DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1-2, 4-12, 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-12, 16-17 of U.S. Patent No. 12138396. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ‘396 patent are narrower than the claims in the instant application and thus fully encompass the claimed subject matter.
Claim 1 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12138396.
Claim 2 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12138396.
Claim 4 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12138396.
Claim 5 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12138396.
Claim 6 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12138396.
Claim 7 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12138396.
Claim 8 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12138396.
Claim 9 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12138396.
Claim 10 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12138396.
Claim 11 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12138396.
Claim 12 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 12138396.
Claim 14 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12138396.
Claim 15 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12138396.
Claim 16 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 12138396.
Claim 17 of the instant application is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12138396.
Claims 3 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11, respectively, of U.S. Patent No. 12138396 in view of Blaise (US 2005/0172966 A1).
Claims 3 and 13 of the instant application differ from claims 1 and 11 of U.S. Patent No. 1213896, respectively as claim 3 requires wherein the constant flow of therapeutic gas is measured by a second flow sensor in fluid communication with the therapeutic gas supply and claim 13 requires measuring the constant flow of therapeutic gas.
However, Blaise discloses a flowmeter 107 which measures the flow of NO through 104 [0049], which is then used to estimate the total amount of NO injected to the patient [0063] and NO flow curve [0067] [0069], both of which can be interpreted as a dose. Further these calculations are displayed on 101 as per [0062]-[0069].
Therefore, it would have been obvious to one having ordinary skill in the art before the invention was made to have modified Blaise’s backup unit to include a flow meter downstream of the valve 139, which data from the flow meter is then used to estimate the total amount of NO injected to the patient [0063] and NO flow curve [0067] [0069], both of which can be interpreted as a backup dose estimate. Further these calculations are displayed on 101 as per [0062]-[0069]. This would be very beneficial to be able to obtain the same information as when the system was working properly without any malfunctions [0072].
Claim 1 of ‘396 as modified by Blaise further discloses the constant flow of therapeutic gas is measured by a second flow sensor (as set forth above) in fluid communication with the therapeutic gas supply (Blaise: downstream of 139 which is in fluid communication with 120 as shown in figure 5) and thus also measuring the constant flow of therapeutic gas as required by claims 3 and 13 of the instant application.
Claim Objections
The claims are objected to because of the following informalities:
After the first instance of “therapeutic gas” and “breathing gas”, all subsequent instances should read “the therapeutic gas” and “the breathing gas”.
Claim 13 recites “the constant flow”. This should read “the known constant flow”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 reads “a therapeutic gas concentration”. It is unclear if this is the same therapeutic gas concentration as recited in claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Blaise (US 2005/0172966 A1).
Regarding claim 1, Blaise discloses:
An apparatus to deliver therapeutic gas to a patient (figure 5), the apparatus comprising:
a therapeutic gas injector module (112 + 100) comprising:
a first inlet in fluid (131) communication with a therapeutic gas supply (120) providing a flow of nitric oxide at a therapeutic gas supply concentration (from 120) [0071];
a second inlet (where 130 means 108) in fluid communication with a breathing gas delivery system (108) providing a flow of a breathing gas [0053]; and
an outlet (at 128) to supply a combined flow of breathing gas (from 108) and therapeutic gas (from 120) to the patient (see figure 5) [0071];
a control circuit (140) including a first flow sensor (106) to measure the flow of breathing gas from the breathing gas delivery system [0054]-[0055], wherein the control circuit comprises a mode (constant mode as discussed in [0061] [0008]) operable to deliver a known constant flow of therapeutic gas (a predetermined flow as per [0061] [0008]) and estimate a backup dose based on the known constant flow of therapeutic gas (a flowmeter 107 which measures the flow of NO through 104 [0049]) and the measured flow of breathing gas [0054]-[0055] (which is then used to estimate the total amount of NO injected to the patient [0063] and NO flow curve [0067] [0069]); and
a display (101) [0062], in communication with the control circuit [0060], that provides the estimate of the backup dose (a flowmeter 107 which measures the flow of NO through 104 [0049], which is then used to estimate the total amount of NO injected to the patient [0063] and NO flow curve [0067] [0069], both of which can be interpreted as a dose. Further these calculations are displayed on 101 as per [0062]-[0069]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-5, 7-9, 11-15 and 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Blaise (US 2005/0172966 A1).
Regarding claim 1 (in an alternative interpretation to the rejection of claim 1 set forth above), Blaise discloses:
An apparatus to deliver therapeutic gas to a patient (figure 5), the apparatus comprising:
a therapeutic gas injector module (112 + 100) comprising:
a first inlet in fluid (131) communication with a therapeutic gas supply (120) providing a flow of nitric oxide at a therapeutic gas supply concentration (from 120) [0071];
a second inlet (where 130 means 108) in fluid communication with a breathing gas delivery system (108) providing a flow of a breathing gas [0053]; and
an outlet (at 128) to supply a combined flow of breathing gas (from 108) and therapeutic gas (from 120) to the patient (see figure 5) [0071];
a control circuit (140) including a first flow sensor (106) to measure the flow of breathing gas from the breathing gas delivery system [0054]-[0055], wherein the control circuit comprises a mode (backup unit mode as discussed in [0071]) operable to deliver a known constant flow of therapeutic gas (a predetermined flow as per [0071])
a display (101) [0062], in communication with the control circuit [0060].
Blaise does not explicitly state a backup dose is estimated based on the known constant flow of therapeutic gas and the measured flow of breathing gas, the display, in communication with the control circuit, that provides the estimate of the backup dose.
However, Blaise discloses a flowmeter 107 which measures the flow of NO through 104 [0049], which is then used to estimate the total amount of NO injected to the patient [0063] and NO flow curve [0067] [0069], both of which can be interpreted as a dose. Further these calculations are displayed on 101 as per [0062]-[0069].
Therefore, it would have been obvious to one having ordinary skill in the art before the invention was made to have modified Blaise’s backup unit to include a flow meter downstream of the valve 139, which data from the flow meter is then used to estimate the total amount of NO injected to the patient [0063] and NO flow curve [0067] [0069], both of which can be interpreted as a backup dose estimate. Further these calculations are displayed on 101 as per [0062]-[0069]. This would be very beneficial to be able to obtain the same information as when the system was working properly without any malfunctions [0072].
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Regarding claim 2, Blaise as modified for claim 1 above further discloses wherein the control circuit assigns a set flow rate (a flowmeter 107 which measures the flow of NO through 104 [0049] [0069]) based on the constant flow of therapeutic gas (107 measures the constant flow).
Regarding claim 3, Blaise as modified for claim 1 above further discloses the constant flow of therapeutic gas is measured by a second flow sensor (see rejection of claim 1 above) in fluid communication with the therapeutic gas supply (downstream of 139 which is in fluid communication with 120 as shown in figure 5).
Regarding claim 4, Blaise as modified for claim 1 above further discloses wherein the display further provides a chart or graphic [0062]-[0069] to predict a therapeutic gas concentration for a plurality of breathing gas flow rates (as shown in figures 7, 8 a ventilation flow curve and NO concentration show curve are shown which predict the therapeutic gas concentration over a plurality of breathing gas flow rates as the curve is semi-sinusoidal).
Regarding claim 5, Blaise as modified for claim 1 above further discloses wherein the display also provides a visual and/or numeric indication of the measured flow of breathing gas [0062] [0068]-[0069].
Regarding claim 7, Blaise as modified for claim 5 above further discloses wherein the visual and/or numeric indication is an icon or graphic on the display that provides a visual and/or numeric indication of the measured flow of breathing gas [0062] [0068]-[0069].
Regarding claim 8, Blaise as modified for claim 5 above further discloses wherein the measured flow of breathing gas is one or more of an average flow rate, an instantaneous flow rate [0054], a peak flow rate and/or a minimum measured flow rate.
Regarding claim 9, Blaise as modified for claim 1 above further discloses wherein the breathing gas delivery system comprises a ventilation apparatus (108).
Regarding claim 11, Blaise discloses: A method of monitoring delivery of a therapeutic gas to a patient comprising:
providing a flow of breathing gas (from 108 [0053]);
providing a flow of therapeutic gas comprising nitric oxide (from 112);
measuring the flow of breathing gas to obtain a measured flow of breathing gas (via flow sensor 106) [0054]-[0055];
obtaining a known constant flow of therapeutic gas (a predetermined flow as per [0071]);
receiving from a user a desired delivery concentration of the therapeutic gas to be delivered to the patient [0061];
delivering the breathing gas and therapeutic gas to the patient (see figure 5) [0071].
Blaise does not explicitly state a backup dose is estimated based on the known constant flow of therapeutic gas and the measured flow of breathing gas, and displaying the estimated backup dose.
However, Blaise discloses a flowmeter 107 which measures the flow of NO through 104 [0049], which is then used to estimate the total amount of NO injected to the patient [0063] and NO flow curve [0067] [0069], both of which can be interpreted as a dose. Further these calculations are displayed on 101 as per [0062]-[0069].
Therefore, it would have been obvious to one having ordinary skill in the art before the invention was made to have modified Blaise’s backup unit to include a flow meter downstream of the valve 139, which data from the flow meter is then used to estimate the total amount of NO injected to the patient [0063] and NO flow curve [0067] [0069], both of which can be interpreted as a backup dose estimate. Further these calculations are displayed on 101 as per [0062]-[0069]. This would be very beneficial to be able to obtain the same information as when the system was working properly without any malfunctions [0072].
Regarding claim 12, Blaise as modified for claim 11 above further discloses wherein the known constant flow of therapeutic gas is a set flow rate (a flowmeter 107 which measures the flow of NO through 104 [0049] [0069]) (further [0071] indicates user sets the flow).
Regarding claim 13, Blaise as modified for claim 11 above further discloses measuring the constant flow of therapeutic gas (see rejection of claim 1 above) (a flowmeter 107 which measures the flow of NO through 104 [0049] [0069]).
Regarding claim 14, Blaise as modified for claim 11 above further discloses: the method comprising displaying a chart or graphic to predict a therapeutic gas concentration for a plurality of breathing gas flow rates a chart or graphic [0062]-[0069] (as shown in figures 7, 8 a ventilation flow curve and NO concentration show curve are shown which predict the therapeutic gas concentration over a plurality of breathing gas flow rates as the curve is semi-sinusoidal).
Regarding claim 15, Blaise as modified for claim 11 above further discloses: the method further comprising displaying the measured flow of breathing gas [0062] [0068]-[0069].
Regarding claim 17, Blaise as modified for claim 15 above further discloses: wherein the measured flow of breathing gas is one or more of an average flow rate, an instantaneous flow rate [0054], a peak flow rate and/or a minimum measured flow rate.
Claim 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Blaise (US 2005/0172966 A1) in view of Miller et al. (US 2007/0274874 A1) in further view of Vandine et al. (US 2009/0205663 A1).
Regarding claim 10, Blaise as modified discloses the claimed invention for claim 9 above and further discloses a user input for achieving a desired therapeutic gas concentration (NO is manually adjustable by the user as per [0071]). Blaise does not explicitly disclose wherein the ventilation apparatus comprises a user input operable to set a certain flow rate or pressure control to achieve a desired therapeutic gas concentration for the backup mode.
However, Miller teaches an NO delivery device [0003] and thus is analogous art wherein the apparatus comprises a user input operable to set a certain flow rate or pressure control to achieve a desired therapeutic gas concentration [0047].
Thus it would have been obvious to one of ordinary skill in the art before the invention was made to have modified Blaise to include a user input operable to set a certain flow rate or pressure control to achieve a desired therapeutic gas concentration as taught by Miller for the benefit of achieving a wide range of NO concentrations in an alternate way (alternate to controlling NO flow) as set forth in [0047].
Miller is not explicit in the ventilation apparatus comprising the user input (310) for setting flow rate or pressure control.
However Vandine discloses a ventilator (abstract) and thus is analogous art wherein there is a user input [0043]-[0044].
Thus it would have been obvious to one having ordinary skill in the art before the invention was made to have modified Blaise to include a user input for setting flow rate or pressure control as taught by Vandine for the benefit of allowing the user to interact with the ventilator directly.
Claims 6 and 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Blaise (US 2005/0172966 A1) in further view of Vandine et al. (US 2009/0205663 A1).
Regarding claim 6, Blaise as modified discloses the claimed invention of claim 5 as set forth above but does not explicitly disclose wherein the visual and/or numeric indication of the measured flow of breathing gas includes one or more of volumetric flow rate, tidal volume, and/or minute ventilation.
However, Vandine discloses a ventilator system (abstract) and thus is analogous art wherein a visual and/or numeric indication of the measured flow of breathing gas includes one or more of volumetric flow rate, tidal volume, and/or minute ventilation ([0044], figure 1 showing flow readings).
Thus it would have been obvious to one having ordinary skill in the art before the invention was made to have modified Blaise to include wherein the visual and/or numeric indication of the measured flow of breathing gas includes one or more of volumetric flow rate, tidal volume, and/or minute ventilation as taught by Vandine in order to visually show the user flow data.
Regarding claim 16, Blaise as modified discloses the claimed invention of claim 15 as set forth above but does not explicitly disclose wherein the displaying includes one or more of displaying volumetric flow rate, tidal volume, and/or minute ventilation.
However, Vandine discloses a ventilator system (abstract) and thus is analogous art wherein a visual and/or numeric indication of the measured flow of breathing gas includes one or more of volumetric flow rate, tidal volume, and/or minute ventilation ([0044], figure 1 showing flow readings).
Thus it would have been obvious to one having ordinary skill in the art before the invention was made to have modified Blaise to include wherein the visual and/or numeric indication of the measured flow of breathing gas includes one or more of volumetric flow rate, tidal volume, and/or minute ventilation as taught by Vandine in order to visually show the user flow data.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Olsson et al. (US 5,615,669 A1) discloses a method for administering breathing gas with NO.
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/VICTORIA MURPHY/Primary Examiner, Art Unit 3785
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