DETAILED ACTION
Primary Examiner acknowledges Claims 1-14 are pending in this application as originally filed on June 25, 2024.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because of the following informalities: Para 0147 recites “As illustrated in Fig. 30, as the expiration flow EF continues, having shifted the lip end LE, the expiratory flow plies a force to the remainder of the deformable portion of the divider that moves the divider away from the venting portion side of the conduit toward a position on the opposite support side of the conduit.” However, it appears perhaps the disclosure of “plies” is a typographical error. Primary Examiner is unsure if this limitation should read “applies” or some other limitation. Additionally, Primary Examiner notes this term “plies” is propagated in the claim listing in Claim 3. Appropriate correction and clarification is required.
Claim Objections
Claim 1 is objected to because of the following informalities: In Claim 1, Line 3, the article “a” does not conform to conventional patent practice, as the term “a respiratory conduit” was introduced in the preamble in Claim 1, Line 2. It appears the recitation of Claim 1, Line 3 should recite “the respiratory conduit”. Appropriate correction and clarification 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 3, and 8-10 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.
Specifically, Claim 3, Line 2 recites the limitation “plies”; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure if this is perhaps a typographical error and should read “applies” or some other limitation. Additionally, Primary Examiner notes this term “plies” is propagated in original disclosure as filed in Para 0147. For purposes of this rejection, Primary Examiner will presume the limitation should read “applies”. However, appropriate correction and clarification is required.
Specifically, Claim 8, Line 2 recites “a first side”; however, the breadth and scope of this limitation is unclear, when considering the recitation of “at least a first portion” in Claim 1, Lines 7-8. Primary Examiner is unsure if the “at least a first portion” of Claim 1 is the same as the “first side” of Claim 8, or some other feature. Dependent claims, Claims 9-10, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-5, 7-10, 12, and 13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Almovist et al. (3,716,053).
As to Claim 1, Almovist discloses an expiratory flow resistor (Figures 3 and 4) to permit a stenting pressure above atmospheric pressure in a respiratory conduit (1, “The gas chamber 1 has been divided into two rooms 12 and 13 by means of a wall 14. … As a result of the dividing of the gas chamber 1 into two rooms 12 and 13 by means of the wall 14 only dry inhalation gas may pass the eye pieces 8, while all the exhalation gas passes directly from the inner mask 5 to the outlet in connection with the room 13.” Column 3, Lines 15-40), comprising: the respiratory conduit (1) having an expiratory flow channel (defined by the flow of air exhaled from the patient at 5 along 13, through 22 and 24 to reach the ambient atmosphere); an aperture (22, “The membrane 21 is provided with openings 22 which are covered by an outlet valve 23.” Column 3, Lines 15-35) of the respiratory conduit (1) to release a flow of the expiratory flow channel (defined by the flow of air exhaled from the patient at 5 along 13, through 22 and 24 to reach the ambient atmosphere) to the atmosphere (via 24, “The exhalation gas reaches the surrounding through holes 24 in a lid 25.” Column 3, Lines 15-35); and a cover component (23, “The membrane 21 is provided with openings 22 which are covered by an outlet valve 23. The exhalation gas reaches the surrounding through holes 24 in a lid 25. The outlet valve 23 may be formed by a rubber disk which is connected with the membrane 21 at the center so that the exhalation gas may pass at the periphery of the exhalation valve 23.” Column 3, Lines 15-35), the cover component (23) configured to selectively block the aperture (21), wherein the cover component (23) is flexible (“formed by a rubber disk” Column 3, Lines 15-35) and is loaded (via 20, wherein 20 connects to 19, 17, and 21/23, “The room 12 comprises an inlet valve 19 which may be loaded by a spring 20 and which is controlled by a membrane 21 in the chamber 18 over a lever 17.” Column 3, Lines 15-35) with a tension (a function of the holding force of 20 as engaged with 19, 17, and 21, such that the expansion of 20 via the application of gas through 16/26 holds the cover component 23 in a tensioned in a closed position, whilst, the compression of 20 via the removal of gas through 16/26 permits the cover component to transition to an open position – “The difference in pressure which occurs over the membrane gives a force which actuates the inlet valve 19 over the lever 17 so that a flow of gas is supplied to the user of the apparatus.” Column 3, Line 50 thru Column 4, Line 5), so that at least the first portion (surface of 23 most proximate 22) of the cover component (23) blocks the aperture (22) unless a pressure of the expiratory flow channel (defined by the flow of air exhaled from the patient at 5 along 13, through 22 and 24 to reach the ambient atmosphere) exceeds a pressure threshold (“The difference in pressure which occurs over the membrane gives a force which actuates the inlet valve 19 over the lever 17 so that a flow of gas is supplied to the user of the apparatus.” Column 3, Line 50 thru Column 4, Line 5) that is above atmospheric pressure.
As to Claim 2, Almovist discloses the cover component (23) is coupled to a pivot (via engagement of 14 about 17).
As to Claim 3, Almovist discloses a wall abutment (18 as abutted with 25) of the respiratory conduit (1) applies the cover component (23) against the aperture (22) to provide the tension (a function of the holding force of 20 as engaged with 19, 17, and 21, such that the expansion of 20 via the application of gas through 16/26 holds the cover component 23 in a tensioned in a closed position, whilst, the compression of 20 via the removal of gas through 16/26 permits the cover component to transition to an open position – “The difference in pressure which occurs over the membrane gives a force which actuates the inlet valve 19 over the lever 17 so that a flow of gas is supplied to the user of the apparatus.” Column 3, Line 50 thru Column 4, Line 5) to the cover component (23).
As to Claim 4, Almovist discloses the cover component (23) comprises a flexible membrane (“formed by a rubber disk” Column 3, Lines 15-35).
As to Claim 5, Almovist discloses the pressure of the expiratory flow channel (defined by the flow of air exhaled from the patient at 5 along 13, through 22 and 24 to reach the ambient atmosphere) expands the flexible membrane (“formed by a rubber disk” Column 3, Lines 15-35) to open the aperture (22).
As to Claim 7, Almovist discloses the respiratory conduit (1) comprises a holder ridge (25) and wherein the cover component (23) is further configured within the holder ridge (25) so that a second portion (surface of 23 most proximate 25) of the cover component (23) is configured to prevent flow from the atmosphere into the expiratory flow channel (defined by the flow of air exhaled from the patient at 5 along 13, through 22 and 24 to reach the ambient atmosphere) unless the pressure in the expiratory flow channel (defined by the flow of air exhaled from the patient at 5 along 13, through 22 and 24 to reach the ambient atmosphere) falls below atmospheric pressure. In operation, when the atmospheric pressure (via 24) is greater than the cover component (23) the valve (23) remains closed, whilst, when the atmospheric pressure (via 24) is lower than the cover component (23) the valve opens.
As to Claim 8, Almovist discloses the cover component (23) comprises a first side (surface of 23 most proximate 25) exposed to the ambient (via 24) of the atmosphere and a second side (surface of 23 most proximate 22), that is opposite the first side (surface of 23 most proximate 25), and is exposed to pressure within the expiratory flow channel (defined by the flow of air exhaled from the patient at 5 along 13, through 22 and 24 to reach the ambient atmosphere).
As to Claim 9, Almovist discloses the pressure of the expiratory flow channel (defined by the flow of air exhaled from the patient at 5 along 13, through 22 and 24 to reach the ambient atmosphere) exceeds the pressure threshold (“The difference in pressure which occurs over the membrane gives a force which actuates the inlet valve 19 over the lever 17 so that a flow of gas is supplied to the user of the apparatus.” Column 3, Line 50 thru Column 4, Line 5) that is above atmospheric pressure, the first portion (surface of 23 most proximate 22) of the cover portion (23) is configured to flex away (“The outlet valve 23 may be formed by a rubber disk which is connected with the membrane 21 at the center so that the exhalation gas may pass at the periphery of the exhalation valve 23.” Column 3, Lines 15-35) from the aperture (22) toward an exterior (via 25) of the respiratory conduit (1) such that at least a portion of the aperture (22) of the respiratory conduit (1) is unblocked to permit release of the flow of the expiratory flow channel (defined by the flow of air exhaled from the patient at 5 along 13, through 22 and 24 to reach the ambient atmosphere) to the atmosphere.
As to Claim 10, Almovist discloses at least a second portion (surface of 23 most proximate 25) of the cover component (23) is configured to prevent flow from the atmosphere into the expiratory flow channel (defined by the flow of air exhaled from the patient at 5 along 13, through 22 and 24 to reach the ambient atmosphere) unless the pressure in the expiratory flow channel (defined by the flow of air exhaled from the patient at 5 along 13, through 22 and 24 to reach the ambient atmosphere) falls below atmospheric pressure. In operation, when the atmospheric pressure (via 24) is greater than the cover component (23) the valve (23) remains closed, whilst, when the atmospheric pressure (via 24) is lower than the cover component (23) the valve opens.
As to Claim 12, Almovist discloses the respiratory conduit (1) comprises an inspiratory channel (defined by the flow of fresh gas from 26 along 16 to 12 to 4/5 as abutting the patient), the inspiratory channel (defined by the flow of fresh gas from 26 along 16 to 12 to 4/5 as abutting the patient) being separated from (defined by the connection of 23, 21, 17, and 19 – whereby 14 as connected in the crosshairs of 17 separates the 12 and 13) the expiratory flow channel (defined by the flow of air exhaled from the patient at 5 along 13, through 22 and 24 to reach the ambient atmosphere) by the cover component (23).
As to Claim 13, Almovist discloses the inspiratory channel (defined by the flow of fresh gas from 26 along 16 to 12 to 4/5 as abutting the patient) is adapted to be coupled with an output of a flow generator (“breathing gas” Column 1, Lines 1-15) of a respiratory treatment apparatus (source of “breathing gas” Column 1, Lines 1-15) and an input (via 26/16 – “As is apparent from the FIGS. 3 and 4 the flow of gas to the inner mask through the conduits and the valves takes place under the influence of the pressure in the supply conduit 26 connected to the inlet 16. Accordingly the fall of pressure in these conduits and valves cannot influence the inhalation resistance. This may also be expressed in such a way that the inhalation gas due to the pressure in the supply conduit 26 is blown through the inlet valve and the conduits to the inner mask, whereby the resistance of the inner mask itself is eliminated.” Column 4, Lines 20-35) of a patient interface (4/5, “FIG. 1 shows a breathing apparatus with an outer mask 4, and an inner mask 5.” Column 2, Lines 40-60).
Allowable Subject Matter
Claims 6, 11, and 14 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Allen (1,818,028) discloses an expiratory flow resistor having a respiratory conduit (1), an exhalation flow channel (defined by the exhaled flow from the patient via 5 along 1 to 12, via 11), an aperture (12) of the respiratory conduit (1); and a cover component (11) to selectively block the aperture (12), whereby the cover component (11) that is held in tension via spring (13). Yet, Allen does not expressly disclose the material composition of the cover component to be flexible nor the configuration of a set of bars through which the flexible membrane is inserted a plug configured to selectively insert the aperture, nor the inspiratory channel with a one way valve that holds pressure against the cover component without delivering a flow to the patient interface.
McKesson (1,896,716) discloses an expiratory flow resistor (best seen Figure 4) having a respiratory conduit (63), an exhalation flow channel (defined by the exhaled flow from the patient via 63 through 65, 66, and 70), an aperture (65) of the respiratory conduit (63), and a cover component (66) that is held in tension via spring (67). Yet, McKesson does not expressly disclose the material composition of the cover component to be flexible nor the configuration of a set of bars through which the flexible membrane is inserted a plug configured to selectively insert the aperture, nor the inspiratory channel with a one way valve that holds pressure against the cover component without delivering a flow to the patient interface.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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