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 .
Response to Amendment
This office action is in response to the amendment filed 7/9/2025. As directed by the amendment, claims 1-20 have been amended. Claims 1-20 are pending in the instant application, wherein claims 7-13 remain withdrawn in response to restriction/election.
Applicant has amended the claims to address the previous numbered objections thereto, which are hereby withdrawn; however, the language of claims 2-3 remain substantially duplicative, because “lower in opening than closing” means the same thing as “higher in closing than opening,” such that the objection regarding potential duplicate claims remains. The objections to the claims are updated below.
Applicant has amended claims 17 and 18 to be supported by the specification as originally filed; the previous rejections of the claims under 35 USC 112(a)/first paragraph are withdrawn.
Applicant has amended claims 1, 6, 14 and 16-18 to clarify the subject matter, but the confusion regarding the “when” phrases in claims 19-20 remains; the rejections under 35 USC 112(b)/second paragraph are updated below, wherein any previous 112b rejection not repeated below has been withdrawn.
Response to Arguments
Applicant's arguments filed 6/20/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Applicant argues on page 10 of Remarks that “claims 2 and 3 use different claim language such that claims 2 and 3 are not substantial duplicates.”
The Examiner respectfully notes that “lower…during opening than…during closing” (claim 2) means the same thing as “higher…during closing than…during opening” (claim 3); therefore, the claims are substantial duplicates because they have the same scope despite using different words. If Applicant wishes the claims to have different scopes, they could amend claim 3 as previously suggested, e.g. to read “lower attenuation…during closing than...during opening” OR “higher…during opening than…during closing”, such that claim 3 would then recite the opposite of claim 2 rather than the same thing as claim 2.
Applicant argues on page 12 of Remarks that DeVires does not teach or suggest two valve assemblies as claimed, alleging that “DeVires et al. merely discloses a flow control valve 42 that regulates…inspiration…[t]here is no other valve assembly in DeVires et al. that is arranged in an exhalation path.”
The Examiner disagrees with Applicant’s mischaracterization of DeVires. DeVires Fig. 1 explicitly depicts exhalation valve 48 in Fig. 1, which is in the exhalation path of DeVires. Moreover, Figs. 2/8 and the disclosure of DeVires would have inferred or reasonably suggested to an artisan before the effective filing date of the claimed invention that the stepper-motor-controlled valve 48 is of the same or substantially similar construction to the stepper-motor-controlled valve 42, as discussed in the updated rejections below. Therefore, DeVires does disclose/teach/suggest two valve assembles, comprising valves 42 and 48, one in the inhalation path and one in the exhalation path, as claimed, and as such, the rejections under 35 USC 102 and 103 are updated below.
Claim Objections
Claims 1-5 and 14-18 are objected to because of the following informalities:
Claim 1, lines 9-14 should read “a/the first volume flow” (5 instances) for clarity
Claim 1, line 11 should read “a first attenuation” for clarity
Claim 1, line 12 should read “an opening of the first volume flow control device” for clarity
Claim 1, line 13 should read “a closing of the first volume flow control device” for clarity
Claim 1, line 24 should read “an opening of the second volume flow control device…the second volume” for clarity
Claim 1, line 25 should read “a closing of the second volume flow control device” for clarity
Claim 1, line 26 should read “the second volume flow” for clarity
Claim 2, line 3 should read “the opening thereof…the closing thereof” for clarity
Claim 3, line 3 should read “the closing thereof…the opening thereof” for clarity
Claim 4, lines 2-3 should read “the opening thereof…the closing thereof” for clarity
Claim 5, line 4 should read “the first volume flow” for clarity
Claim 5, line 5 should read “which limitation is configured to occur
Claim 5, line 6 should read “the opening of the first volume flow control device” for clarity
Claim 5, line 7 should read “limitation is configured to occur
Claim 5, line 6 should read “a control” for clearer antecedent basis
Claim 5, line 7 should read “the closing of the first volume flow control device” for clarity
Claim 14, lines 10-15 should read “a/the first volume flow” (5 instances) for clarity
Claim 14, line 12 should read “a first attenuation” for clarity
Claim 14, line 13 should read “an opening of the first volume flow control device” for clarity
Claim 14, line 14 should read “a closing of the first volume flow control device” for clarity
Claim 14, line 24 should read “a second attenuation” for clarity
Claim 14, line 25 should read “an opening of the second volume flow control device…the second volume” for clarity
Claim 14, line 26 should have a comma after ‘ventilation gas’
Claim 14, line 26 should read “a closing of the second volume flow control device” for clarity
Claim 14, line 27 should read “the second volume flow” for clarity
Claim 15, lines 4-5 should read “the inhalation phase…the exhalation phase” for clearer antecedent basis
Claim 16, line 3 should read “opening thereof…closing thereof” for clarity
Claim 16, line 4 should read “exhalation phase” for clearer antecedent basis
Claim 16, line 5 should read “opening thereof…closing thereof” for clarity
Claim 16, line 7 should read “opening thereof…closing thereof” for clarity
Claim 16, lines 8-9 should read “the opening thereof than during the closing thereof” for clearer antecedent basis
Claim 17, line 3 should read “exhalation phase, respectively, and” for clarity
Claim 18, line 4 should read “during the openings” for clearer antecedent basis
Claim 18, line 5 should read “during the closings” for clearer antecedent basis
Appropriate correction is required.
Applicant is advised that should claim 2 be found allowable, claim 3 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Applicant could address this issue by e.g. amending claim 3, line 2 to recite “lower” OR swapping the terms “closing” and “opening” in claim 3, lines 2-3.
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: “a volume flow control device” in claims 1-6 and 14-20 and “a pneumatic control element” in claim 5 [note: claim 6 provides sufficient structure for the pneumatic control element].
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. That is, “a volume flow control device” corresponds to a diaphragm valve with a pilot valve or pneumatic pump configured to control the fill/emptying rates, where equivalents are considered to be any valve that is capable of having its opening/closing rates controlled, and “a pneumatic control element” corresponds to a pilot valve or pneumatic pump, where equivalents are considered to be any device with a pneumatic compartment whose size and/or pressure can be adjusted.
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 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 1-6 and 14-20 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.
Regarding claim 1 (and thus its dependent claims 2-6), the preamble of claim 1 recites a ventilator as intended use, i.e. the ventilator is not understood to be positively recited, but then lines 3-4 and 15-16 positively recite the valve assemblies in paths of the ventilator, rendering it unclear if the ventilator was or was not intended to be positively recited in claim 1, particularly since claim 14 appears to be intended as a positive combination of the valve assembly of claim 1 with a ventilator, i.e. as a combination including the sub-combination valve assembly of claim 1. For purposes of examination, claim 1 will be considered as directed only to the sub-combination, e.g. lines 3 and 15 will be considered to read “configured to be associated” (two instances).
Regarding claim 14 (and thus its dependent claims 15-18), line 11 recites “a maximum flow volume” and line 23 recites “a maximum flow volume,” wherein it is unclear in the claim whether these are intended to be the same or different flow volume. If the same, line 23 should be amended to read “the maximum flow volume” (i.e. as recited by claim 1). If different, line 11 should be amended to read “a first maximum flow volume” and line 23 amended to read “a second maximum flow volume”.
Regarding claim 19 (and thus its dependent claim 20), claim 19 contains phrases that begin with “when”, wherein is it unclear if these indicate conditional limitations. As best understood, for purposes of examination, claim 19 will be interpreted as if it read “such that” (two instances).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DeVires et al. (US 5,474,062; hereinafter “DeVires”).
Regarding claim 19, DeVires discloses a process for operating a first valve assembly (comprising flow control valve 42, motor 74 and associated software in controller 44) and a second valve assembly (comprising exhalation valve 48, motor 124 and associated software in controller 44) in a ventilator (ventilator 30) (Figs. 1-8), wherein each of the first valve assembly and the second valve assembly comprises an inlet (e.g. inlet 56) for an inflow of a ventilation gas (Fig. 2; col. 7, lines 18-22; wherein an inlet is inherent any valve; therefore, valve 48 must also have an inlet); an outlet (e.g. outlet 60) for an outflow of the ventilation gas (Fig. 2; col. 7, lines 18-22; wherein an outlet is inherent any valve; therefore, valve 48 must also have an outlet) and a volume flow control device (comprising motor 74/124 and valve 42/48, respectively) configured to control the ventilation gas between the inlet and the outlet (col. 6, lines 15-22/col. 6, lines 36-45), the process comprising the steps of:
controlling a volume flow of the ventilation gas in a range between shut off (zero flow) and a maximum volume flow (peak flow) (Figs. 3a-6; col. 7, lines 18-40 in view of col. 9, lines 39-61);
opening the first valve assembly with a first attenuation, as best understood, such that the volume flow of the ventilation gas increases (e.g. Figs. 5-6; rapidly increasing the flow from zero to a peak flow rate, col. 14, lines 9-15; col. 14, line 57-col. 15, line 8), the first valve assembly (comprising flow control valve 42) being associated with an inhalation path of the ventilator (between source 32 and patient 34 in Fig. 1) (col. 5, line 56-col. 6, line 16), the second valve assembly (comprising exhalation valve 48) being associated with an/the exhalation path of the ventilator (between patient 34 and the outlet depicted above exhalation valve 48 in Fig. 1) (col. 6, lines 36-41); and
closing the first valve assembly with a second attenuation, as best understood, such that the volume flow of the ventilation gas decreases (e.g. Figs. 5-6; gradually decreasing…then rapidly decreasing the flow rate back to zero, col. 14, lines 9-15; col. 14, line 57-col. 15, line 8),
wherein the first attenuation differs from the second attenuation (the flow control valve 42 may not be opened and closed at identical rates, col. 11, lines 63-64, in view of e.g. col. 6, lines 15-22 and col. 13, lines 7-40, and see Figs. 4-6).
Regarding claim 20, DeVires discloses the process in accordance with claim 19, further comprising providing a computer program with a program code for carrying out one more steps of the process (see e.g. Figs. 40a-i in view of e.g. col. 6, lines 15-22 and col. 20, lines 26-36), upon the program code being executed on a computer, on a processor or on a programmable hardware component (microcomputer controller 44).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over DeVires et al. (US 5,474,062; hereinafter “DeVires”) in view of Cragg et al. (US 2013/0312757 A1; hereinafter “Cragg”).
Regarding claims 1 and 14, DeVires discloses/suggests a ventilator (ventilator 30) (Figs. 1-2) comprising:
an inhalation flow path (between source 32 and patient 34 in Fig. 1) (col. 5, line 56-col. 6, line 16);
an exhalation flow path (between patient 34 and the outlet depicted above exhalation valve 48 in Fig. 1) (col. 6, lines 36-41);
a first valve assembly (comprising flow control valve 42, motor 74 and associated software in controller 44) associated with one of the inhalation path and the exhalation path (Figs. 1-2 and 8), the valve assembly comprising:
an inlet (inlet 56) configured for an inflow of a ventilation gas (Figs. 1-2; col. 7, lines 18-22);
an outlet (outlet 60) configured for an outflow of the ventilation gas (Figs. 1-2; col. 7, lines 18-22); and
a first volume flow control device (comprising motor 74 and flow control valve 42) configured to control the ventilation gas between the inlet and the outlet (col. 6, lines 15-22) and further configured:
to control a volume flow of the ventilation gas in a range between shut-off (zero flow) and a maximum volume flow (peak flow) (Figs. 3a-6; col. 7, lines 18-40 in view of col. 9, lines 39-61); and
to provide an attenuation of a volume flow change which the volume flow change occurs during an opening, providing an increase in volume flow of the ventilation gas, that differs from an attenuation occurring during a closing, providing a reduction of the volume flow of the ventilation gas (the flow control valve 42 may not be opened and closed at identical rates, col. 11, lines 63-64, in view of e.g. col. 6, lines 15-22 and col. 13, lines 7-40 and see Figs. 4-6);
a second valve assembly (comprising exhalation valve 48, motor 124 and associated software in controller 44) associated with another one of the inhalation path and the exhalation path (Figs. 1-2 and 8), the second valve assembly comprising:
a second inlet (e.g. inlet 56) configured for an inflow of a ventilation gas (Figs. 1-2; col. 6, lines 36-45 and col. 7, lines 18-22 in view of col. 23, lines 4-10 and col. 69, lines 36-43; wherein an inlet in inherent in any valve, and where the position sensors and controls of the valves 42 and 48 are described by DeVires as being identical/substantially the same, which would have inferred or strongly suggested to an artisan before the effective filing date of the claimed invention that the valve structure of valve 48 is identical to that depicted for valve 42, in order to permit the identical control/operation disclosed by DeVires, as well as to predictably provide economies of scale when sourcing parts and/or ease of manufacture/programming by using the same/similar valve construction for both valves);
a second outlet (e.g. outlet 60) configured for an outflow of the ventilation gas (Figs. 1-2; col. 6, lines 36-45 and col. 7, lines 18-22 in view of col. 23, lines 4-10 and col. 69, lines 36-43; wherein an outlet is inherent for any valve and see the discussion above regarding the inference/obviousness that valve 48 have the same/similar construction as depicted for valve 42); and
a second volume flow control device (comprising motor 124 and exhalation valve 48) configured to control the ventilation gas between the second inlet and the second outlet (col. 6, lines 36-45) and further configured:
to control a second volume flow of the ventilation gas in a range between shut-off (zero flow) and the/a maximum volume flow (peak and/or PEEP flow) (Figs. 3a-6; col. 6, line 64-col. 7, line 40 in view of col. 9, lines 39-61 and col. 46, lines 3-50; “the control of the exhalation valve is substantially the same as the control of the flow control valve,” col. 69, lines 36-43); and
to provide a second attenuation of a second volume flow change which second volume flow change occurs during an opening, providing an increase in volume flow of the ventilation gas, that differs from an attenuation occurring during a closing, providing a reduction of the volume flow of the ventilation gas (the flow control valve 42 may not be opened and closed at identical rates, col. 11, lines 63-64, in view of e.g. col. 7, lines 1-16, col. 13, lines 7-50, and Figs. 4-6 in view of col. 69, lines 36-43: “the control of the exhalation valve is substantially the same as the control of the flow control valve”), wherein DeVires thus discloses/teaches that valve 48 is operated similarly to valve 42, which is inferred to include operation where both valves are opened faster than they are closed, and Cragg reinforces this suggested/obvious arrangement, teaching that it was known in the respiratory therapy art before the effective filing date of the claimed invention to provide an exhalation attenuation of an exhalation volume flow change which exhalation volume flow change occurs during an opening of an exhalation valve, providing an increase in volume flow of the ventilation gas, that differs from an attenuation occurring during a closing of the exhalation valve, providing a reduction of the volume flow of the ventilation gas (an expiratory valve…configured…to open a predetermined amount when the opening pressure is reached and then close slowly over the course of expiration…“pops” open…closes back down over the course of expiration, para [0109]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for valve 48 of DeVires to be also configured/operated such that it is not opened and closed at identical rates, i.e. to provide a second attenuation of a second volume flow change which second volume flow change occurs during an opening, providing an increase in volume flow of the ventilation gas, that differs from an attenuation occurring during a closing, providing a reduction of the volume flow of the ventilation gas, as suggested by DeVires and taught by Cragg, in order to provide the predictable result of an exhalation PEEP valve that is quickly opened to allow for initial exhalation (which occurs at a pressure over PEEP) and then slowly closed to act as a pneumatic split (i.e. to establish/maintain a target PEEP) and thus keep the airway open during the remainder of expiration (DeVires col. 6, line 64-col. 7, line 14; Cragg para [0109]).
Regarding claim 2, DeVires in view of Cragg teaches the valve assembly in accordance with claim 1, wherein DeVires further discloses wherein the first volume flow control device provides a lower attenuation of the volume flow change during opening than the attenuation of the volume flow change during closing (e.g. Figs. 5-6; rapidly increasing the flow from zero to a peak flow rate…gradually decreasing…then rapidly decreasing the flow rate back to zero, col. 14, lines 9-15; col. 14, line 57-col. 15, line 8).
Regarding claim 3, DeVires in view of Cragg teaches the valve assembly in accordance with claim 1, wherein DeVires further discloses wherein the first volume flow control device has a higher attenuation of the volume flow change during closing than the attenuation of the volume flow change during opening (e.g. Figs. 5-6; rapidly increasing the flow from zero to a peak flow rate…gradually decreasing…then rapidly decreasing the flow rate back to zero, col. 14, lines 9-15; col. 14, line 57-col. 15, line 8).
Regarding claim 15, DeVires in view of Cragg teaches the ventilator in accordance with claim 14, wherein DeVires further discloses wherein:
the ventilator is configured to carry out an inhalation phase (col. 6, lines 23-24); or
the ventilator is configured to carry out an exhalation phase (col. 6, lines 45-49); or
the ventilator is configured to carry out an inhalation phase (col. 6, lines 23-24) and the ventilator is configured to carry out an exhalation phase (col. 6, lines 45-49).
Regarding claim 16, DeVires in view of Cragg teaches the ventilator in accordance with claim 15, wherein DeVires further discloses/modified DeVires further teaches wherein:
the first volume flow control device provides a lower attenuation for the inhalation phase during the opening [thereof] than during the closing [thereof] (e.g. DeVires Figs. 5-6; rapidly increasing the flow from zero to a peak flow rate…gradually decreasing…then rapidly decreasing the flow rate back to zero, col. 14, lines 9-15; col. 14, line 57-col. 15, line 8) or
the first volume flow control device provides a lower attenuation for the exhalation phase during the opening [thereof] than during the closing [thereof] (the arbitrary assignment of the “first” and “second” volume flow control devices in claim 1 can be switched such that modified DeVires teaches this limitation as discussed below); or
the first volume flow control device provides a lower attenuation for the inhalation phase during the opening [thereof] than during the closing [thereof] (e.g. DeVires Figs. 5-6; rapidly increasing the flow from zero to a peak flow rate…gradually decreasing…then rapidly decreasing the flow rate back to zero, col. 14, lines 9-15; col. 14, line 57-col. 15, line 8) and the second volume flow control device provides a lower attenuation for the exhalation phase during [the] opening thereof than during [the] closing thereof (e.g. DeVires Figs. 5-6; rapidly increasing the flow from zero to a peak flow rate…gradually decreasing…then rapidly decreasing the flow rate back to zero, col. 14, lines 9-15; col. 14, line 57-col. 15, line 8; in view of DeVires disclosure/suggestion that the exhalation valve 48 is operated substantially the same as the inhalation valve 42 and Cragg’s teaching of an expiratory valve that quickly “pops” open and gradually closes back down over the course of expiration as discussed above regarding claims 1/4).
Regarding claims 17-18, DeVires in view of Cragg teaches the ventilator in accordance with claim 16, wherein modified DeVires further discloses wherein the first and second volume flow control devices are configured for the inhalation phase and for the exhalation phase, respectively (see claims 1/14/16 discussions above) and to allow, relative to the same unit of time, volume flow/patient pressure changes during the openings that exceed the volume flow/patient pressure changes occurring during the closings, which DeVires suggests is by at least by a factor of 2, because the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art, see MPEP 2125, and Figs. 5-6 of DeVires depict that the rapid increase in volume flow (and thus patient pressure, because these variables are directly correlated) is at least twice the rate of the gradual decrease; also, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art. MPEP § 2144.05. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified DeVires to include wherein the first and second volume flow control devices are configured for the inhalation phase and for the exhalation phase[, respectively, and] to allow, relative to the same unit of time, volume flow/patient pressure changes during opening that exceed the volume flow/patient pressure changes occurring during closing at least by a factor of 2 as suggested by DeVires, in order to provide the predictable result of a suitably tapered inhalation profile and sufficiently responsive PEEP exhalation valve (DeVires Figs. 5-6; col. 9, line 29-col. 10, line 1; col. 14, line 57-col. 15, line 8; Cragg para [0109]).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over DeVires in view of Cragg as applied to claim 1, and further in view of Dai et al. (CN 107050595 B; hereinafter “Dai”; wherein the citations below refer to the translation provided with this Office Action).
Regarding claim 4, DeVires in view of Cragg teaches the valve assembly in accordance with claim 1, but DeVires is silent regarding wherein the first volume flow control device has a higher inertia during opening than during closing. However, Dai teaches that it was known in the respiratory therapy art before the effective filing date of the claimed invention to include wherein a volume flow control device (electromagnetic valve) has a higher inertia during opening (during T3 when opening, i.e. the slower portion/deacceleration of the opening) than during closing (during T1 when closing, i.e. the faster portion/acceleration of the closing) (Figs. 3-4; second full paragraph from the bottom of page 1; last paragraph on page 2; last two paragraphs on page 4). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified DeVires to include gradients within each of the openings and the closings, such that the first volume flow control device has a higher inertia during (a portion of) opening than during (a portion of) closing, as taught by Dai, in order to reduce pressure oscillations during opening/closing to provide better comfort to the user (Dai abstract).
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over DeVires in view of Cragg as applied to claim 1, and further in view of Chalvignac et al. (FR 2784587; hereinafter “Chalvignac”, wherein the citations below refer to the translation provided with this Office Action).
Regarding claims 5-6, DeVires in view of Cragg teaches the valve assembly in accordance with claim 1, but modified DeVires is silent regarding wherein:
the first volume flow control device comprises a pneumatic control element for controlling the volume flow by means of a first control pressure volume; and
a limitation of a control pressure volume change rate, which limitation occurs during the opening, is different from a limitation of the control pressure volume change rate, which limitation occurs during the closing,
wherein the pneumatic control element comprises either a pilot valve configured to be adjusted by a second control pressure volume, or a pneumatic pump.
However, Chalvignac teaches that it was known in the ventilator art before the effective filing date of the claimed invention for a volume flow control device (balloon valve 32) (Fig. 1) to comprise a pneumatic control element (control circuit 34) for controlling the volume flow by means of a first control pressure volume (the volume within the balloon of valve 32 depicted in e.g. Figs. 1-2) (abstract); and
a limitation of a control pressure volume change rate, which limitation occurs during the opening, and a limitation of the control pressure volume change rate, which limitation occurs during the closing (fifth paragraph on page 4; first five paragraphs on page 5),
wherein the pneumatic control element comprises either a pilot valve (balloon valve 39) configured to be adjusted by a second control pressure volume (the volume within balloon 39), or a pneumatic pump (auxiliary compressor 52 OR the compressor described in the fourth paragraph on page 2).
Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another," the claim is unpatentable under 35 U.S.C. 103(a), see MPEP 2143.I.B. It would have been obvious to an artisan before the effective filing date of the claimed invention to substitute either or both of the stepper-motor-controlled valves of modified DeVires [where either substituted one can be assigned as the “first” for purposes of the rejection of claims 5-6] with the pneumatically-controlled valve of Chalvignac described above such that the first volume flow control device comprises a pneumatic control element for controlling the volume flow by means of a first control pressure volume; and a limitation of a control pressure volume change rate, which limitation occurs during the opening, is different from a limitation of the control pressure volume change rate, which limitation occurs during the closing, wherein the pneumatic control element comprises either a pilot valve configured to be adjusted by a second control pressure volume, or a pneumatic pump, in order to provide the predictable result of valves long known to be suitable for controlling gas flow in a respirator (Chalvignac paragraph seven of page 1), particularly one(s) that allow precise control for quick opening and controlled slower closing, to accommodate exhalation without discomfort while allowing for the generation of PEEP (Chalvignac paragraphs two and seven of page 1, and the top of page 5) and/or provide similar quick response/opening to inhalation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references teaching controlling the rate of opening/closing ventilator valves: Carter (US 5,339,807); Douglas et al. (WO 2021/138287 A1; para [00199]). Additional references teaching piloted valves, including fast-open PEEP valves, in ventilators: Chalvignac et al. (CA 2,230,622 and EP 1177810 B1).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M-Th 7:30a-4:30p, F 7:30a-11:30a ET.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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