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. (AU2021902613) filed on August 20, 2021.
Claim Objections
Claims 38, 40, 53, and 56 are objected to because of the following informalities:
Regrading Claim 38 and 53, “one way” should read as –one-way—
Regrading Claim 38, line 6, a “,” should come after “valve outlet”
Regrading Claim 38, 53 and 56, “pressurised” should read as –pressurized—
Regarding Claim 40, line 1, "the one-way valve formation" should read as –the one-way inspiratory valve formation— for consistency.
Regrading Claim 49, “minimise” should read as –minimize—
Regrading Claim 57, “blower/patent interface” should read as –blower/patient—
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.
Claims 38 and its dependencies (39-57) and claim 42 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.
Claim 38 recites the limitation "a one-way inspiratory valve" in 12. Examiner is unsure if the Applicant is referring to the first a one-way valve in claim 1, or the second a one-way valve. For the purpose of this Office Action, Examiner interprets that it is the same one-way inspiratory valve.
Claim 38 recites the limitation "an expiratory release valve" in line 20. Examiner is unsure if the Applicant is referring to the first expiratory release valve in claim 1 line 1, or the second expiratory release valve. For the purpose of this Office Action, Examiner is interpreting that it is the same expiratory release valve.
Claim 42 recites the limitation “where in the first portion” in line 1. There is insufficient antecedent basis for this limitation in the claim.
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) 38-44, and 47-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuypers et al. (US 20140144447 A1), in view of Krüger’s (US 20170252524 A1).
Regarding Claim 38, Kuypers discloses a combined one way inspiratory valve and expiratory release valve assembly (Figs 1-2C or Figs. 3-4C), for controlling air flow in a respiratory treatment system for delivering pressurised air to an entrance to a patient's airways (para. 0112-0148), the system being configured to maintain a therapy pressure in a range suitable for treating respiratory disorders (Examiner notes: this limitation is functional, the one-way valve system is configured to maintain a certain pressure; para. 0106-0109),
the combined valve assembly comprising:
a housing (Figs. 1-4C; 30) comprising a valve inlet (Fig. 3-4C; 1, 6, 10) a valve outlet (Fig. 3-4C; 1, 6, 10) and at least one vent opening (Fig. 2C or 4C; 15), a diaphragm (Fig. 2A-2C or 4A-4C; 14), sealingly connected to the housing at an outer circumference of the diaphragm, wherein the diaphragm divides the housing into (Fig. 2A-2C or 4A-4C; Examiner notes: the housing is divided into two sections with the diaphragm in the middle);
a) an upstream portion (from the conduit 1, to 6, 10; Reference “A” in Annotated Figure A below), which is in fluid communication with the valve inlet (Fig. 2A-2C or 4A-4C), and
b) a downstream portion (Fig. 2A, 4A; 13, and 15; Reference “B” in Annotated Figure A below) which is in fluid communication with the valve outlet (Fig. 2A-2C or 4A-4C),
wherein an inner portion of the diaphragm defines a one way inspiratory valve configured to (Fig. 2A-2C or 4A-4C; 14 is the valve that opens into 13 best shown in Fig. 2A);
- allow flow from the valve inlet to the valve outlet when the pressure in the upstream portion of the housing exceeds the pressure in the downstream portion of the housing (figs. 2A, 4A; para. 0112-0117); and
- reduce or substantially prevent flow from the valve inlet to the valve outlet when the pressure in the downstream portion is greater than the pressure in the upstream portion (Fig. 2C or 4C; para. 0085),
wherein an outer portion of the diaphragm defines an expiratory release valve (Fig. 2C or 4C; Examiner notes: allowing the flow of gas to go through the vents 15) that,
- when the pressure in the downstream portion exceeds the pressure in the upstream portion, allows flow from the downstream portion of the housing to ambient atmosphere via the at least one vent opening (Fig. 2C or 4C; 15; para. 0085, 0109); and
- when the pressure in the upstream portion exceeds the pressure in the downstream portion, reduces or substantially prevents flow from the downstream portion of the housing to ambient atmosphere via the at least one vent opening (Figs. 2A-2B or 4A-4B; para. 0112-0117; Examiner notes: the valve is opening allowing the air to be delivered to the patient and when the valve is closed the expiratory air is to be released
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through the vents 15).
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[AltContent: textbox (Figure A: Adapted Fig. 2C and 4C)]
Kuypers does not specifically disclose that the diaphragm has an oval, elliptical or stadium shape.
However, Kruger teaches wherein the diaphragm has an oval, elliptical or stadium shape (Fig. 1-5; 19; para. 0026-0033).
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 diaphragm of Kuypers to be an oval, elliptical or stadium shape as taught by Kruger as these are how diaphragm are shaped and sized in the art and would have been an obvious matter of design choice to have diaphragm shaped as an oval, elliptical or stadium shape (Fig. 1-5) to be able to have a one-way duckbill valve to open and close depending on pressure (para. 0003).
Regarding Claim 39, Modified Kuypers discloses the combined valve of claim 38, wherein the diaphragm has an elongate shape (Fig. 1-5; 19; Kruger), and a ratio of the length of the major axis (“A” in Figure B below) of the diaphragm to the length of the minor axis (“B” in Figure B below) of the diaphragm (Fig. 1-5; 19; Kruger).
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Modified Kuypers does not specifically teach that the ratio is at least 4:3.
However, 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 a ratio of the length of the major axis of the diaphragm to the length of the minor axis of the diaphragm is at least 4:3, 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].
Regarding Claim 40, Modified Kuypers discloses the combined valve of claim 39, wherein the one-way valve formation is configured as a duckbill valve (Fig. 2A-2C or 4A-4C; 14 is the valve that opens into 13 best shown in Fig. 2A; Kuypers; and Fig. 1-5; 22; Kruger), and wherein a base of the duckbill valve has a length dimension substantially parallel to the major axis of the diaphragm and a width dimension substantially parallel to the minor axis of the diaphragm (Shown best in Fig. 3 of Kruger), wherein the length is greater than the width (Fig. 3; Kruger).
Modified Kuypers does not disclose wherein the ratio of length to width is at least 1.5:1.
However, 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 of wherein the ratio of length to width is at least 1.5:1, 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].
Regarding Claim 41, Modified Kuypers discloses the combined valve of claim 40, wherein the diaphragm comprises a cylindrical wall (Fig. 4A; Kuypers) and a retention flange (“C” in Annotated Fig. A above) provided to one end of the cylindrical wall.
Regarding Claim 42, Modified Kuypers discloses the combined valve of claim 38,
Modified Kuypers does not specifically disclose wherein the first portion of the diaphragm is made from a different material to an adjacent portion.
However, Kruger teaches wherein the first portion of the diaphragm (reinforcing region/support material; Examiner notes; made from polymer, particularly preferred polypropylene, polyethylene, polycarbonate, polystyrene, polyamide) is made from a different material to an adjacent portion (valve wall/ functional material; Examiner notes: made from a thermoplastic elastomer, silicone or rubber ) (para. 0035-0039).
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 to have the diaphragm of Kuypers to include the two portions adjacent to each other that are made from different material as taught by Kruger for the purpose of particularly effective supporting effect can be achieved (para. 0037) and high supporting effect can be achieved with a comparatively low material volume. It is possible to provide good support for the valve wall with a relatively thin design (para. 0035).
Regarding Claim 43, Modified Kuypers discloses the combined valve of claim 38, wherein the diaphragm (Fig. 2A-2C or 4A-4C; 14) has regions of differing thickness, wherein one of the regions has a thickness which is at least twice the thickness of another of the regions (Examiner notes: “C” in Figure A above is thicker than the lips 14). 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)).
However, Kuypers does not specifically disclose the diaphragm has regions of differing thickness, wherein one of the regions has a thickness which is at least twice the thickness of another of the regions.
Modified Kruger teaches the diaphragm has regions (valve wall/ reinforcing region; 0029-0030) of differing thickness, wherein one of the regions has a thickness which is at least twice the thickness of another of the regions (para. 0029-0030).
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 to have the diaphragm of Kuypers to include regions of differing thickness, wherein one of the regions has a thickness which is at least twice the thickness of another of the regions as taught by Kruger for the purpose of to providing a valve having a reliable valve function (para. 0003).
Regarding Claim 44, Modified Kuypers discloses the combined valve of claim 43, wherein one of the regions has a thickness which is between two and eight times the thickness of another of the regions (Krugers: para. 0029-0030).
Regarding Claim 47, Modified Kuypers discloses the combined valve of claim 38, wherein the diaphragm has no more than a single axis of symmetry (Fig. 2A-2C or 4A-4C; Examiner notes: axis that runs through the valve opening).
Regarding Claim 48, Modified Kuypers discloses the combined valve of claim 38,
wherein the downstream portion (Reference “B” in Annotated Figure A above) of the housing (Fig. 2A-2C or 4A-4C;30) comprises the valve outlet (through the vents 15),
wherein the diaphragm (Fig. 2A-2C or 4A-4C; 14) comprise a pair of lips (Fig. 2A or 4A the two “\/”) that are pushed towards each other to seal the pathway to the patient interface port when the pressure in the downstream portion exceeds the pressure in the upstream portion (para. 0112-0117), and wherein the pair of lips create an opening to allow airflow to pass through towards the patient interface port entrance (shown best in Figs. 2B or 4B), when the pressure in the upstream portion of the housing exceeds the pressure in the downstream portion (para. 0122).
Regarding Claim 49, Modified Kuypers discloses the combined valve of claim 48, wherein a flow guide (Fig. 2C or 4C; alongside the diaphragm) is provided for each vent opening (each of 15), each flow guide configured to avoid or minimise at least one of
a) sharp corners (Fig. 2C or 4C; para. 0114);
b) sharp angles (Fig. 2C or 4C; para. 0114).
Regarding Claim 50, Modified Kuypers discloses the combined valve of claim 49, wherein each flow guide (Fig. 2C or 4C; along the diaphragm to the exit of the device) comprises ramp portion guiding (curved section) the exhalation airflow to the entrance to the vent opening (Fig. 2C or 4C).
Regarding Claim 51, Modified Kuypers discloses the combined valve of claim 50, wherein each flow guide comprises side wall portions (Fig. 2A-2C or 4A-4C; the wall of vents 15; Kuypers) provided to either side of each respective ramp portion (Fig. 2A-2C or 4A-4C).
Regarding Claim 52, Modified Kuypers discloses a patient interface (Fig. 1 or 3; 16) system for providing an airflow generated by a blower (Fig. 1 or 3; 8) to a patient (para. 0106-0109, 0128), the patient interface system comprising the valve of claim 38 (Fig. 1-4C; 30).
Regarding Claim 53, Modified Kuypers discloses a respiratory treatment system for delivering pressurised air to an entrance to a patient's airways (para. 0106-0109, 0128; Fig. 1 or 3; through the patient interface 16), the respiratory treatment system comprising at least;
a. a blower (Fig. 1 or 3; 8) for generating the pressurised air;
b. a patient interface (Fig. 1 or 3; 16), for sealing delivery of the pressurised air to the patient airways; and
c. the combined one way inspiratory valve and expiratory release valve assembly of claim 38, for controlling air flow to the patient interface (Fig. 1-4C; 30).
Regarding Claim 54, Modified Kuypers discloses the respiratory treatment system of claim 53, further comprising a pressure sensor (Fig. 1 or 3; 19) configured to measure pressure within the patient interface (Examiner note; this limitation is functional), wherein the system controls the blower (Fig. 1 or 3; 8) based on data from the pressure sensor (para. 0137-0140, 0143).
Regarding Claim 55, Modified Kuypers discloses the respiratory treatment system of claim 54, wherein the system(Fig. 1-4C; Kuypers) reduces flow from the blower when the pressure sensor detects (Fig. 1 or 3; 19; Kuypers) that the patient is exhaling (para. 0137-0138; Kuypers).
Regarding Claim 56, Modified Kuypers discloses the respiratory treatment system of claim 53, wherein the system further comprises a conduit (Fig. 1 or 3 ; 1) for delivering of the pressurised air to the patient interface (Fig. 1 or 3; 16), and wherein the combined valve (Figs. 2A-2C or 4A-4B) is included in the conduit (Fig. 1 or 3; para. 0110).
Regarding Claim 57, Modified Kuypers discloses the respiratory treatment system of claim 53, wherein the system (Fig. 1-4C; Kuypers) comprises a portable integrated blower (Fig. 1 or 3; 8; Kuypers)/patent interface (Fig. 1 or 3; 16; Kuypers) system wearable on the patient's face or head (para. 0108-0109; Kuypers).
Claim(s) 45-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuypers and Kruger, as applied to claim 43, in view of Sabo (US 5501214 A).
Regarding Claim 45, Modified Kuypers discloses the combined valve of claim 43,
Modified Kuyper does not specifically disclose wherein the one-way inspiratory valve has a first region having a first thickness and a second region, adjacent the first region, having a second thickness.
However, Sabo teaches wherein the one-way inspiratory valve (Fig. 4-6; 116, 134, 150) has a first region (116) having a first thickness and a second region(150), adjacent the first region, having a second thickness (Fig. 4-6). 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 having ordinary skill in the art before the effective filing date of the invention to modify the inspiratory valve of Kuypers to include that two adjacent portion have different thickness as taught by Sabo for the purpose of effective protection against inversion of its valve element while producing an assembly of uncomplicated yet rugged design, comparatively low cost to manufacture and reliable operation (Col. 3 lines 1-25).
Regarding Claim 46, Kuypers discloses the combined valve of claim 43,
Modified Kuyper does not specifically disclose wherein the expiratory release valve has a first region having a first thickness and a second region, adjacent the first region, having a second thickness.
However, Sabo teaches wherein the expiratory release valve (Fig. 4-6; 124, 126) has a first region (126) having a first thickness and a second region (124), adjacent the first region, having a second thickness. 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 having ordinary skill in the art before the effective filing date of the invention to modify the expiratory release valve of Modified Kuypers to include the first region having a first thickness and a second region, adjacent the first region, having a second thickness as taught by Sabo for the purpose of effective protection against inversion of its valve element while producing an assembly of uncomplicated yet rugged design, comparatively low cost to manufacture and reliable operation and rendering the valve element less resistant to the pressure generated by the patient's expiratory efforts. (Col. 3 lines 1-25; Col. 5 lines 60-65).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Other prior art of note includes Ratner (US 5357951 A; Figs. 2-3), Ritchie et al. (US 8336547 B1) and Kuypers et al. (WO 2008147229 A1; Figs. 1-9).
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MAAP A. ELLABIB
Examiner
Art Unit 3785
/M.A.E./Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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