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 .
Claims 1-36, filed 3/6/23, are currently pending.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 125 in fig. 1 and 139 in fig. 4A. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“injector module configured to inject…” in claim 1 and “injector module” in claim 20 (corresponding structure is a structure having a first ending having a first opening and a second end having a second opening, [0045], removed from 112f in claims 2 and 21).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 recites “does of NO” suggested to be changed to --dose of NO-- to correctly a spelling mistake. 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 17 and 34 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.
Claims 17 and 34 recite “about” and “substantially” language, however it is unclear what the scope of the language following these words include.
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 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.
Claims 1-3, 5-6, 9-10, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Tolmie et al. (2007/0181126) in view of Richardson (5,752,506).
Regarding claim 1, in fig. 1 Tolmie discloses a method of delivering nitric oxide gas to a patient in need thereof, the method comprising: providing, through at least one control valve 37 of a nitric oxide delivery system, a flow of nitric oxide gas 38 to an injector module 36 configured to inject the nitric oxide gas into a breathing gas (16 and 18) in an inspiratory limb (tubing just downstream of 36, or 32) of a breathing circuit (structure in fig. 1) affiliated with a ventilator (12 [0018]); measuring, using at least one NO flow sensor 39, NO flow, wherein the at least one NO flow sensor is in fluid communication with a therapeutic gas inlet (where arrow that points to 36 is located) of the injector module; receiving, using a control system 52 in communication with the at least one NO flow sensor (Fig. 1), flow information from the at least one NO flow sensor ([0035] fig. 1); and delivering the nitric oxide gas to the patient (14, abstract), but is silent regarding that the ventilator is a high frequency ventilator or ventilation techniques which provide reverse and/or oscillations in inspiratory pressure or flow. However, Richardson teaches a breathing circuit is affiliated with a high frequency ventilator or ventilation techniques which provide reverse and/or oscillations in inspiratory pressure or flow (Col. 6, ll. 44-47) in addition to nitric oxide delivery (Col. 6, ll. 50-55). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tolmie’s ventilation with high frequency ventilation, as taught by Richardson, for the purpose of providing an alternate ventilation modality depending on the particular patient having the predictable results of ventilating a patient (Col. 1, ll. 18-20 Richardson).
Regarding claim 2, the modified Tolmie discloses that the injector module has an injector body (body of 36, Tolmie) having a first opening (opening that 28 connects to, Tolmie) and a second opening (opening closer to 40, Tolmie), the first opening and the second opening being configured to couple the injector module to the inspiratory limb (conduit just downstream of 36, Tolmie) of the breathing circuit enabling the breathing gas in the breathing circuit to flow through the first opening and the second opening (Fig. 1, Tolmie).
Regarding claim 3, the modified Tolmie discloses that the therapeutic gas inlet is in the injector body (Fig. 1, Tolmie), the therapeutic gas inlet being configured to receive the flow of the nitric oxide gas (Fig. 1, Tolmie) and enable injection of the nitric oxide gas into the injector module (Fig. 1, Tolmie), and in turn into the breathing gas in the inspiratory limb of the breathing circuit (Fig. 1, Tolmie).
Regarding claim 5, the modified Tolmie discloses that the therapeutic gas inlet receives the flow of nitric oxide gas from a nitric oxide source 38, via a conduit (conduit leading to 36 from 38, Tolmie).
Regarding claim 6, the modified Tolmie discloses that the nitric oxide source is a cylinder storing NO ([0021] Tolmie, fig. 1) or an NO generator.
Regarding claim 9, the modified Tolmie discloses that monitoring the flow information, using the control system, to ensure that a desired dose of NO is delivered into the injector module, and in turn into the breathing gas in the inspiratory limb of the breathing circuit ([0028] Tolmie).
Regarding claim 10, the modified Tolmie discloses that monitoring the flow information, using the control system, to ensure a desired does of NO is not under delivered and/or under dosed ([0028] Tolmie).
Regarding claim 14, the modified Tolmie discloses that the inspiratory limb (32 receives both inspiration and expiration, Tolmie) is also an expiratory limb in the breathing circuit.
Regarding claim 17, the modified Tolmie discloses that receiving the flow of nitric oxide gas at the therapeutic gas inlet (where arrow meets 36, Tolmie) via a conduit (conduit that meets 36 at arrow, Tolmie), wherein the conduit has one or more of (i) an internal cross-sectional diameter of about 1/32 of an inch to about 1/4 of an inch and (ii) an internal portion (conduit within 50, Tolmie) within the nitric oxide delivery system (50, Tolmie) and an external portion (conduit outside of 50, Tolmie) outside the nitric oxide delivery system, the internal portion of the conduit having a cross-sectional diameter that is substantially the same as a cross-sectional diameter of the external portion of the conduit (Fig. 1, Tolmie).
Claims 4 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tolmie and Richardson, as applied to claim 1 above, in further view of Sansom (2014/0358022).
Regarding claim 4, the modified Tolmie is silent regarding that the control system is operable to: (i) detect use of the high frequency ventilator; (ii) identify the flow information as missing and interpolate the missing flow information; and/or (iii) identify the flow information as reverse flow. However, in fig. 5 Sansom teaches a control system that is operable to identify the flow information as reverse flow (using a bi-directional constant temperature anemometry flow sensor [0005][0039]). 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 modified Tolmie’s NO flow sensor with a bi-directional constant temperature anemometry flow sensor, as taught by Sansom, for the purpose of providing an alternate flow sensor having the predictable results of determining flow as well as the advantage of determining the direction of flow with reduced dead space and weight ([0005] Sansom).
Regarding claim 12, the modified Tolmie is silent regarding that the at least one NO flow sensor is at least one bi-directional flow sensor. However, in fig. 5 Sansom teaches a flow sensor is at least one bi-directional flow sensor (using a bi-directional constant temperature anemometry flow sensor [0005][0039]). 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 modified Tolmie’s NO flow sensor with a bi-directional constant temperature anemometry flow sensor, as taught by Sansom, for the purpose of providing an alternate flow sensor having the predictable results of determining flow as well as the advantage of determining the direction of flow with reduced dead space and weight ([0005] Sansom).
Regarding claim 13, the modified Tolmie discloses that the at least one bi-directional flow sensor is a thermal mass flow meter ([0005][0039] Sansom) or a thermal dispersion flow meter.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Tolmie and Richardson, as applied to claim 6 above, in further view of Rounbehler et al. (2006/0180147).
Regarding claim 7, the modified Tolmie is silent regarding generating the nitric oxide gas by reaction of a NO-releasing agent with a reductant using the NO generator. However, Rounbehler teaches generating the nitric oxide gas by reaction of a NO-releasing agent with a reductant using the NO generator (abstract). 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 modified Tolmie’s NO gas container with an NO gas generator, as taught by Rounbehler, for the purpose of providing an alternate source of nitric oxide having the predictable results of providing nitric oxide to a user for respiratory therapy.
Regarding claim 8, the modified Tolmie discloses that the NO-releasing agent is nitrogen dioxide and the reductant is ascorbic acid (abstract Rounbehler).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tolmie and Richardson, as applied to claim 1 above, in further view of Jamison (2010/0175695).
Regarding claim 11, the modified Tolmie is silent regarding opening or closing a check valve that is one or more of (i) in fluid communication with the therapeutic gas inlet of the injector module and (ii) is integral to the injector module. However, in fig. 2 Jamison teaches opening or closing a check valve 246 that is one or more of (i) in fluid communication with a therapeutic gas inlet of the injector module 236 and (ii) is integral to the injector module 236. 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 modified Tolmie’s inhalation limb with the addition of a check valve, as taught by Jamison, for the purpose of preventing backflow.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tolmie and Richardson, as applied to claim 1 above, in further view of Bathe et al. (6,581,592).
Regarding claim 15, the modified Tolmie is silent regarding that the NO flow sensor is downstream of the control valve in the nitric oxide delivery system. However, in fig. 1 Bathe teaches an NO flow sensor 40 is downstream of the control valve 30 in the nitric oxide delivery system. 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 modified Tolmie’s NO flow sensor and control valve with the NO flow sensor downstream of the control valve, as taught by Bathe, for the purpose of providing an alternate configuration having the predictable results of determining NO flow to control the control valve.
Regarding claim 16, the modified Tolmie is silent regarding that the control valve is upstream of the NO flow sensor in the nitric oxide delivery system. However, in fig. 1 Bathe teaches a control valve 30 upstream of an NO flow sensor 40 in a nitric oxide delivery system. 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 modified Tolmie’s NO flow sensor and control valve with the control valve upstream of the NO flow sensor, as taught by Bathe, for the purpose of providing an alternate configuration having the predictable results of determining NO flow to control the control valve.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Tolmie and Richardson, as applied to claim 1 above, in further view of Hu et al. (5,939,618).
Regarding claim 18, the modified Tolmie is silent regarding measuring, using at least a second NO flow sensor, NO flow, wherein the second NO flow sensor is in fluid communication with the therapeutic gas inlet and in communication with the control system, receiving, at the control system, flow information from the second NO flow sensor; and detecting, using the control system, a leak when the flow information from the NO flow sensors does not match. However, in fig. 1 Hu teaches measuring, using a first 22 and second 26 flow sensor, wherein first and second flow sensors are in fluid communication with a therapeutic gas inlet 18 and in communication with the control system (Col. 5, ll. 15-21), receiving, at the control system, flow information from the first and second flow sensors (Col. 5, ll. 15-21); and detecting, using the control system, a leak when the flow information from the NO flow sensors does not match (Col. 5, ll. 22-25). 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 modified Tolmie’s NO flow sensor with the addition of a second NO flow sensor, as taught by Hu, for the purpose of determining if a leak occurs.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Tolmie, Richardson and Hu, as applied to claim 18 above, in further view of Nightingale et al. (2013/0133656).
Regarding claim 19, the modified Tolmie is silent regarding increasing the flow of nitric oxide gas if a leak is detected. However, Nightingale teaches increasing gas flow if a leak is detected [0144]. 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 modified Tolmie’s gas flow with increased gas flow if a leak is detected, as taught by Nightingale, for the purpose of compensating for the lost flow due to leakage.
Claims 20-24, 27-28, 30-31 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Tolmie et al. (2007/0181126) in view of Richardson (5,752,506) and Sansom (2014/0358022).
Regarding claim 20, in fig. 1 Tolmie discloses a method of delivering nitric oxide gas to a patient in need thereof, the method comprising: providing, through a conduit (conduit containing 37) and at least one control valve 37 of a nitric oxide delivery system, a flow of nitric oxide gas 38 to a therapeutic gas inlet (where arrow that points to 36 is located) of an injector module 36 from a nitric oxide gas source 38, wherein the nitric oxide is injected into a breathing gas (16 and 18) in an inspiratory limb (tubing just downstream of 36, or 32) of a breathing circuit (structure in fig. 1) affiliated with a ventilator; measuring, using at least one NO flow sensor 39, NO flow in a forward direction through the through the therapeutic gas inlet (Fig. 1 shows NO flow sensor 39 that measures flow in a forward direction that enters the therapeutic gas inlet), wherein the at least one NO flow sensor is in fluid communication with the therapeutic gas inlet (Fig. 1), receiving, using a control system 52 in communication with the at least one NO flow sensor (Fig. 1), flow information ([0035] fig. 1); and delivering the nitric oxide gas to the patient (14, abstract), but is silent regarding that the ventilator is a high frequency ventilator or ventilation techniques which provide reverse and/or oscillations in inspiratory pressure or flow. However, Richardson teaches a breathing circuit is affiliated with a high frequency ventilator or ventilation techniques which provide reverse and/or oscillations in inspiratory pressure or flow (Col. 6, ll. 44-47) in addition to nitric oxide delivery (Col. 6, ll. 50-55). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tolmie’s ventilation with high frequency ventilation, as taught by Richardson, for the purpose of providing an alternate ventilation modality depending on the particular patient having the predictable results of ventilating a patient (Col. 1, ll. 18-20 Richardson). The modified Tolmie is silent regarding that the at least one NO flow sensor is at least one bi-directional flow sensor measuring NO flow in a forward direction and in a reverse direction. However, in fig. 5 Sansom teaches a flow sensor is at least one bi-directional flow sensor measuring flow in a forward direction and in a reverse direction (using a bi-directional constant temperature anemometry flow sensor [0005][0039]). 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 modified Tolmie’s NO flow sensor with a bi-directional constant temperature anemometry flow sensor, as taught by Sansom, for the purpose of providing an alternate flow sensor having the predictable results of determining flow as well as the advantage of determining the direction of flow with reduced dead space and weight ([0005] Sansom).
Regarding claim 21, the modified Tolmie discloses that the injector module has an injector body (body of 36, Tolmie) having a first opening (opening that 28 connects to, Tolmie) and a second opening (opening closer to 40, Tolmie), the first opening and the second opening being configured to couple the injector module to the inspiratory limb (conduit just downstream of 36, Tolmie) of the breathing circuit enabling the breathing gas in the breathing circuit to flow through the first opening and the second opening (Fig. 1, Tolmie).
Regarding claim 22, the modified Tolmie discloses that the therapeutic gas inlet is in the injector body (Fig. 1, Tolmie), the therapeutic gas inlet being configured to receive the flow of the nitric oxide gas (Fig. 1, Tolmie) and enable injection of the nitric oxide gas into the injector module (Fig. 1, Tolmie), and in turn into the breathing gas in the inspiratory limb of the breathing circuit (Fig. 1, Tolmie).
Regarding claim 23, the modified Tolmie discloses that the bi-directional flow information comprises at least forward flow information and reverse flow information ([0005][0039] Sansom).
Regarding claim 24, the modified Tolmie discloses that the nitric oxide source is a cylinder storing NO ([0021] Tolmie, fig. 1) or an NO generator.
Regarding claim 27, the modified Tolmie discloses that monitoring the flow information, using the control system, to ensure that a desired dose of NO is delivered into the injector module, and in turn into the breathing gas in the inspiratory limb of the breathing circuit ([0028] Tolmie).
Regarding claim 28, the modified Tolmie discloses that monitoring the flow information, using the control system, to ensure a desired does of NO is not under delivered and/or under dosed ([0028] Tolmie).
Regarding claim 30, the modified Tolmie discloses that the at least one bi-directional flow sensor is a thermal mass flow meter ([0005][0039] Sansom) or a thermal dispersion flow meter.
Regarding claim 31, the modified Tolmie discloses that the inspiratory limb (32 receives both inspiration and expiration, Tolmie) is also an expiratory limb in the breathing circuit.
Regarding claim 34, the modified Tolmie discloses that receiving the flow of nitric oxide gas at the therapeutic gas inlet (where arrow meets 36, Tolmie) via a conduit (conduit that meets 36 at arrow, Tolmie), wherein the conduit has one or more of (i) an internal cross-sectional diameter of about 1/32 of an inch to about 1/4 of an inch and (ii) an internal portion (conduit within 50, Tolmie) within the nitric oxide delivery system (50, Tolmie) and an external portion (conduit outside of 50, Tolmie) outside the nitric oxide delivery system, the internal portion of the conduit having a cross-sectional diameter that is substantially the same as a cross-sectional diameter of the external portion of the conduit (Fig. 1, Tolmie).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Tolmie, Richardson and Sansom, as applied to claim 24 above, in further view of Rounbehler et al. (2006/0180147).
Regarding claim 25, the modified Tolmie is silent regarding generating the nitric oxide gas by reaction of a NO-releasing agent with a reductant using the NO generator. However, Rounbehler teaches generating the nitric oxide gas by reaction of a NO-releasing agent with a reductant using the NO generator (abstract). 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 modified Tolmie’s NO gas container with an NO gas generator, as taught by Rounbehler, for the purpose of providing an alternate source of nitric oxide having the predictable results of providing nitric oxide to a user for respiratory therapy.
Regarding claim 26, the modified Tolmie discloses that the NO-releasing agent is nitrogen dioxide and the reductant is ascorbic acid (abstract Rounbehler).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Tolmie, Richardson and Sansom, as applied to claim 20 above, in further view of Jamison (2010/0175695).
Regarding claim 29, the modified Tolmie is silent regarding opening or closing a check valve that is one or more of (i) in fluid communication with the therapeutic gas inlet of the injector module and (ii) is integral to the injector module. However, in fig. 2 Jamison teaches opening or closing a check valve 246 that is one or more of (i) in fluid communication with a therapeutic gas inlet of the injector module 236 and (ii) is integral to the injector module 236. 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 modified Tolmie’s inhalation limb with the addition of a check valve, as taught by Jamison, for the purpose of preventing backflow.
Claims 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Tolmie, Richardson and Sansom, as applied to claim 20 above, in further view of Bathe et al. (6,581,592).
Regarding claim 32, the modified Tolmie is silent regarding that the NO flow sensor is downstream of the control valve in the nitric oxide delivery system. However, in fig. 1 Bathe teaches an NO flow sensor 40 is downstream of the control valve 30 in the nitric oxide delivery system. 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 modified Tolmie’s NO flow sensor and control valve with the NO flow sensor downstream of the control valve, as taught by Bathe, for the purpose of providing an alternate configuration having the predictable results of determining NO flow to control the control valve.
Regarding claim 33, the modified Tolmie is silent regarding that the control valve is upstream of the NO flow sensor in the nitric oxide delivery system. However, in fig. 1 Bathe teaches a control valve 30 upstream of an NO flow sensor 40 in a nitric oxide delivery system. 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 modified Tolmie’s NO flow sensor and control valve with the control valve upstream of the NO flow sensor, as taught by Bathe, for the purpose of providing an alternate configuration having the predictable results of determining NO flow to control the control valve.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Tolmie, Richardson and Sansom, as applied to claim 20 above, in further view of Hu et al. (5,939,618).
Regarding claim 35, the modified Tolmie is silent regarding measuring, using at least a second bi-directional NO flow sensor, NO flow, wherein the second bi-directional NO flow sensor is in fluid communication with the therapeutic gas inlet and in communication with the control system, receiving, at the control system, flow information from the second bi-directional NO flow sensor; and detecting, using the control system, a leak when the flow information from the NO flow sensors does not match. However, in fig. 1 Hu teaches measuring, using a first 22 and second 26 flow sensor, wherein first and second flow sensors are in fluid communication with a therapeutic gas inlet 18 and in communication with the control system (Col. 5, ll. 15-21), receiving, at the control system, flow information from the first and second flow sensors (Col. 5, ll. 15-21); and detecting, using the control system, a leak when the flow information from the NO flow sensors does not match (Col. 5, ll. 22-25). 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 modified Tolmie’s NO bi-directional flow sensor with the addition of a second bi-directional NO flow sensor, as taught by Hu, for the purpose of determining if a leak occurs.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Tolmie, Richardson, Sansom and Hu, as applied to claim 35 above, in further view of Nightingale et al. (2013/0133656).
Regarding claim 36, the modified Tolmie is silent regarding increasing the flow of nitric oxide gas if a leak is detected. However, Nightingale teaches increasing gas flow if a leak is detected [0144]. 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 modified Tolmie’s gas flow with increased gas flow if a leak is detected, as taught by Nightingale, for the purpose of compensating for the lost flow due to leakage.
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).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,835,696. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim is broader than the patented claim (i.e. the patented claim 1 recites “detect use of the high frequency ventilator,” which is language not found in instant claim 1). Therefore, any infringement over patented claim would result in infringement over instant claims.
Dependent claim 5 is covered by patented claim 7.
Dependent claim 9 is covered by patented claim 3.
Dependent claim 10 is covered by patented claim 4.
Dependent claim 11 is covered by patented claim 5.
Dependent claim 15-16 is covered by patented claim 6.
Dependent claim 17 is covered by patented claim 7.
Dependent claim 18 is covered by patented claim 8.
Dependent claim 19 is covered by patented claim 9.
Claims 20 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 10,835,696. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim is broader than the patented claim (i.e. the patented claim 10 recites “forward flow information and reverse flow information,” which is language not found in instant claim 20). Therefore, any infringement over patented claim would result in infringement over instant claims.
Dependent claim 27 is covered by patented claim 13.
Dependent claim 28 is covered by patented claim 14.
Dependent claim 29 is covered by patented claim 15.
Dependent claims 32-33 are covered by patented claim 17.
Dependent claim 34 is covered by patented claim 18.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bedini (2009/0241947) and Wondka et al. (2012/0118285) directed towards nitric oxide delivery, Naghavi (2007/0283958) and Lin et al. (2003/0106875) directed towards bidirectional flow sensors.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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