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 .
This action is in response to the filing on 3/8/2023. Since the initial filing, claims 1-15 have been amended, claims 16-20 have been added and no claims have been cancelled. Thus, claims 1-20 are pending in the application.
Drawings
The drawings are not of sufficient quality to permit examination. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
Specifically, the crowded nature of Figures 2-4 and the greyscale of Figures 3 and 4 renders it difficult to determine which elements link and how the circuits and their components are arranged.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because at least the reference characters related to the NO circuits have been used to designate both the main and back up NO circuits. 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. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitations of claim 12 describe relative positioning of the fluid connection of the backup NO circuit to the main NO circuit and the NO/N2 flow control means with the NO circuit being fluidly connected upstream of the flow control. However, preceding claim 1 also describes this relative position, but places the fluid connection downstream of the flow control. These are mutually exclusive and the limitation of claim 12 cannot be evaluated at this time. However, Examiner reserves the right to apply art once the 112 is rectified. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-11 and 13-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Miller (US 2022/0106189).
In regards to claim 1, Miller discloses NO supply device (system 100) comprising: a main gas circuit comprising at least one main NO line connecting at least one NO input port fluidically to a main output orifice, in order to convey a NO/N2 mixture of the said at least one NO input port to the said main output port (NO source also contains inert gas such as nitrogen, paragraph 69 line 19-23); and a backup circuit comprising a backup NO circuit and a backup O2 circuit, wherein: the backup NO circuit comprises a backup NO line which is supplied with NO/N2 mixture obtained from the said at least one NO input port (paragraph 131, see Annotated Fig 4); and the backup O2 circuit comprises a main O2 line which is in fluid communication with an O2 input port, the main O2 line being connected fluidically to the backup NO line in order to form a common line which is in fluid communication with a secondary output, supplying an NO/N2/O2 mixture (paragraph 133, see Annotated Fig 4), wherein the main NO line comprises means for controlling the flow rate of NO/N2 (regulator 112) which are controlled by control means (controller 480), and the main NO line is connected fluidically to the backup NO line, downstream from the means for controlling the flow rate of NO/N2, by means of a first solenoid valve (valve 420) with a plurality of ways (see Annotated Fig 4).
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Annotated Fig 4
In regards to claim 2, Miller discloses the device of claim 1 and Miller further discloses wherein the first solenoid valve has at least 3 ways (paragraph 89).
In regards to claim 3, Miller discloses the device of claim 1 and Miller further discloses wherein the first solenoid valve with a plurality of ways is controlled by the control means such as to direct the flow of NO/N2 mixture obtained from the NO/N2 flow rate control means (paragraph 131 line 34-35): either into a downstream portion of the backup NO line which is in fluid communication with the common line in fluid communication with the secondary output; or into a downstream portion of the main NO line which is in fluid communication with the main output orifice (see Annotated Fig 4).
In regards to claim 4, Miller discloses the device of claim 1 and Miller further discloses wherein the backup NO line comprises a pneumatic valve (flow regulator 412) which makes it possible to control the circulation of the NO/N2 mixture in the backup NO line, and a second solenoid valve (second valve 430) which is controlled by the control means (paragraph 131 line 38-39, see Annotated Fig 4).
In regards to claim 5, Miller discloses the device of claim 1 and Miller further discloses wherein the main O2 line comprises: - a first control valve (regulator 122) controlled by means for actuation which can be actuated by a user in order to control the circulation of the flow of oxygen into the said main O2 line (regulator can be manually adjusted, paragraph 133), the said means for actuation also being configured to supply an activation signal to the control means in response to actuation of the said means for actuation by the user (Fig 13); and - a second pneumatic control valve which is arranged downstream from the first control valve (see Annotated Fig 4).
In regards to claim 6, Miller discloses the device of claim 5 and Miller further discloses wherein the first solenoid valve has at least 3 ways (paragraph 89), and wherein the control means are configured to control the NO/N2 flow rate control means such as to regulate the flow rate of the NO/N2 mixture in the main gas circuit, and to control the first solenoid valve in response to the receipt of the activation signal supplied after actuation of the means for actuation by the user (paragraph 131, Fig 13).
In regards to claim 7, Miller discloses the device of claim 5 and Miller further discloses wherein the main O2 line additionally comprises: - means for measurement of the flow rate of oxygen which are arranged downstream from the first control valve, and are configured to provide at least one measurement of flow rate of oxygen to the control means; and - means for regulation of the flow rate of O2 arranged downstream from the means for measurement of the flow rate of oxygen (paragraph 133).
In regards to claim 8, Miller discloses the device of claim 1 Miller discloses wherein: -it-the device comprises means for regulation of the NO content which are configured to allow a user to select a desired NO content and supply the said desired NO content to the control means (user interface 460, paragraph 135); and - the control means are configured to calculate a flow rate of NO/N2 mixture to be supplied corresponding to the desired NO content, and to control the NO/N2 flow rate control means in order to supply the said flow rate of NO/N2 mixture calculated (paragraph 137-138).
In regards to claim 9, Miller discloses the device of claim 8 and Miller further discloses wherein the main O2 line additionally comprises:- means for measurement of the flow rate of oxygen which are arranged downstream from the first control valve, and are configured to provide at least one measurement of flow rate of oxygen to the control means; and- means for regulation of the flow rate of O2 arranged downstream from the means for measurement of the flow rate of oxygen (paragraph 133), and wherein the control means are configured to calculate the flow rate of NO/N2 mixture to be supplied from the desired NO content, the flow rate of oxygen measured by the means for measurement of the flow rate of oxygen, and an NO content in the NO/N2 mixture conveyed by the main NO line (paragraph 131).
In regards to claim 10, Miller discloses the device of claim 1 and Miller further discloses wherein the secondary output is configured to be connected fluidically to a manual insufflator (paragraph 134).
In regards to claim 11, Miller discloses the device of claim 8 and Miller further discloses further comprising a digital display screen with touch control, and the means for regulating the NO content comprise at least one touch selection key displayed on the display (paragraph 105).
In regards to claim 13, Miller discloses the device of claim 5 and Miller further discloses wherein the means for actuation comprise a rotary switch which can be actuated by the user (user interface 260 may comprise switches or knobs, paragraph 105).
In regards to claim 14, Miller discloses the device of claim 1 and Miller further discloses wherein the control means (controller 480) comprise at least one microprocessor (paragraph 137 and 169).
In regards to claim 15, Miller discloses the device of claim 1 and Miller further discloses an installation (system 401) for administering therapeutic gas containing NO to a patient (patient 150) comprising an NO supply device according to claim 1 (see above rejection), supplied with NO/N2 mixture by at least one pressurized gas container (NO source 110) and with oxygen by a pressurized oxygen container (O2 source 120), the said NO supply device supplying: - either an NO/N2 mixture via the main output orifice, to a respiratory gas circuit connected to a medical ventilator (ventilator 130),- or an NO/N2/O2 mixture via the secondary orifice, to a manual insufflator or BAVU (paragraph 134).
In regards to claim 16, Miller discloses the device of claim 2 and Miller further discloses an installation (system 401) for administering therapeutic gas containing NO to a patient (patient 150) comprising an NO supply device according to claim 2 (see above rejection), supplied with NO/N2 mixture by at least one pressurized gas container (NO source 110) and with oxygen by a pressurized oxygen container (O2 source 120), the said NO supply device supplying: - either an NO/N2 mixture via the main output orifice, to a respiratory gas circuit connected to a medical ventilator (ventilator 130),- or an NO/N2/O2 mixture via the secondary orifice, to a manual insufflator or BAVU (paragraph 134).
In regards to claim 17, Miller discloses the device of claim 3 and Miller further discloses an installation (system 401) for administering therapeutic gas containing NO to a patient (patient 150) comprising an NO supply device according to claim 3 (see above rejection), supplied with NO/N2 mixture by at least one pressurized gas container (NO source 110) and with oxygen by a pressurized oxygen container (O2 source 120), the said NO supply device supplying: - either an NO/N2 mixture via the main output orifice, to a respiratory gas circuit connected to a medical ventilator (ventilator 130),- or an NO/N2/O2 mixture via the secondary orifice, to a manual insufflator or BAVU (paragraph 134).
In regards to claim 18, Miller discloses the device of claim 4 and Miller further discloses an installation (system 401) for administering therapeutic gas containing NO to a patient (patient 150) comprising an NO supply device according to claim 4 (see above rejection), supplied with NO/N2 mixture by at least one pressurized gas container (NO source 110) and with oxygen by a pressurized oxygen container (O2 source 120), the said NO supply device supplying: - either an NO/N2 mixture via the main output orifice, to a respiratory gas circuit connected to a medical ventilator (ventilator 130),- or an NO/N2/O2 mixture via the secondary orifice, to a manual insufflator or BAVU (paragraph 134).
In regards to claim 19, Miller discloses the device of claim 5 and Miller further discloses an installation (system 401) for administering therapeutic gas containing NO to a patient (patient 150) comprising an NO supply device according to claim 5 (see above rejection), supplied with NO/N2 mixture by at least one pressurized gas container (NO source 110) and with oxygen by a pressurized oxygen container (O2 source 120), the said NO supply device supplying: - either an NO/N2 mixture via the main output orifice, to a respiratory gas circuit connected to a medical ventilator (ventilator 130),- or an NO/N2/O2 mixture via the secondary orifice, to a manual insufflator or BAVU (paragraph 134).
In regards to claim 20, Miller discloses the device of claim 6 and Miller further discloses an installation (system 401) for administering therapeutic gas containing NO to a patient (patient 150) comprising an NO supply device according to claim 6 (see above rejection), supplied with NO/N2 mixture by at least one pressurized gas container (NO source 110) and with oxygen by a pressurized oxygen container (O2 source 120), the said NO supply device supplying: - either an NO/N2 mixture via the main output orifice, to a respiratory gas circuit connected to a medical ventilator (ventilator 130),- or an NO/N2/O2 mixture via the secondary orifice, to a manual insufflator or BAVU (paragraph 134).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arielle Wolff whose telephone number is (571)272-8727. The examiner can normally be reached Mon-Fri 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARIELLE WOLFF/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785
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