow 612 and the plug 622 may be interchanged, according to preference, e.g., the typical sleeping position of the patient.” Para 0377) is configured to limit fluid flow through either of the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) or the plenum chamber inlet port (one of 524/524 as shown in Figure 60 or one of 618/618 as shown in Figure 110) when attached thereto, and the rigidized arm (via 610 of 608 as connected with plug 622) is configured to be positioned along the cheek while in use (“Specifically, the nasal assembly is structured such that stability forces applied by the headgear assembly are distributed to the back of the patient's head, the patient's cheeks, and the patient's upper lip to maintain the nasal assembly on the patient's face in use.” Para 0230).
Gunaratnam teaches the rigidized arm (via 610 of 608 as connected with plug 622, wherein 610 of 608) when coupled to the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) comprises a plug (“In the embodiment of FIG. 108, one end of the cushion assembly 604 is provided with a plug 622 and the other end is provided with a swivel elbow 612. The positions of the swivel elbow 612 and the plug 622 may be interchanged, according to preference, e.g., the typical sleeping position of the patient.” Para 0377) removably received within the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) and configured to limit the flow of air through the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110); and an arm portion (via 610 of 608, “As with the fifth main illustrated embodiment, the yoke 608 may include a yoke ring 610. As shown in FIG. 109, the cushion assembly may be adjustably rotated with respect to headgear, to a position which best fits the patient. In FIG. 109, the ring 610 of the yoke 608 of the headgear includes an alignment marker 611a and the cushion includes a plurality of alignment markers 611b that can be selectively aligned with marker 611a.” Para 0379) configured to be positioned adjacent to the cheek (“Specifically, the nasal assembly is structured such that stability forces applied by the headgear assembly are distributed to the back of the patient's head, the patient's cheeks, and the patient's upper lip to maintain the nasal assembly on the patient's face in use.” Para 0230) of the patient.
The resultant effect of this configuration is the ability to interchangeably choose whether the plenum chamber inlet port or the connection inlet port will receive the conduit headgear to accommodate the sleeping position of the patient. (Para 0377). In this configuration, the designated connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) receives either the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618) or the rigidized arm (via 610 of 608 as connected with plug 622) so that ONLY ONE of the plenum chamber inlet port or the connection inlet port provides gas to the patient through the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618), while the OTHER of the plenum chamber inlet port or the connection inlet port only limits flow by the insertion of the plug (622) of the rigidized arm (via 610 of 608 as connected with plug 622).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the conduit headgear as coupled to the connection inlet port and the plenum chamber inlet port of the modified Ackerman to include the cover, as taught by Gunaratnam to interchangeably choose whether the plenum chamber inlet port or the connection inlet port will receive the conduit headgear or the rigidized arm with plug to accommodate the sleeping position of the patient.
As to Claim 3, the modified Ackerman, specifically Gunaratnam teaches the designated connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) receives either the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618) or the rigidized arm (via 610 of 608 as connected with plug 622) so that ONLY ONE of the plenum chamber inlet port or the connection inlet port provides gas to the patient through the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618), while the OTHER of the plenum chamber inlet port or the connection inlet port only limits flow by the insertion of the plug (622) of the rigidized arm (via 610 of 608 as connected with plug 622). Thus, the claimed configuration of the plenum chamber inlet port (one of 524/524 as shown in Figure 60 or one of 618/618 as shown in Figure 110) being configured to receive the flow of air is a function of the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618) coupled to the plenum chamber inlet port (one of 524/524 as shown in Figure 60 or one of 618/618 as shown in Figure 110).
As to Claim 6, the modified Ackerman, specifically Gunaratnam teaches the designated connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) receives either the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618) or the rigidized arm (via 610 of 608 as connected with plug 622) so that ONLY ONE of the plenum chamber inlet port or the connection inlet port provides gas to the patient through the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618), while the OTHER of the plenum chamber inlet port or the connection inlet port only limits flow by the insertion of the plug (622) of the rigidized arm (via 610 of 608 as connected with plug 622). Thus, the claimed configuration of both the rigidized arm (via 610 of 608 as connected with plug 622) and the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618) being interchangeably connected to the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) is met by the designation of which inlet is the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) and which inlet is the plenum chamber inlet port (one of 524/524 as shown in Figure 60 or one of 618/618 as shown in Figure 110).
Claims 1, 4, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Gusky et al. (2016/0095996) in view of Collazo et al. (2013/0019870).
As to Claim 1, Gusky discloses a patient interface (Figure 2A – exploded view; Figure 4 – connected view; and Figure 8A – connected cross-sectional view), comprising: a plenum chamber (10, “Referring to FIGS. 2A-8B, a first illustrative exemplary embodiment of a nasal interface includes a hard base portion 10 and a soft pad portion 200.” Para 0080) pressurizable to a therapeutic pressure (“CPAP system” Para 0111, via “CPAP blower” Para 0093), said plenum chamber (10) including a plenum chamber inlet port (one of 14/18, “The hoses 300 connect to inlets 14, 18 defined by the base 10.” Para 0090) sized and structure to receive a flow of air at a therapeutic pressure for breathing by a patient, and a connection inlet port (other of 14/18, “The hoses 300 connect to inlets 14, 18 defined by the base 10.” Para 0090) sized and structure to receive a flow of air at a therapeutic pressure for breathing by a patient; a seal forming structure (200, “Referring to FIGS. 2A-8B, a first illustrative exemplary embodiment of a nasal interface includes a hard base portion 10 and a soft pad portion 200.” Para 0080) constructed and arranged to form a seal (via 210 of 200, “The upper surfaces 210 may seal around the users nostrils.” Para 0081) with a region of the patient’s face surrounding an entrance to the patient’s airways, said seal forming structure (20) having a hole (216, “These air holes 216 may be sized, positioned, and physically separated (spaced apart) on the upper surfaces 210 of wings 218 to locate the air holes in or near registry with a user's nostrils. … In other embodiments, the upper surfaces 210 could include protrusions or other physically noticeable features about or near the air holes 216 to aid in positioning of the nasal interface with respect to a user's nostrils.” Para 0080) therein such that the flow of air at said therapeutic pressure is delivered to at least the entrance of the patient’s nares (“users nostrils.” Para 0081), the seal forming structure (200) constructed and arranged to maintain said therapeutic pressure throughout the patient’s respiratory cycle in use; and wherein the connection inlet port (other of 14/18) is configured to removably receive a positioning and stabilizing structure (via 300/300’, “In the illustrated embodiment, the base portion 10 can be connected (e.g., glued, welded, snap or press fit, etc.) with one or more fluid supply hoses, such as hoses 300/300′ cross-sections of which are shown in FIGS. 2B and 2C, or any fluid supply hoses. … The hoses 300 connect to inlets 14, 18 defined by the base 10.” Paras 0089-0090) to provide a force (“The hoses 300, in addition to supplying air to the nasal interface, may be utilized for holding the mask in the right position for maintaining connection to (e.g., sealing engagement with) the user's nose.” Para 0092) to hold a seal forming structure (200) in a therapeutically effective position on the patient’s head, the positioning and stabilizing structure (via 300/300’) comprising: a conduit headgear (300/300’, “The hoses 300 connect to inlets 14, 18 defined by the base 10.” Paras 0089-0090) configured to convey the flow of air through the connection inlet port (other of 14/18) to the patient.
Yet, does not expressly disclose the specific therapeutic pressure to be “at least 6 cm of water above ambient pressure”.
Collazo teaches a patient interface suitable for operating as a CPAP device (“The ventilation interface for sleep apnea therapy interfaces a ventilation device which provides positive airway pressure (either continuous, bilevel, or intermittent) with the patient's airways.” Para 0017) to convey air to a patient.
Regarding the remaining limitation of the claims, Collazo teaches the known operational parameters of the CPAP device are “between five and fifteen centimeters of water” (Para 0042; 0047; 0050) to provide sleep apnea treatment to the patient. Hence, Collazo teaches the claimed “at least 6 cm of water”.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the operational parameters of the CPAP device of Gusky to operate at the claimed “at least 6 cm of water” as taught by Collazo to be a known operating parameter for CPAP devices suitable for the treatment of sleep apnea in a patient.
As to Claim 4, the modified Gusky, specifically Gusky discloses the conduit headgear (300/300’) is coupled to the connection inlet port (other of 14/18), the conduit headgear (300/300’) comprising: an inlet (via 300/300’ proximate “CPAP blower” Para 0093) configured to receive the flow of air (via “CPAP blower” Para 0093), the inlet (via 300/300’ proximate “CPAP blower” Para 0093) disposed on a superior portion of the patient’s head in use (“In one embodiment, the hoses may come from a direction above the user's ear.” Para 0092); and a hollow tube (lumen of 300/300’) configured to convey the flow of air to the plenum chamber (10).
As to Claim 7, the modified Gusky, specifically Gusky discloses the patient interface (Figure 2A – exploded view; Figure 4 – connected view; and Figure 8A – connected cross-sectional view) utilizing the method comprising: providing the seal forming structure (200); selecting the positioning and stabilizing structure (via 300/300’) from the conduit headgear (300/300’); connecting the positioning and stabilizing structure (via 300/300’) to the connection inlet port (other of 14/18); connecting an air circuit (“CPAP blower” Para 0093) to the plenum chamber inlet (one of 14/18); and providing a flow of air through the positioning and stabilizing structure (via 300/300’) or the air circuit (“CPAP blower” Para 0093), and limiting the flow of air using the positioning and stabilizing structure (via 300/300’).
Claims 2, 3, 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Gusky et al. (2016/0095996) in view of Collazo et al. (2013/0019870), and further in view of Gunaratnam et al. (2004/0226566).
As to Claim 5, the modified Gusky, specifically Gusky discloses the conduit headgear (300/300’) is coupled to the connection inlet port (other of 14/18), the conduit headgear (300/300’) comprising: an inlet (via 300/300’ proximate “CPAP blower” Para 0093) configured to receive the flow of air (via “CPAP blower” Para 0093), the inlet (via 300/300’ proximate “CPAP blower” Para 0093) disposed on a superior portion of the patient’s head in use (“In one embodiment, the hoses may come from a direction above the user's ear.” Para 0092); and a hollow tube (lumen of 300/300’) configured to convey the flow of air to the plenum chamber (10).
Yet, does not expressly disclose “a cover removably received within the plenum chamber inlet port while the conduit headgear is coupled to the connection inlet port, the cover limiting fluid flow through the plenum chamber inlet port.”
Gunaratnam teaches a patient interface (Figures 108 and 60, “FIGS. 108-113 illustrate yet another preferred embodiment of the present invention. As shown in FIG. 108, a mask assembly 600 includes headgear 602 and a cushion assembly 604, each of which is substantially similar to the headgear and cushion assembly shown, e.g., in FIGS. 60 and 61, respectively.” Para 0376), similar to the modified Gusky, suitable for imparting CPAP therapy to patient (Para 0002). Gunaratnam teaches the construction of the patient interface (Figures 108 and 60) including a plenum chamber (defined by the combination of 516 and 518 of Figure 60, “FIGS. 59-85 illustrate another embodiment of a nasal assembly, indicated as 510. The nasal assembly 510 includes a frame 516 and a nozzle assembly 518 that is removably coupled to the frame 516. As best seen in FIG. 61, the frame 516 includes a pair of first connector portions 524. Referring back to FIG. 59, a pair of inlet conduits 574 are structured to deliver breathable gas into the frame 516 and nozzle assembly 518 for breathing by the patient. The breathable gas is transported from the inlet conduits 574 to the frame 516 and nozzle assembly 518, e.g., via a pair of second connector portions 526 and a pair of angle connectors 542.” Para 0289) having a plenum chamber inlet port (one of 524/524, “As best seen in FIG. 61, the frame 516 includes a pair of first connector portions 524.” Para 0289) sized and structured to receive a flow of air at therapeutic pressure, a connection inlet port (other of 524/524, “As best seen in FIG. 61, the frame 516 includes a pair of first connector portions 524.” Para 0289) sized and structured to receive a flow of air at therapeutic pressure; a seal forming structure (550, “As shown in FIGS. 61-65, the nozzle assembly 518 includes a gusset or base portion 548 and a pair of nozzles 550 attached thereto. The nozzle assembly 518 is coupled with the frame 516 with the pair of nozzles 550 structured to sealingly engage with nasal passages of a patient's nose in use and provide a seal between the nasal assembly 510 and the patient's nasal passages. The nozzles 550 may be designed and structured in a similar manner to the nozzles 50 described above.” Para 0291); wherein the connection inlet port (other of 524/524) is configured to removably receive a positioning and stabilizing structure (the combination of 610 and 614 as engaging with 618 to receive 612, best seen Figure 110B, wherein 610 – “As with the fifth main illustrated embodiment, the yoke 608 may include a yoke ring 610. As shown in FIG. 109, the cushion assembly may be adjustably rotated with respect to headgear, to a position which best fits the patient. In FIG. 109, the ring 610 of the yoke 608 of the headgear includes an alignment marker 611a and the cushion includes a plurality of alignment markers 611b that can be selectively aligned with marker 611a.” Para 0379; wherein 614 – “The seal ring 614 may include first and second protrusions 624, 626, as described above.” Para 0383 and “In addition, the seal ring 614 may be connected to the ring 610 of the yoke 608.” Para 0390; wherein 618 – “The frame 616 includes a first connector portion 618 provided to each end of the frame 616 and/or cushion 617. Each first connector portion 618 is provided with or to a seal ring 614.” Para 0380; wherein 612 – “ In the embodiment of FIG. 108, one end of the cushion assembly 604 is provided with a plug 622 and the other end is provided with a swivel elbow 612. The positions of the swivel elbow 612 and the plug 622 may be interchanged, according to preference, e.g., the typical sleeping position of the patient. An air delivery tube 606 is joined to the swivel elbow 612. The air delivery tube 606 may include a swivel connector 607 and includes an end 609 which also may be provided with a swivel connector. The end 609 is provided with a source of pressurized gas.” Para 0377), the positioning and stabilizing structure (the combination of 610 and 614 as engaging with 618 to receive 612 to provide for conveyance of gas) comprising: a conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618, “An air delivery tube 606 is joined to the swivel elbow 612. The air delivery tube 606 may include a swivel connector 607 and includes an end 609 which also may be provided with a swivel connector. The end 609 is provided with a source of pressurized gas.” Para 0377) configured to convey the flow of air through the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110).
Regarding the remaining limitation of the claims, Gunaratnam teaches a cover (622, “In the embodiment of FIG. 108, one end of the cushion assembly 604 is provided with a plug 622 and the other end is provided with a swivel elbow 612. The positions of the swivel elbow 612 and the plug 622 may be interchanged, according to preference, e.g., the typical sleeping position of the patient.” Para 0377) removably received within the plenum chamber inlet port (one of 524/524 as shown in Figure 60 or one of 618/618 as shown in Figure 110) while the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618) is coupled to the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110), the cover (622) limiting flow through the plenum chamber inlet port (one of 524/524 as shown in Figure 60 or one of 618/618 as shown in Figure 110).
The resultant effect of this configuration is the ability to interchangeably choose whether the plenum chamber inlet port or the connection inlet port will receive the conduit headgear to accommodate the sleeping position of the patient. (Para 0377).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the conduit headgear as coupled to the connection inlet port and the plenum chamber inlet port of the modified Gusky to include the cover, as taught by Gunaratnam to interchangeably choose whether the plenum chamber inlet port or the connection inlet port will receive the conduit headgear to accommodate the sleeping position of the patient.
As to Claim 2, the modified Gusky, specifically Gusky discloses the conduit headgear (300/300’) is coupled to the connection inlet port (other of 14/18), the conduit headgear (300/300’) comprising: an inlet (via 300/300’ proximate “CPAP blower” Para 0093) configured to receive the flow of air (via “CPAP blower” Para 0093), the inlet (via 300/300’ proximate “CPAP blower” Para 0093) disposed on a superior portion of the patient’s head in use (“In one embodiment, the hoses may come from a direction above the user's ear.” Para 0092); and a hollow tube (lumen of 300/300’) configured to convey the flow of air to the plenum chamber (10).
Yet, does not expressly disclose “a rigidized arm configured to limit fluid flow through the connection inlet port, and the rigidized arm configured to be positioned along the patient’s cheek while in use” (Claim 1) and further “where the rigidized arm is coupled to the connection inlet port, the rigidized arm comprises: a plug removably received within the connection inlet port and configured to limit the flow of air through the connection inlet port; and an arm portion configured to be positioned adjacent to a cheek of the patient.” (Claim 2).
Gunaratnam teaches a patient interface (Figures 108 and 60, “FIGS. 108-113 illustrate yet another preferred embodiment of the present invention. As shown in FIG. 108, a mask assembly 600 includes headgear 602 and a cushion assembly 604, each of which is substantially similar to the headgear and cushion assembly shown, e.g., in FIGS. 60 and 61, respectively.” Para 0376), similar to the modified Gusky, suitable for imparting CPAP therapy to patient (Para 0002). Gunaratnam teaches the construction of the patient interface (Figures 108 and 60) including a plenum chamber (defined by the combination of 516 and 518 of Figure 60, “FIGS. 59-85 illustrate another embodiment of a nasal assembly, indicated as 510. The nasal assembly 510 includes a frame 516 and a nozzle assembly 518 that is removably coupled to the frame 516. As best seen in FIG. 61, the frame 516 includes a pair of first connector portions 524. Referring back to FIG. 59, a pair of inlet conduits 574 are structured to deliver breathable gas into the frame 516 and nozzle assembly 518 for breathing by the patient. The breathable gas is transported from the inlet conduits 574 to the frame 516 and nozzle assembly 518, e.g., via a pair of second connector portions 526 and a pair of angle connectors 542.” Para 0289) having a plenum chamber inlet port (one of 524/524, “As best seen in FIG. 61, the frame 516 includes a pair of first connector portions 524.” Para 0289) sized and structured to receive a flow of air at therapeutic pressure, a connection inlet port (other of 524/524, “As best seen in FIG. 61, the frame 516 includes a pair of first connector portions 524.” Para 0289) sized and structured to receive a flow of air at therapeutic pressure; a seal forming structure (550, “As shown in FIGS. 61-65, the nozzle assembly 518 includes a gusset or base portion 548 and a pair of nozzles 550 attached thereto. The nozzle assembly 518 is coupled with the frame 516 with the pair of nozzles 550 structured to sealingly engage with nasal passages of a patient's nose in use and provide a seal between the nasal assembly 510 and the patient's nasal passages. The nozzles 550 may be designed and structured in a similar manner to the nozzles 50 described above.” Para 0291); wherein the connection inlet port (other of 524/524) is configured to removably receive a positioning and stabilizing structure (the combination of 610 and 614 as engaging with 618 to receive 612, best seen Figure 110B, wherein 610 – “As with the fifth main illustrated embodiment, the yoke 608 may include a yoke ring 610. As shown in FIG. 109, the cushion assembly may be adjustably rotated with respect to headgear, to a position which best fits the patient. In FIG. 109, the ring 610 of the yoke 608 of the headgear includes an alignment marker 611a and the cushion includes a plurality of alignment markers 611b that can be selectively aligned with marker 611a.” Para 0379; wherein 614 – “The seal ring 614 may include first and second protrusions 624, 626, as described above.” Para 0383 and “In addition, the seal ring 614 may be connected to the ring 610 of the yoke 608.” Para 0390; wherein 618 – “The frame 616 includes a first connector portion 618 provided to each end of the frame 616 and/or cushion 617. Each first connector portion 618 is provided with or to a seal ring 614.” Para 0380; wherein 612 – “ In the embodiment of FIG. 108, one end of the cushion assembly 604 is provided with a plug 622 and the other end is provided with a swivel elbow 612. The positions of the swivel elbow 612 and the plug 622 may be interchanged, according to preference, e.g., the typical sleeping position of the patient. An air delivery tube 606 is joined to the swivel elbow 612. The air delivery tube 606 may include a swivel connector 607 and includes an end 609 which also may be provided with a swivel connector. The end 609 is provided with a source of pressurized gas.” Para 0377), the positioning and stabilizing structure (the combination of 610 and 614 as engaging with 618 to receive 612 to provide for conveyance of gas) comprising: a conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618, “An air delivery tube 606 is joined to the swivel elbow 612. The air delivery tube 606 may include a swivel connector 607 and includes an end 609 which also may be provided with a swivel connector. The end 609 is provided with a source of pressurized gas.” Para 0377) configured to convey the flow of air through the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110).
Regarding the remaining limitation of the claims, Gunaratnam teaches a rigidized arm (via 610 of 608 as connected with plug 622, wherein 610 of 608 – “As with the fifth main illustrated embodiment, the yoke 608 may include a yoke ring 610. As shown in FIG. 109, the cushion assembly may be adjustably rotated with respect to headgear, to a position which best fits the patient. In FIG. 109, the ring 610 of the yoke 608 of the headgear includes an alignment marker 611a and the cushion includes a plurality of alignment markers 611b that can be selectively aligned with marker 611a.” Para 0379 and wherein 622 – “In the embodiment of FIG. 108, one end of the cushion assembly 604 is provided with a plug 622 and the other end is provided with a swivel elbow 612. The positions of the swivel elbow 612 and the plug 622 may be interchanged, according to preference, e.g., the typical sleeping position of the patient.” Para 0377) is configured to limit fluid flow through either of the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) or the plenum chamber inlet port (one of 524/524 as shown in Figure 60 or one of 618/618 as shown in Figure 110) when attached thereto, and the rigidized arm (via 610 of 608 as connected with plug 622) is configured to be positioned along the cheek while in use (“Specifically, the nasal assembly is structured such that stability forces applied by the headgear assembly are distributed to the back of the patient's head, the patient's cheeks, and the patient's upper lip to maintain the nasal assembly on the patient's face in use.” Para 0230).
Gunaratnam teaches the rigidized arm (via 610 of 608 as connected with plug 622, wherein 610 of 608) when coupled to the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) comprises a plug (“In the embodiment of FIG. 108, one end of the cushion assembly 604 is provided with a plug 622 and the other end is provided with a swivel elbow 612. The positions of the swivel elbow 612 and the plug 622 may be interchanged, according to preference, e.g., the typical sleeping position of the patient.” Para 0377) removably received within the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) and configured to limit the flow of air through the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110); and an arm portion (via 610 of 608, “As with the fifth main illustrated embodiment, the yoke 608 may include a yoke ring 610. As shown in FIG. 109, the cushion assembly may be adjustably rotated with respect to headgear, to a position which best fits the patient. In FIG. 109, the ring 610 of the yoke 608 of the headgear includes an alignment marker 611a and the cushion includes a plurality of alignment markers 611b that can be selectively aligned with marker 611a.” Para 0379) configured to be positioned adjacent to the cheek (“Specifically, the nasal assembly is structured such that stability forces applied by the headgear assembly are distributed to the back of the patient's head, the patient's cheeks, and the patient's upper lip to maintain the nasal assembly on the patient's face in use.” Para 0230) of the patient.
The resultant effect of this configuration is the ability to interchangeably choose whether the plenum chamber inlet port or the connection inlet port will receive the conduit headgear to accommodate the sleeping position of the patient. (Para 0377). In this configuration, the designated connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) receives either the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618) or the rigidized arm (via 610 of 608 as connected with plug 622) so that ONLY ONE of the plenum chamber inlet port or the connection inlet port provides gas to the patient through the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618), while the OTHER of the plenum chamber inlet port or the connection inlet port only limits flow by the insertion of the plug (622) of the rigidized arm (via 610 of 608 as connected with plug 622).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the conduit headgear as coupled to the connection inlet port and the plenum chamber inlet port of the modified Gusky to include the cover, as taught by Gunaratnam to interchangeably choose whether the plenum chamber inlet port or the connection inlet port will receive the conduit headgear or the rigidized arm with plug to accommodate the sleeping position of the patient.
As to Claim 3, the modified Gusky, specifically Gunaratnam teaches the designated connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) receives either the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618) or the rigidized arm (via 610 of 608 as connected with plug 622) so that ONLY ONE of the plenum chamber inlet port or the connection inlet port provides gas to the patient through the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618), while the OTHER of the plenum chamber inlet port or the connection inlet port only limits flow by the insertion of the plug (622) of the rigidized arm (via 610 of 608 as connected with plug 622). Thus, the claimed configuration of the plenum chamber inlet port (one of 524/524 as shown in Figure 60 or one of 618/618 as shown in Figure 110) being configured to receive the flow of air is a function of the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618) coupled to the plenum chamber inlet port (one of 524/524 as shown in Figure 60 or one of 618/618 as shown in Figure 110).
As to Claim 6, the modified Gusky, specifically Gunaratnam teaches the designated connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) receives either the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618) or the rigidized arm (via 610 of 608 as connected with plug 622) so that ONLY ONE of the plenum chamber inlet port or the connection inlet port provides gas to the patient through the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618), while the OTHER of the plenum chamber inlet port or the connection inlet port only limits flow by the insertion of the plug (622) of the rigidized arm (via 610 of 608 as connected with plug 622). Thus, the claimed configuration of both the rigidized arm (via 610 of 608 as connected with plug 622) and the conduit headgear (via cooperative operation of 610 and 606 of Figure 108 as joined to 618) being interchangeably connected to the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) is met by the designation of which inlet is the connection inlet port (other of 524/524 as shown in Figure 60 or other of 618/618 as shown in Figure 110) and which inlet is the plenum chamber inlet port (one of 524/524 as shown in Figure 60 or one of 618/618 as shown in Figure 110).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Matula, Jr. et al. (2005/0199242), Veliss et al. (2008/0060649), Smith (2012/0325219), Wood et al. (2005/0051177), Sleeper et al. (2005/0028822), and Formica et al. (2011/0247619) each disclose a patient interface having a plenum chamber with two inlets, whereby one inlet could be designated as the claimed chamber inlet port, and the other inlet could be designated as the claimed plenum chamber inlet port, so that the designated chamber inlet port is configured to receive the positioning and stabilizing structure in the form of a conduit headgear to provide a flow of gas to the patient. To establish as chasm between all of the aforementioned references including those used in the rejection, it would behoove Applicant to establish structural differences with criticality between the plenum chamber inlet port and the chamber inlet port to preclude the aforementioned analysis.
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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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.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
Prosecution Insights