DETAILED ACTION
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 .
Priority
Acknowledgment is made of applicant’s claim for priority to Application No. (AU2019903367) filed on the September 10, 2019.
Response to Amendment
This office action is responsive to the amendment filed on March 03, 2026. As directed by the amendment: claims 1-6, 12-16, 19-23, 28-33, 36-38, 40-44, 121 have been amended, claim 11 has been canceled, and claim 122 has been added. Thus, claims 1-10, 12-44,75 and 121-122 are presently pending in the application, 7-10, 17-18, 24-27, 34-35, 39, and 75 are currently still withdrawn. Therefore, Claims 1-6,12-16,19-23,28-33,36-38,40-44 and 121-122 are rejected below.
Response to Arguments
Applicant argues on page 9-10 of the remarks that the 103-rejection made does not read on the limitations “and wherein the nasal chamber coupling component is configured to surround an exterior of the nasal chamber opening so as to form part of a sealed connection for fluidly connecting to the vent module in the first mode or for fluidly connecting the nasal portion to the mouth portion in the second mode” in the new amended claim 1. However, Applicant is amended the claim and the new 103 rejection stated below addresses the new limitation of the claim.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the applicant has amended the rejections and the new 103 rejection stated below addresses the new limitation of the claim.
New claim 122 have been entered and rejected below.
Claim Rejections - 35 USC § 103
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.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 1, 5-6, 12-13, 16, 19-23, 29, 44 and 121-122 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidson et al. (US 20060237017 A1), hereafter as Davidson in view of Gunaratnam et al. (US 20040226566 A1), hereafter as Gunaratnam, Drew et al. (US 6581594 B1), hereafter as Drew, and Formica et al. (US 20130199537 A1) first embodiment (Fig. 1-1 to 1-5), hereafter as Formica.
Regarding Claim 1, Davidson disclose a patient interface system for delivery of respiratory therapy to a patient (Figs. 2a-2c), comprising:
a nasal portion (Fig. 2a; 12) including a nasal chamber (inside of 12) and a nasal sealing portion configured to form a seal with the patient's face surrounding the entrance to a patient's nares (Fig. 1a; 17; para. 0021), the nasal chamber including a nasal chamber opening (on either side of 12 or the vents or within 12; Fig. 2b; 37);
a pair of inlet conduits (Fig. 2a-2c; 22 on either side of the mask) configured to connect to respective ones of a pair of inlet openings in the nasal portion to deliver pressurized (into the connector 34) , breathable gas to the nasal chamber, and each of the pair of inlet conduits configured to contact at least a region of a patient's head superior to the otobasion superior of the patient's head (Examiner notes that this limitation is functional; The conduits 22 are flexible and could connect a region on a patient head if need be or is not at use; para. 0061);
a nasal chamber coupling component (Fig. 2c; 90) configured to form part of a releasable fluid coupling to enable the nasal portion (12) to be fluidly coupled to a mouth portion (Fig. 2a-2b; 14) to communicate a portion of the pressurized, breathable gas through the nasal chamber opening to the mouth portion (para. 0066-0068; 0160), wherein the nasal chamber coupling component (2c; 90) is configured to surround an exterior of the nasal chamber opening (2c; 96) so as to form part of a sealed connection for fluidly connecting the nasal portion to the mouth portion in the second mode (Fig. 2a-2c).
Davidson does not specifically disclose and each of the pair of inlet configured to contact at least a region of a patient's head superior to the otobasion superior of the patient's head.
However, Gunaratnam teaches and each of the pair of inlet conduits (Fig. 37; 274) configured to contact at least a region of a patient's head superior to the otobasion superior of the patient's head (Fig. 36-37; para. 0242-0251).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the inlet conduits of Davidson to include the inlet conduits are configured to contact at least a region of a patient's head superior to the otobasion superior of the patient's head taught by Gunaratnam for the purpose of achieving substantially independent adjustment of sealing and stability forces. The patient is able to route the conduit in any suitable manner that is comfortable (para. 0242). Also, the higher stability forces do not affect the more sensitive regions of the patient's face, e.g., nose, as much and improve comfort (para. 0228-0229).
Although Gunaratnam discloses the claimed pair of inlet conduits, an apparatus is able to deliver pressurized breathable air to the patient no matter which way the conduit are structured in used. It would have been obvious to one having ordinary skill in the art at the time the invention was made to allow the inlet conduits to be directed over the head or contact at least a region of a patient's head superior to the otobasion superior of the patient's head, for the purpose of delivering air to the patient comfortably.
Modified Davidson does not disclose that the system further comprising a removable vent module configured to be attached to the nasal chamber to vent gas exhaled by the patient;
However, Drew teaches a removable vent module (Fig. 8; 82, 28, 26, 90, 88) adapted to be attached to chamber (Fig. 7) to vent gas exhaled by the patient (Col. 5 lines 31-49; Col. 6 lines 1-6, 13-59).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the vents of Modified Davidson to include a removable vent module adapted to be attached to the nasal chamber to vent gas exhaled by the patient as taught by Drew for the purpose of removal and replacement of a vent insert while retaining the other components of the mask (Col. 6 lines 34-41).
The new modified Davidson however does not teach the removable vent module is configured to be releasably connectable with the nasal chamber coupling component such that the patient interface system is configurable in a first mode where the vent module is fluidly coupled to the nasal chamber to enable the patient interface system to operate as a nasal only patient interface and a second mode where the vent module is removed from the nasal chamber to enable the nasal portion to be fluidly coupled to the mouth portion to communicate the portion of the pressurized, breathable gas through the nasal chamber opening to the mouth portion.
Formica teaches a removable vent module (decoupling portion 25; Fig. 1-5, 2; para. 0195; 0219, 347) configured to be attached to the nasal chamber (Fig. 1-5, 2; 20, 6) to vent gas exhaled by the patient (para. 0195, 0217-0223); the removable vent module configured to be releasably connectable with the nasal chamber coupling component such that the patient interface system is configurable in a first mode (Fig. 1-1) the vent module is fluidly coupled to the nasal chamber to enable the patient interface system to operate as a nasal only patient interface (para. 0222) and a second mode where the vent module is removed from the nasal chamber to enable the nasal portion to be fluidly coupled to the mouth portion to communicate the portion of the pressurized, breathable gas through the nasal chamber opening to the mouth portion (Fig. 1-2; para. 0195, 0217-0223).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the vent system of Modified Davidson to include the vent modules can be removed for first mode or second mode as taught by Formica II for the purpose of both portions can be adapted to be used without each other or together (para. 206). Furthermore, the present embodiment (Fig. 1-5) of Formica II and Modified Davidson does disclose a positive therapeutic pressure and a vent. However, if the (Fig. 1-5) embodiment does not disclose the vent being sized and shaped to maintain therapeutic pressure in the plenum chamber in use. It would provide a simple substitution of one type of vent for exhausted gases for another vent, to yield the predictable result of expelling exhausted gases. As the modified device has the same structure as the claimed invention, it is understood that the vent of the Modified Davidson, with Drew specifically, device is equally as capable of maintaining therapeutic pressure in the plenum in use.
Regarding Claim 5, Modified Davidson discloses the patient interface system according to claim 1, wherein the coupling component (Fig. 2c; 90) comprises a clip mechanism (Fig. 2c; 98, 92, 100) that extends about the nasal chamber opening (Fig. 2c) and arranged to form part of a resilient clip connection (para. 0066-0068; Examiner notes: the arms 98 are resiliently flexible).
Regarding Claim 6, Modified Davidson discloses the patient interface system according to claim 5, wherein the clip mechanism (Fig. 2c; 90, 98, 100; Davidson) includes a resilient hinge (Fig. 2c; para. 0066-0068; Examiner notes: the arms 98 are resiliently flexible; Davidson).
Regarding Claim 12, Modified Davidson discloses the patient interface system according to claim 1, further teaches comprising at least one guide vane (Fig. 7; 28; Drew) providing an obstruction to the fluid coupling in first mode to direct the flow of gas from the nasal chamber through the vent module (Fig. 7; 28; Drew; Col. 5 lines 31-49; Col. 6 lines 1-6, 13-59)
Regarding Claim 13, Modified Davidson discloses the patient interface system according to claim 12, wherein the at least one guide vane forms part of the vent module (Fig. 7; 28; Drew; Col. 5 lines 31-49; Col. 6 lines 1-6, 13-59).
Regarding Claim 16, Modified Davidson discloses the patient interface system according to claim 1, further comprising the mouth portion (Fig. 2a-2c; 14) including a mouth chamber (inside of 14) and a mouth sealing portion (40/42) configured to form a seal with the patient's mouth, the mouth chamber including a mouth chamber opening (towards the patient mouth; 36; the vents) configured to receive pressurized, breathable gas (para. 0066-0068) from the nasal when the mouth portion has fluid coupling to the nasal portion, such that he nasal portion (Fig. 2a-2c; 12) is configured to communicate the portion of the pressurized (through 90; Fig. 2c), breathable gas to the mouth portion through the nasal chamber opening and the mouth chamber opening (para. 0066-0068).
Regarding Claim 19, Modified Davidson discloses the patient interface system according to claim 16, wherein the mouth portion (Fig. 2a-2c; 14) comprises a mouth cushion (42/40) that forms at least part of the mouth chamber and wherein the mouth chamber opening is formed in the mouth cushion (Figs. 2a-2c; para. 0063-0066).
Regarding Claim 20, Modified Davidson discloses the patient interface system according to claim 16, wherein the mouth portion (Fig. 2a-2c; 14) further comprises a mouth portion mcoupling component (Fig. 2c; 90) arranged to form part of the fluid coupling to connect the nasal portion and the mouth portion (Figs. 2a-2c; para. 0066-0068).
Regarding Claim 21, Modified Davidson discloses the patient interface system according to claim 20, wherein the mouth portion coupling component (Fig. 2c; 90) extends around the mouth chamber (Fig. 2a-2c; 14) opening (Fig. 2c; 94 extends around the opening 36a/36 of chamber 14 or the mouth).
Regarding Claim 22, Modified Davidson discloses the patient interface system according to claim 20, wherein the mouth portion coupling component (Fig. 2c; 90) comprises a clip mechanism (94/98/92) that extends about the mouth chamber opening (Fig. 2c; 36a) and is arranged to form part of a resilient clip connection (para. 0066-0068).
Regarding Claim 23, Modified Davidson discloses the patient interface system according to claim 22, wherein the clip mechanism (Fig. 2c; 90) includes a resilient hinge (para. 0066-0068).
Regarding Claim 29, Modified Davidson discloses the patient interface system according to claim 20, wherein the mouth portion coupling component (Fig. 2c; 90) is configured to connect directly with the nasal chamber coupling component to form the fluid coupling (Fig 2a-2c; 96; para. 0066-0068).
Regarding Claim 44, Modified Davidson discloses the patient interface system according to claim 20, further comprising a locking member (Fig. 2c; 90, 92, 94, 98, 100; Davidson) to form part of the connection formed at least one of the nasal portion (at 36 or 37) or mouth portion coupling components (Fig. 2c; 90) in fluidly coupling the nasal portion (Fig. 2a-2c; 12) to the mouth portion (Fig. 2a-2c; 14) (Para. 0066-0068; Examiner notes: the coupling component has a locking clip to form a connection between the two parts).
Regarding Claim 121, Modified Davidson discloses the patient interface system according to claim 1, wherein the pair of inlet conduits (Fig. 36-37; para. 0242-0251; Gunaratnam) form a part of a hoop configured to pass over the top of the patient's head (Examiner notes: this limitation is functional; Fig. 36-37; Gunaratnam), wherein the pair of conduits are joined at a junction configured to be disposed at a crown region of the patient's head(This limitation is functional; Fig. 36-37; Gunaratnam), and wherein the junction is configured to connect to a source of the pressurised, breathable gas (at the end of 274; where the pressurized gas comes through; 0242-0251; Gunaratnam).
Regarding Claim 122, Modified Davidson discloses the patient interface system according to claim 1, teaches a first and second mode.
Modified Davidson does not specifically teach wherein the removable vent module is configured to be attached to an opening in the mouth portion in the second mode.
However, Drew teaches a removable vent module (Fig. 8; 82, 28, 26, 90, 88) adapted to be attached to chamber (Fig. 7) to vent gas exhaled by the patient (Col. 5 lines 31-49; Col. 6 lines 1-6, 13-59).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the vents of Modified Davidson to include a removable vent module adapted to be attached to the mouth portion as taught by Drew for the purpose of removal and replacement of a vent insert while retaining the other components of the mask (Col. 6 lines 34-41).
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidson, Gunaratnam, Drew, and Formica, as applied to claim 1, in view of Formica et al. (US 20130199537 A1) second embodiment, hereafter as Formica II.
Regarding Claim 2, Modified Davidson discloses the patient interface system according to claim 1, wherein the nasal portion (Fig. 2a; 12) comprises a nasal cushion that forms at least part of the nasal chamber and wherein the nasal chamber opening (Fig. 2a-2b; 37; para.0063, 0066) and the coupling component (Fig. 2c; 90) are formed in the nasal cushion (Figs. 2a-2c; para. 0066-0068).
Davidson does not specifically teach in the embodiment in Fig.2 that the nasal portion has a nasal cushion.
However, Formica II teaches a nasal sealing portion could be nasal pillows, nasal prongs, or nasal cradle, …etc (para. 0259-0265, 0348,; Fig. 5-1 to 13).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the nasal piece in Davidson to include the nasal portion has a nasal cushion as taught by Formica II for the purpose of nares sealing portions being flexible and compliant so as to conform to the shape of the patient's nose and/or nares in use (para. 0263).
Regarding Claim 3, Modified Davidson discloses the patient interface system according to claim 2, wherein the nasal cushion a pillow cushion (para. 0259-0265, 0348,; Fig. 5-1 to 13; Formica).
Regarding Claim 4, Modified Davidson discloses the patient interface system according to claim 2, wherein the nasal cushion is a cradle cushion (para. 0259-0265, 0348,; Fig. 5-1 to 13; Formica II).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidson, Gunaratnam, Drew, and Formica, as applied to claim 12, in further view of Formica third embodiment (Fig. 41), hereafter as Formica III.
Regarding Claim 14, Modified Davidson discloses the patient interface system according to claim 12,
Modified Davidson does not disclose specifically wherein the vent module is an anti-asphyxiation vent (AAV).
However, Formica III 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 (para. 0521; Examiner notes: 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 Davidson to include wherein the vent module is an anti-asphyxiation vent as taught by Formica III for the purpose of breathing backup system to allow the patient to breathe in connection to atmosphere and prevent asphyxia (para. 0521).
Regarding Claim 15, Modified Davidson discloses the patient interface system as claimed in claim 14, wherein the AAV includes a flap (Fig. 41; 1002, 1004; Formica III) and the at least one guide vane (Fig. 7; 28; Drew; Col. 5 lines 31-49; Col. 6 lines 1-6, 13-59) is arranged to direct gas from the nasal chamber (Fig. 2a-2c; 12; Davidson).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidson, Gunaratnam, Drew, and Formica, as applied to claim 20, in view of Dravitzki (US 20120138061 A1).
Regarding Claim 28, Davidson discloses the patient interface system according to claim 20,
Modified Davidson does not disclose wherein the mouth portion coupling component is formed as an overmoulding incorporating a silicone overlay and a rigid backing.
However, Dravitzki teaches a connector (Fig. 70; 2520) is formed as an overmoulding incorporating a silicone overlay (Para. 0201) and a rigid backing (Fig. 70; 2525; para. 0201).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the coupling component of Modified Davidson to include the coupling component is formed as an overmoulding incorporating a silicone overlay and a rigid backing as taught by Dravitzki as it is known in the art that overmolding silicone overlay and rigid backing is made for a permanent connection.
Furthermore, with regard to Claim 28 which is/are a product by process claim(s), the product disclosed by the prior art is identical to the claimed product, even though (it is made by a somewhat different process/the prior art is silent on the method of making). There is no evidence to show that the claimed process imparts any patentable distinction between the claimed product and that of the prior art. When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim although produced by a different process. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). See also MPEP § 2113.
Claim(s) 30, 32, 36-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidson, Gunaratnam, Drew, and Formica, as applied to claim 20, in view of Formica IIII (Figs. 94-102).
Regarding Claim 30, Davidson discloses the patient interface system according to claim 20,
Modified Davidson does not specifically further comprise a connector configured to form part of the fluid coupling and having a nasal portion end configured to be attachable to the nasal chamber coupling component, an opposite mouth portion end attachable to the mouth portion coupling component, and a passage extending between the nasal portion end and the mouth portion end.
However, Formica IIII embodiment Figs 94-102 teach further comprising a connector (Fig. 97; 3012) configured to form part of the fluid coupling and having a nasal portion (Fig. 96; 3000) end configured to be attachable to the nasal chamber coupling component (Fig. 96; end of 3000 that is supposed to attached onto 3012, 3014), an opposite mouth portion end (Fig. 97, 98A; 3002) attachable to the mouth portion coupling component (Fig. 97-102; 3012), and a passage extending between the nasal portion end and the mouth portion end (para. 0460-0476).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the coupling connection of Modified Davidson to include the a connector configured to form part of the fluid coupling and having a nasal portion end configured to be attachable to the nasal chamber coupling component, an opposite mouth portion end attachable to the mouth portion coupling component, and a passage extending between the nasal portion end and the mouth portion end as taught by Formica IIII embodiment (Fig. 94-102) for the purpose of the assembly being more robust and less dependent on tolerances to prevent leak (para. 0476).
Regarding Claim 32, Modified Davidson discloses the patient interface system according to claim 30, wherein at least one of the nasal portion end (Fig. 97; 3000; Formica IIII) includes a clipping mechanism to engage with the coupling component of the mouth portion (Fig. 97; 3014; tabs; Examiner notes: the fitting 3012 and tabs 3014 are adapted to lock when the nasal portion is connected; para. 0472).
Regarding Claim 36, Modified Davidson discloses the patient interface system according to claim 30, wherein the connector (Fig. 97; 3012; Formica IIII) incorporates a connector chamber (Fig. 94-97; Examiner notes: when the nasal portion and mouth portion connect the create connecter chamber; Formica IIII) intermediate the nasal and mouth end portions (para. 0460-0476; Formica IIII).
Regarding Claim 37, Modified Davidson discloses the patient interface system according to claim 30, wherein the connector is formed as a unitary structure (Fig. 97-101; 3012; Formica IIII).
Regarding Claim 38, Modified Davidson discloses the patient interface system according to claim 30, wherein the connector (Fig. 97; 3012; Formica IIII) is formed from multiple components (Fig. 97; 3012, 3014, end of 3000; Formica IIII).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidson, Gunaratnam, Drew, Formica, Formica IIII, as applied to claim 30, in view of Bradley (US 20090038615 A1).
Regarding Claim 31, Modified Davidson discloses the patient interface system according to claim 30, wherein the connector (Fig. 97; 3012; Formica IIII)
Modified Davidson does not further comprise at least one vane disposed in a connector passage of the connector.
However, Bradley teaches that one vane could disposed in a connector passage (para. 0037, 0048).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the connector of Modified Davidson to include the vanes, grooves, or fins as taught by Bradley for the purpose of direct exhaled gases towards laminar flow upon exiting that portion of the conduit (para. 0037).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidson, Gunaratnam, , Drew, Formica, Formica IIII, as applied to claim 30, in view of Formica embodiment X (Fig. 65).
Regarding Claim 33, Modified Davidson discloses the patient interface system according to claim 30,
Modified Davidson does not specifically teach wherein at least one of the nasal portion end or the mouth portion end is resiliently deformable to connect with the coupling component of the nasal portion or mouth portion.
However, Formica X (Fig. 65) teaches that nasal portion end (end of 1590; Fig. 65) is resiliently deformable (para. 0417) to connect with the coupling component(1586, 1589; fig. 65) mouth portion (Fig. 65; 1582; para. 0417).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the end of the nasal or mouth portions of Modified Davidson to include they are resiliently deformable as taught by Formica X for the purpose of the flexibility to be able accept the nasal/mouth portion in the indentations and then snap back into its original shape and have a strong fit (para. 0417).
Claim(s) 40-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidson, Gunaratnam, , Drew, Formica, Formica IIII, as applied to claim 30, in view of Formica III.
Regarding Claim 40, Modified Davidson discloses the patient interface system according to claim 30,
Modified Davidson does not disclose wherein the connector incorporates an anti-asphyxiation vent (AAV) disposed between a nares portion end and a mouth portion end.
However, Formica III 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 (para. 0521; Examiner notes: 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 connector between the nose portion and mouth portion of the mask system of the Modified Davidson to include the connector incorporates an anti-asphyxiation vent (AAV) as taught by Formica III for the purpose of breathing backup system to allow the patient to breathe in connection to atmosphere and prevent asphyxia (para. 0521).
Regarding Claim 41, Modified Davidson discloses patient interface system according to claim 40, wherein the AAV includes a flap that extends across an interior of a passage of the connector (Fig. 41; 1002, 1004; Formica III).
Claim(s) 42-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidson, Gunaratnam, Drew, Formica, Formica IIII, Formica III, as applied to claim 41, in view of Bradley.
Regarding Claim 42, Modified Davidson discloses patient interface system according to claim 41,
Modified Davidson does not disclose wherein the connector includes one or more guide vanes which extend across at least part of the interior of the connector to direct the flow of gas in the passage.
However, Bradley teaches that one vane could disposed in a connector to direct the flow of gas in the passage(para. 0037, 0048).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the connector of Modified Davidson to include the vanes, grooves, or fins as taught by Bradley for the purpose of direct exhaled gases towards laminar flow upon exiting that portion of the conduit (para. 0037).
Regarding Claim 43, Modified Davidson discloses the patient interface system according to claim 42, wherein the one or more guide vanes (para. 0037, 0048; Bradley) is arranged to direct gas from the nasal chamber (Fig. 2a-2c; 12) onto the flap (Fig. 41; 1002, 1004; Formica III).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAAP A ELLABIB whose telephone number is (571)272-5879. The examiner can normally be reached 8-5.
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/MAAP ELLABIB/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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