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 .
Information Disclosure Statement
The Examiner notes that an ISR was issued on 1/10/2025 in the PCT application that claims priority to this application, but no information disclosure regarding the ISR or the documents cited therein has been made in this application.
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 Objections
Claims 9 and 12 are objected to because of the following informalities:
Regarding claim 9, Applicant may wish to amend line 1 to read “further comprising” in order to mirror the same language used in the other dependent claims
Regarding claim 12, Applicant is asked to verify the intended dependency, as claim 12 is presented as dependent on claim 10, but follows claim 11, which is another independent claim
Appropriate correction is required.
Claim Interpretation
Regarding claims 1 and 14, a “normal” anesthetized respiratory rate/tidal volume is understood in light of the instant specification to be the rate/volume which is delivered to a patient under anesthesia before a wake-up/reversal procedure has been initiated.
Further regarding claims 1, 10, 14 and 20, “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 understood to be an intended result that flows directly from the breathing an above-ambient (tailored) amount of carbon dioxide at an above-normal (tailored) respiratory rate and an above-normal (tailored) tidal volume 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 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.
Claim 13 is understood as describing the intended results that flow directly from increasing the tidal volume as recited by claim 11.
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 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 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”.
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) 1-4, 6, 8, 10-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kishiko Nakai et al. Mild hypercapnia with hyperventilation attenuates recovery from anesthesia in elderly patients. J Anesth (2013) 27:712-719 (hereinafter “Nakai”).
Regarding claim 1, 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);
increasing a respiratory rate by the subject to above 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
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).
Regarding claim 2, Nakai discloses the method of claim 1, 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 discloses the method of claim 2, further comprising: 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 4, Nakai discloses the method of claim 1, wherein increasing the respiratory rate comprises increasing the respiratory rate to at least 10 breaths per minute (controlled respiratory rate was increased to 16-20 breaths/min, page 713, right column).
Regarding claim 6, Nakai discloses the method of claim 1, wherein increasing the tidal volume comprises increasing the tidal volume 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).
Regarding claim 8, Nakai discloses the method of claim 1, further comprising: 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 discloses the method of claim 1, 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], 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).
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);
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).
Regarding claim 12, Nakai discloses the method of claim 10, further comprising: 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 discloses the method of claim 11, 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 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).
Regarding claim 15, Nakai discloses the system of claim 14, 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 discloses the system of claim 15, further comprising: 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 discloses the system of claim 14, 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 discloses the system of claim 17, 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 discloses the system of claim 14, 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 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).
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) 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Nakai in view of Fukunaga et al. (US 2005/0022828 A1; hereinafter “Fukunaga”).
Regarding claim 5, Nakai discloses the method of claim 4, wherein Nakai teaches that the respiratory rate is increased above an initial 8-10 breaths/min (page 713, right column), but Nakai does not explicitly disclose 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, particularly 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) 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 7, Nakai discloses the method of claim 6, wherein Nakai teaches that the tidal volume is increased above an initial 6-10 ml/kg (page 713, right column), but Nakai does not explicitly disclose wherein increasing the tidal volume comprises increasing the tidal volume to 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. 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) 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).
Claim(s) 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over 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”).
Regarding claims 9 and 19, Nakai discloses the method of claim 1 [and system of claim 14], comprising: [a fresh gas source that enables the ventilator to deliver at least 10 L of fresh gas to the subject per minute for] causing the subject to breathe at least 10 L of fresh gas per minute (fresh gas flow was increased to 10 l/min, page 713, right column), but 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references regarding breathing an above-ambient amount of carbon dioxide at an above-normal respiratory rate and an above-normal tidal volume to accelerate the reversal of the effects of inhaled anesthesia: Orr (US 2005/0247316 A1); Guo et al. (CN 109718444 A); Sakata et al. Rapid Recovery from Sevoflurane and Desflurane with Hypercapnia and Hyperventilation, Anesth & Analgesia (2007) 105(1):79-82. References regarding TREK-1 activation as a known mechanism for action of volatile anesthetics: Patel et al. Inhalational anesthetics activate two-pore-domain background K+ channels. (1999) Neurosci 2(5): 422-426; Lazdunski et al. (WO 00/47738); Lindsley et al. (US 2024/0182445 A1). Reference regarding extracellular acidification as a known means for inhibiting TREK-1: Sandoz et al. Extracellular acidification exerts opposite actions on TREK1 and TREK2 potassium channels via a single conserved histidine residue. PNAS (2009) 106(34): 14628-14633. Additional reference regarding standard respiratory rates and tidal volumes when ventilating under anesthesia: Parker et al. (US 2007/0157931 A1; para [0169]).
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 7:30a-3:30p, T/Th 8:30a-2:30p, W 11:30a-4:30p, F 1-4p ET.
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/KATHRYN E DITMER/ Primary Examiner, Art Unit 3785