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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 10/14/2025 has been entered.
Response to Amendment
This office action is in response to the amendment filed 10/14/2025. As directed by the amendment, claims 16 and 28-30 have been amended. Claims 16-30 are pending in the instant application.
Response to Arguments
Applicant's arguments filed 10/14/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
With regards to amended claim 16, Applicant argues on page 8 of Remarks that “Wallin does not provide any description with respect to resuming an ordinary ventilation after the predetermined amount of time for the oxygen flush has elapsed and thus does not provide any showing or suggestion that an expiratory phase would be triggered upon deactivation thereof.”
The Examiner disagrees that Wallin does not provide any description that ordinary ventilation is resumed after the oxygen flush is terminated. Para [0077] of Wallin discusses resuming delivery of anesthesia “after this [oxygen] flush procedure,” where the delivery of anesthesia is under ordinary ventilation per e.g. Wallin paras [0050], [0058], [0097-102]. Thus, Wallin does teach resuming an ordinary ventilation upon termination of an oxygen flush, and Rauscher and/or an obvious choice between three valve operations educates modified Wallin to include the newly added step when resuming ordinary/anesthesia-delivering ventilation after an oxygen flush, for the reasons discussed in the updated rejections below.
With regards to amended claim 16, as best understood, Applicant argues on pages 8-9 of Remarks that Ironstone teaches a high flow flush mode and low flow maintenance mode, but that Ironstone “does not describe or suggest that an expiratory phase is triggered prior to resuming ventilation in, for example, the low flow setting.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Ironstone need not disclose the contested limitation, because it is already obvious in view of Rauscher and/or an obvious choice between three valve operations, as discussed in the updated rejections below.
With regards to amended claim 16, Applicant argues on page 9 of Remarks that Rauscher teaches “a cycling between the inspiratory and expiratory phases remains constant, regardless of the selected mode. Thus, an expiratory phase is not triggered by a switching from one mode to another.”
The Examiner respectfully notes that the claims do not specify the phase that the valve is in when the oxygen flush is deactivated, and since flush deactivation and triggering of an exhalation phase are fully capable of occurring simultaneously and are obvious to occur out simultaneously out of the finite times during a breathing cycle in which a flush can be deactivated, Rauscher teaches the newly added limitation as discussed in the updated rejections below. Moreover, the Examiner has also provided a reasoned statement as to why the claimed option, out of the 3 valve positions taught by Wallin, would have been obvious, regardless of what position the valve is in/phase the respiration is in when the flush is deactivated, i.e. in order to provide the predictable result of immediately preparing the patient to inhale a full breath of anesthetic by emptying the oxygen-flush-containing lungs by triggering an exhalation, to ensure that anesthesia delivery into the lungs is immediately resumed after the flush is discontinued so that the patient is maintained under anesthesia despite the oxygen flush. Therefore, the claims remain rejected in view of the prior art as discussed in the updated rejections below.
With regards to amended claim 16, Applicant argues on page 9 of Remarks that Haggblom “does not show or suggest an oxygen flush, much less adjusting any settings of a breathing apparatus upon deactivation thereof.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Haggblom need not disclose the contested limitation, because it is already obvious in view of Rauscher and/or an obvious choice between three valve operations, as discussed in the updated rejections below.
With regards to amended claims 28-30 and dependent claims 19, 20 and 25, on pages 10-12 of Remarks, Applicant refers to the same arguments as made with regards to claim 16.
The Examiner refers to her rebuttals above and the updated rejections below.
Claim Interpretation
Regarding the independent claims, per page 10, lines 18-20, of the instant specification, the term “ongoing/ordinary ventilation” relates to an ordinary ventilation operation where the patient is ventilated with fresh gas and/or recirculated expiratory gas.
Regarding claim 23, the cycling step being “preceded” by a step of providing an expiratory phase supplementing the interrupted inspiratory phase is understood to mean that claim 23 requires an interrupted inspiratory phase that begins with ongoing ventilation but ends with oxygen flush/continuous flow of oxygen, followed by an expiratory phase entirely of oxygen flush/continuous flow of oxygen, then a second, uninterrupted/full inspiratory phase of oxygen flush/continuous flow of oxygen, followed by a second expiratory phase at least beginning with oxygen flush/continuous flow of oxygen.
Regarding claim 29, a “computer program product that is connected to a computer” is understood in light of instant pages 18-19 to be a “suitable digital storage medium” for “hold[ing] machine readable data in a non-transitory manner,” e.g. a CD as shown in instant Fig. 5, that is in electronic communication with a computer of a breathing apparatus as claimed.
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: “calculation units” and “control units” in claims 28 and 29 and “control unit” in claim 30.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 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.
Claim 16-18, 21-24 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Wallin et al. (US 2015/0250976 A1; hereinafter “Wallin”) in view of Ironstone (US 2018/0169369 A1; hereinafter “Ironstone”), Rauscher et al. (US 4,267,827; hereinafter “Rauscher”) and Haggblom et al. (US 2011/0232641 A1; hereinafter “Haggblom”).
Regarding claims 16, 18, 28 and 29, Wallin discloses a computer program (product) (computer program 200 on computer-readable medium 210) embedded in/connected to a computer (paras [0105-106]) comprising computer readable code (comprising code segment 226) (para [0106]) configured to cause one or more calculation units (inferred from paras [0073-84]) of one or more control units (control unit 60) to perform a method for delivering an oxygen flush in an anaesthetic breathing apparatus (Fig. 6; paras [0074-76], [0084], [0104-106]), the anaesthetic breathing apparatus comprising a breathing circuit (circle system 7) (Fig. 6), a fresh gas section (comprising gas sources 20A,B and fresh gas line 18) providing fresh gas to a patient (Fig. 6; para [0100]), and a ventilator section (comprising gas sources 20D, E) providing ventilation by providing driving gas for inspiration and controlling flow of expiratory gas from the patient (Fig. 6; paras [0092-100]), wherein the fresh gas section and the ventilator section are connected to the breathing circuit (Fig. 6), wherein the fresh gas section comprises an oxygen supply (oxygen gas source 20A) (para [0094]) and at least one further gas supply (air gas source 20B and/or nitrous oxide gas source) (para [0094]), and the ventilator section comprises an expiratory pressure control valve (expiratory valve 40) (para [0097]), a driving gas line (driving gas line 51), an inspiratory pressure control valve (inspiratory valve 30, 32, 660 and/or 661) (paras [0099-101]), and a rebreathing gas reservoir (volume reflector 26) (para [0102]), the method comprising steps of:
starting a continuous flow of oxygen from the oxygen supply into at least a portion of the breathing circuit and interrupting an ongoing ventilation in order to activate the oxygen flush (paras [0074-76], [0084], [0104-106]); and
maintaining the continuous flow of oxygen (paras [0075-77], e.g. for 10 seconds).
While Wallin teaches the oxygen flush lasting for some non-transient period of time, e.g. 1-10 seconds (para [0075]), where at least 10 seconds would encompass at least two consecutive breathing cycles even at the low end of average adult breathing (12-20 breaths/min) and even more consecutive breathing cycles for infants and children (30-60 breaths/min, depending on age), Wallin is silent regarding wherein the method provides for maintaining ventilation during the oxygen flush, such that the continuous flow of oxygen is maintained during a number of consecutive breathing cycles, the method including:
wherein during the maintaining step performing a step of cycling the expiratory pressure control valve between an upper pressure level setting to provide an inspiratory phase of a breathing cycle and a lower pressure level setting that is a PEEP level setting of the expiratory pressure control valve to provide an expiratory phase of the breathing cycle.
However, Ironstone demonstrates that it was well known in the oxygen flush art before the effective filing date of the claimed invention for a patient to be breathing during an oxygen flush (paras [0082-83]), and Rauscher teaches that it was known in the ventilation flush art before the effective filing date of the claimed invention for a method of ventilation to include maintaining ventilation during a flush (abstract) such that the flow of flush gas is maintained during a number of consecutive breathing cycles, the method including:
wherein during the maintaining step (“wash out” period) (col. 1, lines 52-54) performing a step of cycling the expiratory pressure control valves (control valve 110+PEEP valve 108) between an upper pressure level setting (when control valve 110 is closed during inspiration) to provide an inspiratory phase of a breathing cycle and a lower pressure level setting that is a PEEP level setting of the expiratory pressure control valves (when control valve 110 and PEEP valve 108 are open during expiration) to provide an expiratory phase of the breathing cycle (cols. 7-8), with Haggbloom further demonstrating the obviousness of a single valve (expiration valve 37) (Fig. 1) for controlling exhalation phase as well as PEEP (paras [0035-37]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the method of Wallin to include maintaining ventilation during the oxygen flush such that the continuous flow of oxygen is maintained during a number of consecutive breathing cycles, wherein during the maintaining step performing a step of cycling the expiratory pressure control valve between an upper pressure level setting to provide an inspiratory phase of a breathing cycle and a lower pressure level setting to provide an expiratory phase of the breathing cycle as suggested/taught by Wallin, Ironstone, Rauscher and Haggbloom, in order to provide the predictable result of allowing the flush to occur without any interruption of the mechanical ventilation and for multiple breathing cycles to allow adequate flushing of the patient’s lungs [i.e. ensuring that the higher-oxygen-concentration gas is being delivered into the lungs of the patient, i.e. during the continued mechanical inhalation periods, for absorption thereof and diluted/exhaled gas is being carried away, i.e. during the continued mechanical exhalation periods, so as to raise the patient’s blood oxygen concentration as quickly as possible by ensuring that a high oxygen concentration is present in the lungs for a sufficient amount of time/breaths to encourage diffusion within the alveoli] and without variation in one or more ventilation parameters, which might otherwise result in further health complications (Rauscher, col. 2, lines 1-8), while utilizing a single valve to achieve both exhalation phase and PEEP (with the provision of PEEP being obvious for the well-known reason of preventing lung collapse during exhalation/facilitation of reinflation, see Rauscher col. 7, lines 11-19) for cost savings and/or to reduce the number of parts that could potentially fail.
While Wallin further teaches resuming ordinary ventilation/anesthetic delivery upon deactivation of the oxygen flush (Wallin para [0077] in view of paras [0050], [0058], [0097-102]), modified Wallin is silent regarding setting the expiratory pressure control valve to the lower pressure level setting, upon deactivation of the oxygen flush, to trigger an expiratory phase in order to terminate a current breathing cycle prior to resuming an ordinary ventilation. However, Rauscher further educates modified Wallin to include setting the expiratory pressure control valve to the lower pressure level setting, upon deactivation of the oxygen flush at the same time that an expiration should occur during the ongoing ventilation, which would have been obvious to occur out of the finite times during a respiratory cycle in which to end a flush with the expected result ending the flush when the patient has been sufficiently oxygenated, to trigger an expiratory phase (i.e. the expiratory phase that was slated to occur at the time the flush was ended) in order to terminate a current breathing cycle prior to resuming an ordinary ventilation, because when the triggering of the flush occurs at the same time an expiration was already set to occur, the claimed simultaneous step will occur in the modified method of Wallin in view of Ironstone, Rauscher and Haggblom, because the ventilation cycles are taught by Rauscher to be maintained (via expiratory PEEP valve setting) before/during/after switching to the flush (Rauscher abstract; cols. 7-8). Additionally and/or alternatively, out of the three readily apparent options for resuming ventilated anesthetic delivery upon deactivation of the oxygen flush that arise from the valve cycling taught by modified Wallin as discussed above, i.e.: 1) no change to the expiratory pressure control valve, thus maintaining whatever breathing phase the system is in at the time of deactivation, 2) setting the expiratory pressure control valve to the upper pressure level setting to trigger an inhalation phase, or 3) setting the expiratory pressure control valve to the lower pressure level setting to trigger an exhalation phase, the instantly claimed option 3 would have been obvious to an artisan before the effective filing date of the claimed invention in order to provide the predictable result of immediately preparing the patient to inhale a full breath of anesthetic by emptying the oxygen-flush-containing lungs by triggering an exhalation, to ensure that anesthesia delivery into the lungs is immediately resumed after the flush is discontinued so that the patient is maintained under anesthesia despite the oxygen flush.
Regarding claim 17, Wallin in view of Ironstone, Rauscher and Haggblom teaches the method according to claim 16, wherein Rauscher further educates modified Wallin to include wherein the cycling step is performed at a previously set respiratory rate (respiratory rate…constant, abstract) and a previously set ratio between the inspiratory phase and the expiratory phase (inspiratory time…constant, abstract; wherein a set respiratory rate and inspiratory time necessarily results in a set expiratory time/ratio between inspiratory and expiratory times) (Rauscher abstract; col. 7-8; where the respiratory rate and inspiratory time (and thus expiratory time) are set/maintained the same throughout xenon delivery and throughout the flush thereafter).
Regarding claim 21, Wallin in view of Ironstone, Rauscher and Haggblom teaches the method according to claim 16, wherein Wallin as modified to include a single expiratory PEEP valve that is closed during inhalation and open during exhalation as discussed above regarding claim 16 further teaches wherein the upper pressure level setting (i.e. the higher pressure during inspiration) is at a pressure above a PEEP level setting (i.e. the lower pressure during expiration).
Regarding claim 22, Wallin in view of Ironstone, Rauscher and Haggblom teaches the method according to claim 16, wherein Rauscher further educates modified Wallin to include wherein when the starting step is performed at the time that an expiration should occur during the ongoing ventilation, which would have been obvious to occur out of the finite times during a respiratory cycle in which to start a flush with the expected result providing the flush when needed by the patient, the method further comprising a substantially simultaneous step of: triggering an expiratory phase (i.e. the expiratory phase that was slated to occur when the flush was triggered) with the expiratory pressure control valve by performing a step of setting the expiratory pressure control valve at the lower pressure level setting, because when the triggering of the flush occurs at the same time an expiration was already set to occur, the claimed simultaneous step will occur in the modified method of Wallin in view of Ironstone, Rauscher and Haggblom, because the ventilation cycles are taught by Rauscher to be maintained (via expiratory PEEP valve setting) before/during/after switching to the flush (abstract; cols. 7-8).
Regarding claim 23, Wallin in view of Ironstone, Rauscher and Haggblom teaches the method according to claim 16, wherein Rauscher further educates modified Wallin to include wherein when the starting step is performed amidst an inspiratory phase during ventilation, which would have been obvious to occur out of the finite times during a respiratory cycle in which to start a flush with the expected result providing the flush when needed by the patient, the inspiratory phase is continued by performing a step of setting the expiratory pressure control valve at the higher pressure level setting for a remaining time period of the inspiratory phase (i.e. the expiratory control valve is maintained in the position already set for inhalation), and the cycling step is preceded by a step of providing an expiratory phase supplementing the inspiratory phase to complete a breathing cycle by setting the expiratory pressure control valve at the lower pressure level setting (i.e. the next expiratory phase that occurs after starting the flush), because when the triggering of the flush/switch occurs during an inhalation, the claimed setting steps will occur in the combined method of Wallin in view of Ironstone, Rauscher and Haggblom, because the ventilation cycles are taught by Rauscher to be maintained (via expiratory PEEP valve setting) before/during/after switching to the flush (abstract; cols. 7-8).
Regarding claim 24, Wallin in view of Ironstone, Rauscher and Haggblom teaches the method according to claim 16, wherein Wallin further discloses wherein the fresh gas section comprises an oxygen valve (valve 30) controlling flow of oxygen, and wherein the starting step comprises a step of opening at least partially the oxygen valve (paras [0070-74] and [0100]).
Regarding claim 26, Wallin in view of Ironstone, Rauscher and Haggblom teaches the method according to claim 16, wherein Wallin further discloses wherein the starting step is preceded by a step of ventilating a patient in (a) a volume or pressure controlled mode of ventilation of the anaesthetic breathing apparatus (paras [0050-51], [0058]).
Regarding claim 27, Wallin in view of Ironstone, Rauscher and Haggblom teaches the method according to claim 26, wherein Wallin further discloses wherein the ventilating step comprises a step of recirculating a portion of expiratory gas from the patient in the anaesthetic breathing apparatus (Fig. 6; paras [0050], [0044], [0100]).
Regarding claim 30, Wallin discloses an anaesthetic breathing apparatus (Fig. 6; paras [0074-76], [0084, [0104-106]), comprising:
a breathing circuit (circle system 7) (Fig. 6);
a fresh gas section (comprising gas sources 20A,B and fresh gas line 18) providing fresh gas to a patient (Fig. 6; para [0100]), the fresh gas section including an oxygen supply (oxygen gas source 20A) (para [0094]) and at least one further gas supply (air gas source 20B and/or nitrous oxide gas source) (para [0094]);
a ventilator section (comprising gas sources 20D, E) providing ventilation by providing driving gas for inspiration and controlling flow of expiratory gas from the patient (Fig. 6; paras [0092-100]), the ventilator section including an expiratory pressure control valve (expiratory valve 40) (para [0097]), a driving gas line (driving gas line 51), an inspiratory pressure control valve (inspiratory valve 30, 32, 660 and/or 661) (paras [0099-101]), and a rebreathing gas reservoir (volume reflector 26) (para [0102]), wherein the fresh gas section and the ventilator section being connected to the breathing circuit (Fig. 6); and
at least one control unit (control unit 60),
wherein the anaesthetic breathing apparatus is configured to:
start a continuous flow of oxygen from the oxygen supply into at least a portion of the breathing circuit [and interrupt an ongoing ventilation], in order to activate the oxygen flush (paras [0074-76], [0084], [0104-106]); and
maintain the continuous flow of oxygen (paras [0075-77], e.g. for 10 seconds).
While Wallin teaches that manual flushing was known in the oxygen flush art before the effective filing date of the claimed invention (para [0076]) and that the oxygen flush should last for some non-transient period of time, e.g. 1-10 seconds (para [0075]), where at least 10 seconds would encompass at least two consecutive breathing cycles even at the low end of average adult breathing (12-20 breaths/min) and even more consecutive breathing cycles for infants and children (30-60 breaths/min, depending on age), Wallin is silent regarding wherein the apparatus is configured, upon user input, to start the flush and the control unit configured to provide for maintaining ventilation during the oxygen flush, such that the continuous flow of oxygen is maintained during a number of consecutive breathing cycles, and cycle, during the maintenance of the continuous flow of oxygen, the expiratory pressure control valve between an upper pressure level setting to provide an inspiratory phase of a breathing cycle and a lower pressure level setting to provide an expiratory phase of the breathing cycle.
However, Wallin does teach that it is desirable for the user to take action in response to the O2 alarm (para [0067]), and Ironstone demonstrates that it was well known in the oxygen flush art before the effective filing date of the claimed invention for a patient to be breathing during an oxygen flush (paras [0082-83]), and Rauscher teaches that it was known in the ventilation flush art before the effective filing date of the claimed invention to maintain ventilation during a flush (abstract) such that the flow of flush gas is maintained during a number of consecutive breathing cycles, and cycle, during the maintaining step (“wash out” period) (col. 1, lines 52-54), the expiratory pressure control valves (control valve 110+PEEP valve 108) between an upper pressure level setting (when control valve 110 is closed during inspiration) to provide an inspiratory phase of a breathing cycle and a lower pressure level setting (when control valve 110 and PEEP valve 108 are open during expiration) to provide an expiratory phase of the breathing cycle (cols. 7-8), with Haggbloom further demonstrating the obviousness of a single valve (expiration valve 37) (Fig. 1) for controlling exhalation phase as well as PEEP (paras [0035-37]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the apparatus and control unit of Wallin such that an oxygen flush can be manually triggered, i.e. upon user input, and to include maintaining ventilation during the oxygen flush such that the continuous flow of oxygen is maintained during a number of consecutive breathing cycles, i.e. the control unit is configured to cycle the expiratory pressure control valve between an upper pressure level setting to provide an inspiratory phase of a breathing cycle and a lower pressure level setting to provide an expiratory phase of the breathing cycle as taught/suggested by Wallin, Ironstone, Rauscher and Haggbloom, in order to provide the predictable result of providing an oxygen flush as a user-triggerable option with which to respond to the O2 alarm (Wallin paras [0066] and [0076]) and/or to avoid “unauthorized practice of medicine” with the automated system, and allowing the flush to occur without any interruption of the mechanical ventilation and for multiple breathing cycles to allow adequate flushing of the patient’s lungs [i.e. ensuring that the higher-oxygen-concentration gas is being delivered into the lungs of the patient, i.e. during the continued mechanical inhalation periods, for absorption thereof and diluted/exhaled gas is being carried away, i.e. during the continued mechanical exhalation periods, so as to raise the patient’s blood oxygen concentration as quickly as possible by ensuring that a high oxygen concentration is present in the lungs for a sufficient amount of time/breaths to encourage diffusion within the alveoli] and without variation in one or more ventilation parameters, which might otherwise result in further health complications (Rauscher, col. 2, lines 1-8), while utilizing a single valve to achieve both exhalation phase and PEEP (with the provision of PEEP being obvious for the well-known reason of preventing lung collapse during exhalation/facilitation of reinflation, see Rauscher col. 7, lines 11-19) for cost savings and/or to reduce the number of parts that could potentially fail.
While Wallin further teaches resuming ordinary ventilation/anesthetic delivery upon deactivation of the oxygen flush (Wallin para [0077] in view of paras [0050], [0058], [0097-102]), modified Wallin is silent regarding setting the expiratory pressure control valve, upon deactivation of the oxygen flush, to the lower pressure level setting to trigger an expiratory phase in order to terminate a current breathing cycle prior to resuming an ordinary ventilation. However, Rauscher further educates modified Wallin to include setting the expiratory pressure control valve, upon deactivation of the oxygen flush at the same time that an expiration should occur during the ongoing ventilation, which would have been obvious to occur out of the finite times during a respiratory cycle in which to end a flush with the expected result ending the flush when the patient has been sufficiently oxygenated, to the lower pressure level setting to trigger an expiratory phase (i.e. the expiratory phase that was slated to occur at the time the flush was ended) in order to terminate a current breathing cycle prior to resuming an ordinary ventilation, because when the triggering of the flush occurs at the same time an expiration was already set to occur, the claimed simultaneous step will occur in the modified method of Wallin in view of Ironstone, Rauscher and Haggblom, because the ventilation cycles are taught by Rauscher to be maintained (via expiratory PEEP valve setting) before/during/after switching to the flush (Rauscher abstract; cols. 7-8). Additionally and/or alternatively, out of the three readily apparent options for resuming ventilated anesthetic delivery upon deactivation of the oxygen flush that arise from the valve cycling taught by modified Wallin as discussed above, i.e.: 1) no change to the expiratory pressure control valve, thus maintaining whatever breathing phase the system is in at the time of deactivation, 2) setting the expiratory pressure control valve to the upper pressure level setting to trigger an inhalation phase, or 3) setting the expiratory pressure control valve to the lower pressure level setting to trigger an exhalation phase, the instantly claimed option 3 would have been obvious to an artisan before the effective filing date of the claimed invention in order to provide the predictable result of immediately preparing the patient to inhale a full breath of anesthetic by emptying the oxygen-flush-containing lungs by triggering an exhalation, to ensure that anesthesia delivery into the lungs is immediately resumed after the flush is discontinued so that the patient is maintained under anesthesia despite the oxygen flush.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Wallin view of Ironstone, Rauscher and Haggblom as applied to claim 16, and further in view of Panin (US 2021/0008322 A1; hereinafter “Panin”).
Regarding claim 19, Wallin in view of Ironstone, Rauscher and Haggblom teaches the method according to claim 16, but Wallin in view of Ironstone, Rauscher and Haggblom is silent regarding wherein the upper pressure level setting is at a level below a threshold pressure level of a pressure relief valve of the anaesthetic breathing apparatus. However, Panin demonstrates that it was well known in the ventilator art before the effective filing date of the claimed invention to include wherein the upper pressure level setting of an exhalation valve (one NO proportion SV, para [0021]) is at a level below a threshold pressure level of a pressure relief valve (safety valve 2.23) of the anaesthetic breathing apparatus (paras [0021-22] and [0043-44] in view of para [0071], where the closed exhalation valve/setting provides for normal inhalation pressure, and pressures above that setting cause the safety valve to activate), such that it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Wallin in view of Ironstone, Rauscher and Haggblom to include an inspiratory pressure relief valve such that the upper pressure level setting is at a level below a threshold pressure level of a pressure relief valve of the anaesthetic breathing apparatus as taught by Panin, in order to provide the predictable result of providing a means to avoid over pressurization during inhalation to prevent lung damage.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wallin view of Ironstone, Rauscher and Haggblom as applied to claim 16, and further in view of Manigel et al. (US 6,651,657 B1; hereinafter “Manigel”).
Regarding claim 20, Wallin in view of Ironstone, Rauscher and Haggblom teaches the method according to claim 16, but Wallin in view of Ironstone, Rauscher and Haggblom is silent regarding wherein the upper pressure level setting is at a plateau pressure level as determined at inspiratory zero-flow to the patient. However, Manigel teaches that it was known in the ventilator art before the effective filing date of the claimed invention for an upper pressure level to be at a plateau pressure level setting (maximum airway pressure Pinsp…corresponds to the plateau pressure, col. 6, lines 1-3) as determined at inspiratory zero-flow to the patient (Fig. 2), such that it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Wallin in view of Ironstone, Rauscher and Haggblom such that the upper pressure level setting is at a plateau pressure level as determined at inspiratory zero-flow to the patient as taught by Manigel, in order to utilize a known suitable maximum airway pressure during pressure-controlled respiration to provide the predicable result of a maximum pressure during inspiration that does not injure the lungs of the patient.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Wallin view of Ironstone, Rauscher and Haggblom as applied to claim 16, and further in view of Dunlop (WO 01/43803 A1; hereinafter “Dunlop”).
Regarding claim 25, Wallin in view of Ironstone, Rauscher and Haggblom teaches the method according to claim 16, but modified Wallin is silent regarding wherein the anaesthetic breathing apparatus comprises a dedicated oxygen flush valve connected to the oxygen supply and wherein the starting step comprises a step of opening at least partially the dedicated oxygen flush valve. However, Dunlop demonstrates that it was well known in the oxygen flush art before the effective filing date of the claimed invention for an anaesthetic breathing apparatus (Fig. 1) to comprise a dedicated oxygen flush valve (flush valve 20) connected to the oxygen supply (pressurized source of oxygen 1) and wherein the starting step comprises a step of opening at least partially the dedicated oxygen flush valve (page 11, lines 8-12). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Wallin to include wherein the anaesthetic breathing apparatus comprises a dedicated oxygen flush valve connected to the oxygen supply and wherein the starting step comprises a step of opening at least partially the dedicated oxygen flush valve as taught by Dunlop, in order to provide the predictable result of a means for providing the oxygen flush that circumvents the nebulizer to avoid damage thereto (Dunlop, page 5, lines 1-7).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: the prior art of Rauscher teaches maintaining the same ventilation before, during, and after a flush, which educates modified Wallin to have pressure-controlled ventilation before, during and after the oxygen flush. However, the instant application at page 15, lines 17-21 discloses volume-controlled or volume-support mode ventilation before a flush, which is temporarily deactivated then resumed once the flush (performed with pressure-controlled ventilation) is stopped. Therefore, if the limitations of claim 26 were included in the independent claims (before the “start[ing]” step) with the two instances of “or pressure” therein removed, and the independent claims clarified to read “interrupt[ing] the volume controlled or volume supported mode of ventilation”, “maintain[ing]…consecutive breathing cycles performed in a pressure controlled mode of ventilation” and “resuming the volume controlled or volume support mode of ventilation,” the claims would define over the prior art. The Examiner attempted unsuccessfully to contact Applicant’s Representative Oleg Kaplin multiple times during the week of March 16-20, 2026, to discuss these amendments.
Conclusion
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785