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. (AU2020904177) filed on the November 13, 2020.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “wherein the at least one plenum chamber inlet port is a single plenum chamber inlet port disposed substantially centrally in the nasal portion” in claim 134 and “a pair of loops, each loop of the pair of loops positioned at a lateral side of the nasal portion, and wherein upper straps of the positioning and stabilizing structure are configured to wrap around the pair of loops” in Claim 135 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 134 and 135 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in and such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 134, the claim recites “wherein the at least one plenum chamber inlet port is a single plenum chamber inlet port disposed substantially centrally in the nasal portion”, in lines 1-2 while claim 134 depends from claim 130 that recites “wherein the at least one plenum chamber inlet port includes a pair of plenum chamber inlet ports, each positioned at a lateral side of the nasal plenum chamber; and wherein conduits connect to the pair of plenum chamber inlet ports”, in lines 48-49. This is a written description issue because claim 134 requires the “single” plenum chamber inlet port when there is already two plenum ports claimed in claim 130, meaning there are two different locations of where the inlets are claimed. Therefore, the specification fails to described the claimed subject matter in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
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 134 and 135 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 134, the claim recites “wherein the at least one plenum chamber inlet port is a single plenum chamber inlet port disposed substantially centrally in the nasal portion”, in lines 1-2 while claim 134 depends from claim 130 that recites “wherein the at least one plenum chamber inlet port includes a pair of plenum chamber inlet ports, each positioned at a lateral side of the nasal plenum chamber; and wherein conduits connect to the pair of plenum chamber inlet ports”, in lines 48-49. This is an indefinite issue because claim 134 requires there to be a “single” plenum chamber inlet port when there is already two plenum ports claimed in claim 130. Only time any plenum inlet is mentioned is with the nasal plenum chamber in Claim 130. Therefore, it is unclear how the plenum two inlet ports mentioned could then simultaneously being arranged as a single inlet port in front of the interface. Examiner is not making a judgment on the subject matter of claim 134 because the Examiner is unable to provide cogent and reasonable interpretation for claim 134 that would resolve the issue(s) listed above.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 134 and 135 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding Claim 134, the claim recites “wherein the at least one plenum chamber inlet port is a single plenum chamber inlet port disposed substantially centrally in the nasal portion”, in lines 1-2 while claim 134 depends from claim 130 that recites “wherein the at least one plenum chamber inlet port includes a pair of plenum chamber inlet ports, each positioned at a lateral side of the nasal plenum chamber; and wherein conduits connect to the pair of plenum chamber inlet ports”, in lines 48-49. Which does not further limit the independent claim. Therefore, Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 130-133, 136, 139-140, 142-147, 149, and 157is/are rejected under 35 U.S.C. 103 as being unpatentable over Barlow et al. (US 20160082214 A1), hereafter as Barlow in view of Kooij et al. (US 20190022343 A1), hereafter as Kooij, and Baluchagi et al. (WO 2019119058 A1), hereafter as Baluchagi.
Regrading Claim 130, Barlow discloses a patient interface (3a-3u) for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to a patient's airways including at least an entrance of a patient's nares (para. 0266), wherein the patient interface (3000) is configured to maintain a therapy pressure in a range of about 4 cmH20 to about 30 cmH20 above ambient air pressure in use (para. 0429), throughout a patient's respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing (Intended use and configured for language meaning this limitation is functional; para. 0016);
said patient interface (Fig. 3a-3u; 3000) comprising:
a cushion (Fig. 3a-3u; 3110, 3112) comprising:
a nasal portion comprising:
a nasal plenum chamber (Fig. 3u; 3104) at least partially forming a nasal cavity pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure (para. 0274-0275; 0429), and
a nasal seal-forming structure (Fig. 3c; 3112) constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's nares (para. 0266), said nasal seal-forming structure having 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 (Fig. 3u; 3103), the nasal seal-forming structure constructed and arranged to maintain said therapeutic pressure in the nasal plenum chamber throughout the patient's respiratory cycle in use (para. 0429); and an oral portion comprising:
an oral plenum chamber (3200) at least partially forming an oral cavity pressurisable above ambient air pressure(para. 0429); and
an oral seal-forming structure (3110) constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's mouth (para. 0276), said oral seal-forming structure having a hole therein such that air in the oral cavity is delivered to at least an entrance to the patient's mouth (Fig. 3h, 3u; 3101), the oral seal-forming structure constructed and arranged to maintain said therapeutic pressure in the oral plenum chamber throughout the patient's respiratory cycle in use (Fig.3a-3u; 3600; para. 0429);
a positioning and stabilising structure (Fig. 3a, 3o; 3300, 3301, 3310, 3312) to provide a force to hold the nasal seal-forming structure and the oral seal-forming structure in a therapeutically effective position on the patient's head (para.0025-0027, 0276); and
a vent structure (Fig. 3j; 3400) connected to the nasal plenum chamber (Examiner notes: it is indirectly connected to the nasal chamber) and configured to allow a continuous flow of gases exhaled by the patient from an interior of the nasal plenum chamber to ambient (This limitation is functional), said vent structure being sized and shaped to maintain the therapeutic pressure in the nasal plenum chamber in use (Examiner notes: in Fig. 3h the vent holes purpose of the holes being sized, shaped, and a large enough number provided to permit sufficient carbon dioxide washout but also para. 0429 talked that the pressure is maintain when in use);
wherein the nasal portion is permanently connected to the oral portion with a decoupling portion (Fig. 3c; 3106) formed between the nasal plenum chamber and the oral plenum chamber (para. 0264), the decoupling portion including an angled portion extending toward the nasal seal-forming structure and the oral seal-forming structure (shown best 8b-8c; para. 0295), the decoupling portion configured to allow the nasal portion to pivot relative to the oral portion(para. 0316);
wherein a curved surface (Fig. 3h; 3106.2 and 3114) opposite to the decoupling portion connects the nasal seal- forming structure and the oral seal-forming structure (Fig. 3h and 3u), and wherein the curved surface is configured stretch toward a planar orientation while worn by the patient (Fig 3q); and
Barlow does not specifically disclose that the nasal plenum chamber including at least one plenum chamber inlet port configured to convey the flow of air into the nasal plenum chamber; wherein the patient interface is configured to allow the patient to breath from ambient through their mouth in the absence of a flow of pressurised air through the plenum chamber inlet port (this limitation is functional); wherein the curved surface forms a continuous surface between the nasal seal-forming structure and the oral seal-forming structure; wherein conduits connect to the pair of plenum chamber inlet ports, the conduits configured to convey the flow of air through each plenum chamber inlet port of the pair of plenum chamber inlet ports.
However, Kooij teaches the nasal plenum chamber including at least one plenum chamber inlet port configured to convey the flow of air (through conduits 3350; Fig. 3B) into the nasal plenum chamber (Fig. 4A); wherein the curved surface (Fig. 4a; in between 3170 and 3180) forms a continuous surface between the nasal seal-forming structure (3170) and the oral seal-forming structure (3180); wherein conduits (3350, 3360) connect to the pair of plenum chamber inlet ports (Fig. 4A; the conduit connect to the ports on either side of the nasal plenum chamber 3170), the conduits configured to convey the flow of air through each plenum chamber inlet port of the pair of plenum chamber inlet ports (Fig. 4A; para. 0143, 0152-0153, 0307).
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 upper part of the stabilizing structure of Barlow to include air inlets with at least one plenum chamber inlet port configured to convey the flow of air into the nasal plenum chamber and wherein conduits connect to the pair of plenum chamber inlet ports, the conduits configured to convey the flow of air through each plenum chamber inlet port of the pair of plenum chamber inlet ports as taught by Kooij for the purpose of urging the cushion assembly into the patient's face with a sufficiently large force to maintain an effective seal, without causing excessive discomfort (para. 0307).
Modified Barlow does not specifically teach wherein the patient interface is configured to allow the patient to breath from ambient through their mouth in the absence of a flow of pressurised air through the plenum chamber inlet port (this limitation is functional);
However, Baluchagi teaches wherein the patient interface is configured to allow the patient to breath from ambient through their mouth in the absence of a flow of pressurised air through the plenum chamber inlet port (para. 0187).
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 interface of Modified Barlow to include the anti-asphyxia valve configured to allow the patient to breath from ambient through their mouth in the that as taught by Baluchagi for absence of a flow of pressurised air through the plenum chamber inlet port and the patient is comfortable when needed(para. 0187).
Regrading Claim 131, Modified Barlow discloses the patient interface of claim 130, wherein the nasal seal-forming structure(Fig. 3c; 3112) is configured to contact the patient's columella and is not configured to contact the patient's nasal ridge superior to the patient's pronasale (Examiner notes: this limitation is functional, Figure shows that the columella is contacted and the nasal ridge is not in contact with the patient interface; Fig. 3q; para. 0041).
Regrading Claim 132, Modified Barlow discloses the patient interface of claim 130, wherein the conduits (3350; Kooij) form a portion of the positioning and stabilizing structure (3300; Kooij) and are configured to provide a tensile force to the nasal portion in use (Examiner notes: this limitation is functional; para. 0038).
Regrading Claim 133, Modified Barlow discloses the patient interface of claim 132, wherein the conduits (3350; Kooij).
Modified Barlow does not specifically include concertina sections configured to expand upon application of a tensile force.
Kooij teaches that the conduits include concertina sections (Fig. 3b, 3k; 3350, 3360, 3362) configured to expand upon application of a tensile force (Fig. 3k).
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 conduit tube that are connected to the nasal plenum inlet ports of Modified Barlow to include the concertina sections as taught by Kooij for the purpose of the plurality of folds or bellows able to fold and unfold independently or in concert to shorten or lengthen the concertina tube section and to be altered as well as their length, which also helps the patient interface be adjusted to fit the patient's specific head size and head shape (para. 197).
Regrading Claim 136, Modified Barlow discloses the patient interface of claim 130, wherein the oral portion (3200) includes a pair of connectors (Fig. 3a; 3250; para. 0359) spaced apart from one another.
Regrading Claim 142, Modified Barlow discloses the patient interface of claim 136, wherein the positioning and stabilizing structure (Fig. 3o; 3300, 3312; Barlow; Fig. 3b, 3k; 3350, 3360, 3362; Kooij) includes lower straps selectively connected to the oral portion via the connectors (Fig. 3a; 3250; para. 0359).
Regrading Claim 143, Modified Barlow discloses the patient interface of claim 130, wherein the decoupling portion (Fig. 3c; 3106) is configured to at least partially decouple a force applied by the positioning and stabilizing structure (Fig. 3o; 3300, 3312; Barlow; Fig. 3k, 3b; 3350, 3360, 3362; Kooij)) to the oral portion (3200) from the nasal portion (3202; Examiner notes: this limitation is functional; para. 0034).
Regrading Claim 144, Modified Barlow discloses the patient interface of claim 130,
Modified Barlow teaches wherein an angle of the decoupling portion (Fig. 3c; 3106) between the oral portion (3200) and the nasal portion (3202) in a relaxed position is about 1° to about 90° (Fig. 3f; 3106.1; Examiner notes: the angle is “about”).
However, The prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125)).
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 between the oral portion (3200) and the nasal portion (3202) in a relaxed position is about 1° to about 90°. Applicant has not disclosed that about 1° to about 90° provides criticality of this range as evidenced by the Applicant' s specification para. 0067 which recites “the decoupling portion is configured to at least partially decouple a force applied by the positioning and stabilizing structure to the oral portion from the nasal portion; b) an angle of the decoupling portion between the oral portion and the nasal portion in a relaxed position is about 1° to about 90°; c) the angle is about 10° to about 50° in the relaxed position; and/or d) the angle is about 20° to about 40° in the relaxed position. Since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). One of ordinary skill in the art, furthermore, would have expected that interface of Modified Barlow device and Applicant' s interface to perform equally well because these interface have similar structures.
Therefore, it would have been prima facie obvious to modify the device taught Modified Barlow to incorporate the decoupling portion (Fig. 3c; 3106) between the oral portion (3200) and the nasal portion (3202) in a relaxed position is about 1° to about 90°, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired device size and thus fails to patentably distinguish over the prior art of Modified Barlow.
Regrading Claim 145, Modified Barlow discloses the patient interface of claim 144, wherein the angle is about 10° to about 50° in the relaxed position (Fig. 3f; 3106.1).
The prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125)).
Regrading Claim 146, Modified Barlow discloses the patient interface of claim 145, wherein the angle is about 20° to about 40° in the relaxed position (Fig. 3f; 3106.1).
The prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125)).
Regrading Claim 147, Modified Barlow discloses the patient interface of claim 130, further comprising a passage (See Annotated Fig. A and B of different views of interface, Reference “A” below specifically in Fig. A; Examiner notes: can also best be seen in the embodiment of 8c, 8h and 16b) formed between the nasal cavity (3202) and the oral cavity (3200), the passage configured to provide fluid communication between the nasal cavity and the oral cavity (para. 0034; Examiner notes: this limitation is functional).
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Figure A and B: Adapted Figure 3q and 3h from Barlow et al.
Regrading Claim 149, Modified Barlow discloses the patient interface of claim 147, wherein the passage (See Annotated Fig. A and B above; Also, best be seen in the embodiment of 8c, 8h and 16b) is substantially aligned with the decoupling portion (Fig. 3b,3c; 3106; Barlow) and the curved surface (Fig. 3h; 3106.2 and 3114; Barlow).
Regrading Claim 157, Modified Barlow discloses the patient interface of claim 130, wherein the curved surface (Fig. 3h; 3106.2 and 3114) is configured to lie flat against a patient's face in use to form a single seal along the patient's lip superior (para. 0041; examiner notes: the nasal sling contacts the patient columella, and then the curved surface is able to forms seal against the person face; this limitation is functional).
Claim(s) 137-138 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barlow, Kooij, Baluchagi, as applied to claim 136, in further view of Barlow second embodiment (20a-20s).
Regrading Claim 137, Modified Barlow discloses the patient interface of claim 136, Modified Barlow does not specifically disclose that the pair of connectors are magnets.
However, Barlow in a different embodiment (20c-20d) teach the pair of connectors are magnets (para. 0043, 0381, 0416).
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 connectors of Modified Barlow to include the magnets as taught by different embodiment of Barlow for the purpose of arrangement may provide for more control of the attachment of the positioning and stabilising structure to the lower attachment features and may provide for more stability for the seal of the oral cushion against the patient's face (para. 0381).
Regrading Claim 138, Modified Barlow discloses the patient interface of claim 136,
Modified Barlow does not specifically teach wherein the oral portion is molded around the pair of connectors.
However, Barlow second embodiment teaches wherein the oral portion is molded around the pair of connectors (Fig. 20f; para. 0412).
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 connectors of Modified Barlow to include the wherein the oral portion is molded around the pair of connectors as taught by another embodiment in Barlow as it is alternative arrangement and may provide for more control of the attachment of the positioning and stabilising structure to the lower attachment features and may provide for more stability for the seal of the oral cushion against the patient's face (para. 0381).
Claim(s) 139 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barlow, Kooij, Baluchagi, as applied to claim 136, in view of Leksutin et al. (WO 2006074273 A2), hereafter Leksutin.
Regrading Claim 139, Modified Barlow discloses the patient interface of claim 136, wherein the pair of connectors (Fig. 3a; 3250; para. 0359).
Modified Barlow does not specifically teach that the connectors are selectively removable from the oral portion.
Leuksutin teaches that the connectors (Fig. 8; end pieces 42) are selectively removable from the oral portion (Fig. 8; connecting to 51) (Pg. 4 lines 17- Pg. 5 lines 17).
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 connectors on the oral portion of Modified Barlow to be able to be selectively removably as taught by Leuksutin to provide a means of connecting a head gear to a mask such that they are easily and smoothly connected and released (Pg. 2; lines 5-9).
Claim(s) 140 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barlow, Kooij, Baluchagi, and Leksutin, as applied to claim 139, in view of Ng et al. (US 20170043113 A1), hereafter as NG.
Regrading Claim 140, Modified Barlow discloses the patient interface of claim 139, further comprising an insert (Fig. 3a; 3204) including the pair of connectors (Fig. 3a; 3250; para. 0359),
Modified Barlow does not disclose that the insert being selectively coupled to the oral plenum chamber with a press fit.
However, NG teaches the insert (Fig. 28; 20, 23) being selectively coupled to the plenum chamber (Fig. 28; 40) with a press fit.
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 insert and oral chamber of Modified Barlow to include the connection piece of insert being selectively coupled to the chamber with a press fit as taught by NG for the purpose of attachment mechanisms and the two parts can be a locked in different angular positions with respect to the each other (para. 0199-0200).
Claim(s) 141 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barlow, Kooij, Baluchagi, Leksutin, and NG, as applied to claim 140, in view of Berthon-Jones et al. (US 5560354 A), hereafter Berthon-Jones.
Regrading Claim 141, Modified Barlow discloses the patient interface of claim 140,
Modified Barlow does not disclose wherein the insert includes an anti-asphyxia valve (AAV).
However, Berthon-Jones teaches the insert (Fig. 3b; 42) includes an anti-asphyxia valve (AAV) (Fig. 3b; 56).
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 interface of Modified Barlow to include the insert includes an anti-asphyxia valve (AAV) as taught by Berthon-Jones as anti-asphyxia valves would perform the same function regardless of the location, the location of the anti-asphyxia valve is considered a matter of design choice.
Claim(s) 148 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barlow, Kooij, Baluchagi, as applied to claim 147, in view of third embodiment in Barlow (Figs 8a-8g).
Regrading Claim 148, Modified Barlow discloses the patient interface of claim 147, Modified Barlow embodiment (Figs. 3a-3u) does not specifically disclose wherein the passage is a substantially elliptical shape.
However, Barlow embodiment teaches wherein the passage (Fig. 8f-k) is a substantially elliptical shape (A; Examiner notes: the passage is “substantially” elliptical; See Annotated Figure C below).
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Figure C: Adapted Figure 8h from Barlow et al.
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 passage of Modified Barlow to include the passage is a substantially elliptical shape as taught by Barlow other embodiment, since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative shape dimensions of the claimed device (elliptical shaped passageway), and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. [MPEP 2144.04, I. Aesthetic Design Changes].
Claim(s) 150-153 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barlow, Kooij, Baluchagi, as applied to claim 130, in view of Xu et al. (US 20040226563 A1), hereafter as Xu.
Regrading Claim 150, Modified Barlow discloses the patient interface of claim 130, Modified Barlow embodiments (Figs. 3a-3u) does not specifically disclose the interface further comprising a membrane formed between the nasal cavity and the oral cavity.
However, Xu teaches a membrane (Fig. 2; 106) formed between the nasal cavity (104a) and the oral cavity (104b) (para. 0060, 0064-0065).
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 cavities of Modified Barlow to include the membrane that divides the nasal and oral cavity as taught by Xu for the purpose of substantially dividing the inner face piece into a nose portion and a mouth portion, thereby, forming a nose chamber and a mouth chamber, such that the gas communication between the two chambers is minimized and such that exhalation air can be directed to the mouth chamber, whereby the re-inhalation of residual exhaled air is totally eliminated (para. 0023, 0031).
Regrading Claim 151, Modified Barlow discloses the patient interface of claim 150, wherein the membrane (Fig. 2; 106; Xu) extends between the decoupling portion (Fig. 3c; 3106; 1st Barlow embodiment) and the curved surface (Fig. 3h; 3106.2 and 3114; 1st Barlow embodiment).
Regrading Claim 152, Modified Barlow discloses the patient interface of claim 150, wherein the membrane (Fig. 2; 106; Xu) is slack before the patient interface contacts the patient (para. 0064; Xu).
Regrading Claim 153, Modified Barlow discloses the patient interface of claim 150, wherein the membrane (Fig. 2; 106; Xu) is substantially solid and is configured to prevent airflow from traveling within the cushion between the nasal cavity and the oral cavity (para. 0060, 0064-0065; Xu; Examiner notes: this limitation is functional).
Claim(s) 150, and 154-156 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barlow, Kooij, Baluchagi, as applied to claim 130, in view of Wood (US 6478026 B1).
Regrading Claim 150, Modified Barlow discloses the patient interface of claim 130, Modified Barlow embodiments (Figs. 3a-3u) does not specifically disclose the interface further comprising a membrane formed between the nasal cavity and the oral cavity.
However, Wood teaches a membrane (Fig. 11; 78) formed between two cavities (36) and (38) (Col. 7 lines 38-52).
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 cavities of Modified Barlow to include the membrane that divides the nasal and oral cavity as taught by Wood for the purpose of retaining heat and/or moisture from the exhale air passing therethrough. When the patient then draws his or her inhale air, heat and/or moisture retained by the filters is absorbed into the inhale air thereby providing for increased comfort of the patient (Col. 7 lines 38-52).
Regrading Claim 154, Modified Barlow discloses the patient interface of claim 150, wherein the membrane (Fig. 11-12; 78; Wood) is configured to allow airflow from traveling within the cushion (Fig. 3a-3u; 3110, 3112; Barlow) between the nasal cavity (3202; Barlow) and the oral cavity (3110; Barlow) through at least one hole (Examiner notes: the filter has many holes; Wood).
Regrading Claim 155, Modified Barlow discloses the patient interface of claim 154, wherein the at least one hole is a plurality of spaced apart holes (Col. 7 lines 38-52; Wood), and wherein the plurality of spaced apart holes (Fig. 11-12; 78; Wood) are sized to allow a predetermined flow of air between the nasal cavity (3202; Barlow) and the oral cavity(3110; Barlow).
Regrading Claim 156, Modified Barlow discloses the patient interface of claim 150, where the membrane includes a porosity on a microscopic and/or molecular level that is configured to allow a predetermined flow of air traveling (Fig. 11-12; 78; Wood) within the cushion to flow between nasal cavity (3202; Barlow) and the oral cavity (3110; Barlow).
Conclusion
The Examiner notes that no art rejection has been made for claims 134-135 at this time as the prior art of record fails to disclose the claims as written. The Examiner retains the right to make a new art-based rejection on these claims once the 35 U.S.C. 112(a) and 112(b) rejections have been resolved by the Applicant.
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/MAAP ELLABIB/
Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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