DETAILED ACTION
This Office Action is in response to the filing of a preliminary amendment to the claims on 6/07/2023. As per the preliminary amendments, claims 3-9, 11-14, and 16-21 have been amended, and no claims have been added or cancelled. Thus, claims 1-21 are pending in the application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to because Figs. 7, 10, 13, 15-16, 21, 42, 47-50, and 55 fail to comply with 37 CFR 1.84(h)(1) where an exploded view needs to be embraced by a bracket to show the structural relationship between the elements. 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 Objections
Claims 2 and 6 are objected to because of the following informalities:
Claim 2 recites the terms “Push-fit & Twist-release” in line 12. Examiner suggests changing to read --push-fit & twist-release-- in order to remove erroneous capitalization.
Claim 6 recites the terms “Clip-on module” in line 3. Examiner suggests changing to read --clip-on module-- in order to remove erroneous capitalization.
Claim 9 recites the term “PAPR” in line 2. Examiner suggests changing to read --powered air purifying respirator (PAPR)-- in order to clarify the meaning of the acronym.
Claim 13 recites the term “APR” in line 2. Examiner suggests changing to read --air purifying respirator (APR)-- in order to clarify the meaning of the acronym.
Claim 17 recites the term “to normalize persons breathing.” in lines 16-17. Examiner suggests changing to read --adapted to normalize a person’s breathing.-- in order to clarify that a human is not being claimed, as well as correct grammatical issues.
Claim 19 recites the term “Clip-on module” in line 4. Examiner suggests changing to read --clip-on module-- in order to remove erroneous capitalization.
Claim 19 recites the term “PCB” in line 16. Examiner suggests changing to read --printed circuit board (PCB)-- in order to clarify the meaning of the acronym.
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 1-21 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 1 recites the term “such as” in line 7. It is unclear whether or not the limitations which follow are being positively claimed, or are merely exemplary. For the purposes of examination, the limitations will be considered optional and not needed.
Claim 2 recites the term “can each” in line 11. It is unclear whether or not the limitations which follow are being positively claimed, or are merely exemplary. For the purposes of examination, the limitations will be considered optional and not needed.
Claim 6 recites the term “can be” in lines 3 and 5. It is unclear whether or not the limitations which follow are being positively claimed, or are merely exemplary. For the purposes of examination, the limitations will be considered optional and not needed.
Claim 10 recites the limitation "the exhalation valve membrane" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the term “can be” in lines 16 and 18. It is unclear whether or not the limitations which follow are being positively claimed, or are merely exemplary. For the purposes of examination, the limitations will be considered optional and not needed.
Claim 11 recites the limitation "the exhaust filter" in lines 6 and 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the membrane" in line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the term “can be” in lines 16 and 18. It is unclear whether or not the limitations which follow are being positively claimed, or are merely exemplary. For the purposes of examination, the limitations will be considered optional and not needed.
Claim 15 recites the limitation "the short ends" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the head strap buckle" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the head strap " in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 introduces a “clip-on module” in line 4. However, claim 6 upon which it depends already introduces a clip-on module. Hence, it is unclear whether or not this is a new and different clip-on module. For the purposes of examining, they are the same.
Claim 21 recites the language “wherein the mask assembly fits no or more speech diaphragms, no or more inlet valves, no or more exhalation valves” in lines 5-6. It is unclear what this limitation is claiming, as the term “no or more” is not well-understood. For the purposes of examination, any number of these components (including zero) will be understood to meet the claim limitation.
Claim 21 recites the term “can be” in line 7. It is unclear whether or not the limitations which follow are being positively claimed, or are merely exemplary. For the purposes of examination, the limitations will be considered optional and not needed.
Claim 21 recites the limitation “with or without bellow-clips, bellow-links, case-clips, clip-on connectors, bayonet or thread connectors, push-fit and twist-release connectors; wherein the main unit contains any parts, in any sequences to perform any breathing functions.” in lines 8-12. This limitation is indefinite as it appears to contain a respirator and mask assembly that can have any part attached to it. This limitation is so broad that is unclear what elements or “parts” are capable of being attached to the device, and in fact appears to include any physical structure in existence. Furthermore, listing components as “with or without” does not limit the claim in any meaningful way, as any mask device/ respirator can conceivably be “with or without” any component. For the purposes of examination, these limitations are understood to not provide any narrowing of the claim language, and any respirator and mask assembly will be understood to inherently be capable of containing (or not containing) these parts.
Any remaining claims are rejected for being dependent on a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9, 11-14, 16-18, and 20-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fu (WO 2019/071296).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Fu discloses a generic modular respirator comprises: a mask assembly (Fig. 1 mask 40) having a first end (Fig. 1 mask inlet 50) and a second end (Fig. 1 mask outlet 52), a replaceable main unit (Fig. 8 filter unit 14, exhalation unit 16, and air flow generator 20) having a first housing (Fig. 8 a first of filter unit 14 and exhalation unit 16) with a first push-fit and twist release connector (Fig. 7 connection assembly 30; see also [0183]) to engage the first end of the mask, and a second housing (Fig. 8 a second of filter unit 14 and exhalation unit 16) with a second push-fit and twist-release connector (Fig. 7 connection assembly 30; see also [0183]) to engage the second end of the mask, wherein the mask assembly and the main unit are adapted to perform breathing functions (see abstract, by nature of being of respirator), such as breathing protection, breathing training, breathing measurement and diagnostics (see abstract, where the mask at least provides physical protection; see also [0221]); such that the mask assembly is adapted to be quickly fitted to and released (Fig. 7 via connection assembly 30; see also [0183]) from the main unit by actuating the first and second push-fit and twist-release connectors (see [0183]).
Regarding claim 2, Fu discloses wherein the first push-fit and twist release connector comprises a first circular air-passing socket (Figs. 11-12 element C and the airflow path through its circular shape) and a first rotatable control ring (Figs. 11 and 16-17 connection assembly 30 and ring 77) with a latching spring (Fig. 16 spring 178), wherein the second push-fit and twist-release connector comprises a second circular air-passing socket (Figs. 11 and 13 connection assembly 30 and the right-most element (analogous to ‘C’ in Fig. 11)) and a second rotatable control ring (Figs. 11 and 16-17 connection assembly 30 and ring 77) with a latching spring (Fig. 16 spring 178), wherein the first end of the mask assembly has a first pairing air-passing stud (Fig. 12 the extension of filter inlet 66) to connect with the first push-fit and twist- release connector of the main unit and wherein the second end of the mask assembly has a second pairing air-passing stud (Fig. 13 the extension of small air passage 81) to connect with the second push-fit and twist-release connector of the main unit wherein the first and second air- passing studs can each freely rotate within the first and second Push-fit & Twist-release connectors respectively (see Figs. 11-13 where the connection assembly 30 is attached to the extensions of filter inlet 66/ small air passage 81 by a push-fit connection held by a stud (e.g. stud 79) to block longitudinal movement, but there is no structure which blocks rotational movement, thus allowing for free rotation within the connector assembly).
Regarding claim 3, Fu discloses wherein the mask assembly has an internal bridge piece (see Fig. 45 bridge structure 321), wherein the mask assembly comprises an exhalation valve (see [0208] where the mask can include a drain valve, allowing some amount of exhalation when active), wherein the bridge piece stiffens the internal cavity of the mask (see Fig. 45 bridge structure 321, which is understood to provide some stiffening to the mask in the same manner as the applicant’s claimed invention).
Regarding claim 4, Fu discloses wherein the first housing and the second housing each comprises a middle portion (see Fig. 1 the middle of filter unit 14 and exhalation unit 16) with flexible concertina shaped walls (Figs. 48-50 the outer walls of bellows 336) wherein the middle portion is a connector assembly (Fig. 8 where each of the filter unit 14 and exhalation unit 16 have pipe threads 62/70 that act as a connector assembly) comprises a bellow-link (Figs. 48-50 bellows 336) and a case-clip (Figs. 48-50 threaded adjusting ring 332) wherein the connector assembly is each adapted for connecting the proximal portion to the distal portion of the housings (see Fig. 8 where the connector assemblies of threads 62/70 connect the housings of units 14/16 to the rest of the body), such that the bellow- link allows the housings to arcuate when the neck abuts the middle portion (see Figs. 36-37 where the neck portion at neck band 142 is arcuate about the neck, and shaped based on the connections from the units 14/16 to the rest of the device), such that the case-clip allows modularity between the proximal portion of the housing and the distal portion of the housing (see [0232] where the ring 332 allows for adjustments), such that the case-clip allows servicing the proximal portion and the distal portion of the housing differently (see [0232] where the ring 332 allows for adjustments to the length of the pipe, and thus servicing the length of the housings).
Regarding claim 5, Fu discloses wherein the first housing and the second housing each comprises a distal portion (see Fig. 1 distal parts of filter unit 14 and exhalation unit 16) with a case-clip (Figs. 10-11 connector assembly 30 having studs 79).
Regarding claim 6, Fu discloses wherein the first housing and the second housing each comprises a Clip-on module at the bottom of the housing (Fig. 13 air filter 74 and cover 75 filter unit 14 and exhalation unit 16; see [0164] and [0166] where the filter and cover snap into the bottom of the housing of each of filter unit 14 and exhalation unit 16), wherein the Clip-on module can be removed from the first housing and the second housing, wherein the first housing and second housing can be washed and serviced ([0164] where the filter can be removed and cleaned), wherein the first housing and the second housing each comprises an add-on module (see Figs. 11-13 where the extensions of filter inlet 66/ small air passage 81 are an add-on module) with or without a push-fit and twist-release connector at the distal portion of the housing (Fig. 1 where the connector assembly 30 can be included).
Regarding claim 7, Fu discloses wherein the first housing and the second housing are further linked by a neck assembly (Figs. 6-11 air flow generator 20 connecting the filter unit 14 to the exhalation unit 16) having a first end (Figs. 6-11 blower unit 22) and a second end (Figs. 6-11 controlling unit 26), wherein the first end of the neck assembly is adapted to engage with a first distal end (Figs. 6-11 where blower unit 22 has a connector assembly 30 to engage with filter unit 14) of the first housing, and the second end of the neck assembly is adapted to engage with a second distal end (Figs. 6-11 where controlling unit 26 has a connector assembly 30 to engage with exhalation unit 16) of the second housing, wherein the neck assembly provides a channel for fluid communication (Figs. 32-34 where blower unit 22 if part of an air circuit of air flow generator 20, having a channel for airflow) and/or for electrical communication (Fig. 9 cable 140; see [0205]) between the first housing and the second housing; wherein one or more connections (Fig. 9 cable 140; see [0205]) between the neck assembly and the housings are fixed wherein one of more connections between the neck assembly and the housings are removeable by a bayonet or thread connectors (Fig. 7 connection assembly 30 and [0183] where the blower unit 22 an controlling unit 26 removably connect via the connection assembly 30 with its push-fit connection to the filter unit 14 and exhalation unit 16).
Regarding claim 8, Fu discloses wherein the mask assembly has a head strap assembly (Fig. 3I pull-over bands 48) attachment means for securing a head strap assembly to the mask assembly (see Figs. 1-2 where the bands 48 connect to the mask 40); wherein the first housing, the second housing and the neck assembly have cooperating means to engage with the head strap assembly for securing the respirator to the head (Fig. 11 see neck band 80 which connects to the filter unit 14 and exhalation unit 16 via the connector assemblies 30).
Regarding claim 9, Fu discloses wherein the respirator is adapted as Healthcare PAPR (see [0088]) to be used for respiratory protection; wherein the first housing encapsulates a prefilter (Fig. 24 pre-filter 110), a blower (Fig. 24 blower 108) and a main filter (Fig. 12 filter inlet 66) wherein the second housing encapsulates a control unit (Fig. 2 controlling unit 26) with a power source (Fig. 23 power unit 24), an exhalation valve (Figs. 13-14 exhalation valve 73) and filter (Fig. 13-14l exhaled air filter 74) wherein the mask is in fluid communication with the first housing and the second housing (see Figs. 1-2 where mask 40 communicates with filter unit 14 and exhalation unit 16); wherein the blower is adapted for pumping the filtered air from the first housing to the mask ([see [0213]), wherein the exhaled air exits from the mask to the second housing, wherein the first housing (see [0166]), the mask and the second housing jointly form an air passage to pass therethrough (see Figs. 1-2 and [0166] and [0213] where and air flow passage is formed between mask 40 and exhalation unit 16 to exhale the air).
Regarding claim 11, Fu discloses wherein the first distal portion has a prefilter slot (Fig. 24 prefilter 110 having some space that receives it) adapted for receiving a prefilter frame (Fig. 24 prefilter 110, which is received within the slot designated for it formed by the walls of blower casing 100 and filter cover 112), wherein the prefilter is mountable to the prefilter frame (see Fig. 24 where the prefilter 110 is mounted within the walls of the casing 100); and wherein a cross-sectional shape of the slot is arcuate from an upper surface to a lower surface of the first distal end (Fig. 24 prefilter 110 where the cross-sectional shape is circular, and thus arcuate); wherein any one of the main filter and the exhaust filter is adapted to be comoulded or glued to a filter frame (Fig. 24 prefilter 110 which is part of the blower casing 100 and capable of being moulded alongside the casing 100 and filter cover 112), wherein the filter frame has a rectanguloid profile (Figs. 18 and 24 where blower unit 22 has prefilter 110, with the frame 112 fitting over it and having an arrangement of holes that are in a rectangular profile).
Regarding claim 12, Fu discloses wherein the first distal end of the first housing and the second distal end of the second housing each has a cable outlet (Fig. 37 cable 140 having an outlet into each of filter unit 14 and exhalation unit 16) for receiving insulated electrical cables such that the control unit is in electrical communication with the blower (see Fig. 37 cable 140 and [0205] which must have some insulation); wherein the insulated electrical cable is covered by an elastic sleeve (Fig. 37 neck band 142 and [0188] and [0205]-[0206] where the neck band is elastic and sleeve-shaped).
Regarding claim 13, Fu discloses wherein the respirator is adapted as a healthcare APR ([0014]-[0015]) to be used for respiratory protection (see [0221]); wherein the mask assembly, the first proximal portion of the first housing and the second proximal portion of the second housing having a Healthcare PAPR structure (see [0088]); wherein the first housing encapsulates a main filter (Fig. 12 filter unit 16) wherein the second housing encapsulates an exhalation valve and filter (Fig. 13 filter 74 and valves 73) wherein the mask is in fluid communication with the first housing and the second housing wherein the first distal portion of the first housing has an air inlet (Figs. 1 and 12 where filter inlet 66 is the air inlet that communicates with mask 40), and wherein a first proximal portion of the first housing has an air outlet (Fig. 12 filter outlet 67 directly connecting to mask 40); wherein the second proximal portion of the second housing has an exhaust inlet (Fig. 13 exhaust inlet 72), an exhaust outlet (Fig. 13 exhaust outlet 75), such that the exhalation valve and filter are positioned between the exhaust inlet and the exhaust outlet, wherein the exhalation valve membrane has a long pivot (Fig. 13 where valves 73 and filter 74 are between the inlet 72 and outlet 75) that allows the membrane to open along the long sides under positive pressure (see Fig. 13 where valves 73 are one-way valves, thus having a membrane that opens only under positive pressure), wherein the distal portion of first housing has a case-clip (Figs. 11-12 stud 79 on filter unit 14), a cord clip (Fig. 11 mating unit 82 which has a clip member attaching to neck band 80), a prefilter (Figs. 11 and 21 adjusting means 84, which performs some amount of filtering through its holes) and an air inlet (Fig. 21 the airholes of adjusting means 84), wherein the distal portion of the second housing has a case-clip (Figs. 11 and 13 exhalation unit 16 having stud 79), a cord clip (Fig. 11 mating unit 82 which has a clip member attaching to neck band 80) and a blocked end (Fig. 21 stub 82); wherein by removing the distal portions of the first and second housing, both the main filter and exhaust filter can be replaced, and the entire airpath comprising the mask assembly, the proximal portion of the first and second housings can be washed or sterilized and wherein the healthcare APR is interchangeable (see [0164] where the pieces can be removed from one another, allowing for easy replacement).
Regarding claim 14, Fu discloses wherein the respirator is adapted to be used as an Industrial PAPR ([0014]-[0015]) for filtering particulates or gas in industrial occupations, wherein the front of the mask assembly comprises an exhalation valve; (Fig. 35 exhalation assembly 203 being valves on the front of the mask) wherein the first housing encapsulates a prefilter (Fig. 24 prefilter 110), and a main filter (Fig. 12 filter 65), wherein the second housing encapsulates a controller (Fig. 23 controlling unit 26), a battery pack (Fig. 23 power unit 24; see also [0174]) and a sealed airpath (Fig. 32- 33 blower unit 22 being an airpath sealed by the blower casing 100), wherein the neck assembly encapsulates a blower (Fig. 34 electric blower 108 and [0211]) wherein the blower is adapted for pumping the filtered air from the first distal end of the first housing to the mask assembly via the second distal end of the second housing ([see [0213]), wherein the neck assembly comprises a bellow connector (Fig. 34 thread connector 202) engageable between a first bellowed portion and a second bellowed portion (Fig. 34 blower 22 and electric blower 108 where there is an air pipe 204 that is bellowed and on either end of the blowers; see [0214]), wherein the first bellowed portion is in connection with the first distal end of the first housing with a releasable bayonet connector (Fig. 34 thread connector 202 and [0217]-[0219]) and the second bellowed portion is in connection with the second distal end of the second housing with a fixed connector;(Fig. 34 thread connector 202 and [0217]- [0219]) wherein the bellow connector is adapted to receive a blower (see Fig. 34 where the blowers 22/108 are received within the two thread connectors 202) therein wherein the controller is in electrical communication with the blower (Fig. 34 electric cable 201), wherein the controller measures the pressure in the mask, and based on the pressure measurement, the controller dynamically regulates the blowing strength of the blower such that a positive air pressure in the mask assembly is maintained (see [0176]).
Regarding claim 16, Fu discloses wherein the sealed airpath in the second housing transports filtered air (Figs. 36-45 the shown respirator 10 and the housing components thereof; see [0222]-[0236]) from the distal end to the proximal end, wherein an electrical cable (Figs. 36-45 cable assembly 318; see [0222]-[0236]) is entered at the distal end of the airpath to link between the blower and the controller, wherein the cable entry is sealed by a grommet (Fig. 38 where the cable is shown to be held by a grommet member), wherein the middle section of the neck assembly has a soft neckpad (Figs. 36-45 neckband 142), wherein there is a retaining means to help engage with the head strap buckle (Figs. 36-45 string 312 and latch 316), wherein the head strap pulls the neck assembly against back of the neck to secure the respirator around the head (Figs. 36-45 see string strap assembly 310; see also [0222]-[0236]).
Regarding claim 17, Fu discloses wherein the respirator is adapted to be used as a measurement respirator (see [0169]); wherein the first housing encapsulates a battery (see [0174] is within the casing of controlling unit 26) and a desiccator (Fig. 12 filter 65; see also [0162] where the activated carbon filter absorbs contaminants, and thus acts as a desiccator), and wherein the second housing encapsulates a control unit (see [0168]) and a breathing airway (see [0168]); wherein the mask encapsulating a breath sampler (see [0168]-[0169]); wherein a flexible concertina shaped neck assembly (Fig. 34 air pipe 204) encapsulating a pump (Fig. 34 blower 108) and a CO2 sensor (see [0173]); wherein the pump is adapted for pumping sampled air from the breath sampler to the CO2 sensor via the desiccator (see [0178]-[0179]); wherein the control unit is in electrical communication with the pump and the CO2 sensor (see [0178]-[0179]); wherein the control unit measures and records the breathing related physiological data (see [0178]-[0179]), and wherein the recorded data is wirelessly communicated from the control unit to a remote terminal unit (see [0178]-[0179]); wherein the desiccator is in fluid communication between the breath sampler, and the CO2 sensor (see Figs. 32-34 where the desiccator is within the filter unit 14); wherein the measurement respirator provides a tool to normalise persons breathing (see [0176] via the controller operating the blower).
Regarding claim 18, Fu discloses wherein the respirator is adapted to be used as a training respirator ([0088]), wherein a first distal end of the first housing has an air flow dial ([0167]) adapted to adjust a size of an opening ([0187]) for air to enter the first housing, and for controlling inhalation resistance (see [0187]); wherein the air flow dial comprises a multi-step setting to set the opening into different predetermined sizes (see [0187]); wherein a second distal end of the second housing has a circular exhaust membrane for exhaled air to exit the second housing (Fig. 13 valve 73); wherein the circular exhalation valve membrane has an off-centre pivot pin (Fig. 13 the pins of valves 73 which are not centrally-located within exhalation unit 16).
Regarding claim 20, Fu discloses wherein the respirator is adapted to be used as a training respirator ([0088]) with breathing measurement ([0169]) and programmable breathing resistance; ([0176] and [0216]) wherein the add-on module of the first housing comprises an electronic actuator to control the air flow dial or breathing resistance based on
the measured breathing related physiological parameters ([0176] where the breathing resistance from the blower is controlled by the controller), wherein the add-on module is in fixed connection (Figs. 36-45 hooks 314 and [0222]-[0236]) to the first housing to allow electrical connection between the first housing and the add-on module (see [0222]-[0236] and Fig. 37 where the hook 314 helps carry and allow cable 140 enter the housing), wherein the electronic actuator is one selected from a group of a solenoid valve and a blower (see [0176] where there is a blower) for blowing against the direction of inhalation and wherein the breathing resistance is electrically controlled and is programmable (see [0176] where the blower is controlled by the controller).
Regarding claim 21, Fu discloses wherein the mask assembly covers nose, or nose and mouth, or nose and mouth and eyes (see Fig. 1 the oronasal style mask 40, covering at least the nose and mouth); wherein the mask assembly fits no or more speech diaphragms, no or more inlet valves, no or more exhalation valves (indefinite as seen in above 25 U.S.C. 112(b) rejection. Limitation requires no actual listed components to be met, and therefore is inherent to any and every mask assembly); wherein the main unit can be adapted to a specific functional respirator (see Fig. 1 where the units 14/16 and generator 20 act as a respirator) with or without bellow-clips, bellow-links, case-clips, clip-on connectors, bayonet or thread connectors, push-fit and twist-release connectors; wherein the main unit contains any parts, in any sequences to perform any breathing functions (indefinite, and covered by any mask assembly).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Fu as applied to claim 9 above, and further in view of Virr et al. (WO 2011/006206).
Regarding claim 10, Fu discloses wherein the connector assembly of the first
housing comprises an airflow guard (Fig. 24 blower inlet 106 provides some physical airflow guarding structure), wherein the blower is received in the airflow guard (Fig. 24 blower unit 22 within the structure defined by the blower inlet 106), wherein the first distal portion of the first housing has an air inlet (Fig. 24 prefilter 110), and wherein a first proximal portion of the first housing has an air outlet (Fig. 24 blower outlet 107) wherein the second proximal portion of the second housing has an exhaust inlet (Fig. 13 exhaust inlet 72), an exhaust outlet (Fig. 13 exhaust outlet 71) such that the exhalation valve and filter are positioned between the exhaust inlet and the exhaust outlet (see Fig. 13 the filter 74 and valves 73 between the inlet and outlet 71/72), wherein the exhalation valve membrane (Fig. 13 membrane of one-way valve 73) has a long pivot (Fig. 13 central pivoting pin of valve 73) that allows the membrane to open along the long sides under positive pressure (see [0166]), wherein there is a pressure sensing port ([0168]) between the proximal and distal portion of the second housing and wherein by removing the distal portions of the first and second housing, both the main filter and exhaust filter can be replaced (see [0164]), and the entire airpath comprising the mask assembly, the proximal portion of the first and second housings can be washed or sterilized (see [0164]).
Fu lacks a detailed description of wherein the sensing port uses an air-passing membrane to block moisture and foreign substance to enter the sensing port.
However, Virr teaches a respirator device, wherein an airflow path uses an air-passing membrane (Fig. 15 wicking material 44 and page 17 lines 12-19) to block moisture and foreign substance to enter the sensing port (see page 17 lines 12-19).
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 sensing airflow path of Fu to include a wicking membrane as taught by Virr, as it would provide a membrane that removes any moisture from the air while letting the air pass, to maintain more accurate readings as well as prevent moisture from clogging or damaging the sensing port.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Fu as applied to claim 14 above, and further in view of Kao et al. (US Pat. 10,786,691) in view of Virr.
Regarding claim 15, Fu discloses wherein the first housing comprises two shell halves linked by a tether (see Figs. 24-28 where a top shell 102 and bottom shell 104 are joined by a joint tether; see [0189]); the air inlet (see Fig. 12 filter inlet 66), and an integrated airpath at the air outlet (see Fig. 12 filter outlet 67); wherein the integrated airpath of the main filter has a bayonet connection at the outlet for releasably connecting with the neck assembly (see [0161]-[0164]); wherein the first circular push-fit socket is blocked by a plug (see Fig. 8 where the extension of push-fit connector 79 acts as a block to at least partially block the socket of connector assembly 30); wherein the exhalation valve membrane is in oval shape with two pivot pins (see Fig. 13 valve 73 with the pivot pins over each valve), wherein the membrane opens along the short ends under positive pressure (see [0166]).
Fu lacks a detailed description of wherein the two shell halves are closed by a filter door and secured by a lock.
However, Kao teaches a respirator where the filter is connected to a housing by being enclosed by a filter door (see Figs. 47-48 door 515 that fits over filter cartridge 516), and secured with a locking mechanism (see Figs. 47-48 via lug 530).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the placement of the filter within the housing of Fu to be held within a filter door secured by a lock as taught by Kao, as it would easy access to replace the filter as needed, while being able to secure it in place when in use.
The modified Fu device lacks a detailed description of wherein the main filter comprises a pleated paper section, wherein a curved pleated prefilter is fitted with the filter door.
However, Virr teaches a respirator device, where a filter can be a HEPA filter made of paper (see page 26 lines 5-7, where a HEPA filter is understood to be pleated).
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 type of filter of the modified FU device to be a pleated HEPA filter as taught by Virr, as it would be a simple substitution of one type of filter for another, to yield the predictable result of providing a filter for contaminants. In the modified Fu device, the filter is arranged to curve with the shape of the filter door (Kao; see Figs. 47-48 where filter 516 aligns with door 515 in a curved shape).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Fu as applied to claim 6 above, and further in view of Fu.
Regarding claim 19, Fu discloses wherein the respirator is adapted to be used as a training respirator (see [0088]) with breathing measurement (see [0169]); wherein the first and second housing each has a Clip-on module (see Fig. 13 filter and filter cover 74/75 on unit 16; and see Figs. 32-33 the filter on unit 14); wherein the first housing has a flow element to produce signals for the entered airflow (see Figs. 12 and 32-33 where filter 65 is a flow element, and will produce some signal change in the airflow); wherein the second housing has a flow element to produce signals for the exhaled flow (see Figs. 13 and 32-33 where valves 73 are a flow element, and will produce some signal change in the airflow); wherein the distal portion of the first and second housing each has an add-on module with or without a push-fit and twist-release connector (see Figs. 11-13 and 21 where unit 14 has an add-on of dial 84, and unit 16 has an add-on of valves 73); wherein the add-on module of the first housing has an air flow dial adapted to adjust a size of an opening for air to enter the first housing (see Fig. 21 dial 84; see also [0184]); wherein the add-on module of the second housing has a circular exhaust membrane for exhaled air to exit the second housing (see Figs. 13-14 the shape of valves 74 and their membrane flaps); wherein the circular exhalation valve membrane has an off-centre pivot pin (see Figs. 13-14 where the pivot pins in the middle of valves 73 are off-centre with respect to the housing of exhalation unit 16); wherein the clip-on modules on the second housing comprises a sensing PCB and a battery (Fig. 23 and [0168] and [0216]); wherein the clip-on modules sense the signals for the entered and exhaled air for measuring breathing data (see [0168]-[0170] and [0172]-[-182] where air pressure and carbon dioxide are measured); wherein the breathing data include power of breathing, work of breathing, and other breathing data (see [0168]-[0170] and [0172]-[-182] where air pressure and carbon dioxide are measured, which can correlate to power and work of breathing); wherein power of breathing and work of breathing data are used to quantity the breathing effort of the user against the resistance imposed by the respirator (see [0176] and [0180]-[0181] where the breathing data can be used to control the blower and resistance); wherein power of breathing and work of breathing are used to quantity the breathing efficiency of the user when doing certain exercises (see [0178] and [0221] where the analyzed data can be analytically used during breathing technique training, and thus is indicative of an efficacy of the training); wherein the sensing PCBs transmit the measured breathing data to remote devices (see [0178]).
Fu lacks a detailed description of wherein the clip-on modules on the first housing comprises a sensing PCB and a battery.
However, Fu further teaches where the electronics for sensing and a flow sensor can be fitted on the blower unit (see Figs. 9 and 18-22 where blower unit 22, which is attached to the filter unit 14, can have the sensor as well; see also [0173]).
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 first housing of Fu to contain the flow sensing system on the blower as taught by Fu (Figs. 9 and 18-22; see also [0173]), as it would provide additional analytics and control over the airflow to the person, allowing for more accurate data and granularity over controlling the airflow. It is understood that the modified blower unit contains the same system as the exhalation unit, and thus also contains a sensing PCB and battery.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Templeton et al. (US Pub. 2004/0003810) and Kippax (US Pat. 5,584,286) are cited to show similar respirator devices.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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