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 .
Status of Claims
2. Claims 2-21 are pending and currently under consideration for patentability under 37 CFR 1.104.
Claim Objections
Claims 2 and 12 are objected to because of the following informalities:
Claim 2, lines 11-12 recite “configured to compression and actively decompress” and the Examiner suggests –configured to compress and actively decompress--.
Claim 12, lines 11-12 recite “configured to compression and actively decompress” and the Examiner suggests –configured to compress and actively decompress--.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 2-21 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 2, lines 8-10 recite “automated chest compression device … in alignment with a heart of the individual such that an orientation of the automated chest compression device relative to the heart of the individual is maintained” which is encompassing a human organism. The Examiner suggests –automated chest compression device … configured to be in alignment with a heart of the individual such that an orientation of the automated chest compression device relative to the heart of the individual is configured to be maintained--.
Claim 6, lines 3-4 recite “the orientation of the automated chest compression device relative to the heart of the individual is substantially perpendicular to a sternum of the individual” which is encompassing a human organism. The Examiner suggests –the orientation of the automated chest compression device relative to the heart of the individual is configured to be substantially perpendicular to a sternum of the individual--.
Claim 12, lines 8-10 recite “automated chest compression device … in alignment with a heart of the individual such that an orientation of the automated chest compression device relative to the heart of the individual is maintained” which is encompassing a human organism. The Examiner suggests –automated chest compression device … configured to be in alignment with a heart of the individual such that an orientation of the automated chest compression device relative to the heart of the individual is configured to be maintained--.
The remaining claims are rejected based on their dependence on a rejected base claim.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 2-16 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Cantrell et al. (2004/0116840) in view of Voss et al. (2012/0330200), and Toole et al. (3,765,406).
Regarding claim 2, Cantrell discloses a head up cardiopulmonary resuscitation (CPR) system (Fig. 1), comprising:
moving the patient within a range of elevation angles (“victims may be positioned supine, upright or at various angles to accommodate mobility and space limitations” see the penultimate sentence of [0066]; “The head may now be elevated above the heart, thereby enhancing blood return from the head”); and
the range of elevation angles comprises a lowermost elevation angle, an uppermost elevation angle, and a plurality of intermediate elevation angles (there is necessarily a range of elevation angles between a lowermost angle and uppermost angle);
an automated chest compression device (compression device 40 with control system 50, Fig. 2, Fig. 11) in alignment with a heart of the individual (placed over sternum 14, see Fig. 2) such that an orientation of the automated chest compression device relative to the heart of the individual is maintained throughout an entirety of the range of elevation angles (the automated chest compression device 40 will deliver chest compressions to the heart, by the chest-positioning/pad unit 20 providing “proper positioning over sternum 14” see para. [0062]. This pad 20 is held tightly to the patient via assembly 60 securing the compression device 40 to the victim 10. The pad 20 is thus configured to be in contact with the sternum throughout the use), wherein the automated chest compression device (40, 50) is configured to compress[ion] (via compression device 40, sternal pad 23, Fig. 2, Fig. 4) and actively decompress a chest of the individual (“Recoil spring 90 lifts compression device 40 and anterior chest wall 12 during relaxation (diastole) phase of CPR … provides a passive means to expand the chest wall 12 beyond normal diastole relaxation position… referred to in Active Compression-Decompression” see para. [0041]. Although the spring is passive, it expands the chest wall beyond normal relaxation position, and is referred to as Active Compression-Decompression).
Cantrell is silent regarding an elevation device comprising an upper support that is configured to elevate a head and shoulders of an individual positioned on the upper support relative to a support surface on which the elevation device is positioned; the upper support is movable within the range of elevation angles; the automated chest compression device being coupled with the elevation device; a positive pressure airway device configured to interface with an airway of the individual and to deliver positive pressure ventilation to the individual; and an impedance threshold device (ITD) coupled with the positive pressure airway device.
Voss teaches a related CPR system (Fig. 10C, Fig. 12) including a positive pressure airway device (device 760 “for providing, facilitating, or modulating patient airway pressure, such as an impedance threshold device (ITD) mechanism” see Fig. 10C and the last 11 lines of [0106]) configured to interface with an airway of the individual (as seen in Fig. 10C) and to deliver positive pressure ventilation to the individual (“methods may include ventilating the patient by provide a positive pressure ventilation through or around the one-way valve. Methods may also include actively removing respiratory gases from the patient's lungs with a low-level vacuum. Relatedly, systems may include means for providing a low-level vacuum. In some instances, the low-level vacuum is continuous. In some instances, the low-level vacuum is intermittent. Some methods may include actively withdrawing respiratory gases from the patient's lungs, and subsequently delivering a positive pressure breath to the patient” see para. [0023]; “given by a ventilation source, e.g., manual or mechanical resuscitator” see para. [0119]); and an impedance threshold device (ITD) coupled with the positive pressure airway device (the ITD mechanism is coupled with device 760, which also provides positive pressure ventilation, see para. [0106]). This allows the patient to be automatically ventilated during CPR, and ITD techniques “can be used to enhance circulation” … “can provide perfusion on demand by regulating pressures in the thorax during states of hypotension“ (see generally para. [0116], which lists a variety of benefits of ITD techniques).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the CPR system of Cantrell to include a positive pressure airway device configured to interface with an airway of the individual and to deliver positive pressure ventilation to the individual; and an impedance threshold device (ITD) coupled with the positive pressure airway device as taught by Voss because this allows the patient to be automatically ventilated during CPR, and ITD techniques can be used to enhance circulation. provide perfusion on demand by regulating pressures in the thorax, etc.
The modified Cantrell/Voss device discloses a desire to adjust the elevation of the CPR delivery (“The head may now be elevated above the heart, thereby enhancing blood return from the head” to reduce intracranial pressure, see para. [0067] of Cantrell), but is silent regarding an elevation device comprising an upper support that is configured to elevate a head and shoulders of an individual positioned on the upper support relative to a support surface on which the elevation device is positioned; the upper support movable within the range of elevation angles; the automated chest compression device being coupled with the elevation device.
Toole teaches a related elevation device (tiltable surface 12 and motor 18, Fig. 2) comprising an upper support (tiltable surface 12, Fig. 2) that is configured to elevate a head and shoulders of an individual positioned on the upper support (12; “if the patient's blood pressure exceeds preset upper pressure limits, the head or upper end of the tiltable bed is raised sufficiently to bring the blood pressure within the preset limits” see col. 1, lines 48-51) relative to a support surface (supporting component 16, Figs. 1-2, shown to be directly adjacent to the bottom surface of 12) on which the elevation device is positioned (tiltable surface 12 and motor 18 are positioned on the support surface 16, see Figs. 1-2); the upper support (12) movable within a range of elevation angles (“bed angle is preferably restricted to lie between +25˚ and -12˚” see col. 4, the last line, through col. 5, line 2), the range of elevation angles comprising a lowermost elevation angle (-12˚), an uppermost elevation angle (25˚), and a plurality of intermediate elevation angles (there are necessarily a plurality of intermediate elevation angles, as the claims do not require the elevation device to pause at any of the intermediate elevation angles. Furthermore, Toole states the bed arc is broken into 8˚ increments to provide noticeable changes in blood pressure, see col. 5, lines 7-23). The upper support (12) is movable within the range of elevation angles (see col. 5, lines 1-23). Toole relies on blood pressure sensor(s) (blood pressure sensing device 24, Fig. 2, Fig. 3) to automatically adjust the angle of the bed to help raise or lower the blood pressure as conditions require (see the last sentence of the Abstract, see col. 1, lines 48-51).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the CPR system of Cantrell/Voss to include a blood pressure sensor and an elevation device comprising an upper support that is configured to elevate a head and shoulders of an individual positioned on the upper support relative to a support surface on which the elevation device is positioned; the upper support movable within the range of elevation angles as taught by Toole so the system can monitor when the patient’s blood pressure is too high, and accordingly elevate the patient’s head.
In the modified device, the automated compression device (40, Cantrell) would be coupled with the elevation device by having the back plate (i.e., 76, 77, Fig. 2 of Cantrell) on the upper support (12, Toole).
Regarding claim 3, the modified Cantrell/Voss/Toole device discloses wherein: the elevation device (12, 18, Fig. 2 of Toole) is configured to tilt the upper support (12) between -12˚ and +24˚ (see col. 4, the last line, through col. 5, line 2 of Toole) to optimize blood pressure (see para. [0067] of Cantrell; see col. 1, lines 48-51), but does not specifically state being configured to elevate the head to a height of between 10 and 30 cm relative to the support surface (16) and to elevate the heart to a height of between 1 and 10 cm relative to the support surface (16). It is noted that the claim does not require these heights to be obtained simultaneously.
However, the particular height at which the head and heart are elevated is considered an obvious matter of optimizing a result-effective variable. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the elevation device of Cantrell/Voss/Toole to be configured to elevate the head to a height of between 10 and 30 cm relative to the support surface and to elevate the heart to a height of between 1 and 10 cm relative to the support surface, since it has been held that discovering an optimum value of a result effective variable (Cantrell and Toole state that blood pressure is impacted by the elevation of the head) involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). MPEP 2144.05(II).
Regarding claim 4, the modified Cantrell/Voss/Toole device as currently combined has one or more physiological sensors (i.e., blood pressure sensor 24 of Toole) but is silent regarding wherein: at least one of a compression depth, a decompression depth, a rate of compression and decompression, and/or a duty cycle of the automated chest compression device is determined based on a measurement from one or more physiological sensors.
However, Voss additionally teaches one or more physiological sensors (“can measure a physiological parameter … include[ing] ventilation rates, temperature, blood pressure, heart rate, and respiratory rate, and other vital signs” see the first three sentences of [0107]) to monitor physiological parameters and provide feedback to the CPR system to adjust the operation of the CPR (see all of para. [0107] and see Fig. 13). Voss has at least compression depth determined based on the measurement from one or more physiological sensors (“Feedback information includes … depth of compression” see para. [0107], and note that Voss provides automated CPR in Fig. 12, see para. [0110]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the CPR system of Cantrell/Voss/Toole to have one or more physiological sensors providing feedback for adjusting at least a compression depth based on a measurement from the one or more physiological sensors as taught by Toole, so the delivery of the CPR is optimized to produce a desired physiological outcome.
Regarding claim 5, the modified Cantrell/Voss/Toole device discloses wherein: the one or more physiological sensors comprise at least one of an end tidal CO2 sensor, a cerebral oximetry sensor, or a cerebral perfusion pressure sensor (“set of operator instructions is based at least in part on a physiological parameter … an end tidal carbon dioxide measure” see the latter half of para. [0011] of Voss. See also “(Optional) End-Tidal CO2 Monitor” in Fig. 11 of Cantrell).
Regarding claim 6, the modified Cantrell/Voss/Toole device discloses wherein: the orientation of the automated chest compression device (40, Cantrell) relative to the heart of the individual is substantially perpendicular to a sternum of the individual (see sternum 14 in Figure 2 of Cantrell).
Regarding claim 7, the modified Cantrell/Voss/Toole device as currently combined is silent regarding wherein: the automated chest compression device is configured to deliver up to 20 pounds of decompression force to the chest of the individual.
However, Voss additionally teaches that the CPR system determines “a decompression force of 20 lbs should be applied during the treatment” (see para. [0053]; “decompression force target can be set at a fixed value (e.g. 20 lbs), regardless of chest size” see the penultimate sentence of [0062]). Thus, 20 pounds of decompression is expected to be suitable for CPR for a wide range of patients.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of decompression force of Cantrell/Voss/Toole to be configured to deliver up to 20 pounds of decompression force to the chest of the individual as taught by Voss because this is expected to be a suitable amount of decompression for a wide range of patients.
Regarding claim 8, the modified Cantrell/Voss/Toole device discloses wherein: one or both of a rate of elevation of the upper support and a timing of elevation of the upper support is controlled based on a measurement from one or more physiological sensors (the blood pressure sensor 24 of Toole provides a measurement to control at least a timing of elevation of the upper support. “If the patient's blood pressure exceeds preset upper pressure limits, the head or upper end of the tiltable bed is raised sufficiently to bring the blood pressure within the preset limits” See col. 1, lines 48-51 and Figure 4 of Toole. Thus the timing of the activation of the tilting is based on the measurement of blood pressure).
Regarding claim 9, the modified Cantrell/Voss/Toole device as currently combined is silent regarding wherein: the one or more physiological sensors comprise at least one of an end tidal CO2 sensor, a cerebral oximetry sensor, or a cerebral perfusion pressure sensor.
However, Voss additionally teaches one or more physiological sensors (“can measure a physiological parameter … include[ing] ventilation rates, temperature, blood pressure, heart rate, and respiratory rate, and other vital signs” see the first three sentences of [0107]) to monitor physiological parameters and provide feedback to the CPR system to adjust the operation of the CPR (see all of para. [0107] and see Fig. 13). Voss has at least compression depth determined based on the measurement from one or more physiological sensors (“Feedback information includes … depth of compression” see para. [0107], and note that Voss provides automated CPR in Fig. 12, see para. [0110]). The physiological sensors comprise an end tidal CO2 sensor (“set of operator instructions is based at least in part on a physiological parameter … an end tidal carbon dioxide measure” see the latter half of para. [0011] of Voss).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Cantrell/Voss/Toole to include an additional physiological sensor, such as an end tidal CO2 sensor as taught by Voss to provide feedback for adjusting at least a compression depth based on a measurement from the one or more physiological sensors as taught by Toole, so the delivery of the CPR is optimized to produce a desired physiological outcome.
Regarding claim 10, the modified Cantrell/Voss/Toole device discloses wherein: the one or more physiological sensors are coupled with the elevation device (the blood pressure sensor 24 of Toole is coupled with the control of the elevation device 12, 18. See col. 1, lines 48-51 of Toole).
Regarding claim 11, the modified Cantrell/Voss/Toole device discloses wherein: the automated chest compression device (40, Cantrell) is removably attached to the elevation device (as currently modified, the compression device 40 is placed on top of tilting surface 12, not fixedly fastened).
Regarding claim 12, Cantrell discloses a head up cardiopulmonary resuscitation (CPR) system (Fig. 1), comprising:
moving the patient within a range of elevation angles (“victims may be positioned supine, upright or at various angles to accommodate mobility and space limitations” see the penultimate sentence of [0066]; “The head may now be elevated above the heart, thereby enhancing blood return from the head”);
the range of elevation angles comprises a lowermost elevation angle, an uppermost elevation angle, and a plurality of intermediate elevation angles (there is necessarily a range of elevation angles between a lowermost angle and uppermost angle);
an automated chest compression device (compression device 40 with control system 50, Fig. 2, Fig. 11) in alignment with a heart of the individual (placed over sternum 14, see Fig. 2) such that an orientation of the automated chest compression device relative to the heart of the individual is maintained throughout an entirety of the range of elevation angles (the automated chest compression device 40 will deliver chest compressions to the heart, by the chest-positioning/pad unit 20 providing “proper positioning over sternum 14” see para. [0062]. This pad 20 is held tightly to the patient via assembly 60 securing the compression device 40 to the victim 10. The pad 20 is thus configured to be in contact with the sternum throughout the use), wherein the automated chest compression device (40, 50) is configured to compress[ion] (via compression device 40, sternal pad 23, Fig. 2, Fig. 4) and actively decompress a chest of the individual (“Recoil spring 90 lifts compression device 40 and anterior chest wall 12 during relaxation (diastole) phase of CPR … provides a passive means to expand the chest wall 12 beyond normal diastole relaxation position… referred to in Active Compression-Decompression” see para. [0041]. Although the spring is passive, it expands the chest wall beyond normal relaxation position, and is referred to as Active Compression-Decompression);
a controller (control system 50, Fig. 1, Fig. 11) that is configured to control one or more features of the automated chest compression device (“control and monitor chest pressure, motor 56 performance, and ventilation parameters” see para. [0044]).
Cantrell is silent regarding an elevation device comprising an upper support that is configured to elevate a head and shoulders of an individual positioned on the upper support relative to a support surface on which the elevation device is positioned, wherein: the upper support is movable within a range of elevation angles; the automated chest compression device being coupled with the elevation device; an impedance threshold device (ITD) configured to interface with an airway of the individual; one or more physiological sensors that are coupled with the elevation device; and controlling one or more features of the elevation device or automated chest compression device based at least in part on a measurement from the one or more physiological sensors.
Voss teaches a related CPR system (Fig. 10C, Fig. 12) including a an impedance threshold device (ITD) (device 760 “for providing, facilitating, or modulating patient airway pressure, such as an impedance threshold device (ITD) mechanism” see Fig. 10C and the last 11 lines of [0106]) configured to interface with an airway of the individual (as seen in Fig. 10C) and to deliver positive pressure ventilation to the individual (“methods may include ventilating the patient by provide a positive pressure ventilation through or around the one-way valve. Methods may also include actively removing respiratory gases from the patient's lungs with a low-level vacuum. Relatedly, systems may include means for providing a low-level vacuum. In some instances, the low-level vacuum is continuous. In some instances, the low-level vacuum is intermittent. Some methods may include actively withdrawing respiratory gases from the patient's lungs, and subsequently delivering a positive pressure breath to the patient” see para. [0023]; “given by a ventilation source, e.g., manual or mechanical resuscitator” see para. [0119]).This allows the patient to be automatically ventilated during CPR, and ITD techniques “can be used to enhance circulation” … “can provide perfusion on demand by regulating pressures in the thorax during states of hypotension“ (see generally para. [0116], which lists a variety of benefits of ITD techniques).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the CPR system of Cantrell to include an impedance threshold device (ITD) configured to interface with an airway of the individual as taught by Voss because this allows the patient to be automatically ventilated during CPR, and ITD techniques can be used to enhance circulation. provide perfusion on demand by regulating pressures in the thorax, etc.
The modified Cantrell/Voss device is still silent regarding an elevation device comprising an upper support that is configured to elevate a head and shoulders of an individual positioned on the upper support relative to a support surface on which the elevation device is positioned, wherein: the upper support is movable within a range of elevation angles; the automated chest compression device being coupled with the elevation device; one or more physiological sensors that are coupled with the elevation device; and controlling one or more features of the elevation device or automated chest compression device based at least in part on a measurement from the one or more physiological sensors.
Toole teaches a related elevation device (tiltable surface 12 and motor 18, Fig. 2) comprising an upper support (tiltable surface 12, Fig. 2) that is configured to elevate a head and shoulders of an individual positioned on the upper support (12; “if the patient's blood pressure exceeds preset upper pressure limits, the head or upper end of the tiltable bed is raised sufficiently to bring the blood pressure within the preset limits” see col. 1, lines 48-51) relative to a support surface (supporting component 16, Figs. 1-2, shown to be directly adjacent to the bottom surface of 12) on which the elevation device is positioned (tiltable surface 12 and motor 18 are positioned on the support surface 16, see Figs. 1-2); the upper support (12) is movable within a range of elevation angles (“bed angle is preferably restricted to lie between +25˚ and -12˚” see col. 4, the last line, through col. 5, line 2), the range of elevation angles comprising a lowermost elevation angle (-12˚), an uppermost elevation angle (25˚), and a plurality of intermediate elevation angles (there are necessarily a plurality of intermediate elevation angles, as the claims do not require the elevation device to pause at any of the intermediate elevation angles. Furthermore, Toole states the bed arc is broken into 8˚ increments to provide noticeable changes in blood pressure, see col. 5, lines 7-23). The upper support (12) is movable within the range of elevation angles (see col. 5, lines 1-23). Toole discloses one or more physiological sensors (blood pressure sensing device 24, Fig. 2, Fig. 3) that are coupled with the elevation device (at least operably coupled, see col. 1, lines 48-51) and controlling one or more features of the elevation device based at least in part on a measurement from the one or more physiological sensors (automatically adjusting the angle of the bed to help raise or lower the blood pressure as conditions require, see the last sentence of the Abstract, see col. 1, lines 48-51).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the CPR system of Cantrell/Voss to include a blood pressure sensor as a physiological sensor and an elevation device comprising an upper support that is configured to elevate a head and shoulders of an individual positioned on the upper support relative to a support surface on which the elevation device is positioned; the upper support movable within the range of elevation angles, and to have the controller be further configured to control one or more features of the elevation device based at least in part on a measurement from the one or more physiological sensors as taught by Toole so the system can monitor when the patient’s blood pressure is too high, and accordingly elevate the patient’s head.
Regarding claim 13, the modified Cantrell/Voss/Toole device discloses wherein: the controller (50 of Cantrell, as modified to include the elevation device control functions taught by Toole) is coupled with the elevation device and the automated chest compression device (in the modified device, the controller 50 of Cantrell is operably coupled with the automated chest compression device 40, and the controller 50 has been modified to be further configured to control one or more features of the elevation device as taught by Toole. Thus, the modified controller is operably coupled with both the automated chest compression device 50 of Cantrell and the elevation device 12, 18, of Toole).
Regarding claim 14, the modified Cantrell/Voss/Toole device discloses wherein: the one or more features comprise at least one of a compression depth of the automated chest compression device, a decompression depth of the automated chest compression device, a rate of compression and decompression of the automated chest compression device, a duty cycle of the automated chest compression device, a rate of elevation of the upper support, or a timing of elevation of the upper support (at least a timing of the elevation of the upper support. The blood pressure sensor 24 of Toole provides a measurement to control at least a timing of elevation of the upper support. “If the patient's blood pressure exceeds preset upper pressure limits, the head or upper end of the tiltable bed is raised sufficiently to bring the blood pressure within the preset limits” See col. 1, lines 48-51 and Figure 4 of Toole. Thus the timing of the activation of the tilting is based on the measurement of blood pressure.
Regarding claim 15, the modified Cantrell/Voss/Toole device discloses wherein: a positive pressure airway device configured to interface with the airway of the individual and to deliver positive pressure ventilation to the individual (Voss provides a ventilation mechanism, which is a positive pressure airway device configured to interface with the airway. “[M]ethods may include ventilating the patient by provide a positive pressure ventilation through or around the one-way valve. Methods may also include actively removing respiratory gases from the patient's lungs with a low-level vacuum. Relatedly, systems may include means for providing a low-level vacuum. In some instances, the low-level vacuum is continuous. In some instances, the low-level vacuum is intermittent. Some methods may include actively withdrawing respiratory gases from the patient's lungs, and subsequently delivering a positive pressure breath to the patient” see para. [0023]; “given by a ventilation source, e.g., manual or mechanical resuscitator” see para. [0119]).
Regarding claim 16, the modified Cantrell/Voss/Toole device as currently combined is silent regarding wherein: the one or more physiological sensors comprise at least one of an end tidal C02 sensor, a cerebral oximetry sensor, or a cerebral perfusion pressure sensor.
However, Voss additionally teaches one or more physiological sensors (“can measure a physiological parameter … include[ing] ventilation rates, temperature, blood pressure, heart rate, and respiratory rate, and other vital signs” see the first three sentences of [0107]) to monitor physiological parameters and provide feedback to the CPR system to adjust the operation of the CPR (see all of para. [0107] and see Fig. 13). Voss has at least compression depth determined based on the measurement from one or more physiological sensors (“Feedback information includes … depth of compression” see para. [0107], and note that Voss provides automated CPR in Fig. 12, see para. [0110]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the CPR system of Cantrell/Voss/Toole to have one or more physiological sensors providing feedback for adjusting at least a compression depth based on a measurement from the one or more physiological sensors such as an end tidal CO2 sensor as taught by Toole, so the delivery of the CPR is optimized to produce a desired physiological outcome.
Regarding claim 18, the modified Cantrell/Voss/Toole device as currently combined is silent regarding wherein: the automated chest compression device comprises a suction cup that is configured to interface with a chest of the individual.
However, Voss additionally teaches that its active compression-decompression CPR can “utilize[] a suction cup or other attachment mechanism to actively lift the chest wall during the decompression phase [to] enhance[] the refilling of the heart in between compressions…” (see the first sentence of [0139]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the CPR system of Cantrell/Voss/Toole to include a suction cup on the automated chest compression device as taught by Voss because this provides an expected result of helping to actively lift the chest wall during decompression to enhance the refilling of the heart.
Regarding claim 19, the modified Cantrell/Voss/Toole device discloses wherein: the elevation device comprises a back plate that is configured to be positioned below the heart of the individual (in the modified device, there is a back plate i.e., 76, 77, Fig. 2 of Cantrell, which will be positioned below the heart of the individual and can be considered part of the elevation device as it rests directly on the tiltable surface 12 of Toole).
Regarding claim 20, the modified Cantrell/Voss/Toole device discloses wherein: the automated chest compression device (40, Fig. 2 of Cantrell) is coupled with the back plate (76, 77, see Fig. 2 of Cantrell).
Regarding claim 21, the modified Cantrell/Voss/Toole device discloses wherein: the back plate (76, 77, Fig. 2 of Cantrell) is maintained at a non-parallel angle with respect to the support surface (back plate 76, 77, of Cantrell will follow the angle of the tiltable surface 12 of Toole. This angle can be maintained at a non-parallel angle with respect to the support surface 16 of Toole, as Toole adjusts at 8˚ increments between -12˚ and +24˚. See col. 4, the last line, through col. 5, line 23 of Toole).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Cantrell et al. (2004/0116840) in view of Voss et al. (2012/0330200), and Toole et al. (3,765,406) as applied to claim 12 above, and further in view of Tupin Jr. (2015/0164417).
Regarding claim 17, the modified Cantrell/Voss/Toole device is silent regarding wherein: the controller is further configured to alert a rescuer when the individual has a stable heart rhythm.
Tupin teaches a related CPR system (Fig. 2) wherein the controller (processor 105, Fig. 1a; see also Fig. 2) configured to alert a rescuer when the individual has a stable rhythm (“a notification that that the patient has or has not returned to spontaneous circulation by indicating with one or more LEDs on the device or by audibly instructing the rescuer to continue to apply compressions” see para. [0020]; see also para. [0033]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of Cantrell/Voss/Toole to be further configured to alert a rescuer when the individual has a stable heart rhythm as taught by Tupin so the rescuer can be alerted of their potential recovery, and take any corresponding steps.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,259,988 in view of Cantrell et al. (2004/0116840) in view of Voss et al. (2012/0330200), and Toole et al. (3,765,406).
Claims 1-25 of U.S. Patent No. 11,259,988 disclose an elevation device used in CPR with a support mechanism configured to elevate the heart to a height of between 3 cm and 8 cm above the support surface and elevate the head to a second height of between about 10 cm and 40 cm and thus discloses various aspects of instant claims 2-21. Furthermore, any limitations in claims 2-21 that are not disclosed by claims 1-25 of U.S. Patent No. 11,259,988, are rendered obvious in view of Cantrell, Voss, and/or Toole as described in the 35 USC 103 rejection(s) above, and would merely provide expected results.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,728,070 in view of Cantrell et al. (2004/0116840) in view of Voss et al. (2012/0330200), and Toole et al. (3,765,406).
Claims 1-14 of U.S. Patent No. 12,728,070 disclose a head up CPR system with an upper support configured to elevate a patient’s upper body, with a chest compression device and a positive pressure ventilation system and thus discloses various aspects of instant claims 2-21. Furthermore, any limitations in claims 2-21 that are not disclosed by claims 1-14 of U.S. Patent No. 12,728,070, are rendered obvious in view of Cantrell, Voss, and/or Toole as described in the 35 USC 103 rejection(s) above, and would merely provide expected results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Paradis et al. (2012/0016179) discloses a related CPR system that includes one or more physiological parameter sensors to provide feedback to adjust one or more CPR operating parameters such as compression depth, to optimize blood flow. Lemire et al. (2007/0157385) discloses a patient support with an upper support that elevates the user’s head and heart. Bhai (2011/0083271) discloses a related patient support with an upper support that elevates the user’s head and heart. Phillips (2011/0132377) discloses a related patient support that elevates the user’s head and heart to modulate blood pressure. Illindala (2014/0276269) discloses a related CPR system that is attachable to an elevation device, such that CPR can be applied to the patient while the head and heart are elevated relative to the lower body. Chun (4,915,095) discloses a related CPR system that is attachable to an elevation device, such as a chair that can have the head and heart elevated relative to the lower body. Hindes (4,168,554) discloses a related CPR support device that can elevate the patient’s head for hyperventilation purposes. Woerlee et al. (WO 2010/004499 A1) discloses a related CPR system with one or more physiological parameter sensors, including an end tidal CO2 sensor, that measures the variable and provides feedback to adjust an operating parameter of the CPR, to optimize blood flow.
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/CHRISTOPHER E MILLER/ Examiner, Art Unit 3785
