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 .
Claim Objections
Claim(s) 1-15 is/are objected to because of the following informalities:
The claims repeatedly recite “N2” which should be written with a subscript as N2
Claim 1 twice recites “said signal” which should read “said at least one measurement signal” for consistency with the earlier recitation in the claim
Claim 6 recites “said signal” which should read “said at least one measurement signal” for consistency with claim 1
Claim 7 recites “said signal” which should read “said at least one measurement signal” for consistency with claim 1
Claim 9 recites “said signal” which should read “said at least one measurement signal” for consistency with claim 1
Claim 9, Ln. 4 recites “NO/nitrogen” which should read “NO/N2”
Claim 14 recites “a loss of signal” which should read “a loss of said at least one measurement signal” for consistency with claim 1
Claim 15 recites “the signal” which should read “the at least one measurement signal” for consistency with claim 1
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(s) 7 and 9 is/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 pre-AIA the applicant regards as the invention.
Claim 7 recites the term “preferably” which deems the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 9 recites the limitation “a backup flow rate” in Ln. 2 which deems the claim indefinite. It is unclear is the limitation refers to the same flow rate as the backup gas flow rate of claim 1 or to an alternate flow rate during backup. The limitations appear directed to the same flow rate. For the purposes of examination the limitation will be interpreted as reading “the backup gas flow rate”.
Claim 9 recites the term “typically” which deems the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Interpretation - 35 USC § 112(f)
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”) (“control means” in claim 1) 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: “flow rate control device” in claim 1.
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.
The corresponding structure for the “flow rate control device” is best understood from the specification as at least: flow rate control device 210 including or forming a proportional calibrated orifice 204 (¶0200 of the PGPub copy of the instant application).
The corresponding structure for the “control means” is best understood from the specification as at least: control means 130 as common electrical controls (¶0170 of the PGPub copy of the instant application).
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.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-15 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,576,233 in view of Westermark et al. (U.S. Pub. 2017/0348503). Patent claim 17, depending from patent claim 1, generally recites the limitations of instant claim 1 (e.g. the backup line and backup solenoid valve of instant claim 1 as corresponding to the emergency line and emergency solenoid valve of patent claim 1; the loss of signal in instant claim 1 as corresponding to the malfunctioning of patent claim 1). However, instant claim 1 recites the flow rate sensor as within the patient circuit while patent claim 1 recites its flow rate measurement device as in the injection line. But the resultant backup/emergency flow in both instant claim 1 and patent claim 1 are pre-regulated in the same manner.
Westermark teaches a nitric oxide delivery system (Figs. 1-2; ¶¶0036-0037) including a backup flow rate control device (Fig. 1 #210; ¶0072) configured to supply a NO/N2 gas mixture at a pre-set backup gas flow rate (¶0072), where said backup gas flow rate is determined by a control means on the basis of a measurement signal supplied by a flow rate sensor in a patient circuit (Fig. 1 #6; ¶0060) (¶¶0063, 0072 – e.g. patient type as adult vs. child is determined from the sensor rate and its range of readings). Westermark teaches a pre-regulated backup flow rate as providing the benefit of supplying variable flow to ensure patient safety across various patient types when operation in a backup mode is required (¶¶0053, 0063, 0072). One of ordinary skill in the art would further have considered it prima facie obvious that additional flow sensors within the system would improve precision of gas flow control.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in patent claim 17 a flow rate sensor within the patient circuit which is used to pre-regulate a backup gas flow rate in order to provide the benefit of including an additional flow sensor within the system to improve precision of gas flow control while adding further input into the backup/emergency gas flow rate of patent claim 1, in view of Westermark. A further mapping of dependent claims is as follows:
Instant claim 2 vs. Westermark (Fig. 1)
Instant claim 3 vs. limitations in patent claim 1 (The particular type of the flow rate measurement device of patent claim 1 would obviously also be applied to the flow sensor on the patient circuit. The flow rate measurement device of patent claim 1 invokes 35 U.S.C. 112(f) as has a disclosed structure of a mass-flow sensor or a differential pressure sensor (Col. 10, Ln. 52-56).)
Instant claim 4 vs. limitations in patent claim 1 (The particular type of the flow rate measurement device of patent claim 1 would obviously also be applied to the flow sensor on the patient circuit. The flow rate measurement device of patent claim 1 invokes 35 U.S.C. 112(f) and has a disclosed structure corresponding to that recited by the instant claim (Col. 10, Ln. 59 – Col. 11, Ln. 22).)
Instant claim 5 vs. limitations in patent claim 1 (The particular type of the flow rate measurement device of patent claim 1 would obviously also be applied to the flow sensor on the patient circuit. The flow rate measurement device of patent claim 1 invokes 35 U.S.C. 112(f) and has a disclosed structure corresponding to that recited by the instant claim (Col. 10, Ln. 59 – Col. 11, Ln. 22).)
Instant claim 6 vs. limitations in patent claim 1 (e.g. pre-regulated)
Instant claim 7 vs. Westermark (¶¶0051, 0053 – predetermined number of patient inspirations)
Instant claim 8 as obvious in view of patent claim 1 (a proportional solenoid valve is merely one specific form of valve device which one of ordinary skill in the art would have obviously selected from amongst when desiring to choose a particular form of valve device to perform the opening and closing functions recited of the valve device in patent claim 1)
Instant claim 9 vs. Westermark (¶¶0051, 0053 – predetermined number of patient inspirations; ¶¶0048, 0050, 0063 – NO concentration needs to be within safe range)
Instant claim 10 vs. limitations in patent claim 1 (The flow rate control device of patent claim 1 invokes 35 U.S.C. 112(f) and has a disclosed structure corresponding to that recited by the instant claim (Col. 14, Ln. 4-18).)
Instant claim 11 vs. limitations in patent claim 1 (The control means of patent claim 1 invokes 35 U.S.C. 112(f) and has a disclosed structure corresponding to that recited by the instant claim (Col. 11, Ln. 35-44).)
Instant claim 12 as obvious in view of patent claim 1 (The passing of the valve device to a closed position during malfunction would have obviously suggested to one of ordinary skill in the art a default state of the valve device as closed.)
Instant claim 13 as obvious in view of patent claim 1 (The passing of the emergency solenoid valve device to an open position during malfunction would have obviously suggested to one of ordinary skill in the art a default state of the emergency solenoid valve device as open.)
Instant claim 14 as obvious in view of patent claim 1 (The valve device motions recited in patent claim 1 during malfunction would have obviously been expected by one of ordinary skill in the art to correspond to an idle state of the two valve devices.)
Instant claim 15 vs. limitations in patent claim 1 (e.g. pre-regulated)
Claim(s) 1-15 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of copending Application No. 18/975,632 in view of Westermark et al. (U.S. Pub. 2017/0348503). Reference claim 14, depending from reference claim 1, generally recites the limitations of instant claim 1 (e.g. the backup line and backup solenoid valve of instant claim 1 as corresponding to the emergency line and emergency solenoid valve of reference claim 1; the loss of signal in instant claim 1 as corresponding to the malfunctioning of reference claim 1). However, instant claim 1 recites the flow rate sensor as within the patient circuit while reference claim 1 recites its flow rate measurement device as in the injection line. But the resultant backup/emergency flow in both instant claim 1 and reference claim 1 are pre-regulated in the same manner.
Westermark teaches a nitric oxide delivery system (Figs. 1-2; ¶¶0036-0037) including a backup flow rate control device (Fig. 1 #210; ¶0072) configured to supply a NO/N2 gas mixture at a pre-set backup gas flow rate (¶0072), where said backup gas flow rate is determined by a control means on the basis of a measurement signal supplied by a flow rate sensor in a patient circuit (Fig. 1 #6; ¶0060) (¶¶0063, 0072 – e.g. patient type as adult vs. child is determined from the sensor rate and its range of readings). Westermark teaches a pre-regulated backup flow rate as providing the benefit of supplying variable flow to ensure patient safety across various patient types when operation in a backup mode is required (¶¶0053, 0063, 0072). One of ordinary skill in the art would further have considered it prima facie obvious that additional flow sensors within the system would improve precision of gas flow control.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in reference claim 14 a flow rate sensor within the patient circuit which is used to pre-regulate a backup gas flow rate in order to provide the benefit of including an additional flow sensor within the system to improve precision of gas flow control while adding further input into the backup/emergency gas flow rate of reference claim 1, in view of Westermark. Note is made that reference claim 14 recites dependence on any preceding claim. A further mapping of dependent claims is as follows:
Instant claim 2 vs. Westermark (Fig. 1)
Instant claim 3 vs. limitations in reference claim 1 (The particular type of the flow rate measurement device of reference claim 1 would obviously also be applied to the flow sensor on the patient circuit. The flow rate measurement device of reference claim 1 invokes 35 U.S.C. 112(f) as has a disclosed structure of a mass-flow sensor or a differential pressure sensor (¶0165 of the PGPub copy of the reference application).)
Instant claim 4 vs. limitations in reference claim 1 (The particular type of the flow rate measurement device of reference claim 1 would obviously also be applied to the flow sensor on the patient circuit. The flow rate measurement device of reference claim 1 invokes 35 U.S.C. 112(f) and has a disclosed structure corresponding to that recited by the instant claim (¶¶0166-0168 of the PGPub copy of the reference application).)
Instant claim 5 vs. limitations in reference claim 1 (The particular type of the flow rate measurement device of reference claim 1 would obviously also be applied to the flow sensor on the patient circuit. The flow rate measurement device of reference claim 1 invokes 35 U.S.C. 112(f) and has a disclosed structure corresponding to that recited by the instant claim (¶¶0166-0168 of the PGPub copy of the reference application).)
Instant claim 6 vs. limitations in reference claim 1 (e.g. pre-regulated)
Instant claim 7 vs. Westermark (¶¶0051, 0053 – predetermined number of patient inspirations)
Instant claim 8 vs. limitations in reference claim 11
Instant claim 9 vs. Westermark (¶¶0051, 0053 – predetermined number of patient inspirations; ¶¶0048, 0050, 0063 – NO concentration needs to be within safe range)
Instant claim 10 vs. limitations in reference claim 1
Instant claim 11 vs. limitations in reference claim 10
Instant claim 12 vs. limitations in reference claim 1
Instant claim 13 vs. limitations in reference claim 1
Instant claim 14 vs. limitations in reference claim 1
Instant claim 15 vs. limitations in reference claim 1
This is a provisional nonstatutory double patenting rejection.
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 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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 1-2, 6-12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (EP 2522384 A1; citations from attached machine translation) in view of Westermark et al. (U.S. Pub. 2017/0348503).
Regarding claim 1, Boulanger discloses installation (Fig. 3; Pg. 5-10) for supplying gas to a patient, comprising: an NO delivery device (Fig. 3 #30; Pg. 6) configured to supply an NO/N2 gas mixture (Pg. 4-5), comprising: an NO injection line (Fig. 3 into and out of #45) for conveying the NO/N2 gas mixture, a valve device (Fig. 3 #45; Pg. 6) arranged on the injection line in order to control the circulation of the NO/N2 gas mixture in the injection line, a backup line (Fig. 3 #5; Pg. 5) that connects fluidly to the injection line upstream and downstream of the valve device (Fig. 3), said backup line comprising a backup solenoid valve (Fig. 3 #51; Pg. 6), and control means (Fig. 3 #70; Pg. 6) configured to interact with the backup solenoid valve, the flow rate control device and the valve device (Fig. 3), a medical ventilator (Fig. 3 #9; Pg. 4) configured to supply a respiratory gas containing oxygen (Pg. 4), a patient circuit (Fig. 3 #630, 660; Pg. 7) to which the NO delivery device and the medical ventilator are fluidly connected in order to supply said patient circuit with said NO/N2 gas mixture and with said respiratory gas containing oxygen (Fig. 3), and a flow rate sensor (Fig. 3 #635; Pg. 7) configured to supply to the control means of the NO delivery device at least one measurement signal representing at least one gas flow rate within the patient circuit, characterized in that in the event of the interruption of reception, by the control means of the NO delivery device, of said at least one measurement signal supplied by the flow rate sensor (Pg. 5 – a failure of device 2 will cause loss of signal communication from the flow sensor 635): the backup solenoid valve is configured to switch to an open position in order to allow the circulation of the NO/N2 gas mixture in the backup line (Pg. 6 – solenoid valve 51 powered during failure), the valve device is configured to switch to a closed position in order to stop any circulation of gas in the injection line (Pg. 6 – solenoid valve 45 will lose power during failure).
Boulanger fails to disclose a flow rate control device, and wherein the flow rate control device is configured to supply the NO/N2 gas mixture at a pre-set backup gas flow rate, where said backup gas flow rate is determined by the control means on the basis of at least one measurement signal supplied by the flow rate sensor, before said interruption of reception of said signal, and pre-regulated by a command to the flow rate control device from said control means, before said interruption of reception of said signal.
Westermark teaches a nitric oxide delivery system (Figs. 1-2; ¶¶0036-0037) including a backup flow rate control device (Fig. 1 #210; ¶0072), and wherein the backup flow rate control device is configured to supply a NO/N2 gas mixture at a pre-set backup gas flow rate (¶0072), where said backup gas flow rate is determined by a control means on the basis of a measurement signal supplied by a flow rate sensor (¶¶0063, 0072 – e.g. patient type as adult vs. child is determined from the sensor rate and its range of readings), before interruption of reception of said measurement signal, and pre-regulated by a command to the flow rate control device from said control means, before said interruption of reception of said signal (¶0072 – orifice selected based on patient type). Westermark teaches a pre-regulated backup flow rate as providing the benefit of supplying variable flow to ensure patient safety across various patient types when operation in a backup mode is required (¶¶0053, 0063, 0072).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Boulanger a flow rate control device, and wherein the flow rate control device is configured to supply the NO/N2 gas mixture at a pre-set backup gas flow rate, where said backup gas flow rate is determined by the control means on the basis of at least one measurement signal supplied by the flow rate sensor, before said interruption of reception of said signal, and pre-regulated by a command to the flow rate control device from said control means, before said interruption of reception of said signal in order to provide the benefit of supplying variable flow to ensure patient safety across various patient types when operation in a backup mode is required in view of Westermark.
Regarding claim 2, Boulanger teaches the invention as modified above and Westermark as incorporated therein further suggests as obvious the flow rate sensor (Fig. 2 #6; ¶0046) is arranged on the patient circuit. Westermark in Fig. 2 teaches that it would have been prima facie obvious to one having ordinary skill in the art to have moved the flow sensor of Boulanger to be on the patient circuit.
Regarding claim 6, Boulanger teaches the invention as modified above and Westermark as incorporated therein further teaches the control means are configured to determine the backup gas flow rate on the basis of at least one measurement signal supplied by the flow rate sensor, before said interruption of reception of said signal, and on the basis of a desired final NO concentration (¶¶0048, 0050, 0063 – NO concentration needs to be within safe range).
Regarding claim 7, Boulanger teaches the invention as modified above and Westermark as incorporated therein further teaches the backup gas flow rate is determined on the basis of an average gas flow rate calculated on the basis of a plurality of gas flow rates measured by the flow rate sensor in a given duration (¶¶0051, 0053 – predetermined number of patient inspirations), before said interruption of reception of said signal
Regarding claim 8, Boulanger teaches the invention as modified above and further suggests as obvious the valve device comprises a proportional solenoid valve (Pg. 2 – solenoid valve 45 will preferably be of a proportional type).
Regarding claim 9, Boulanger teaches the invention as modified above and Westermark as incorporated therein further teaches the control means are configured to determine a backup flow rate on the basis of at least one respiratory gas flow rate measured by the flow rate sensor (¶¶0051, 0053 – predetermined number of patient inspirations), before the interruption of reception of said signal, and on the basis of a final NO concentration to be obtained after mixing of the NO/N2 mixture coming from the NO delivery device and the flow of respiratory gas containing oxygen coming from the ventilator (¶¶0048, 0050, 0063 – NO concentration needs to be within safe range)
Regarding claim 10, Boulanger teaches the invention as modified above and Westermark as incorporated therein further teaches the flow rate control device comprises a proportional calibrated orifice system commanded by the control means to regulate the pre-set backup gas flow rate (¶¶0063, 0072). It is noted that the instant claim does not invoke 35 U.S.C. 112(f) in regards to the flow rate control device.
Regarding claim 11, Boulanger teaches the invention as modified above and further teaches the control means of the NO delivery device comprise at least one microprocessor (Pg. 6). It is noted that the instant claim does not invoke 35 U.S.C. 112(f) in regards to the control means.
Regarding claim 12, Boulanger teaches the invention as modified above and further teaches the valve device of the NO delivery device is configured so that it is normally in a closed position corresponding to an idle state, preventing any circulation of gas in the injection line (Fig. 3 – solenoid valve 45 is symbolically illustrated as a 2/2 valve which is normally closed).
Regarding claim 15, Boulanger teaches the invention as modified above and Westermark as incorporated therein further teaches the flow rate control device of the backup line comprises a proportional calibrated orifice system (¶¶0063, 0072).
Boulanger as modified fails to explicitly teach the control means of the NO delivery device are further configured to, prior to any interruption of the reception or loss of the signal coming from the flow rate sensor, act on the proportional calibrated orifice system in order to pre-regulate the desired backup gas flow rate. It is noted that the instant claim does not invoke 35 U.S.C. 112(f) in regards to the flow rate control device.
However, it is noted that the patient type determination in Westermark based upon the flow sensor can be determined at any time prior to loss of signal or other malfunctioning (e.g. ¶¶0063, 0072). Once the gas backup module 200 recognizes what patient type is being treated one of ordinary skill in the art would have considered it prima facie obvious for the gas backup module 200 to pre-select a desired orifice from its plurality of interchangeable orifices which matches the patient type in use such that any subsequent system failure or malfunctioning would not impede the gas backup module 200 from being able to deliver gas as intended.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in the modified Boulanger the control means of the NO delivery device are further configured to, prior to any interruption of the reception or loss of the signal coming from the flow rate sensor, act on the proportional calibrated orifice system in order to pre-regulate the desired backup gas flow rate in order to provide the benefit of pre-select a desired orifice from its plurality of interchangeable orifices which matches the patient type in use such that any subsequent system failure or malfunctioning would not impede the gas backup module 200 from being able to deliver gas as intended in view of the overall teachings of Westermark.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (EP 2522384 A1; citations from attached machine translation) in view of Westermark et al. (U.S. Pub. 2017/0348503) and further in view of Boulanger (U.S. Pub. 2021/0308411, henceforward “Boulanger ‘411”).
Regarding claim 3, Boulanger teaches the invention as modified above but is silent as to whether the flow rate sensor is a mass flow sensor or a differential pressure measurement sensor. Boulanger does not discuss a particular form of flow rate sensor.
Boulanger ‘411 teaches a nitric oxide delivery system (Fig. 1; ¶0078) including a flow rate sensor (Fig. 1 #100; ¶0087) having the form of a differential pressure measurement sensor (¶0087). Boulanger ‘411 teaches a differential pressure measurement sensor as a preferred form of breathing gas flow sensor (¶0087).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in the modified Boulanger the flow rate sensor is a differential pressure measurement sensor in order to provide the benefit of selecting a differential pressure measurement sensor as a preferred form of breathing gas flow sensor in view of Boulanger ‘411.
Regarding claim 4, Boulanger teaches the invention as modified above but is silent as to whether the flow rate sensor is of the type that measures differential pressure, comprising a measurement module traversed by an internal gas passage comprising an internal restriction, an upstream line and a downstream line for measuring pressure being fluidly connected to the measurement module of the flow rate sensor so as to make it possible to measure the pressure upstream and downstream of the internal restriction. Boulanger does not discuss a particular form of flow rate sensor.
Boulanger ‘411 teaches a nitric oxide delivery system (Fig. 1; ¶0078) including a flow rate sensor (Fig. 1 #100; ¶0087) of the type that measures differential pressure (¶0087), comprising a measurement module (Fig. 1 within #100) traversed by an internal gas passage comprising an internal restriction (Fig. 1 #101; ¶0087), an upstream line (Fig. 1 #103; ¶0087) and a downstream line (Fig. 1 #102; ¶0087) for measuring pressure being fluidly connected to the measurement module of the flow rate sensor so as to make it possible to measure the pressure upstream and downstream of the internal restriction (¶0087). Boulanger ‘411 teaches a differential pressure measurement sensor as a preferred form of breathing gas flow sensor (¶0087).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in the modified Boulanger the flow rate sensor is of the type that measures differential pressure, comprising a measurement module traversed by an internal gas passage comprising an internal restriction, an upstream line and a downstream line for measuring pressure being fluidly connected to the measurement module of the flow rate sensor so as to make it possible to measure the pressure upstream and downstream of the internal restriction in order to provide the benefit of selecting a differential pressure measurement sensor as a preferred form of breathing gas flow sensor in view of Boulanger ‘411.
Regarding claim 5, Boulanger teaches the invention as modified above and together with Boulanger ‘411 further teaches a differential pressure sensor (Boulanger ‘411 – Fig. 1 #104; ¶0088) is connected to the flow rate sensor via the upstream and downstream pressure measurement lines (Boulanger ‘411 – Fig. 1; ¶¶0087-0088), said differential pressure sensor being arranged in the NO delivery device (Boulanger – Fig. 3) and interacting with the control means (Boulanger – Fig. 3; Boulanger ‘411 – Fig. 1) in order to supply them with the pressure values measured by the flow rate sensor.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (EP 2522384 A1; citations from attached machine translation) in view of Westermark et al. (U.S. Pub. 2017/0348503) and further in view of Blaise et al. (U.S. Pub. 2005/0172966).
Regarding claim 13, Boulanger teaches the invention as modified above but fails to teach the backup solenoid valve of the NO delivery device is configured so that it is normally in an open position corresponding to an idle state, allowing the circulation of gas in the backup line.
Blaise teaches a nitric oxide delivery system (Figs. 5-6; ¶¶0049-0052) including a backup solenoid valve (Fig. 5 #137; ¶0071) configured so that it is normally in an open position corresponding to an idle state (¶0072), allowing the circulation of gas in the backup line. Blaise teaches a normally open backup solenoid valve as providing the benefit of directly supplying backup flow in the event of a full electrical power failure, while only requiring the operation of two valves, one for normal flow and one for backup flow (¶0072).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have substituted in the modified Boulanger the backup solenoid valve of the NO delivery device is configured so that it is normally in an open position corresponding to an idle state, allowing the circulation of gas in the backup line in order to provide the benefit of directly supplying backup flow in the event of a full electrical power failure, while only requiring the operation of two valves, one for normal flow and one for backup flow in view of Blaise.
Regarding claim 14, Boulanger teaches the invention as modified above and further teaches in the event of a loss of signal, the control means is configured to stop operating the valve device of the NO delivery device, which then automatically switches to its idle state (Fig. 3 – solenoid valve 45 is symbolically illustrated as a 2/2 valve which is normally closed).
Boulanger as modified fails to teach in the event of a loss of signal, the control means is configured to stop operating the backup solenoid valve, which then automatically switches to its idle state.
Blaise teaches a nitric oxide delivery system (Figs. 5-6; ¶¶0049-0052) including a backup solenoid valve (Fig. 5 #137; ¶0071) configured so that it is normally in an open position corresponding to an idle state (¶0072), thus not operating during a failure. Blaise teaches a normally open backup solenoid valve as providing the benefit of directly supplying backup flow in the event of a full electrical power failure, while only requiring the operation of two valves, one for normal flow and one for backup flow (¶0072).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have substituted in the modified Boulanger in the event of a loss of signal, the control means is configured to stop operating the backup solenoid valve, which then automatically switches to its idle state in order to provide the benefit of directly supplying backup flow in the event of a full electrical power failure, while only requiring the operation of two valves, one for normal flow and one for backup flow in view of Blaise.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Note is made that claim 1 can also be rejected beginning from Blaise et al. (U.S. Pub. 2005/0172966; Fig. 1 with backup valve assembly 129) and incorporating Westermark et al. (U.S. Pub. 2017/0348503), for the same general teaching considerations cited from Westermark in the 35 U.S.C. 103 rejection of claim 1 above.
It is noted that Boulanger et al. (FR 3131538 A1) has been cited as relevant art but does not qualify as prior art based on its sharing of all inventors with the instant application, which causes that reference to be excepted under 35 U.S.C. 102(b)(1)(A).
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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