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 .
Election/Restrictions
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/23/2025.
Drawings
The drawings are objected to because it is difficult to interpret the claimed features of the invention in Figures 3-5, 7-9 13-17, 23, 28, 30-32, 34, and 38-41 due to the quality of the drawings. 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.
Specification
The disclosure is objected to because of the following informalities: “Error! Reference source not found” ([00110] of specification and all further recitations).
Appropriate correction is required.
Claim Objections
Claims 1, 7-9, and 11 are objected to because of the following informalities:
Claim 1 (line 14) and claims 7-9: “the housing vent hole” should read “the at least one housing vent hole” for consistency and clarity.
Claim 1 (line 14), claims 7-9, and claim 11: “the piston wall vent hole” should read “the at least one piston wall vent hole” for consistency and clarity.
Appropriate correction is required.
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 13 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 13 recites the limitation "the piston opening" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the above limitation is a recitation of the piston opening disclosed in claim 12 (line 2), or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation will be interpreted as – the piston opening – as disclosed in claim 12 (line 2). Additionally, claim 13 will be interpreted as dependent on claim 12, instead of claim 10, to provide antecedent basis for the limitation.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-3, 6, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Brekke & Lacke (US 4151843 A), hereinafter Brekke, in view of Pedro et al. (US 9629975 B1), hereinafter Pedro.
Regarding claim 1, Brekke discloses a nasal ventilator assembly (Fig. 1), comprising:
a nasal interface (mask 12; Fig. 1) comprising at least one opening for fluid communication with the nares of a patient (protrusions 28 and 30 of mask 12; Fig. 8; col. 4, lines 37-39);
an air chamber (interior volume of 92 closed on the top by 94 and 96, and closed on the bottom by 106; Figs. 9-11) in fluid communication with the nasal interface (hollow extension 116 fluidly connects the interior volume of closed cylinder 104 to mask 12; Fig. 9; col. 4, lines 10-12), a gas supply port (114; Fig. 9),
a vent assembly (92, 94, 96, cylinder 104 closed by bottom wall 106, 128, 118, 110, 120; Fig. 9) comprising:
a vent housing (cylinder 104 closed by bottom wall 106 and cap 118; Fig. 9) comprising at least one housing vent hole (110, where 110 is connected to an opening of exhaust conduit 120; Fig. 9); and
a piston assembly (94, 96, 128, 92; Fig. 9) comprising a piston (94; Fig. 9), a spring (128; Fig. 9), a piston end wall (96; Fig. 10) operatively connected with the piston and the spring (96 is connected to 94 and 128, see Figs. 10-11) and a piston driven wall (92; Fig. 9) operatively connected with the piston (92 connected to 94; Figs. 9-11) and the spring (spring connected to 92 via 94 and 96; Figs. 9-11), the piston driven wall (92; Fig. 9) comprising at least one piston wall vent hole (100 and 102; Fig. 9) in fluid communication with the air chamber (100 and 102 in fluid communication with interior volume of 92, where the interior volume of 92 is enclosed on the top by 94 and 96, and enclosed on the bottom by 106; Figs. 9-11),
wherein motion of the piston is caused by inhalation and exhalation of a patient (col. 4, lines 25-31; Figs. 10-11) to move the housing vent hole to align with the piston wall vent hole upon exhalation of the patient (92 is pushes up against and compresses spring 128 due to exhaling pressure causing 100 to align with 110; Fig. 11) to cause the air chamber (interior volume of 92 closed on the top by 94 and 96, and closed on the bottom by 106; Figs. 9-11) to be in fluid communication with an exhaust conduit upon exhalation of the patient (during exhalation, interior volume 92 enclose by 94, 96, and 106 is in fluid communication with exhaust conduit 120 via 100 and 110; Figs. 9 and 11) and to be fluidically sealed from the exhaust conduit during inhalation of the patient (during inhalation, interior volume of 92, enclosed by 94, 96, and 106, is fluidically sealed from 110 and 120 as the interior surface of 92 is closed on the top b 96 and 94; Figs. 10-11). Brekke does not disclose an end tidal sample port.
However, Pedro teaches a nasal ventilation mask (10; Fig. 2) including an end tidal sample port (18; Fig. 2; col. 3, lines 25-27).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mask of Brekke with the end tidal sample port taught by Pedro, such that the mask (12; Fig. 1) includes an end tidal sample port (Pedro: 18; Fig. 2; col. 3, lines 25-27) to monitor concentration levels of gas, such as CO2, exhaled by the patient (Pedro: col. 3, lines 37-42).
Additionally, Brekke fails to disclose the at least one housing vent hole (110, where 110 is connected to an opening of exhaust conduit 120; Fig. 9) of the vent housing (cylinder 104 closed by bottom wall 106 and cap 118; Fig. 9) in fluid communication with ambient atmosphere.
However, Brekke does teach the exhaust conduit (120; Fig. 9) can attach to the exhaust line (57; Fig. 9; col. 4, lines 13-14). Hence, the exhaust line (57; Fig. 9) can detach from the exhaust conduit (120; Fig. 9), where in a detached stated, the exhaust conduit (120; Fig. 9) is in fluid communication with the ambient atmosphere.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Brekke to explicitly teach the vent housing (cylinder 104 closed by bottom wall 106 and cap 118; Fig. 9) comprising at least one housing vent hole (110, where 110 is connected to an opening of exhaust conduit 120; Fig. 9) in fluid communication with ambient atmosphere (120 is in fluid communication with ambient atmosphere when detached from 57; Fig. 9) to reduce cost of the device by minimizing materials used. Furthermore, Brekke as modified now teaches wherein motion of the piston is caused by inhalation and exhalation of a patient (col. 4, lines 25-31; Figs. 10-11) to move the housing vent hole to align with the piston wall vent hole upon exhalation of the patient (92 is pushes up against and compresses spring 128 due to exhaling pressure causing 100 to align with 110; Fig. 11) to cause the air chamber (interior volume of 92 closed on the top by 94 and 96, and closed on the bottom by 106; Figs. 9-11) to be in fluid communication with the ambient atmosphere upon exhalation of the patient (during exhalation, interior volume 92 enclose by 94, 96, and 106 is in fluid communication with exhaust conduit 120 via 100 and 110, hence the interior volume of 92 is in fluid communication with the ambient atmosphere via 100, 110, and 120; Figs. 9 and 11) and to be fluidically sealed from the ambient atmosphere during inhalation of the patient (during inhalation, interior volume of 92, enclosed by 94, 96, and 106, is fluidically sealed from 110 and 120 as the interior surface of 92 is closed on the top by 96 and 94, hence the interior volume of 92 is fluidically sealed from the ambient atmosphere via 94 and 96; Figs. 10-11).
Regarding claim 2, Brekke as modified teaches the invention as set forth in claim 1, wherein the piston assembly (94, 96, 128, 92; Fig. 9) is inserted into the vent housing (94, 96, 128, and 92 are inserted into cylinder 104 closed by bottom wall 106 and cap 118; Figs. 10-11), with the piston driven wall (92; Fig. 9) and the piston end wall (96; Fig. 10) moveable within the vent housing according to movement of the piston and the spring (92 and 96 move within 104 according to movement of 94 and 128; Figs. 10-11).
Regarding claim 3, Brekke as modified teaches the invention as set forth in claim 1, wherein the vent housing (cylinder 104 closed by bottom wall 106 and cap 118; Fig. 9) has a front vent wall (exterior surface of cylinder 104; Figs. 9-11), the front vent wall (exterior surface of cylinder 104; Figs. 9-11) including the at least one housing vent hole (110 and openings of 114 and 116, where openings of 114 and 116 are in contact the exterior surface of cylinder 104; Figs. 9-11).
Regarding claim 6, Brekke as modified teaches the invention as set forth in claim 1, wherein the vent housing (cylinder 104 closed by bottom wall 106 and cap 118; Fig. 9) includes a plurality of housing vent holes (110 and openings of 114 and 116, where openings of 114 and 116 are connected to cylinder 104; Figs. 9-11) and the piston driven wall (92; Fig. 9) comprises a corresponding plurality piston wall vent holes (openings 100 and 102 of 92 correspond with the openings of 114 and 116 and opening 110 of cylinder 104; Figs. 10-11).
Regarding claim 10, Brekke as modified teaches the invention as set forth in claim 1, wherein the piston driven wall (92; Fig. 9) includes an additional vent hole (98; Fig. 9).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Brekke (US 4151843 A) in view of Pedro (US 9629975 B1) as applied to claim 1 above, and further in view of Cucin (US 6346107 B1).
Regarding claim 4, Brekke as modified teaches the invention as set forth in claim 1. Brekke as modified fails to teach wherein the piston assembly (94, 96, 128, 92; Fig. 9) comprises a slide rail and the vent housing (cylinder 104 closed by bottom wall 106 and cap 118; Fig. 9) comprises a slide rail opening corresponding to the slide rail, such that the slide rail is moveable within the slide rail opening, thus constraining movement of the piston assembly within the vent housing.
However, Cucin teaches an analogous piston assembly, where provides a keying system to maintain inner aspiration apertures (8A, 8B, 8C, and 8D; Figs. 2A-2B) are aligned with outer aspiration apertures (16A, 16B, 16C, and 16D; Fig. 2A; col. 10, lines 36-38), where the keying system includes a keying element (4D; Figs. 2A-2B; col. 10, lines 36-42) disposed on an outer surface of an inner cannula, where the keying element (4D; Figs. 2A-2B) slides within an elongated outer aperture (16B; Fig. 2A; col. 10, lines 43-44), where the elongated outer aperture (16B; Fig. 2A) is located on an outer cannula (Fig. 2A).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inner surface of the vent housing and the outer surface of the piston assembly, specifically the outer surface of the piston driven wall, as taught by Brekke, as modified, with the keying system taught by Cucin, such that the piston assembly (94, 96, 128, 92; Fig. 9) comprises a slide rail (92 of Brekke includes keying element 4D as taught by Cucin) and the vent housing (cylinder 104 closed by bottom wall 106 and cap 118; Fig. 9) comprises a slide rail opening (inner surface of 104 includes an elongated aperture 16B as taught by Cucin) corresponding to the slide rail (16B of Cucin corresponds with 4D of Cucin, see Cucin Figs. 2A-2B and Cucin col. 10, lines 43-44), such that the slide rail is moveable within the slide rail opening (see Cucin col. 10, lines 43-44), thus constraining movement of the piston assembly within the vent housing (see Cucin col. 10, lines 36-38), and to prevent rotational movement of the piston assembly as it translationally slides within the vent housing (Cucin: col. 10, lines 43-46).
Regarding claim 5, Brekke as modified teaches the invention as set forth in claim 4, wherein the piston driven wall (92; Fig. 9) comprises the slide rail (92 of Brekke includes keying element 4D as taught by Cucin, see claim 4 above) and the vent housing (cylinder 104 closed by bottom wall 106 and cap 118; Fig. 9) comprises the slide rail opening (inner surface of 104 includes an elongated aperture 16B as taught by Cucin, see claim 4 above).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Brekke (US 4151843 A) in view of Pedro (US 9629975 B1) as applied to claim 1 above, and further in view of Cecka et al. (US 20070083677 A1), hereinafter Cecka.
Regarding claim 7, Brekke as modified teaches the invention as set forth in claim 1. Brekke as modified fails to teach wherein the housing vent hole (110, where 110 is connected to an opening of exhaust conduit 120; Fig. 9) has a star cross section and the piston wall vent hole (100 and 102; Fig. 9) has a star cross section.
However, Cecka teaches an analogous valve assembly including apertures (30) that are designed to allow flow to pass through a support (20; [0093], lines 1-2), where the cross-section of the apertures (30) may be a star, circular, or square ([0093], lines 4-5).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cross section of the housing vent hole and piston wall vent hole taught by Brekke, as modified, with the variously shaped cross sections of the apertures taught by Cecka, such that the housing vent hole (110, where 110 is connected to an opening of exhaust conduit 120; Fig. 9) has a star cross section (Cecka: [0093], lines 4-5) and the piston wall vent hole (100 and 102; Fig. 9) has a star cross section (Cecka: [0093], lines 4-5) to modify the angle between the sides of the vent holes relative to the predominant fluid flow (Cecka: [0093], lines 8-12).
Regarding claim 8, Brekke as modified teaches the invention as set forth in claim 1, wherein the housing vent hole (110, where 110 is connected to an opening of exhaust conduit 120; Fig. 9) has a substantially circular cross section (see Figs. 9-11). Brekke as modified further discloses one piston wall vent hole (100; Fig. 9) has a substantially circular cross section (see Fig. 9), but fails to teach a second piston wall vent hole (102; Fig. 9) has a substantially circular cross section.
However, Brekke as modified by Cecka teaches the housing vent hole (110, where 110 is connected to an opening of exhaust conduit 120; Fig. 9) has a substantially circular cross section (see Figs. 9-11) and the piston wall vent hole (100 and 102; Fig. 9) has a substantially circular cross section (100 has a substantially circular cross section, see Fig. 9; 102 has a substantially circular cross section as taught by Cecka, see [0093], lines 4-5 of Cecka, see claim 7 above) to modify the angle between the sides of the vent holes relative to the predominant fluid flow (Cecka: [0093], lines 8-12).
Regarding claim 9, Brekke as modified teaches the invention as set forth in claim 1. Brekke, as modified, fails to explicitly teach wherein the housing vent hole (110, where 110 is connected to an opening of exhaust conduit 120; Fig. 9) has a substantially rectangular cross section and the piston wall vent hole (100 and 102; Fig. 9) has a substantially rectangular cross section.
However, Brekke as modified by Cecka teaches wherein the housing vent hole (110, where 110 is connected to an opening of exhaust conduit 120; Fig. 9) has a substantially rectangular cross section (Cecka teaches the cross section of an aperture may be square, hence 110 as modified by Cecka has a substantially rectangular cross section, see Cecka [0093], lines 4-5) and the piston wall vent hole (100 and 102; Fig. 9) has a substantially rectangular cross section (Cecka teaches the cross section of an aperture may be square, hence 100 as modified by Cecka has a substantially rectangular cross section, see Cecka [0093], lines 4-5; 102 has a substantially rectangular cross section, see Fig. 9, see claim 7 above) to modify the angle between the sides of the vent holes relative to the predominant fluid flow (Cecka: [0093], lines 8-12).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Brekke (US 4151843 A) in view of Pedro (US 9629975 B1) as applied to claims 1 and 10 above, and further in view of Cragg et al. (US 20140246024 A1), hereinafter Cragg.
Regarding claim 11, Brekke as modified teaches the invention as set forth in claim 10, wherein the additional vent hole (98; Fig. 9) has a substantially circular configuration (Figs. 9-11), but does not teach the additional vent hole (98; Fig. 9) having a cross sectional area smaller than the piston wall vent hole.
However, Cragg teaches an analogous valve assembly with a variable resistance valve device (200) including an iris valve (202), where the iris valve (202) adjusts the cross sectional diameter of an opening (204), wherein during the course of the expiratory phase, the iris of the iris valve (202) closes partially such that the cross sectional diameter of the opening (204) is a smaller cross sectional diameter ([0225]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the additional vent hole taught by Brekke, as modified, with the iris valve and opening taught by Cragg such that the additional vent hole (opening 204 taught by Cragg, see [0225] of Cragg) has a substantially circular configuration (Cragg: 204; Figs. 17A-17C) having a cross sectional area smaller than the piston wall vent hole (during exhalation, the opening 204 taught by Cragg will have a smaller diameter than 100 and 102 taught by Brekke, see [0225] of Cragg, hence the opening 204 as taught by Cragg will have a smaller cross sectional area compared to 100 and 102 taught by Brekke) to provide a resistance to the exhaled air of the patient while allowing the exhaled air to escape (see first sentence of Cragg [0225]).
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 12, Brekke & Lacke (US 4151843 A), hereinafter Brekke, as modified by Pedro et al. (US 9629975 B1), hereinafter Pedro, in claim 1 (see claim 1 above), the closest prior art of record, discloses the invention as set forth in claim 1 (see claim 1 above)
Brekke as modified by Pedro fails to teach, disclose, or render obvious the piston end wall (96; Fig. 10) comprises a piston opening therethrough, in addition to other limitations. The device of Brekke as modified does not structurally allow for an opening through the piston end wall (96; Fig. 10), as an opening in the piston end wall (96; Fig. 10) would simultaneously fluidically connect the gas supply port (114; Fig. 9), the air chamber (interior volume of 92 closed on the top by 94 and 96, and closed on the bottom by 106; Figs. 9-11), and the ambient atmosphere, nullifying the function of the piston assembly. Hence, Brekke as modified by Pedro fails to teach, disclose, or render obvious the piston end wall (96; Fig. 10) comprising a piston opening therethrough, and therefore, is novel.
Regarding claim 13, as best understood by the Examiner, claim 13 is dependent on claim 12, and thus is found to contain allowable subject matter by virtue of its dependency. Additionally, Brekke as modified by Pedro, the closest prior art of record, fails to teach, disclose, or render obvious wherein a location of the piston opening corresponds to the gas supply port (114; Fig. 9) in fluid communication with the air chamber (interior volume of 92 closed on the top by 94 and 96, and closed on the bottom by 106; Figs. 9-11) for at least the same reasons as stated above for claim 12 (see claim 12 above). Hence, Brekke as modified by Pedro fails to teach, disclose, or render obvious a location of the piston opening corresponding to the gas supply port in fluid communication with the air chamber, and therefore, is novel.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Holyoake et al. (WO 2016157105 A1): Regarding a valve assembly with a piston and spring.
Lurie et al. (US 20100319691 A1): Regarding a valve assembly with a piston and spring, where the movement of the piston and spring causes a change from a delivery of gas to a patient to venting of expired air from the patient to the atmosphere.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785