DETAILED ACTION
This Office Action is in response to the filing of a preliminary amendment to the claims on 1/16/2024. As per the preliminary amendment, claims 1, 4, 6, 10, 14, 18, 21, 26, and 28 have been amended, claims 15, 19, and 22-24 have been cancelled, and claims 30-34 have been added. Thus, claims 1-14, 16-18, 20-21, and 25-34 are pending in the application.
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 21 is objected to because of the following informalities:
Claim 21 recites the term “about 98 mm” in line 2. Examiner suggests changing to read --about .98 mm-- in order to include the missing decimal.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “positioning and stabilising structure” in claims 32 and 34.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 2 is 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.
Claim 2 recites the limitation “wherein the anchor sockets are keyed with the anchor pegs so that only anchor pegs with the same shape as the anchor sockets are receivable within the anchor sockets.” However, it is unclear how an anchor socket would be able to prevent a different shaped anchor peg from being at least partially received within the socket. As a non-limiting example for illustrative purposes, an anchor socket shaped as a hexagon would be able to have non-hexagon shaped anchor pegs enter the socket, provided that the pegs have a smaller cross-sectional profile such that the smaller peg enters the larger socket without interference. As such, claiming that the anchor pegs can “only” be the “same shape” as the anchor sockets appears to be too narrow, as other shaped pegs are understood to be at least partially receivable into the sockets. For the purposes of examination, pegs and anchor which interface with one another are understood to be “keyed” with one another such that they are received in one another.
Any remaining claims are rejected for being dependent on a rejected claim.
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 1-2, 6-7, 11, 25, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Formica et al. (US Pub. 2013/0199537) in view of Dantanarayana et al. (US Pat. 8,439,035) in view of Rosenfeld et al. (US Pub. 2017/0087313).
Regarding claim 1, Formica discloses a patient interface comprising: a mouth plenum chamber pressurisable to a therapeutic pressure (the interior space of subassembly 3002 in Figs. 96-97, bounded by fascia 3008 and cushion 3006 which receives positive air pressure through elbow 3004), a wall of said mouth plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (see the front opening of fascia 3008 in Figs. 96-97 which connects to the elbow 3004, and is an inlet to the mouth plenum chamber), a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways (see cushion 3006 and pillows 3000 in Figs. 96-97 which seal around the mouth and nose respectively); and a vent structure configured to allow a continuous flow of gases exhaled by the patient from an interior of the mouth plenum chamber to ambient (see the vent hole on elbow 3004 in Fig. 96 which acts as a vent; which is analogous to vent 6 in Fig. 1-1 which acts as an exhaust vent to ambient as seen in [0327]), said vent structure being sized and shaped to maintain the therapeutic pressure in the mouth plenum chamber in use (see [0327] where the vent is described as allowing for exhaled air to be expelled, and thus are capable of and sized for maintaining the applied air pressure into the plenum).
Formica device lacks a detailed description of the therapeutic pressure being of at least 6 cmH20 above ambient air pressure, and the vent structure comprising: a main body configured to be secured to the wall of the mouth plenum chamber the main body comprising a vent wall with a plurality of vent holes, a main body receptacle, and a pair of anchor sockets located on opposing lateral sides of the main body receptacle; a cover comprising a pair of anchor pegs on lateral sides of the cover, the anchor pegs being configured to be inserted into the anchor sockets to secure the cover to the main body; and a diffuser received within the main body receptacle between the anchor sockets, the diffuser being sandwiched between the main body and the cover.
However, Dantanarayana teaches a respiratory mask system, where an applied therapeutic pressure can be above 6 cmH20 in order to maintain a proper contact force and seal between the patient interface and the patient’s face (Figs. 33 and 34, see also Col. 1 lines 32-40 and Col. 10 line 66 to Col. 11 line 4 where the system operates at a range of pressures, including pressures above 6 cmH20) a vent structure comprising (see vent 150 in Figs. 25-27, which attaches to flow parts 192 of Fig. 24): a main body configured (see Figs. 25-27 housing 154) to be secured to the wall of the mouth plenum chamber (see Figs. 24-27 where the housing 154 has mounting bosses 194 to engage with and attach to the flow ports 192 of the mask) the main body comprising a vent wall with a plurality of vent holes (see Figs. 25-27 where the bottom surface of the housing 154 has passages 204 as vent holes in the wall of the housing), a main body receptacle (see Figs. 25-27 the internal interior space of housing 154); a cover secured to the main body (see Figs. 25-27 cover 172 which is secured to housing 154); and a diffuser received within the main body receptacle (see Figs. 25-27 diffuser 198), the diffuser being sandwiched between the main body and the cover (see Figs. 25-27 where the diffuser 198 is located between the cover 172 and the main body 154).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the applied therapeutic pressure to the mask of Formica to be at least 6 cmH20, and to include a vent structure with a cover and diffuser as taught by Dantanarayana, as it would be an application of well-known CPAP pressure ranges as understood in the art (Dantanarayana; see Col. 1 lines 32-40). Further, the inclusion of the vent as taught by Dantanarayana allows for tuned control over the relationship between mask pressure and gas flow area (see Col. 12 lines 40-45 and Col. 14 line 65 to Col. 15 line 2).
The modified Formica device lacks a detailed description of a pair of anchor sockets located on opposing lateral sides of the main body receptacle; a pair of anchor pegs on lateral sides of the cover, the anchor pegs being configured to be inserted into the anchor sockets to secure the cover to the main body; and a diffuser received within the main body receptacle between the anchor sockets.
However, Rosenfeld teaches a device and patient interface for delivering gas to a user’s mouth, where a pair of anchor sockets located on opposing lateral sides of the cover (see Figs. 5-6 where cap 9 has holes 14 on opposing lateral sides); a pair of anchor pegs on lateral sides of the main body receptacle (see Figs. 5-6 where cover 6 has protuberances 15 on lateral sides of it), the anchor pegs being configured to be inserted into the anchor sockets to secure the cover to the main body (see Figs. 5-6 and [0022]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection between the cover and main body receptacle of the modified Formica device to be aligned anchor pegs and anchor sockets on the sides as taught by Rosenfeld, as it would be a simple substitution of one means for holding the cover onto the main body for another, to yield the predictable result of affixing the cover to the main body. It is noted that the diffuser of the modified Formica device, as taught by Dantanarayana, is located between the lateral edges of the vent, and thus between the anchor sockets as taught by Rosenfeld. It is also noted that Rosenfeld teaches the inverse relationship, where the sockets are on the cover and the pegs are on the main body. However, modifying the teaching of Rosenfeld such that the anchor sockets are on the main body, and the anchor pegs are on the cover, would amount to no more than an obvious reversal of parts, see MPEP 2144.04(VI)(A). This reversal of parts amounts to merely swapping which end of a connection is the male end, and which end of a connection is the female end, which is understood to be an obvious modification that is readily apparent to one of ordinary skill in the art.
Regarding claim 2, the modified Formica device has wherein the anchor sockets are keyed with the anchor pegs so that only anchor pegs with the same shape as the anchor sockets are receivable within the anchor sockets (Rosenfeld; see Figs. 5-6 where holes 14 and protuberances 15 are shaped so as to fit and interface with one another, having complimentary shapes. Also, see the above rejection of the claim under 35 U.S.C. 112(b)).
Regarding claim 6, the modified Formica device has wherein the vent wall encloses an end of the main body receptacle that is closest to the interior of the mouth plenum chamber (Dantanarayana; see Figs. 24-27 where the bottom wall of housing 154 (adjacent mounting bosses 194) encloses the bottom of the interior space within the housing 154, and is located closest to the mouth plenum (Fig. 24 where it is closed to ports 192)).
Regarding claim 7, the modified Formica device has wherein the diffuser is spaced apart from the vent holes (Dantanarayana; see Figs. 25-27 where diffuser 198 is spaced from passages 204).
Regarding claim 11, the modified Formica device has a perimeter of the cover and a perimeter of the main body.
The modified Formica device lacks a detailed description of perimeter of the cover is smaller than a perimeter of the main body so that a gap is formed between the main body and the cover when the cover is secured to the main body.
However, Dantanarayana further teaches an embodiment where the perimeter of the cover is smaller than a perimeter of the main body (see Figs. 14-16 where cover 172 fits over vent 150, having a smaller perimeter than the vent 150) so that a gap is formed between the main body and the cover when the cover is secured to the main body (see Figs. 14-16 where cover 172 fits over the walls of the elbow joint 170 such that there is a gap formed between the cover and the joint walls when they are secured).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the perimeter of the cover in relation to the main body of the modified Formica device to be a smaller perimeter as further taught by Dantanarayana, as it would be a simple substitution of one type of vent embodiment for another, to yield the predictable result of providing a vent, while also providing a cover with snap arms for easy detachment for replacement and cleaning (Dantanarayana; see Col. 15 lines 55-56).
Regarding claim 25, the modified Formica device has a respiratory therapy system comprising: the patient interface of claim 1 (see above rejection of claim 1); a respiratory pressure therapy device configured to generate the flow of air at the therapeutic pressure (Formica; see Fig. 1-2 and abstract); and an air circuit configured to direct the flow of air at the therapeutic pressure from the respiratory pressure therapy device to the patient interface (Formica; where the patient interface is connected to an air circuit to deliver the air, such as flexible tube 5 in Fig. 1-1; see also [0206]).
Regarding claim 31, the modified Formica device has wherein the seal-forming structure has a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares (Formica; the interior passageways of pillows 3000 which allow the flow of air to reach the nares of the patient in Figs. 96-97), the seal-forming structure being configured to maintain said therapeutic pressure in the mouth plenum chamber throughout the patient's respiratory cycle in use (Formica; the cushion 3006 and pillows 3000 in Figs. 96-97 seal against the mouth and nose of the patient, maintaining an applied pressure against the seal; see also [0277] where the mouth sealing portion seals against the force, and [0491] where the nasal portion forms a seal with the nose due to applied pressure, and where the embodiment in Figs. 96-97 is understood to perform the same function), wherein the seal-forming structure comprises: a mouth portion that forms at least part of the mouth plenum chamber and is configured to seal around the patient's mouth (Formica; cushion 3006 in Figs. 96-97), the mouth portion comprising a receptacle (Formica; the interior space of subassembly 3002 and cushion 3006 in Figs. 96-97); and a nasal portion that is configured to seal with the patient's nares (Formica; pillows 3000 in Figs. 96-97; analogous to sealing portion 1662 of nares portion 1660 in Fig. 73 ), the nasal portion comprising a nasal plenum chamber with an inlet opening (Formica; where the nares portion 1660 has a sealing ring 1665 to connect to the mouth portion 1652 in Fig. 73), the nasal plenum chamber being configured to be received within the mouth portion receptacle (Formica; the interior space of the nasal portion of Figs. 96-97 below the pillows 3000; see Fig. 73 where the analogous nares portion 1660 shows the interior space of the nasal portion, and the nares portion 1660 fits into the mouth portion 1652 via sealing ring 1665).
The modified Formica device lacks a detailed description of wherein the patient interface is configured to allow the patient to breathe from ambient through their mouth in the absence of a flow of pressurised air through the plenum chamber inlet port. It is noted that the vent in the elbow as seen in Fig. 103 does appear to be an anti-asphyxia valve and would work in the required manner, but the nature of the vent is not elaborated on.
However, Formica teaches a separate embodiment of the device in Fig. 41 where a similar oro-nasal mask system includes an anti-asphyxia valve (AAV) at opening 1002/ flap 1004 on the mask system 993, in order to provide a back-up breathing system so that the patient can breathe even when airflow is not applied to the system (see [0521], where AAVs are known and used for preventing asphyxia by allowing a patient to breathe with atmosphere).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mouth portion of the mask system of the modified Formica device (Figs. 96-97) to include an anti-asphyxia valve on the mouth portion of the mask as taught by Formica in Fig. 41, as it would provide a breathing backup system to allow the patient to breathe in connection to atmosphere and prevent asphyxia.
Regarding claim 31, the modified Formica device has a positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head (Formica; see Figs. 5-1 and 15 where the positioning structure for the device is shown, and it is understood that the embodiment in Figs. 96-97 has the connections to a positioning structure; see headgear strap 61 and lower headgear strap 63 in Fig. 5-1 or likewise headgear 160 in Fig. 15).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Formica in view of Dantanarayana in view of Rosenfeld as applied to claim 1 above, and further in view of Hallett et al. (US Pub. 2018/0133426).
Regarding claim 3, the modified Formica device has the anchor sockets and the anchor pegs.
The modified Formica device lacks a detailed description of wherein the anchor sockets are tapered so that the anchor pegs become wedged in the anchor sockets when the cover is secured to the main body.
However, Hallett teaches a respiratory mask system, wherein the anchor sockets are tapered so that the anchor pegs become wedged in the anchor sockets when secured to one another (see Fig. 4 and [0063] where spigots 114a are tapered to connect to a pressure tube, the tapered shape allowing them to engage and form a gastight seal).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection between the anchor pegs and anchor sockets of the modified Formica device to be tapered as taught by Hallett, as it would allow for the peg and sockets to interface to form a gastight seal (Hallett; see [0063]).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Formica in view of Dantanarayana in view of Rosenfeld as applied to claim 1 above, and further in view of Kwok et al. (US Pat. 8,826,910).
Regarding claim 4, the modified Formica device has the main body and the mouth plenum chamber comprises a vent opening (Dantanarayana; see Fig. 24 ports 192 being vent openings of the modified mouth plenum chamber of Formica).
The modified Formica device lacks a detailed description of wherein the main body comprises a first flange and a second flange that forms a channel with the first flange, wherein the wall of the mouth plenum chamber comprises a vent opening and a rim of the vent opening is received in the channel when the main body is secured to the wall of the mouth plenum chamber.
However, Kwok teaches a vent on a respiratory mask, wherein the main body comprises a first flange (see Figs. 8 and 11 where a first side 44 of insert 20 forms a first flange) and a second flange (see Figs. 8 and 11 where a second side 46 of insert 20 forms a second flange) that forms a channel with the first flange (see Figs. 8 and 11 groove 24), wherein the wall of the mouth plenum chamber comprises a vent opening (see Fig. 8 where the walls of shell 12 have an opening in which insert 20 sits) and a rim of the vent opening is received in the channel when the main body is secured to the wall of the mouth plenum chamber (see Fig. 8 where the rim 28 of shell 12 sits within groove 24).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the attachment between the main body of the vent and the mask plenum of the modified Formica device to be formed by a first and second flange on the vent body as taught by Kwok, as it would be a simple substitution of one structure for holding the vent onto the mask body for another structure, to yield the predictable result of allowing the vent to connect to the mask plenum.
Regarding claim 5, the modified Formica device has wherein the anchor sockets extend deeper than the channel (Kwok; see Fig. 8 where the groove 24 is approximately the same depth as the shell 12; and further see Rosenfeld Figs. 5-6 where the holes 14 (on the main body as modified) extend deeper into the main body than the channel that exists between the modified cover and main body).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Formica in view of Dantanarayana in view of Rosenfeld as applied to claim 1 above, and further in view of Barger et al. (US Pat. 4,267,835).
Regarding claim 8, the modified Formica device has multiple anchor sockets.
The modified Formica device lacks a detailed description of wherein each anchor socket has a different size.
However, Barger teaches a connection between two components of a medical device, where a first connecting member has different shaped sockets (see Fig. 6 entrances 60 and 61) which interface with correspondingly different shaped lugs (see Figs. 5 and 7, lug 49) in order to ensure that proper connection between the components is achieved (see Col. 4 lines 25-34, where retainer 46 has entrances 60/61 to align with connectors 45/48).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the holes and protuberances for connecting the cover to the main body of the modified Formica device to be differently sized and shaped holes and pegs as taught by Barger, as it will ensure that the components are always properly oriented with one another when connected (Barger; see Col. 4 lines 25-34).
Regarding claim 9, the modified Formica device has a plurality of anchor sockets.
The modified Formica device lacks a detailed description of wherein each anchor socket has a different shape.
However, Barger teaches a connection between two components of a medical device, where a first connecting member has different shaped sockets (see Fig. 6 entrances 60 and 61) which interface with correspondingly different shaped lugs (see Figs. 5 and 7, lug 49) in order to ensure that proper connection between the components is achieved (see Col. 4 lines 25-34, where retainer 46 has entrances 60/61 to align with connectors 45/48).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the holes and protuberances for connecting the cover to the main body of the modified Formica device to be differently sized and shaped holes and pegs as taught by Barger, as it will ensure that the components are always properly oriented with one another when connected (Barger; see Col. 4 lines 25-34).
Regarding claim 10, the modified Formica device has wherein the anchor sockets are configured so that the cover is securable to the main body.
The modified Formica device lacks a detailed description of wherein the anchor sockets are configured so that the cover is securable to the main body in only one predetermined orientation.
However, Barger teaches a connection between two components of a medical device, where a first connecting member has different shaped sockets (see Fig. 6 entrances 60 and 61) which interface with correspondingly different shaped lugs (see Figs. 5 and 7, lug 49) in order to ensure that proper connection between the components is achieved (see Col. 4 lines 25-34, where retainer 46 has entrances 60/61 to align with connectors 45/48).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the holes and protuberances for connecting the cover to the main body of the modified Formica device to be differently sized and shaped holes and pegs as taught by Barger, as it will ensure that the components are always properly oriented with one another when connected (Barger; see Col. 4 lines 25-34).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Formica in view of Dantanarayana in view of Rosenfeld as applied to claim 1 above, and further in view of Ng et al. (US Pub. 2009/0050156).
Regarding claim 12, the modified Formica device has the vent holes and the diffuser.
The modified Formica device lacks a detailed description of wherein the vent holes are tapered so that the vent holes narrow in a direction toward the diffuser.
However, Ng teaches vent holes on a respiratory mask, where the vent holes taper so as to be narrower in the direction headed towards atmosphere (see Figs. 2-21-3 and 2-21-4; see also [0204], [0206], and [0208] where the vent orifice 1828 and 1856 can taper so as to be narrower leading towards the outlet).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the vent holes of the modified Formica device to be tapered multi-orifice vents as taught by Ng, as it would be a simple substitution of one shape of vent orifice for guiding airflow to atmosphere for another shape of vent orifice, to yield the predictable result of providing a vent for expelling air. Further, it would also have the added benefit of creating a flow pattern that reduces noise (Ng; see [0208]).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Formica in view of Dantanarayana in view of Rosenfeld in view of Ng as applied to claim 12 above, and further in view of Geist (US Pat. 7,353,827).
Regarding claim 13, the modified Formica device has wherein opposing sides of the interior wall of each vent hole forms an angle of taper 10 to 35 degrees (Ng; see Figs. 2-21-3 and 2-21-4 where the angle of taper of the orifice walls of 1828 and 1856 appear to be somewhere in the range of 10-35 degrees).
In the alternative that the modified Formica device lacks a detailed description of wherein opposing sides of the interior wall of each vent hole forms an angle of taper 10 to 35 degrees, then it is taught by Geist.
However, Geist teaches vent holes on a respiratory mask, where the vent holes are angled in the direction headed towards atmosphere (see Figs. 12-13A and Col. 5 lines 40-61 where vent holes are angled at 30 degrees).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the angle of the taper of the vent holes of the modified Formica device to be a 30 degree angle as taught by Geist, as it would provide an angle that allows exhaled air to escape at an angle that does not interfere with or cause discomfort to the patient (Geist; see Col. 5 lines 57-61).
Regarding claim 14, the modified Formica device has wherein the angle of taper is about 10 degrees or about 35 degrees (Geist; see Figs. 12-13A and Col. 5 lines 40-61 where vent holes are angled at 30 degrees, as modifying the taper angle of the teachings from Ng in the modified Formica device).
Claims 16-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Formica in view of Dantanarayana in view of Rosenfeld as applied to claim 1 above, and further in view of Ng.
Regarding claim 16, the modified Formica device has a base of each vent hole.
The modified Formica device lacks a detailed description of wherein a base of each vent hole is flared.
However, Ng teaches a mask vent system, where the base of each vent hole is flared (see Fig. 2-21-4 where the bottom of orifice 1856 is flared at diameter D4).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the vent holes of the modified Formica device to be flared as taught by Ng, as it would help to control the flow to reduce vent noise during use (Ng; see [0208]).
Regarding claim 17, the modified Formica device has wherein the flared portion of the vent hole has a radius of curvature of 0.2 mm to 0.4 mm (Ng; see [0210] where D4 has a radius of about .565, and can be adjusted to fit other dimensions such that a person of ordinary skill in the art would, as a matter of design choice, choose different sized radii of curvature, such as .4 mm, depending on the desired flow dynamics. Further, the specific range of values in the claim appear to lack criticality).
Regarding claim 18, the modified Formica device has wherein the radius of curvature is about 0.25 mm or about 0.3 mm (Ng; see [0210] where D4 has a radius of about .565, and can be adjusted to fit other dimensions such that a person of ordinary skill in the art would, as a matter of design choice, choose different sized radii of curvature, such as .3 mm, depending on the desired flow dynamics. Further, the specific range of values in the claim appear to lack criticality).
Regarding claim 20, the modified Formica device has wherein a smallest diameter of each vent hole is 0.5 mm to 2.0 mm (Ng; see [0210] where D3 has a diameter of about .3 mm, and can be adjusted to fit other dimensions such that a person of ordinary skill in the art would, as a matter of design choice, choose different sized diameters, such as .5 mm, depending on the desired flow dynamics. Further, the specific range of values in the claim appear to lack criticality).
Regarding claim 21, the modified Formica device has wherein the smallest diameter is about 0.89 mm, about 98 mm, about 1.01 mm, or about 1.17 mm (Ng; see [0210] where the diameters can fit within the range of values claimed).
Claim 26-27, 29, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Formica in view of Dantanarayana in view of Kwok.
Regarding claim 26, Formica discloses a patient interface comprising: a mouth plenum chamber pressurisable to a therapeutic pressure (the interior space of subassembly 3002 in Figs. 96-97, bounded by fascia 3008 and cushion 3006 which receives positive air pressure through elbow 3004), a wall of said mouth plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (see the front opening of fascia 3008 in Figs. 96-97 which connects to the elbow 3004, and is an inlet to the mouth plenum chamber), a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways (see cushion 3006 and pillows 3000 in Figs. 96-97 which seal around the mouth and nose respectively); and a vent structure configured to allow a continuous flow of gases exhaled by the patient from an interior of the mouth plenum chamber to ambient (see the vent hole on elbow 3004 in Fig. 96 which acts as a vent; which is analogous to vent 6 in Fig. 1-1 which acts as an exhaust vent to ambient as seen in [0327]), said vent structure being sized and shaped to maintain the therapeutic pressure in the mouth plenum chamber in use (see [0327] where the vent is described as allowing for exhaled air to be expelled, and thus are capable of and sized for maintaining the applied air pressure into the plenum).
Formica lacks a detailed description of the therapeutic pressure being of at least 6 cmH20 above ambient air pressure, and the vent structure comprising: a vent wall with a plurality of vent openings, at least one side wall extending from the vent wall, an outer surface of the at least one side wall.
However, Dantanarayana teaches a respiratory mask system, where an applied therapeutic pressure can be above 6 cmH20 in order to maintain a proper contact force and seal between the patient interface and the patient’s face (Figs. 33 and 34, see also Col. 1 lines 32-40 and Col. 10 line 66 to Col. 11 line 4 where the system operates at a range of pressures, including pressures above 6 cmH20) a vent structure comprising (see the vent in Figs. 30-32): a vent wall (see Figs. 30-32 housing 154) with a plurality of vent openings (see Figs. 30-32 where the bottom surface of the housing 154 has passages 204 as vent openings in the wall of the housing), and at least one side wall extending from the vent wall with an outer surface (see the vertical sides of housing 154 in Figs. 30-32).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the applied therapeutic pressure to the mask of Formica to be at least 6 cmH20, and to include a vent structure as taught by Dantanarayana, as it would be an application of well-known CPAP pressure ranges as understood in the art (Dantanarayana; see Col. 1 lines 32-40). Further, the inclusion of the vent as taught by Dantanarayana allows for tuned control over the relationship between mask pressure and gas flow area (see Col. 12 lines 40-45 and Col. 14 line 65 to Col. 15 line 2).
The modified Formica device lacks a detailed description of a trough on an outwardly facing surface of the vent wall that completely encircles the vent openings.
However, Formica teaches another embodiment where the vent housing has a trough on an outwardly facing surface of the vent wall that completely encircles the vent openings (see Figs. 19-20 where the vent 150 has convex surfaces surrounding the vent orifice 160, forming an outward facing trough that encircles the orifice).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer vent housing wall shape of the modified Formica device to be a trough as taught by Formica in the embodiment of Fig. 19, as it would be a simple substitution of one shape of the vent housing for another, to yield the predictable result of having the vent housing with an outward facing surface around the vent openings.
The modified Formica device lacks a detailed description of a flange extending from an end of the at least one side wall so that an edge of the vent wall, an outer surface of the at least one side wall, and the flange together form a channel configured to receive a rim around the vent opening in the wall of the mouth plenum chamber, the flange being configured to be received inside the mouth plenum chamber.
However, Kwok teaches a vent on a respiratory mask, wherein the main body comprises a first flange (see Figs. 8 and 11 where a first side 44 of insert 20 forms a first flange) and a second flange (see Figs. 8 and 11 where a second side 46 of insert 20 forms a second flange) that forms a channel (see Figs. 8 and 11 groove 24), wherein the wall of the mouth plenum chamber comprises a vent opening (see Fig. 8 where the walls of shell 12 have an opening in which insert 20 sits) and a rim of the vent opening is received in the channel when the main body is secured to the wall of the mouth plenum chamber (see Fig. 8 where the rim 28 of shell 12 sits within groove 24).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the attachment between the main body of the vent and the mask plenum of the modified Formica device to be formed by a first and second flange on the vent body as taught by Kwok, as it would be a simple substitution of one structure for holding the vent onto the mask body for another structure, to yield the predictable result of allowing the vent to connect to the mask plenum.
Regarding claim 27, the modified Formica device has wherein the outwardly facing surface of the vent wall is convex (Dantanarayana; see Figs. 30-32 where a top surface of cover 172 is convex).
The modified Formica device lacks a detailed description of an inwardly facing surface of the vent wall opposite the outwardly facing surface is convex.
However, Dantanarayana teaches another embodiment of the vent housing and vent wall, where an inward facing surface of the vent wall opposite the outward facing surface is convex (see Fig. 16 where surface 161 is an inward facing convex surface of the vent).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the inward surface of the vent wall of the modified Formica device to be convex as taught by Dantanarayana, as it would be a simple substitution of one shape of vent wall for another, to yield the predictable result of providing a vent wall that surrounds the vent holes.
Regarding claim 29, the modified Formica device has a respiratory therapy system comprising: the patient interface of claim 26 (see above rejection of claim 26); a respiratory pressure therapy device configured to generate the flow of air at the therapeutic pressure (Formica; see Fig. 1-2 and abstract); and an air circuit configured to direct the flow of air at the therapeutic pressure from the respiratory pressure therapy device to the patient interface (Formica; where the patient interface is connected to an air circuit to deliver the air, such as flexible tube 5 in Fig. 1-1; see also [0206]).
Regarding claim 33, the modified Formica device has wherein the seal-forming structure has a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares (Formica; the interior passageways of pillows 3000 which allow the flow of air to reach the nares of the patient in Figs. 96-97), the seal-forming structure being configured to maintain said therapeutic pressure in the mouth plenum chamber throughout the patient's respiratory cycle in use (Formica; the cushion 3006 and pillows 3000 in Figs. 96-97 seal against the mouth and nose of the patient, maintaining an applied pressure against the seal; see also [0277] where the mouth sealing portion seals against the force, and [0491] where the nasal portion forms a seal with the nose due to applied pressure, and where the embodiment in Figs. 96-97 is understood to perform the same function), wherein the seal-forming structure comprises: a mouth portion that forms at least part of the mouth plenum chamber and is configured to seal around the patient's mouth (Formica; cushion 3006 in Figs. 96-97), the mouth portion comprising a receptacle (Formica; the interior space of subassembly 3002 and cushion 3006 in Figs. 96-97); and a nasal portion that is configured to seal with the patient's nares (Formica; pillows 3000 in Figs. 96-97; analogous to sealing portion 1662 of nares portion 1660 in Fig. 73 ), the nasal portion comprising a nasal plenum chamber with an inlet opening (Formica; where the nares portion 1660 has a sealing ring 1665 to connect to the mouth portion 1652 in Fig. 73), the nasal plenum chamber being configured to be received within the mouth portion receptacle (Formica; the interior space of the nasal portion of Figs. 96-97 below the pillows 3000; see Fig. 73 where the analogous nares portion 1660 shows the interior space of the nasal portion, and the nares portion 1660 fits into the mouth portion 1652 via sealing ring 1665).
The modified Formica device lacks a detailed description of wherein the patient interface is configured to allow the patient to breathe from ambient through their mouth in the absence of a flow of pressurised air through the plenum chamber inlet port. It is noted that the vent in the elbow as seen in Fig. 103 does appear to be an anti-asphyxia valve and would work in the required manner, but the nature of the vent is not elaborated on.
However, Formica teaches a separate embodiment of the device in Fig. 41 where a similar oro-nasal mask system includes an anti-asphyxia valve (AAV) at opening 1002/ flap 1004 on the mask system 993, in order to provide a back-up breathing system so that the patient can breathe even when airflow is not applied to the system (see [0521], where AAVs are known and used for preventing asphyxia by allowing a patient to breathe with atmosphere).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mouth portion of the mask system of the modified Formica device (Figs. 96-97) to include an anti-asphyxia valve on the mouth portion of the mask as taught by Formica in Fig. 41, as it would provide a breathing backup system to allow the patient to breathe in connection to atmosphere and prevent asphyxia.
Regarding claim 34, the modified Formica device has a positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head (Formica; see Figs. 5-1 and 15 where the positioning structure for the device is shown, and it is understood that the embodiment in Figs. 96-97 has the connections to a positioning structure; see headgear strap 61 and lower headgear strap 63 in Fig. 5-1 or likewise headgear 160 in Fig. 15).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Formica in view of Dantanarayana in view of Kwok as applied to claim 26 above, and further in view of Ng.
Regarding claim 28, the modified Formica device has the vent openings and the outwardly facing surface of the vent wall.
The modified Formica device lacks a detailed description of wherein the vent holes are tapered so that the vent holes narrow in a direction toward the outwardly facing surface of the vent wall.
However, Ng teaches vent holes on a respiratory mask, where the vent holes taper so as to be narrower in the direction headed towards atmosphere (see Figs. 2-21-3 and 2-21-4; see also [0204], [0206], and [0208] where the vent orifice 1828 and 1856 can taper so as to be narrower leading towards the outlet).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the vent holes of the modified Formica device to be tapered multi-orifice vents as taught by Ng, as it would be a simple substitution of one shape of vent orifice for guiding airflow to atmosphere for another shape of vent orifice, to yield the predictable result of providing a vent for expelling air. Further, it would also have the added benefit of creating a flow pattern that reduces noise (Ng; see [0208]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Formica in view of Dantanarayana in view of Rosenfeld as applied to claim 1 above, and further in view of Hallett in view of Kwok in view of Barger in view of Ng in view of Geist.
Regarding claim 30, the modified Formica device has wherein the anchor sockets are keyed with the anchor pegs so that only anchor pegs with the same shape as the anchor sockets are receivable within the anchor sockets (Rosenfeld; see Figs. 5-6 where holes 14 and protuberances 15 are shaped so as to fit and interface with one another, having complimentary shapes. Also, see the above rejection of the claim under 35 U.S.C. 112(b)), wherein the vent wall encloses an end of the main body receptacle that is closest to the interior of the mouth plenum chamber (Dantanarayana; see Figs. 24-27 where the bottom wall of housing 154 (adjacent mounting bosses 194) encloses the bottom of the interior space within the housing 154, and is located closest to the mouth plenum (Fig. 24 where it is closed to ports 192)), wherein the diffuser is spaced apart from the vent holes (Dantanarayana; see Figs. 25-27 where diffuser 198 is spaced from passages 204).
The modified Formica device lacks a detailed description of perimeter of the cover is smaller than a perimeter of the main body so that a gap is formed between the main body and the cover when the cover is secured to the main body.
However, Dantanarayana further teaches an embodiment where the perimeter of the cover is smaller than a perimeter of the main body (see Figs. 14-16 where cover 172 fits over vent 150, having a smaller perimeter than the vent 150) so that a gap is formed between the main body and the cover when the cover is secured to the main body (see Figs. 14-16 where cover 172 fits over the walls of the elbow joint 170 such that there is a gap formed between the cover and the joint walls when they are secured).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the perimeter of the cover in relation to the main body of the modified Formica device to be a smaller perimeter as further taught by Dantanarayana, as it would be a simple substitution of one type of vent embodiment for another, to yield the predictable result of providing a vent, while also providing a cover with snap arms for easy detachment for replacement and cleaning (Dantanarayana; see Col. 15 lines 55-56).
The modified Formica device lacks a detailed description of w