DETAILED ACTION
This office action is in response to the claims filed 6/14/2023. As directed by the amendment, no claims have been amended, claims 1-79 have been cancelled, and claims 80-105 have been newly added. Thus, claims 80-105 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 80, 83-92, 94-98, and 100-103 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baigent (2017/0326320) or, in the alternative, under 35 U.S.C. 103 as obvious over Baigent in view of Guney (2009/0044808).
Regarding claim 80, Baigent in figs 6-7 discloses an embodiment of a patient interface comprising: a chassis portion at least partially forming a plenum chamber (3200) (para [0285]) pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure (patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure in use) (para [0072]), said plenum chamber (3200) including a plenum chamber inlet port (3600) (connection port) sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (configured for connection to a connection circuit (4170) for supplying pressurized air to a patient) (para [0285]); a membrane portion (3100) (sealing-forming structure) connected to the chassis portion (3200) and at least partially forming the plenum chamber (as shown in fig 6a-b, membrane portion (3100) is shown to be fluidly connected to the chassis portion (3200) and therefore can at least partially form the plenum chamber), wherein the membrane portion (3100) is constructed and arranged to be flexible to allow for relative movement with the chassis portion (3200) in use (seal forming structure (3100) can be formed from a flexible material and inflate under pressure to maintain a seal while being subjected to movement of the patient or the patient interface (3000)) (para [0305]), and wherein the membrane portion (3100) does not have a predetermined three-dimensional shape in the absence of positive pressure with respect to atmospheric pressure in the plenum chamber (seal forming structure (3100) is configured to inflate under pressure and as shown in fig 7, does not disclose any underlying structure that would provide a predetermined three-dimensional shape in the absence of positive pressure with respect to atmospheric pressure, and therefore is considered to not a predetermined three-dimensional shape in the absence of positive pressure with respect to atmospheric pressure in the plenum chamber); wherein the patient interface the patient interface is configured to leave the patient's mouth uncovered (as shown in fig 6B, patient interface is configured to leave a patient’s mouth uncovered).
The fig 6-7 embodiment of Baigent does not disclose a vent to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use.
However, Baigent in the embodiment shown in fig 18 teaches a patient interface including a plenum chamber (3200) and a membrane (3100) (seal forming structure) (para [0463]), wherein the plenum chamber (3200) is provide a vent (3400) (para [0463]), wherein the vent is configured to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient (para [0422]), said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use (vent would be configured to maintain the therapeutic pressure in the plenum chamber in use in order to allow the patient interface to deliver the therapeutic pressure to the patient in use).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the fig 6-7 embodiment of the patient interface of Baigent by providing a vent to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use as taught by the fig 18 embodiment of Baigent in order to allow for the washout of exhaled gases such as carbon dioxide (Baigent, para [0422]), and one or more features of any one example may be combinable with one or more features of another example or other examples (Baigent, para [0280]).
The now-modified Baigent’s device discloses that the seal-forming structure can comprises a pair of nasal pillows, each nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient (Baigent, para [0299]), and therefore the modified Baigent’s device is considered to include a pair of nasal pillows, each nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient (para [0299]), each nasal pillow having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least the patient's nares (nasal pillows require a hole to deliver a flow of air to the patient’s nares), the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use (nasal pillows would be configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use in order to allow the patient interface to deliver the therapeutic pressure to the patient in use).
In the alternative, Guney in fig 5 teaches a patient interface including a membrane portion (2523) (common support), and a seal-forming structure comprising a pair of nasal pillows (2524) (nasal prongs), wherein a pair of nasal pillows (2524) are supported on the membrane portion (2523) (para [0301]), each nasal pillow (2524) being constructed and arranged to form a seal with a respective naris of the nose of a patient (para [0221]), each nasal pillow (2524) having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least the patient's nares (as shown in fig 5-23-2, each nasal prong (2524) is shown to have a hole to allow flow of air at a therapeutic pressure to be delivered to at least the patient's nares in use), the seal-forming structure (2524) constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use (provides an arrangement for delivering positive airway pressure as a means of therapy) (para [0226]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Baigent by providing a seal-forming structure can comprising a pair of nasal pillows, each nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient, each nasal pillow having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use, wherein the nasal pillows are supported on the membrane portion as taught by Guney in order to provide an effective seal or interface with the patient’s nose (Guney, para [0015]).
Regarding claim 83, Baigent discloses the membrane portion (3100) is constructed and arranged to inflate to conform to one or more portions of the patient's nose in use (para [0305]).
Regarding claim 84, the modified Baigent’s references discloses the membrane portion (3200 of Baigent) is constructed and arranged to inflate (Baigent, para [0305]), and because the membrane portion is below a user’s nose when in use (see fig 6B if Baigent and figs 5-23-2 and 5-37 of Guney), would be configured to urge each of the nasal pillows (2524 of Guney) towards a respective one of the patient's nares in use when the membrane portion is inflated.
Regarding claim 85, Baigent discloses the membrane portion (3100) is configured to engage the patient's lip superior in use (fig 6B, para [0301]).
Regarding claim 86, Baigent discloses the membrane portion (3100) is formed at least partially from a textile material (para [0305]).
Regarding claim 87, Baigent discloses the membrane portion (3100) comprises a textile layer and an air impermeable layer (seal-forming structure may be formed from a textile material and an air impermeable layer (sealing material) applied in a thin layer) (para [0296]).
Regarding claim 88, the modified Baigent’s reference discloses each of the nasal pillows (2524 of Guney) is formed from an elastomeric material (nasal prongs may be formed from a silicone material) (Guney, para [0223]).
Regarding claim 89, Baigent discloses the membrane portion (3100) is formed from an elastomer (seal-forming structure can be formed from an elastomer such as silicone or a textile or fabric material made impermeable to air by applying an elastomer sealing material such as silicone) (para [0296]).
Regarding claim 90, Baigent discloses the membrane portion (3100) is formed from silicone (seal-forming structure can be formed from silicone or a textile or fabric material made impermeable to air by applying a sealing material such as silicone) (para [0296]).
Regarding claim 91, modified Baigent in fig 7a discloses the membrane portion (3100) is in the form of a sheet (membrane portion (3100) is shown to be a thin, flat sheet) connected to the chassis portion (3200) at edges of the membrane portion (3100) (edges of membrane portion (3100) are attached to clip (3103) which is structured to connect to chassis portion (3200)) (para [0308]).
Regarding claim 92, modified Baigent discloses a chassis portion.
Modified Baigent does not disclose the chassis portion is formed from an elastomeric material.
However, Baigent in the fig 20 embodiment teaches a patient interface including a membrane portion (3100) and a chassis portion (3200) (plenum chamber), wherein the chassis portion (3200) is formed from an elastomeric material (thermoplastic elastomer (TPE)) (para [0319]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Baigent so that the chassis portion is formed from an elastomeric material as taught by the fog 20 embodiment of Baigent, as the use of an elastomeric material such as TPE to form a chassis portion of a patient interface is known in the art, and one or more features of any one example may be combinable with one or more features of another example or other examples (Baigent, para [0280]).
Regarding claim 94, the modified Baigent’s reference discloses each of the nasal pillows (2524 of Guney) is stalkless (Guney, fig 5-23-2, para [0303]).
Regarding claim 95, the modified Baigent’s reference discloses each of the nasal pillows (2524 of Guney) comprises a frustoconical portion having a tip and a base wider than the tip, the base being attached directly to the membrane portion (2523 of Guney) (as shown in fig 5-23-2 of Guney, each nasal pillow (2524 of Guney) is shown to have comprises a frustoconical portion having a tip and a base wider than the tip, with the base being attached directly to the membrane portion (2523 of Guney)) (Guney, fig 5-23-2, para [0303]).
Regarding claim 96, the modified Baigent’s references discloses each nasal pillow can be formed from silicone (Guney, para [0223]), and the membrane portion can be formed from a textile material (Baigent, para [0293]), and therefore, each nasal pillow is formed from a different material to the membrane portion.
Regarding claim 97, the modified Baigent’s reference discloses each of the nasal pillows (2524 of Guney) is formed from an elastomeric material (nasal prongs may be formed from a silicone material) (Guney, para [0223]).
Regarding claim 98, the modified Baigent’s reference discloses each of the nasal pillows (2524 of Guney) is formed from silicone (nasal prongs may be formed from a silicone material) (Guney, para [0223]).
Regarding claim 100, modified Baigent discloses nasal pillows.
Modified Baigent does not disclose each of the nasal pillows is formed from a single wall.
However, Guney in fig 5-14-1 teaches a patient interface comprising a nasal pillow (1624), wherein the nasal pillow is formed from a single wall with a relatively thin wall thickness (para [0282]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Baigent by providing the nasal pillows with a single wall with a relatively thin wall thickness as taught by Guney in order to allow the single wall to bulge outwardly or slightly inflate (in use to accommodate and/or conform to the patient's nose in use (Guney, para [0282]).
Regarding claim 101, modified Baigent discloses nasal pillows.
Modified Baigent does not disclose each of the nasal pillows comprises a double wall structure.
However, Guney in fig 3-1 teaches a patient interface comprising a nasal pillow (24) (nasal prongs), wherein the nasal pillows comprise a double wall structure (includes inner wall (26) and outer wall (28)) (para [0236]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Baigent so that each of the nasal pillows comprises a double wall structure as taught by Guney in order to improve jetting performance by making it possible to reorient the inner exit hole at any angle while retaining a "square" sealing orientation for the outer wall (Guney, para [0237]).
Regarding claim 102, modified Baigent discloses a seal-forming structure.
Modified Baigent does not disclose the seal-forming structure further comprises an oral portion configured to form a seal around the patient's mouth such that the flow of air at said therapeutic pressure is delivered to the patient's mouth.
However, the fig 11 embodiment of Baigent teaches a patient interface including a chassis portion (3200) and a seal-forming portion (3100), wherein the seal-forming portion further comprises an oral portion configured to form a seal around the patient's mouth such that the flow of air at said therapeutic pressure is delivered to the patient's mouth (as shown in fig 11C, seal forming structure (3100) may be provided with openings (3101) to seal with the nares and the mouth of the patient) (para [0314]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Baigent so that the seal-forming structure further comprises an oral portion configured to form a seal around the patient's mouth such that the flow of air at said therapeutic pressure is delivered to the patient's mouth as taught by the fig 11 embodiment of Baigent in order to allow air to be delivered to a mouth of a patient, and one or more features of any one example may be combinable with one or more features of another example or other examples (Baigent, para [0280]).
Regarding claim 103, Baigent in fig 11A-C discloses the membrane portion forms the oral portion of the seal-forming structure (as shown in fig 11A and C, sealing-forming portion is formed by the membrane portion (3100) by combining thermoformed textiles and forms the oral portion at opening (3101) configured to seal with a mouth of a patient) (para [0314]).
Claim 81-82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baigent et al in view of Guney et al as applied to claim 80 above, and further in view of Chang (2006/0254593).
Regarding claim 81, modified Baigent discloses a membrane.
Modified Baigent does not disclose the membrane portion is stretchable.
However, Chang teaches a patient interface including sealing portion (310) (face sealing edge of mask cap (30)) (para [0016]) and a membrane (50) connected to the sealing portion (para [0017]), wherein the membrane (50) includes creases (521, 522) to allow the membrane (50) to be stretchable outward or foldable inward when there is a change in pressure in the patient interface (para [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Baigent so that the membrane portion is stretchable by proving creases so that deformation of the membrane will not affect the tension of the head attachment straps so that the problem of discomfort that may be caused to the wearer's face can be eliminated efficiently (Chang, para [0021]).
Regarding claim 82, the modified Baigent’s reference discloses the membrane portion (50 of Chang) is constructed and arranged to stretch during inflation upon pressurisation of the plenum chamber to the therapeutic pressure in use (when the pressure inside the mask cap (30 of Chang) increases, the membrane (50 of Chaing) is stretched outward as shown in fig 4) (Chang, para [0021]).
Claim 93 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baigent et al in view of Guney et al as applied to claim 80 above, and further in view of Trimble et al (4,782,832).
Regarding claim 93, modified Baigent discloses nasal pillows.
Modified Baigent does not disclose the nasal pillows are formed separately from the membrane portion and are attached to the membrane portion.
However, Trimble in figs 15-16 teaches a patient interface including a plenum chamber (106) having a forward face (110), and a pair of nasal pillows (180) (hollow nares elements) formed with a soft, deformable synthetic resin material that is shown to be formed separately from the plenum chamber (106) and are attached to the forward face (110) of the plenum chamber (106) (col 5, ln 66-col 6, ln 9).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Baigent so that the nasal pillows are formed separately from the membrane portion and are attached to the membrane portion as taught by Trimble in order to allow the nasal pillows to be made of a different material than the membrane portion, such as soft, deformable synthetic resin material that can be readily deformed by a user to give a comfortable fit (Trimble, col 6, ln 1-5).
Claim 99 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baigent et al in view of Guney et al as applied to claim 80 above, and further in view of Ellis (2017/0049983).
Regarding claim 99, modified Baigent discloses nasal pillows.
Modified Baigent does not disclose each of the nasal pillows is formed at least partially from a textile material.
However, Ellis in fig 10 teaches a patient interface including nasal pillows (410) (nasal pillow cushion) (para [0129]), wherein the nasal pillows (410) are formed from a laminar composite body (414) least partially formed from a textile material (composite body (414) includes a first layer (428) which may be a fleeced knit fabric such as a sweatshirt fabric and a second layer (430) that can be a puffy brushed surface (430a) and a fleeced knit fabric (430b)) (para [0115]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Baigent by forming the nasal pillows at least partially from a textile material to form a laminar composite body as taught by Ellis in order to provide a seal made of a soft resilient material that can comfortably conform to the contours of a person's face, having sufficient resilience to return to its original, or at least substantially its original, shape upon removal from the wearer's face (Ellis, para [0025]) and to counteract the oils emanating from human skin that allow filmy surfaces of existing interface devices to slide around during use (Ellis, para [0026]).
Claim 104-105 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baigent et al in view of Guney et al as applied to claim 80 above, and further in view of Veliss et al (2008/0060649).
Regarding claim 14, modified Baigent discloses a patient interface comprising a positioning and stabilising structure (3300 of Baigent) comprising side straps (3301 of Baigent) to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head (Baigent, para [0307]).
Modified Baigent does not disclose the positioning and stabilising structure comprising a tie, the tie being constructed and arranged so that at least a portion overlies a region of the patient's head superior to an otobasion superior of the patient's head in use.
However, Veliss teaches a patient interface including a an interfacing structure (20) including a chassis (22) (frame) (para [0103]) and a positioning and stabilizing structure (30) (air delivery and stabilizing system) (para [0102]), wherein the positioning and stabilizing comprises a pair of inlet conduits (42) configured to deliver breathable gas to a respective end of the chassis (22) and including a tie (70) (manifold), and shown in fig 1-4, the tie (70) being constructed and arranged so that at least a portion overlies a region of the patient's head superior to an otobasion superior of the patient's head in use (manifold (70) is configured to located on or in front of the crown of the patient's head in use, which is superior to an otobasion superior of the patient's head) (para [0101]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Baigent by substituting the side strap positioning and stabilizing structure with a positioning and stabilizing positioning and stabilizing positioning and stabilizing structure comprising a pair of inlet conduits configured to deliver breathable gas to a respective end of the chassis and including a tie being constructed and arranged so that at least a portion overlies a region of the patient's head superior to an otobasion superior of the patient's head in us as taught by Veliss in order to provide a positioning and stabilizing structure with two inlet tubes that are comfortable to lie on (Veliss, para [0015]) and having sufficient redundancy that if some or one of the conduits is occluded, the system retains sufficient flow of air at therapeutic pressure (Veliss, para [0016]).
Regarding claim 105, the modified Baigent’s reference discloses the positioning and stabilising structure (30 of Veliss) comprises a pair of gas delivery tubes (42 of Veliss) (inlet conduits) (para [0102]) and the chassis portion (22 of Veliss) comprises a pair of laterally projecting connection portions (25 of Veliss) (tube portions) configured to connect to the gas delivery tubes (42 of Veliss) and which are sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (Veliss, fig 2-1, para [0103]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Scheiner (2018/0318539) and Hammer (2021/0260324) disclose patient interface with textile membranes, and O’Connor (2019/0298958), Scheiner et al (2011/0056497), and Klenner et al (2016/0030696) discloses patient interfaces with an oral sealing section, nasal pillows, and/or a positioning and stabilizing structure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS YOUNG SUL whose telephone number is (571)270-5260. The examiner can normally be reached on Monday-Friday 8:30 am-5 pm EST.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785