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 5/26/2026. As directed by the amendment, claims 1, 11, 12 and 14 have been amended, and claims 4, 5, 7, 9 and 19 have been cancelled. As such, claims 1-3, 6, 8, 10-18 and 19 are pending in the instant application.
The drawings filed 5/26/2026 appear to be unchanged from those filed 7/18/2023, and they still contain difficult-to-discern/fuzzy greyscale drawings in Figs. 1-4; the drawing objection is maintained below.
Applicant has cancelled claim 9 and amended claim 12 to address a minor informality; the objections to the claims are withdraw.
Applicant has not removed the active language from claim 14 nor clarified claim 20; the rejections of claim 14 (and its dependent claims) and claim 20 under 35 USC 112(b)/second paragraph are maintained below.
Response to Arguments
Applicant's arguments filed 5/26/2026 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Regarding the rejection of claims 14-20 under 35 USC 112(b)/second paragraph, Applicant argues on page 7 of Remarks that “none of claims 14, 15, 17 or 20 recites both a product and process…[they] recite elements of system.”
The Examiner respectfully notes that claim 14 recites the active steps of “a ventilator that ventilates”, “a breathing circuit that establishes”, “an anesthesia reversal device…that causes” and “the ventilator and the anesthesia reversal device causing”, claim 15 recites the active step of “the anesthesia reversal device causes”, and claims 17-18 recite the active step of “the ventilator ventilates”. These are processes. The Examiner provided Applicant with clear examples for how to avoid the active language to provide the necessary clarity, but these suggestions were not implemented; the rejection of claim 14 and its dependent claims under 35 USC 112(b)/second paragraph is maintained below.
Applicant’s Remarks do not address the additional rejection of claim 20 under 35 USC 112(b)/second paragraph, and claim 20 has not been amended.
As such, the additional rejection of claim 20 under 35 USC 112(b)/second paragraph is maintained below.
Regarding claims 1 and 14, Applicant argues at the bottom of page 9 of Remarks that Nakai does not recognize the claimed effects on (TREK-1) ion channel activity, asserting that Nakai “is limited to a method of inducing hyperventilation in an elderly subject in an effort to reduce the amount of time it takes the elderly subject to wake up from anesthesia.”
The Examiner respectfully notes that “reduc[ing] the amount of time it takes…to wake up from anesthesia” is the same stated goal as the instantly claimed methods/system, i.e. “accelerating reversal of the effects of inhaled anesthesia.” In response to applicant's argument that Nakai does not discuss the effects of the method steps on (TREK-1) ion channel activity, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The contest limitation of “to [cause/achieve extracellular acidification to] inhibit [TREK-1] ion channel activity in and to restore electrical signaling by neurons involved in controlling brain function including consciousness and respiration of the subject” is an intended result that flows directly from the breathing an above-ambient amount of carbon dioxide at an above-normal respiratory rate and an above-normal tidal volume tailored to accelerate the reversal of the effects of inhaled anesthesia via hypercapnic hyperpnoea, see e.g. instant para [0008]. It is noted that a “use” directed to the result/properties of a known structure/method is/are anticipated by prior art disclosing said known structure/ method. See MPEP 2112.02.II. Also, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114. Modified Nakai renders obvious the instantly claimed steps/structure as discussed in the updated rejections below; therefore, in as far as the intended result flows directly from these steps/structure used to accelerate reversal of the effects of inhaled anesthesia, the steps/structure of Nakai are considered to provide the intended result with regards to (TREK-1) ion channel activity, absent objective evidence to the contrary.
Regarding claim 1 (as amended to include the limitations from claims 5 and 7), Applicant argues on page 11 of Remarks that Fukunaga “teaches away from using such large tidal volumes and high ventilatory frequencies by indicating that they are “often associated with serious side effects.””
First, the Examiner respectfully notes that many medical interventions are associated with serious side effects, as anyone who has ever listened to a drug commercial knows; this does not necessarily preclude their use/render it non-obvious, because side effects may be worth the risk when the potential benefits are considered. Second, the Examiner notes that Fukunaga teaches that the effects noted by Applicant are avoided by adding rebreathing of carbon dioxide, see e.g. Fukunaga para [0015], i.e. as claimed and disclosed by the base reference of Nakai. Therefore, Fukunaga’s discussion of serious side effects is not germane to the rejection, because it involves rebreathing of carbon dioxide. Furthermore, 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 (emphasis added). The base reference of Nakai already discloses increasing both bpm and tidal volume from a base range of 8-10 bpm and 6-10 mL/kg of body weight of the subject, respectively, such that it already teaches “using such large tidal volumes and high ventilatory frequencies” as discussed by the section of Fukunaga cited by Applicant. The claimed increases (to 10-12 bpm and 8-10 mL/kg) are above values disclosed by Nakai (i.e. 8-10 bpm and 6-8 mL/kg), such that arriving within the claimed ranges through routine experimentation would have been obvious (even in the absence of Fukunaga establishing known values within the claimed ranges), as the claimed ranges are increases from Nakai and Nakai teaches increasing, particularly since the instant specification does not indicate any particular criticality for the claimed ranges, and it even considers the range of 16-20 bpm disclosed by Nakai page 713, right column, to be suitable, see e.g. paras [0040], [0050] and [0054] of the instant specification. Applicant has provided no objective evidence to demonstrate that the claimed ranges are anything other than product of routine experimentation within known ranges to achieve predictable results, i.e. hypercapnic hyperventilation with hypernea to accelerate reversal of the effects of inhaled anesthesia; therefore, the rejection of claim 1 is maintained below.
Regarding claim 1, Applicant argues at the bottom of page 11/top of page 12 of Remarks that “the Office has not provided a convincing line of reasoning as to why [PHOSITA] would have been motivated to cause a subject to breathe [as claimed] to inhibit TREK-1 ion channel activity [as claimed]…Fukunaga merely teaches…reduc[ing] PaCO2, while Nakai merely teaches that hyperventilation…decreases the amount of time it takes a subject to recover from anesthesia…neither Nakai or Fukunaga teaches or suggests cause a subject to breathe [as claimed] that are together tailored to inhibit TREK-1 ion channel activity [as claimed].” (emphasis added)
The Examiner disagrees that a convincing line of reasoning has not been provided. The Examiner notes that it was already known before the effective filing date of the claimed invention that TREK-1 activation is a mechanism of action for volatile anesthetics (see previously-cited art in the Conclusion section on page 18 of the Office Action mailed 2/25/2026), and that extracellular acidification inhibits TREK-1, such that inactivating/inhibiting TREK-1 via extracellular acidification [i.e. as results from hypercapnic hyperventilation with hypernea] would predictably reverse said action, i.e. this is inferred to be the mode of action that provides the accelerated reversal of anesthesia disclosed by Nakai, as well as the previously-cited art of Orr, Guo and Sakata in the Conclusion section on page 18 of the Office Action mailed 2/25/2026. Indeed, as discussed above, inhibiting TREK-1 ion channel activity [as claimed] is affirmed by instant para [0008] of the instant specification to be a result that flows directly from the claimed steps/structure. The line of reasoning for modifying Nakai to arrive at the limitations of claim 1 is taken directly from the teachings of the prior art, as discussed in the updated rejection of claim 1 below, and it is convincing because the results are predictable. Since modified Nakai teaches the claimed steps/structure as discussed in the updated rejections below, the steps/structure of Nakai are considered to provide the intended result with regards to (TREK-1) ion channel activity, absent objective evidence to the contrary.
On page 12 of Remarks, Applicant makes no arguments with regards to the application of Jacobson to claims 9 and 19, the limitations of which are now included in claims 11 and 14.
As such, the rejections of claims 11 and 14 over Nakai in view of Jacobson are updated/maintained below.
Drawings
Per 37 CFR 1.84(b)(1) and MPEP 608.02.VII.B, “Photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention.” Because the instant drawings do not illustrate one of the exempted types of images described in 37 CFR 1.84(b)(1) and MPEP 608.02.VII.B, a photograph or grayscale image is not the only practical medium for illustrating the claimed invention and thus the photograph or grayscale images within the instant drawings (Figs. 1-4) should be replaced by line drawings.
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 1-3, 6, 8, 10 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, 3, 6, 8, and 10), the amended language in claim 1 is unclear, because “increasing…above a normal…[rate/volume] of [X range]” reads as if the normal rate/volume range is [X range], which would be an issue under 35 UAC 112(a)/first paragraph if not interpreted as below, because it is clear from the spec and now-cancelled claims 4-5 and 7 that [X range] is actually the increased range for the rate/volume. As best understood, for compact prosecution, claim 1 will be interpreted as meaning “increasing a respiratory rate by the subject to above a normal anesthetized respiratory rate for the subject, wherein the increasing of the respiratory rate comprises increasing the respiratory rate to, wherein the increasing of the tidal volume comprises increasing the tidal volume to
Regarding claims 14 (and thus its dependent claims 15-20), 15, 17 and 20, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite, see MPEP 2173.05(p).II. To address this rejection, Applicant could amend claim 14 to recite “a ventilator configured to ventilateconfigured to establish is configured to cause configured to cause”, amend claim 15 to read “the anesthesia reversal device is configured to cause is configured to ventilate
Regarding claim 20, the phrase “can cause” renders it unclear whether the subject matter after the phrase is required or not. Applicant could address this rejection by amending the claim to read “are configured to cause”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1, from which claim 6 depends, as best understood (see discussion above), requires that the increasing the tidal volume comprises increasing the tidal volume to 8 mL/kg to 10 mL/kg as previously recited in now-cancelled claim 7, such that claim 6 is a broader recitation of the narrower range and thus fails to properly further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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(s) 1-3, 6, 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kishiko Nakai et al. Mild hypercapnia with hyperventilation attenuates recovery from anesthesia in elderly patients. J Anesth (2013) 27:712-719 (hereinafter “Nakai”) in view of Cameron Jacobson, Evaluating the Effects of Hypercapnia on Recover Time and Nausea in the Post Anesthetic Care Unit. 2010 Rocky Mountain NASA Space Grant Consortium, pages 1-6 (hereinafter “Jacobson”) and Fukunaga et al. (US 2005/0022828 A1; hereinafter “Fukunaga”).
Regarding claims 1 and 6, Nakai discloses a method for accelerating reversal of the effects of inhaled anesthesia on a subject once administration of the inhaled anesthesia to the subject is complete (title, abstract, right column of page 713), comprising:
causing the subject to breathe an above-ambient amount of carbon dioxide (allows patients to partially rebreathe their expired CO2, page 713, left column; page 713, right column, middle para of the left column of page 718, and Fig. 1);
causing the subject to inhale at least 10 L of fresh gas per minute (fresh gas flow was increased to 10 l/min, page 713, right column);
increasing a respiratory rate by the subject to above a normal anesthetized respiratory rate for the subject, as best understood, wherein the increasing is to a rate above 10 breaths per minute (controlled respiratory rate was increased [from 8-10 breaths/min] to 16-20 breaths/min, page 713, right column); and
increasing a tidal volume of respiration by the subject to above a normal anesthetized tidal volume for the subject (the tidal volume was increased [from 6-10 ml/kg], page 713, right column),
the causing the subject to breathe the above-ambient amount of carbon dioxide, the increasing the respiratory rate, and the increasing the tidal volume together tailored to inhibit TREK-1 ion channel activity in and to restore electrical signaling by neurons involved in controlling brain function including consciousness and respiration of the subject ([using] the ANEclear [Note: this is the same device as used by Applicant, see para [0046] of the instant specification]…to maintain normal to mild hypercapnic levels during hyperpnea to speed recovery from inhaled anesthetics…use of mild hypercapnia in conjunction with hyperventilation [to] reduce the recovery time [from inhaled anesthesia], page 713, left column (in view of the Discussion section, which confirms the hypothesis), page 713, right column and Fig. 1; wherein the use of the same device as instantly disclosed according to the same method steps as claimed to achieve hypercapnic hyperpnoea as instantly disclosed, see e.g. para [0008] of the instant specification, is inferred to produce the intended results as claimed, per MPEP 2112.02.II, absent objective evidence to the contrary).
Nakai is silent regarding wherein the fresh gas is explicitly oxygen. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Jacobson teaches that it was known in the art of accelerated reversal of anesthesia using hypercapnia in conjunction with hyperventilation before the effective filing date of the claimed invention to supply explicitly oxygen at a flow of 10 L/min (page 2, left column). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Nakai such that the fresh gas is oxygen as taught by Jacobson, in order to provide the predictable result of a known gas suitable for accelerated recovery from anesthesia (Jacobson abstract and page 2, left column).
While Nakai teaches that the respiratory rate is increased above an initial 8-10 breaths/min (page 713, right column), Nakai does not explicitly disclose, as best understood, [wherein increasing the respiratory rate comprises increasing the respiratory rate to] 10 breaths per minute to 12 breaths per minute. However, the instant specification does not indicate any particular criticality for the claimed range; indeed, it even considers the range of 16-20 disclosed by Nakai page 713, right column, to be suitable, see e.g. paras [0040], [0050] and [0054] of the instant specification. 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, see MPEP § 2144.05, and Fukunaga teaches that it was traditional in the art of hypercapnic hyperventilation with hypernea before the effective filing date of the claimed invention to utilize a respiratory rate of 10 breaths per minute to 12 breaths per minute (paras [0080], [0082], [0085] and [0092]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Nakai to include wherein increasing the respiratory rate as taught by Nakai comprises increasing the respiratory rate to 10 breaths per minute to 12 breaths per minute through routine experimentation within a known range, e.g. to the range explicitly taught by Fukunaga, in order to provide a suitable increase in minute ventilation (particularly when starting from an initial 8 breaths/min as disclosed by Nakai) that takes into account a given user’s respiratory system/comfort when achieving the hypercapnia in conjunction with hyperventilation and hypernea of Nakai (page 713, right column).
While Nakai teaches that the tidal volume is increased above an initial 6-10 ml/kg (page 713, right column), Nakai does not explicitly disclose, as best understood, [wherein increasing the tidal volume comprises increasing the tidal volume to] at least 8 mL/kg, i.e. 8 mL/kg to 10 mL/kg of body weight of the subject. However, the instant specification does not indicate any particular criticality for the claimed range, 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, see MPEP § 2144.05, and Fukunaga teaches that it was traditional in the art of hypercapnic hyperventilation with hypernea before the effective filing date of the claimed invention to utilize a tidal volume of 10 mL/kg of body weight of the subject (paras [0080], [0082], [0085] and [0092]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Nakai to include wherein increasing the tidal volume as taught by Nakai comprising increasing the tidal volume to 8 mL/kg to 10 mL/kg of body weight of the subject through routine experimentation within a known range, e.g. to the value within the claimed range explicitly taught by Fukunaga, in order to provide a suitable increase in minute ventilation (particularly when starting from an initial 6 ml/kg as disclosed by Nakai) that takes into account a given user’s respiratory system/comfort when achieving the hypercapnia in conjunction with hyperventilation and hypernea of Nakai (page 713, right column).
Regarding claim 2, Nakai in view of Jacobson and Fukunaga teaches the method of claim 1, wherein Nakai further discloses wherein causing the subject to breathe an elevated level of carbon dioxide includes causing the subject to rebreathe exhaled carbon dioxide (allows patients to partially rebreathe their expired CO2, page 713, left column; rebreathing loop, page 713, right column; middle para of the left column of page 718 and Fig. 1).
Regarding claim 3, Nakai in view of Jacobson and Fukunaga teaches the method of claim 2, wherein Nakai further discloses filtering anesthesia from gases exhaled and/or reinhaled by the subject (preventing the rebreathing of inhaled anesthetics through the addition of a gas absorber, page 713, left column; a charcoal canister absorbs the volatile anesthetics to prevent their rebreathing, middle para of the left column of page 718).
Regarding claim 8, Nakai in view of Jacobson and Fukunaga teaches the method of claim 1, wherein Nakai further discloses filtering anesthesia from gases exhaled and/or reinhaled by the subject (preventing the rebreathing of inhaled anesthetics through the addition of a gas absorber, page 713, left column; a charcoal canister absorbs the volatile anesthetics to prevent their rebreathing, middle para of the left column of page 718).
Regarding claim 10, Nakai in view of Jacobson and Fukunaga teaches the method of claim 1, wherein modified Nakai anticipates wherein the causing the subject to breathe the above-ambient amount of carbon dioxide, the increasing the respiratory rate, and the increasing the tidal volume are together tailored to cause extracellular acidification to inhibit the TREK-1 ion channel activity in and to restore the electrical signaling by the neurons involved in controlling brain function ([using] the ANEclear…[to induce] mild hypercapnia [during hyperpnea] in conjunction with hyperventilation [to] reduce the recovery time [from inhaled anesthesia], Nakai page 713, left column (in view of the Discussion section, which confirms the hypothesis), page 713, right column and Fig. 1; wherein the use of the same device as instantly disclosed according to the same method steps as claimed to achieve hypercapnic hyperpnoea as instantly disclosed, see e.g. para [0008] of the instant specification, is inferred to produce the intended results as claimed, per MPEP 2112.02.II, absent objective evidence to the contrary, particularly in light of the inferred mode of action of the ANEclear device/method Nakai discussed in the Response to Arguements section above).
Claim(s) 11-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nakai in view of Jacobson.
Regarding claim 11, Nakai discloses a method for accelerating reversal of the effects of inhaled anesthesia on a subject once administration of the inhaled anesthesia to the subject is complete (title, abstract, right column of page 713), comprising:
causing the subject to rebreathe exhaled carbon dioxide (allows patients to partially rebreathe their expired CO2, page 713, left column; rebreathing loop, page 713, right column; middle para of the left column of page 718 and Fig. 1);
causing the subject to inhale at least 10 L of fresh gas per minute (fresh gas flow was increased to 10 l/min, page 713, right column);
increasing a respiratory rate by the subject to at least 10 breaths per minute (controlled respiratory rate was increased to 16-20 breaths/min, page 713, right column); and
increasing a tidal volume of respiration by the subject to at least 8 mL/kg of body weight of the subject (the tidal volume is increased [above an initial 6-10 ml/kg], page 713, right column, which thus anticipates, in at least those patients whose tidal volume is initially 8-10 ml/kg, an increased tidal volume greater than 8 ml/kg in the accelerated recovery stage).
Nakai is silent regarding wherein the fresh gas is explicitly oxygen. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Jacobson teaches that it was known in the art of accelerated reversal of anesthesia using hypercapnia in conjunction with hyperventilation before the effective filing date of the claimed invention to supply explicitly oxygen at a flow of 10 L/min (page 2, left column). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Nakai such that the fresh gas is oxygen as taught by Jacobson, in order to provide the predictable result of a known gas suitable for accelerated recovery from anesthesia (Jacobson abstract and page 2, left column).
Regarding claim 12, Nakai in view of Jacobson teaches the method of claim 11, wherein Nakai further discloses filtering anesthesia from gases exhaled and/or reinhaled by the subject (preventing the rebreathing of inhaled anesthetics through the addition of a gas absorber, page 713, left column; a charcoal canister absorbs the volatile anesthetics to prevent their rebreathing, middle para of the left column of page 718).
Regarding claim 13, Nakai in view of Jacobson teaches the method of claim 11, wherein Nakai further discloses wherein increasing the tidal volume of respiration by the subject controls respiratory acidosis while causing the subject to rebreathe exhaled carbon dioxide (page 713, left column, page 713, right column and Fig. 1; wherein the use of the same device as instantly disclosed according to the same method as claimed, i.e. including an increase of tidal volume to within the claimed range, to achieve hypercapnic hyperpnoea as instantly disclosed, see e.g. para [0008] of the instant specification, is inferred to produce the intended results as claimed, per MPEP 2112.02.II, absent objective evidence to the contrary).
Regarding claim 14, Nakai discloses a system (Fig. 1) for accelerating reversal of the effects of inhaled anesthesia on a subject once administration of the inhaled anesthesia to the subject is complete (title, abstract, right column of page 713), comprising:
a ventilator (anesthesia machine and ventilator) (page 713, from the bottom of the left column to the middle of the right column and Fig. 1) that ventilates the subject at a respiratory rate that exceeds a normal anesthetized respiratory rate for the subject (controlled respiratory rate was increased [from 8-10 breaths/min] to 16-20 breaths/min, page 713, right column) and at a tidal volume that exceeds a normal anesthetized tidal volume for the subject (the tidal volume was increased [from 6-10 ml/kg], page 713, right column);
a fresh gas source that enables the ventilator to deliver at least 10 L of fresh gas to the subject per minute (fresh gas flow was increased to 10 l/min, page 713, right column);
a breathing circuit (breathing circuit comprising a “Y” piece and endotracheal tube) that establishes communication between the ventilator and the subject (page 713 right column and Fig. 1); and
an anesthesia reversal device (ANEclear) (Fig. 1; ANEclear…an easy-to-use anesthesia recovery device, page 713, left column) in communication with the breathing circuit in a manner that causes the subject to inhale an above-ambient amount of carbon dioxide (ANEclear…allows patients to partially rebreathe their expired CO2, page 713, left column; the [ANEclear] device was inserted between the endotracheal tube and the breathing circuit “Y” piece, page 713, right column; middle para of the left column of page 718 and Fig. 1),
with the ventilator and the anesthesia reversal device causing the subject to breathe in a manner that inhibits ion channel activity in and restores electrical signaling by neurons involved in controlling brain function including consciousness and respiration of the subject ([using] the ANEclear…[in combination with the anesthesia machine/ventilator to induce] mild hypercapnia in conjunction with hyperventilation [to] reduce the recovery time [from inhaled anesthesia], page 713, left column, in view of the Discussion section, which confirms the hypothesis, page 713, right column, and Fig. 1; wherein the use of the same device as instantly disclosed to perform the same method steps as claimed to achieve hypercapnic hyperpnoea as instantly disclosed, see e.g. para [0008] of the instant specification, is inferred to produce the intended results as claimed, per MPEP 2112.02.II, absent objective evidence to the contrary. Moreover, assuming the device is amended to be “configured” to perform as claimed, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim, see MPEP 2114. The system of Nakai comprises a known ventilator connected to the known ANEclear device, which together are configured to operate/achieve the intended results as claimed because they are operable to perform the method steps, i.e. ventilate with above-ambient (rebreathed) CO2 levels at a higher-than-normal rate and tidal volume per Nakai page 713, right column).
Nakai is silent regarding wherein the fresh gas is explicitly oxygen. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Jacobson teaches that it was known in the art of accelerated reversal of anesthesia using hypercapnia in conjunction with hyperventilation before the effective filing date of the claimed invention to supply explicitly oxygen at a flow of 10 L/min (page 2, left column). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Nakai such that the fresh gas is oxygen as taught by Jacobson, in order to provide the predictable result of a known gas suitable for accelerated recovery from anesthesia (Jacobson abstract and page 2, left column).
Regarding claim 15, Nakai in view of Jacobson teaches the system of claim 14, wherein Nakai further discloses wherein the anesthesia reversal device causes the subject to rebreathe exhaled carbon dioxide (ANEclear…allows patients to partially rebreathe their expired CO2, page 713, left column; rebreathing loop, page 713, right column; middle para of the left column of page 718 and Fig. 1).
Regarding claim 16, Nakai in view of Jacobson teaches the system of claim 15, wherein Nakai further discloses an anesthesia filter (gas absorber/charcoal canister) associated with an inspiratory limb of the breathing circuit and/or an expiratory limb of the breathing circuit (preventing the rebreathing of inhaled anesthetics through the addition of a gas absorber, page 713, left column and Fig. 1; a charcoal canister absorbs the volatile anesthetics to prevent their rebreathing, middle para of the left column of page 718; wherein the gas absorber in the ANEclear is associated with both limbs because it is attached to the shared limb of the “Y” piece in Fig. 1).
Regarding claim 17, Nakai in view of Jacobson teaches the system of claim 14, wherein Nakai further discloses wherein the ventilator ventilates the subject at a minute ventilation of at least 80 mL/kg of body weight of the subject (respiratory rate of 8-10 breaths/min [rr] and a tidal volume [VT] of 6-10 ml/kg, page 713, right column, such that a patient initially receiving 8-10 breaths/min at 10 ml/kg is being ventilated at a minute ventilation of 80-100 mL/kg (8x10=80 and 10x10=100); moreover, even a patient initially receiving the lowest levels of initial rr and VT, i.e. 8 breaths/min at 6 ml/kg, when the minute ventilation is doubled in the accelerated recovery stage per page 713, right column, goes to a minute ventilation of 96 mL/kg (8x6x2=96), such that all of the minute ventilation levels in the accelerated recovery stage are at least 80 mL/kg [note: claim 17 improperly recites a method step within an apparatus claim, the claimed ventilation is not actually required to occur in combination with CO2 rebreathing, and regardless, the ventilator of Nakai is fully capable of/configured to operate as claimed/disclosed because it is able to provide the claimed minute ventilation per page 713, right column as discussed, see MPEP 2114]).
Regarding claim 18, Nakai in view of Jacobson teaches the system of claim 17, wherein Nakai further discloses wherein the ventilator ventilates the subject at a minute ventilation of 80 ml/kg to 120 ml/kg of body weight of the subject (see claim 17 discussion, where 80 mL/kg, 96 mL/kg and 100 mL/kg as discussed above are all within the claimed range, and the ventilator of Nakai is fully capable of/configured to operate as claimed because it is able to provide minute ventilation within the claimed range per page 713, right column, see MPEP 2114]).
Regarding claim 20, Nakai in view of Jacobson teaches the system of claim 14, wherein Nakai further discloses wherein the ventilator and the anesthesia reversal device can cause the subject to breathe in a manner that achieves extracellular acidification and inhibits TREK-1 ion channel activity in and restores electrical signaling by neurons involved in controlling brain function including consciousness and respiration of the subject ([using] the ANEclear…[in combination with the anesthesia machine/ventilator to induce] mild hypercapnia in conjunction with hyperventilation [to] reduce the recovery time [from inhaled anesthesia], page 713, right column, in view of the Discussion section, which confirms the hypothesis, page 713, right column, and Fig. 1; wherein the use of the same device as instantly disclosed to perform the same method steps as claimed to achieve hypercapnic hyperpnoea as instantly disclosed, see e.g. para [0008] of the instant specification, is inferred to produce the intended results as claimed, per MPEP 2112.02.II, absent objective evidence to the contrary. Moreover, assuming the device is amended to be “configured” to perform as claimed, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim, see MPEP 2114. The system of modified Nakai comprises an obvious oxygen-supplying ventilator connected to the known ANEclear device, which together are configured to operate/achieve the intended results as claimed because they are operable to perform the method steps, i.e. ventilate with above-ambient (rebreathed) CO2 levels at a higher-than-normal rate and tidal volume per Nakai page 713, right column).
Conclusion
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.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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