DETAILED ACTION
This office action is in response to the claims filed 1/12/2024. Claims 1-11 are presently pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 6 is objected to because of the following informalities: Line 1 of fig 6 recites, “wherein the variable is PCO2”; it is suggested to amend the claim to recite –wherein the variable is a partial pressure of carbon dioxide (PCO2)-- so that it is clear what the term “PCO2” refers to.
Appropriate correction is required.
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 of this title, 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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al (2016/0000935) in view of Collins (Collins et al. “Relating oxygen partial pressure, saturation and content: The hemoglobin-oxygen dissociation curve”. Breathe (Sheff) 2015; 11: 194-201).
Regarding claim 1, Jiang discloses a method of inducing a deoxyhemoglobin bolus in a subject, the method comprising: selecting a first end-tidal partial pressure of oxygen (PETO2) (attaining a starting end tidal concentration of oxygen (PetO2) which lies in the range of 350 to 450 mm Hg) (para [0034]) and a second PETO2 (providing an incremental decrease in PetO2 in the range of approximately 375 to approximately 425 mm of Hg, the second PETO2 lower than the first PETO2 (second PetO2 can be an incremental decrease of approximately 375 to approximately 425 mm of Hg) (para [0034]); targeting the first PETO2 in the subject using a sequential gas delivery device (delivering controlled amounts of oxygen and carbon dioxide to attain the tidal concentration of oxygen (PetO2) (para [0034]); after targeting the first PETO2, targeting the second PETO2 using the sequential gas delivery device while controlling a variable that contributes to the rate of change of the partial pressure of oxygen (PO2) in the subject's lung (stimulation sequences are used to manipulate the subject’s arterial blood gases (para [0072]); and after targeting the second PETO2, targeting a third PETO2 using the sequential gas delivery device, wherein the third PETO2 higher than the second PETO2 (providing an increased fine-tuning increment to the target PetCO2 such that surrogate measures of tumor oxygenation for each respective pair of targets may be used to substantially optimize tumor oxygenation and/or determine the maximum susceptibility of the tumor in question to a reduction in hypoxia at that point in time; and/or may be used to establish end tidal partial pressures of carbon dioxide and oxygen at which tumor oxygenation for the tumor in question is at least temporally optimized (para [0042]).
Jiang does not disclose selecting the first end-tidal partial pressure of oxygen (PETO2) and the second PETO2 based on target [dOHb] where the relationship between PETO2 and [dOHb] is described by an oxygen-hemoglobin dissociation curve.
However, Collins teaches a method of determining an amount of hemoglobin saturation, wherein the amount of hemoglobin saturation is determined by an oxygen-hemoglobin dissociation curve (“Understanding oxygen saturation and partial pressure”, page 196, second column, first and second paragraphs).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of Jiang by electing the first end-tidal partial pressure of oxygen (PETO2) and the second PETO2 based on target [dOHb] where the relationship between PETO2 and [dOHb] is described by an oxygen-hemoglobin dissociation curve as taught by Collins in order to determine an amount of oxygen saturation based on the partial pressure of oxygen delivered to a patient (Collins, “Understanding oxygen saturation and partial pressure”, page 196, second column, first and second paragraphs).
Regarding claim 6, Jiang discloses in fig 3b the variable is PCO2, the method further comprising targeting a PCO2 in the subject using the sequential gas delivery device while targeting the second PETO2, the PCO2 elected to shift the oxyhemoglobin dissociation curve to the right and increase the [dOHb] in the subject for a given arterial PCO2 (as shown in fig 3b, PCO2 is shown to increase while targeting the second PETO2 at minutes 10-14 (fig 3b, para [0055]), and an increased PCO2 would shift the oxyhemoglobin dissociation curve to the right and increase the [dOHb] in the subject for a given arterial PCO2).
Claim(s) 2-5 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al and Collins et al as applied to claim 1 above and further in view of Klein et al (2014/0311491).
Regarding claim 2, modified Jiang discloses that targeting feasible end tidal concentrations of carbon dioxide and oxygen can optionally be undertaken simultaneously using a prospective targeting system as described in WO/2013/082703 (Jiang, para [0066]).
Modified Jiang does not disclose that the variable that contributes to the rate of change of the partial pressure of oxygen (PO2) in the subject’s lung comprises a breathing pattern, and wherein the subject inhales a tidal volume greater than the subject's resting tidal volume while the second PETO2 is targeted.
However, Klein (which is the US national stage application of WO/2013/082703) teaches a device and method for controlling an amount of a gas in a subject's lung to target a targeted end tidal partial pressure of gas (para [0009]), wherein the controlling the amount of gas is governed by a mass balance equation shown in para [0222], wherein a variable that contributes to the rate of change of the partial pressure of oxygen in the subject’s lung (partial pressure in the subject’s lung is assumed to be equal to the target end-tidal partial pressure of O2) (para [0242]) comprises a breathing pattern, wherein the subject inhales a tidal volume while the PETO2 is being targeted (subject can be coached or trained to breathe to a defined volume using a prompter, or if the subject is mechanically ventilated, this parameter can be determined from the ventilator settings or ventilator operator) (para [0239]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of Jiang by the variable that contributes to the rate of change of the partial pressure of oxygen (PO2) in the subject’s lung comprises a breathing pattern, and wherein the subject inhales a tidal volume as taught by Klein, as Jiang discloses that end-tidal partial pressures may be controlled using the method and system of WO/2013/082703 and Klein is the US national stage application of WO/2013/082703, and therefore it is known in the art to control end-tidal partial pressures of oxygen using a mass balance equation taught by Klein, and it appears that the method of modified Jiang would perform equally well to control end-tidal partial pressures of oxygen using a mass balance equation disclosed by Klein.
The now-modified Jiang’s method discloses the patient inhales a tidal volume; however, Jiang does not specifically disclose that the tidal volume greater than the subject's resting tidal volume while the second PETO2 is targeted.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Jiang so that the patient inhales a tidal volume greater than the subject's resting tidal volume while the second PETO2 is targeted, as it has been held that optimization of ranges are within the level of skill of one of ordinary skill in the art. Therefore, optimizing the tidal volume inhaled by routine experimentation using the mass balance equation disclosed in para [0222] of Jiang would have been an obvious modification in order to provide a tuning sequence to optimally set a target end-tidal pressure of O2 (Klein, para [0220]).
Regarding claim 3, modified Jiang discloses the patient inhales a tidal volume.
Modified Jiang does not disclose the tidal volume is between the subject's resting tidal volume and the subject's vital capacity.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Jiang so that the patient inhales a tidal volume which is between the subject's resting tidal volume and the subject's vital capacity while the second PETO2 is targeted, as it has been held that optimization of ranges are within the level of skill of one of ordinary skill in the art. Therefore, optimizing the tidal volume inhaled by routine experimentation using the mass balance equation disclosed in para [0222] of Jiang would have been an obvious modification in order to provide a tuning sequence to optimally set a target end-tidal pressure of O2 (Klein, para [0220]).
Regarding claim 4, modified Jiang discloses that targeting feasible end tidal concentrations of carbon dioxide and oxygen can optionally be undertaken simultaneously using a prospective targeting system as described in WO/2013/082703 (Jiang, para [0066]).
Modified Jiang does not disclose that the variable that contributes to the rate of change of the partial pressure of oxygen (PO2) in the subject’s lung comprises a breathing pattern, and wherein the subject exhales until the subject's lung volume is less than the subject's functional residual capacity (FRC) at rest, while the second PETO2 is targeted.
However, Klein (which is the US national stage application of WO/2013/082703) teaches a device and method for controlling an amount of a gas in a subject's lung to target a targeted end tidal partial pressure of gas (para [0009]), wherein the controlling the amount of gas is governed by a mass balance equation shown in para [0222], wherein a variable that contributes to the rate of change of the partial pressure of oxygen in the subject’s lung (partial pressure in the subject’s lung is assumed to be equal to the target end-tidal partial pressure of O2) (para [0242]) comprises a breathing pattern, wherein a subject can be coached or trained to increase ventilation using a prompter or if the subject is mechanically ventilated, this parameter can be determined from the ventilator settings or ventilator operator (para [0237], para [0239]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Jiang so that the patient can be coached or provided by a ventilator to provide an increased ventilation or a defined volume as taught by Klein, as Jiang discloses that end-tidal partial pressures may be controlled using the method and system of WO/2013/082703 and Klein is the US national stage application of WO/2013/082703, and therefore it is known in the art to control end-tidal partial pressures of oxygen using a mass balance equation taught by Klein, and it appears that the method of modified Jiang would perform equally well to control end-tidal partial pressures of oxygen using a mass balance equation disclosed by Klein to provide increased ventilation or a defined volume.
The now-modified Jiang’s method does not specifically disclose that the subject exhales until the subject's lung volume is less than the subject's functional residual capacity (FRC) at rest, while the second PETO2 is targeted.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Jiang so that the subject exhales until the subject's lung volume is less than the subject's functional residual capacity (FRC) at rest, while the second PETO2 is targeted, as it has been held that optimization of ranges are within the level of skill of one of ordinary skill in the art. Therefore, optimizing the level of ventilation and the amount of gas respired by routine experimentation so that the subject's lung volume is less than the subject's functional residual capacity (FRC) at rest, while the second PETO2 is targeted using the mass balance equation disclosed in para [0222] of Jiang would have been an obvious modification in order to provide a tuning sequence to optimally set a target end-tidal pressure of O2 (Klein, para [0220]).
Regarding claim 5, modified Jiang discloses that targeting feasible end tidal concentrations of carbon dioxide and oxygen can optionally be undertaken simultaneously using a prospective targeting system as described in WO/2013/082703 (Jiang, para [0066]).
Modified Jiang does not disclose that the variable comprises a breath rate, and wherein the subject breathes at a rate faster than the subject's resting breath rate while the second PETO2 is targeted.
However, Klein (which is the US national stage application of WO/2013/082703) teaches a device and method for controlling an amount of a gas in a subject's lung to target a targeted end tidal partial pressure of gas (para [0009]), wherein the controlling the amount of gas is governed by a mass balance equation shown in para [0222], wherein a variable that contributes to the rate of change of the partial pressure of oxygen in the subject’s lung (partial pressure in the subject’s lung is assumed to be equal to the target end-tidal partial pressure of O2) (para [0242]) comprises a breathing rate (breath period (Tb)) (para [0231]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Jiang so that the variable that contributes to the rate of change of the partial pressure of oxygen (PO2) in the subject’s lung comprises a breath rate as taught by Klein, as Jiang discloses that end-tidal partial pressures may be controlled using the method and system of WO/2013/082703 and Klein is the US national stage application of WO/2013/082703, and therefore it is known in the art to control end-tidal partial pressures of oxygen using a mass balance equation which includes a breath rate as taught by Klein, and it appears that the method of modified Jiang would perform equally well to control end-tidal partial pressures of oxygen using a mass balance equation disclosed by Klein to provide increased ventilation or a defined volume.
The now-modified Jiang’s method does not specifically disclose that the subject breathes at a rate faster than the subject's resting breath rate while the second PETO2 is targeted.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Jiang so that the subject breathes at a rate faster than the subject's resting breath rate while the second PETO2 is targeted, as it has been held that optimization of ranges are within the level of skill of one of ordinary skill in the art. Therefore, optimizing the breath rate by routine experimentation using the mass balance equation disclosed in para [0222] of Jiang so that the subject breathes at a rate faster than the subject's resting breath rate while the second PETO2 is targeted by routine experimentation would have been an obvious modification in order to provide a tuning sequence to optimally set a target end-tidal pressure of O2 (Klein, para [0220]).
Regarding claim 11, modified Jiang discloses that targeting feasible end tidal concentrations of carbon dioxide and oxygen can optionally be undertaken simultaneously using a prospective targeting system as described in WO/2013/082703 (Jiang, para [0066]).
Modified Jiang does not disclose that targeting the second PETO2 until the subject inhales a cumulative volume of gas approximately equal to 3 times the subject's FRC.
However, Klein (which is the US national stage application of WO/2013/082703) teaches a device and method for controlling an amount of a gas in a subject's lung to target a targeted end tidal partial pressure of gas (para [0009]), wherein the controlling the amount of gas is governed by a mass balance equation shown in para [0222], wherein a variable that contributes to the rate of change of the partial pressure of oxygen in the subject’s lung (partial pressure in the subject’s lung is assumed to be equal to the target end-tidal partial pressure of O2) (para [0242]) comprises a breathing pattern, wherein a cumulative amount of gas inhaled by a user would be determined by a tidal volume (Vt) (para [0238]) and number of breaths (n) (para [0240])
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of Jiang by the variable that contributes to the rate of change of the partial pressure of oxygen (PO2) in the subject’s lung comprises a breathing pattern, and wherein the subject inhales a cumulative volume of gas determined by a mass balance equation including a tidal volume and number of breaths as taught by Klein, as Jiang discloses that end-tidal partial pressures may be controlled using the method and system of WO/2013/082703 and Klein is the US national stage application of WO/2013/082703, and therefore it is known in the art to control end-tidal partial pressures of oxygen using a mass balance equation taught by Klein, and it appears that the method of modified Jiang would perform equally well to control end-tidal partial pressures of oxygen using a mass balance equation disclosed by Klein.
The now-modified Jiang’s method discloses the patient inhales a tidal volume and a number of breaths; however, modified Jiang does not specifically disclose targeting the second PETO2 until the subject inhales a cumulative volume of gas approximately equal to 3 times the subject's FRC.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Jiang targeting the second PETO2 until the subject inhales a cumulative volume of gas approximately equal to 3 times the subject's FRC, as it has been held that optimization of ranges are within the level of skill of one of ordinary skill in the art. Therefore, optimizing a total volume inhaled by a subject by routine experimentation until the subject inhales a cumulative volume of gas approximately equal to 3 times the subject's FRC using the mass balance equation disclosed in para [0222] of Jiang would have been an obvious modification in order to provide a tuning sequence to optimally set a target end-tidal pressure of O2 (Klein, para [0220]).
Allowable Subject Matter
Claims 7-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement for reasons for allowance: The closest prior art of the record, Jiang et al (2016/0000935) and Collins et al disclose the limitations of claim 1. However, neither Jiang et al, Collins et al, nor the other prior art of record, disclose that selecting the first PETO2 and second PETO2 based on the oxygen-hemoglobin dissociation curve comprises determining the slope of the oxygen-hemoglobin dissociation curve and selecting the first PETO2 and second PETO2 based on the slope of the oxygen-hemoglobin dissociation curve as recited in claim 7.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Friedrich et al (2017/0325784), Hasan et al (2017/0135615), Deuchar et al (2015/0313540), Slessarev et al (2009/0120435), and Santosh et al (2009/0246138) disclose devices and methods of delivering oxygen to a patient for use as a contrast agent for MRI.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785
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