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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in France on June 24, 2022. It is noted, however, that applicant has not filed a certified copy of the FR 2206335 application as required by 37 CFR 1.55.
Drawings
The drawings are objected to because:
Figs. 2 and 3 are very dark and difficult to read.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because:
Line 1 contains the phrase “The invention relates to” which is a phrase that can be implied.
The abstract uses legal phraseology often used in claims such as “means” (line 2, line 2, line 3, line 3, line 3, and line 4) and “comprising” (line 1) that should be avoided.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-15 are objected to because of the following informalities:
In claim 1, it is suggested that the “-“ before each indented section be deleted for clarity.
In claim 1, it is suggested that “NO supply device” in line 1 be amended to read: --A nitric oxide (NO) supply device-- for clarity.
In each of claims 2-12, it is suggested that “Device” in line 1 be amended to read: --The device
In claim 13, it is suggested that “Installation for delivering therapeutic gas containing NO to a patient (P)” in line 1 be amended to read: --An installation nitric oxide (NO) to a patient (P)-- for clarity.
In each of claims 14-15, it is suggested that “Installation” in line 1 be amended to read: --The installation .
Appropriate correction is required.
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 use the word “means,” and are 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:
“control means” in claims 1-4 and 8, interpreted according to page 5, lines 28-33 of the specification
“dose selection means” in claim 1, interpreted according to page 5, lines 8-9 of the specification
“means for starting treatment” in claims 1, 3, 5, and 6, interpreted according to page 4, line 29 - page 5, line 4 of the specification
“means for stopping treatment” in claims 1, 4-6, and 8 interpreted according to page 4, line 29 - page 5, line 4 of the specification
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:
“actuation element” in claim 5, interpreted according to page 5, line 1-4 of the specification
“actuation elements” in claim 6, interpreted according to page 5, line 1-4 of the specification
(It is noted that “one or more actuation elements” in claim 7 is not interpreted under 15 USC 112(f) because sufficient structure to perform the actuation is recited (one or more virtual keys)
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function.
Such claim limitation(s) is/are:
“valve means” in claim 1, which is preceded by the structural modifier “valve”
“memory storage means” in claim 1, which is preceded by the structural modifier “memory storage”
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-15 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.
In claim 1, line 2, the phrase "typically" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 1 recites “which means” in line 10. Since multiple “means” have been claimed, it is not expressly clear which of the means the limitation is referring to. It is suggested the limitation be amended to read --means for starting treatment configured to be actuatedto cooperate with the control means…--.
Claim 1 recites “which means” in line 12. Since multiple “means” have been claimed, it is not expressly clear which of the means the limitation is referring to. It is suggested the limitation be amended to read --means for stopping treatment configured to be actuatedto cooperate with the control means…--.
Claim 7 recites “the one or more actuation elements” in line 1. However, only one actuation element has been recited in parent claim 5. Thus, there is lack of antecedent basis for “the one or more actuation elements”.
Claims 2-6 and 8-15 are rejected based solely on their dependency to rejected claims.
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, 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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Blandin et al. (US 2021/0146086), in view of Montgomery et al. (US 2007/0062527).
As to claim 1, Blandin discloses a NO supply device 1 (Fig. 1, Fig. 2) comprising:
an internal passage 2 for conveying a gaseous flow containing NO, typically a gaseous mixture NO/N2 (paragraphs [0123]-[0124]),
valve means 5 for controlling the gaseous flow in the internal passage (paragraph [0125]),
control means 6 for controlling at least the valve means (paragraph [0138]),
dose selection means configured to allow a user to choose or adjust an NO dose to be administered (a user can select a flow rate of gas passing through the valve means 5 (see paragraphs [0126]-[0127],[0131]), which will determine the concentration of NO in the delivered gas),
memory storage means configured to store information (paragraph [0065],[0075]),
means 9a,9d for starting treatment, which means are actuatable by the user and cooperate with the control means in order to initiate or resume a treatment by NO (Fig. 1, Fig. 3, paragraph [0138]-[0142]),
means 9a, 9d for stopping treatment, which means are actuatable by the user and cooperate with the control means in order to pause or definitively discontinue a treatment by NO (Fig. 1, Fig. 3, paragraph [0138]-[0142]), and
a graphic display 7 (Figs. 1-3, paragraph [0129]) configured to display, during the treatment by NO, the dose administered to the patient (in Fig. 3, the measured concentration of NO (in ppm) in the delivered gas is displayed on the right side of the screen 7 above the NO2 concentration and the O2 concentration, see also paragraph [0186] which discloses that the NO, O2 and NO2 concentrations in the gas are displayed).
Blandin further appears to suggest, in Fig. 3, that the graphic display 7 is configured to display, before the commencement of the treatment by NO, the NO dose to be administered (Fig. 3 appears to show the display 7 as it would look before beginning treatment, as evidenced by the status shown in the display screen 7 “READY…PATIENT NOT BEING TREATED” and the presence of the “Start Treatment” virtual key 9a, without the “Pause/Resume/End Treatment” keys 9b-9d, see paragraph [0186]-[0187]; In this state shown, a dose/concentration is displayed between box 10 and box 9a as “NO 10ppm” that would presumably correspond to a set NO concentration/dose to be administered once treatment commences), but does not expressly disclose displaying the NO dose to be administered before commencement of the treatment, and continuing to display the NO dose administered to the patient during a downtime in which the treatment by NO is interrupted temporarily, in response to an actuation, by the user, of the means for stopping treatment.
However, Montgomery teaches a NO supply device (the pharmaceutical gas delivered can be CO or NO, see paragraph [0034]) having a dose selection means 13, 15 (Fig. 2, paragraph [0039], input setting knobs 13, 15 set the delivery rate and time duration from which the desired dose 16 is calculated and displayed) and a graphic display 6 being configured to display, before the commencement of the treatment by NO, an NO dose to be administered 16 (in this case, monitor display 6 displays a ”Total Dose” value 16 expressed in mg of CO/NO (“120 mg”) calculated from the set delivery rate 13 (60 mg/hr) and the total set time duration 15 (2.0 hrs), see Fig. 2, paragraph [0040]), and further configured to display, during the treatment, the NO dose administered to the patient (monitor display 6 displays the “Delivered Dose “17 (32 mg) which is a running total of the amount of CO/NO in mg, updated as the CO/NO gas is delivered to the patient, Fig. 2, paragraph [0040]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the NO supply device of Blandin so that the graphic display is configured to display, before treatment, a total dose of NO to be administered, and during treatment, a running total of the NO dose administered, as taught by Montgomery, in order to provide a clear indication to the user of the amount of cumulative NO the patient is getting, which is updated in real-time for better monitoring of the progress of delivery throughout the treatment session.
As to the limitation that the graphic display is configured to continue to display the NO dose administered (the running total “Delivered Dose” taught by Montgomery) to the patient, during a downtime in which the treatment by NO is interrupted temporarily, in response to an actuation, by the user, of the means for stopping treatment, Blandin does disclose that some values (N, TL, TC) may be permanently available on the graphic display as an alternative to appearing on screen only after being called up by the user, paragraph [0173]). Thus, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to continue to display the NO dose administered (the running total “Dose Delivered” taught by Montgomery) permanently on the display, including during the downtime/pause of Blandin, since there is no foreseeable reason to turn off or hide the running total Delivered Dose of NO during a temporary pause and since keeping the display active allows a user to view the settings and progress towards the total dose desired before the treatment is continued again. Information about how much of the NO total dose has been delivered thus far would be useful to a user making decisions of when/if to continue the treatment or how to adjust the treatment.
As to claim 2, modified Blandin discloses the device according to Claim 1, characterized in that the control means are configured to control the graphic display to display the NO dose to be administered (the Total Dose taught by Montgomery), before and during the treatment by NO and during the downtime (dt) in which the treatment by NO is interrupted temporarily (As discussed in claim 1 above, the display of modified Blandin, continues to be active during the downtime/pause, as would have been obvious to one of ordinary skill in the art. Thus, the display of the Total Dose taught by Montgomery (Fig..2, paragraph [0040]) would also continue to be active during the downtime/pause of the NO treatment).
As to claim 3, modified Blandin discloses the device according to Claim 1, characterized in that the control means 6 are further configured to control the valve means 5 in order to supply a gaseous flowrate corresponding to the NO dose to be administered during the treatment by NO, in response to the actuation, by the user, of the means for starting treatment (see Blandin, Fig. 1, paragraphs [0127],[0133],[0144]).
As to claim 4, modified Blandin discloses the device according to Claim 1, characterized in that the control means 6 are further configured to control the valve means 5 in order to temporarily interrupt all gaseous flow during the downtime (dt), in response to the actuation, by the user, of the means for stopping treatment (Fig. 1, paragraph [0146]: interrupts the circulation of gas in the internal passage 2 in the direction of the patient).
As to claim 5, modified Blandin discloses the device according to Claim 1, characterized in that the means for starting treatment and the means for stopping treatment comprise one and the same actuation element, which is actuatable by the user (paragraphs [0149]-[0150]: one same “Start/Pause/Resume treatment” virtual key).
As to claim 6, modified Blandin discloses the device according to Claim 1, characterized in that the means for starting treatment and the means for stopping treatment comprise separate actuation elements, which are actuatable by the user (paragraph [0150]: one same key to start/resume treatment and another key to temporarily pause/end treatment).
As to claim 7, modified Blandin discloses the device according to Claim 5, characterized in that the one or more actuation elements comprise one or more virtual keys displayed on the graphic display 7 (paragraphs [0132],[0148]-[0150]: virtual keys 9a-d displayed on touchscreen 7, Fig. 3).
As to claim 8, modified Blandin discloses the device according to Claim 1, characterized in that the control means 6 are configured to control the graphic display 7 to continue to display, during the downtime (dt), the NO dose having been administered to the patient just before actuation, by the user, of the means for stopping treatment, that is to say before a pause (the Delivered Dose value taught by Montgomery is displayed as a running total of NO delivered which is updated as gas is administered to the patient and calculated as the flow rate of NO gas (in mg/hr) times the running elapsed duration (see Fig. 2, paragraph [0040]); Blandin discloses that a duration of treatment counter for a patient is not incremented during a pause and is only resumed again once the pause is ended and treatment resumes again (see paragraph [0153]); thus, when treatment is paused, the duration of treatment will stay constant and the calculated running total of delivered NO will likewise stay constant until the treatment and duration counter resume). In other words, the Delivered Dose value will not update during the pause when NO is not being delivered; rather, the last updated value before the pause started would be the value displayed until treatment resumes again).
As to claim 9, modified Blandin discloses the device according to Claim 8, characterized in that the memory storage means are configured to store the last dose of NO administered to the patient immediately before the commencement of the downtime (dt) (the dose administered (Delivered Dose taught by Montgomery) will inherently need to be stored in some type of memory of the CPU 40 in order to be displayed by the display, Fig. 2 of Montgomery, paragraph [0040],[0062]).
As to claim 10, modified Blandin discloses the device according to Claim 1, characterized in that the downtime (dt) has a duration of less than or equal to 30 minutes (the user selects the amount of time between stopping and starting treatment; thus, the downtime/length of the pause can be less than or equal to 30 minutes as chosen by the user).
As to claim 11, modified Blandin discloses the device according to Claim 7, characterized in that the one or more virtual keys displayed on the graphic display are touch-sensitive keys (see Blandin, paragraph [0132]).
As to claim 12, modified Blandin discloses the device according to Claim 1, characterized in that the graphic display 7 is a touch panel (touch/digital screen 7, see Blandin, Fig. 1, Fig. 3, paragraph [0129]).
As to claim 13, modified Blandin discloses an installation 20 (gas administration installation 20, Fig. 2) for administering therapeutic gas containing NO to a patient (Fig. 2, paragraph [0174]),comprising an NO supply device 1 according to Claim 1, supplied with NO/N2 mixture by at least one pressurized gas container 21 (Fig. 2, paragraph [0174]) and with oxygen by a pressurized oxygen container (paragraph [0176]: oxygen supply line 34 running through the hospital building), said NO supply device 1 supplying an NO/N2 mixture to a respiratory gas circuit 29 connected to a medical ventilator 23 supplying an O2/N2 mixture or air (Fig. 2, paragraphs [0177]-[0179]).
As to claim 14, modified Blandin discloses the installation according to Claim 13, characterized in that said at least one pressurized gas container 21 contains an NO/N2 mixture containing from 100 to 1000 ppmv of NO, the remainder being nitrogen (800 ppmv, paragraph [0174] of Blandin).
As to claim 15, modified Blandin discloses the installation according to Claim 13, characterized in that the respiratory gas circuit 29 comprises a flowrate sensor 36 (Fig. 2 of Blandin, paragraph [0184]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bathe et al. (US 5,732,693) discloses a NO delivery device having a pause control.
Montgomery et al. (US 2012/0180790) discloses a delivery device for delivering a gas such as NO to a patient, including a display of the Delivered Dose and the Total Dose desired to be delivered.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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