DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 3-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s arguments are drawn to the amended limitations not being taught by any of the previously relied on art. However, Wilhoit is being relied on for the teachings of the controller capable of storing desired recall positions.
Claim Objections
Claims 1, 4, 6 are objected to because of the following informalities:
In line 27 of claim 1, the phrase “a different combinations” should be changed to read - - different combinations - - or - - a different combination - -.
In line 29 of claim 1, the phrase “wherein at least one of first inflation state” changed to read - - wherein at least one of the first inflation state - -.
In line 1 of claim 4, the phrase “wherein the superior end the at least two lateral” should be changed to read - - wherein the superior end and the at least two lateral - -.
In line 1 of claim 6, the phrase “wherein inflation ports” should be changed to read - - wherein the first, second, and third inflation ports --.
In line 10 of claim 22, the phrase “a different combinations” should be changed to read - - different combinations - - or - - a different combination - -.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-21 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.
Claim 1 includes the limitation “a partially-inflatable state” in line 30. It is unclear if “a partially-inflatable state” is one of the previously defined “three inflation states” or a different inflation state.
Claim 3 includes the limitation “wherein the three states include a fully-deflated shape, a partially inflated shape, and a fully-inflated shape”. It is unclear if “a partially inflated shape” is the same as “a partially-inflatable state” as claimed in claim 1.
For purpose of examination the Examiner considers the terms “a partially inflated shape” and “a partially-inflatable state” to be referring to the same state.
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) 1, 3-13, 15-16, 18, 20, 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nissen et al. (US Patent No. 7,716,763 – hereainfter Nissen) in view of Wilhoit (US Patent No. 5,771,514).
Regarding Claim 1: Nissen discloses an intubation positioning device (see the abstract of Nissen) configured to selectively adjust a head, neck, and upper back of a patient lying on a surgical table (see Col. 3, lines 15-18 of Nissen which discloses “patients undergoing a surgical procedure”), the intubation device comprising: a body having a top (see annotated copy of Fig. 3 of Nissen), a bottom (see annotated copy of Fig. 3 of Nissen), a superior end (see annotated copy of Fig. 3 of Nissen), an inferior end relative to the neck (see annotated copy of Fig. 3 of Nissen), the inferior end spaced from the superior end along a longitudinal direction (see annotated copy of Fig. 3 of Nissen), and at least two lateral sides that extend from the superior end to the inferior end along the longitudinal direction (see annotated copy of Fig. 4 of Nissen), the body including an outer casing (see Col. 4, lines 8-11 of Nissen - “Referring to FIG. 1, the apparatus in accordance with the present invention is constructed of high-strength plastic or other types of polymers that impart strength to the pillow like structure.”) that permits expansion and contraction of the body in at least a vertical direction that is transverse to the longitudinal direction (via the cells of Nissen being inflatable and deflatable), wherein the superior end is sized and shaped to receive the head of the patient (see Fig. 10 of Nissen which shows a person’s head being supported by the device); a first inflatable chamber (see annotated copy of Fig. 3 with the cells numbered 1-6) disposed in the body and substantially oriented along the longitudinal direction (as shown in Fig. 4 of Nissen); a second inflatable chamber (see annotated copy of Fig. 3 of Nissen) disposed in the body and substantially oriented along the longitudinal direction (see annotated copy of Fig. 3 of Nissen), the second inflatable chamber disposed in a contiguous position relative to the first inflatable chamber (see annotated copy of Fig. 3 of Nissen); a third inflatable chamber (see annotated copy of Fig. 3 of Nissen) disposed in the body and substantially oriented along the longitudinal direction (see annotated copy of Fig. 3 of Nissen), the third inflatable chamber (see annotated copy of Fig. 3 of Nissen) disposed in a contiguous position relative to the second inflatable chamber (see annotated copy of Fig. 3 of Nissen), wherein each inflatable chamber has three inflation states (deflated, fully inflated and partially inflated - see Col. 7, lines 6-23 of Nissen which discloses “Preferably, pillow 10 is partially inflated on the operating table before placing the patient thereon. Alternatively, it would not be outside the scope of the present invention if pillow 10 was completely deflated before placing the patient on it. After the patient is positioned on pillow 10, back support inflatable sections 36 and 38, base support inflatable sections 40 and 42 and head rest inflatable sections 46 and 48 are slowly inflated to properly align the upper body so that the pinna and sternum are in the same horizontal plane. Back support inflatable sections 36 and 38, base support inflatable sections 40 and 42 and head rest inflatable sections 46 and 48 are inflated by setting deflate valve 54 to the closed position and inflate valve 60 to the open position. On/off switch 62 for base support inflatable sections 40 and 42 and head rest inflatable sections 46 and 48 is placed in the on position. On/off switch 66 for back support inflatable sections 36 and 38 is placed in the on position. Air is supplied to pillow 10 until the "sniffing" position 82 is achieved.”); a first inflation port coupled to the first inflatable chamber (see the inlet into each of the cells shown in Fig. 8 of Nissen), the first inflation port configured to permit a fluid to enter the first inflatable chamber (see Col. 5, line 66-Col. 6, line 24 of Nissen); a second inflation port (see the inlet into each of the cells shown in Fig. 8 of Nissen) coupled to the second inflatable chamber, the second inflation port configured to permit the fluid to enter the second inflatable chamber (see Col. 5, line 66-Col. 6, line 24 of Nissen which discloses “When air system 50 is set for inflation, deflate valve 54 is closed in the closed position and inflate valve 60 is set to the open position. In one embodiment of air system 50 in accordance with the present invention, hospital compressed air supply 52 is routed through air input 72, which is provided with a special medical grade quick disconnect fitting to allow for quick disconnect of the system in the event that a pressure regulator 56 malfunctions. The compressed air is then routed through pressure regulator 56 to ensure proper inflation pressure and to ensure that pillow 10 does not become over inflated.”), a third inflation port coupled to the third inflatable chamber (see the inlet into each of the cells shown in Fig. 8 of Nissen), the third inflation port configured to permit the fluid to enter the third inflatable chamber (see Col. 5, line 66-Col. 6, line 24 of Nissen which discloses “When air system 50 is set for inflation, deflate valve 54 is closed in the closed position and inflate valve 60 is set to the open position. In one embodiment of air system 50 in accordance with the present invention, hospital compressed air supply 52 is routed through air input 72, which is provided with a special medical grade quick disconnect fitting to allow for quick disconnect of the system in the event that a pressure regulator 56 malfunctions. The compressed air is then routed through pressure regulator 56 to ensure proper inflation pressure and to ensure that pillow 10 does not become over inflated.”); […] a controller (hand-held push button valve assembly 68 as shown in Fig. 9 of Nissen) coupled to the first, second, and third inflation ports (Col. 6, lines 42-46 of Nissen “an easy to sue hand-held push button valve assembly 68 that is operably connected to air system 50”), wherein the controller is configured to [….].
Nissen further discloses “the number of inflatable sections and how they are grouped together for inflation and deflation purposes can be as varied as the differences in human anatomy dictate” (Col. 4, lines 38-41 of Nissen) such that a spine of the patient is aligned with an orientation of the head and the neck of the patient (see annotated copy of Fig. 3, Col. 1, lines 15-23, and Claim 15 of Nissen which discusses inflating portions of the pillow for aligning and adjusting the head of a patient for intubation).
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Nissen does not disclose a user interface presenting selections for a plurality of preconfigured inflation positions, the user interface configured to receive a user input selecting a preconfigured inflation position out of the plurality of preconfigured inflation positions, each of the plurality of preconfigured inflation positions defining a different combinations of a first inflation state for the first inflatable chamber, a second inflation state for the second inflatable chamber, and a third inflation state for the third inflatable chamber, wherein at least one of first inflation state, the second inflation state and the third inflation state is a partially-inflatable state; and a controller coupled to the first, second, and third inflation ports, wherein the controller is configured to;1) receive the user input representing the position selection from the plurality of preconfigured inflation positions; and 2) selectively and independently cause the first inflatable chamber to change to the first inflation state based on the user input, cause the second inflatable chamber to change to the second inflation state based on the user input, and cause third inflatable chamber to change to the third inflation state based on the user input such that a spine of the patient is aligned with an orientation of the head and the neck of the patient.
In the same field of endeavor, inflatable supports (see the abstract of Wilhoit), Wilhoit teaches a user interface (control system 12 of Wilhoit) presenting selections for a plurality of preconfigured inflation positions (Col. 6, lines 42-49 of Wilhoit – “In addition to the above, modern electronics permits the addition of an inexpensive memory unit 82, which will retain inflation pressure settings, heat level, and/or massage operation settings for more than a single individual user of the present pillow 10. While three different memory settings are shown, it will be seen that more or fewer such settings may be incorporated within the present control system 12, as desired.”) the user interface configured to receive a user input selecting a preconfigured inflation position out of the plurality of preconfigured inflation positions (preset menu shown in Fig. 4 of Wilhoit showing the three memory settings referenced in Col. 6, lines 42-49 of Wilhoit), each of the plurality of preconfigured inflation positions defining a different combinations of a first inflation state for the first inflatable chamber, a second inflation state for the second inflatable chamber, and a third inflation state for the third inflatable chamber (Col. 5, lines 9-15 of Wilhoit – “The control system 12 selectively controls the independent inflation and deflation of each of the chambers 16, 18, 20, as will be discussed below, via interconnecting inflation and deflation tubes, respectively 40, 42, and 44. Air (or other gas or liquid, hereinafter described as a fluid) is selectively pumped to or from each of the chambers 16, 18, 20 by pump means, described further below, through the tubes 40, 42, and 44” and Col. 6, lines 42-48 of Wilhoit - “In addition to the above, modern electronics permits the addition of an inexpensive memory unit 82, which will retain inflation pressure settings, heat level, and/or massage operation settings for more than a single individual user of the present pillow 10. While three different memory settings are shown, it will be seen that more or fewer such settings may be incorporated within the present control system 12, as desired.”), wherein at least one of first inflation state, the second inflation state and the third inflation state is a partially-inflatable state (see the Examiner’s note below); and a controller coupled to the first, second, and third inflation ports (tubes 40, 42, and 44 connected to controls 12 and inflatable chambers 16, 18, and 20 - Fig. 5 of Wilhoit), wherein the controller is configured to; 1) receive the user input representing the position selection from the plurality of preconfigured inflation positions (selection of one of the at least three preset memories 1, 2, and 3 shown in Fig. 4 and discussed in Col. 6, lines 42-49 of Wilhoit); and 2) selectively and independently cause the first inflatable chamber to change to the first inflation state based on the user input, cause the second inflatable chamber to change to the second inflation state based on the user input, and cause third inflatable chamber to change to the third inflation state based on the user input (Col. 7, line 61- Col. 8, line 6 of Wilhoit - “For such pillows 10 which use electrical power, the optional heating and/or massage means 46 and/or 48 may also be activated as desired, for further relaxation and comfort. In the event of a pillow 10 incorporating memory means 82, the above functions could be programmed into the memory 82, thus allowing all of the above inflation, heating, and/or massage functions to be activated as desired with the press of a single button.”) such that a spine of the patient is aligned with an orientation of the head and the neck of the patient (see Col. 7, line 48-59 of Wilhoit – “In summary, the adjustable contour pillow 10 will be seen to provide a most desirable means of relaxing the neck muscles of a person suffering from such muscle strain. The user need only place the pillow 10 in a suitable position, provide appropriate electric power (batteries 76 or external power 110), and recline with the neck resting upon the cushion portion 36 above the first chamber 16, with the back of the head nesting in the valley 34 above the second chamber 18 and between the two higher cushion portions 36 and 38. The upper back portion of the head will thus be cradled by the higher cushion portion 38 above the third chamber 18.”).
Examiner’s note: The original disclosure of the current application does not provide a definition of the “partially inflatable state” (claims 1 and 22), “partially inflated shape” (claims 3 and 11) or “a partial inflation” (claim 15). Since Wilhoit teaches selecting different levels of inflation for each chamber for different users, the partially inflatable state or partially inflated shape are considered any state with some level of inflation below a maximum pressure level/fully inflated state).
One having ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine Nissen (inflatable intubation support) and Wilhoit (inflation support with independently adjustable balloons and with memory for storing desired settings) with a reasonable expectation of success by replacing the manual controls of Nissen with a controller as taught by Wilhoit and replacing the grouped bladders with individual bladders. One having ordinary skill would have been motivated to make such a combination because a controller with a memory “enabl[es] different users to select a preset optimum setting of inflation pressures for multiple chambers” (Col. 1, lines 46-51 of Wilhoit).
Regarding Claim 3: Nissen in view of Wilhoit make obvious the device of claim 1, wherein the three states include a fully-deflated shape, a partially inflated shape, and a fully-inflated shape (deflated, fully inflated and partially inflated - see Col. 7, lines 6-23 of Nissen which discloses “Preferably, pillow 10 is partially inflated on the operating table before placing the patient thereon. Alternatively, it would not be outside the scope of the present invention if pillow 10 was completely deflated before placing the patient on it. After the patient is positioned on pillow 10, back support inflatable sections 36 and 38, base support inflatable sections 40 and 42 and head rest inflatable sections 46 and 48 are slowly inflated to properly align the upper body so that the pinna and sternum are in the same horizontal plane. Back support inflatable sections 36 and 38, base support inflatable sections 40 and 42 and head rest inflatable sections 46 and 48 are inflated by setting deflate valve 54 to the closed position and inflate valve 60 to the open position. On/off switch 62 for base support inflatable sections 40 and 42 and head rest inflatable sections 46 and 48 is placed in the on position. On/off switch 66 for back support inflatable sections 36 and 38 is placed in the on position. Air is supplied to pillow 10 until the "sniffing" position 82 is achieved.”).
Regarding Claim 4: Nissen in view of Wilhoit make obvious the device of claim 3, wherein the superior end the at least two lateral sides extend substantially perpendicular to the top and the bottom as the first inflatable chamber, the second inflatable chamber, and the third inflatable chamber is transitioned between the three states (see the annotated copy of Fig. 3 of Nissen).
Regarding Claim 5: Nissen in view of Wilhoit make obvious the device of claim 1, where the outer casing of the body is constructed of a flexible material (see Col. 4, lines 8-11 of Nissen which discloses “the present invention is constructed of high-strength plastic” and also see Col. 7, lines 8-10 of Nissen which discuss the device being completely deflated. These teachings collectively disclose that the device is formed of a flexible material since the complete deflation of the device would only be possible with a flexible material).
Regarding Claim 6: Nissen in view of Wilhoit make obvious the device of claim 1, wherein inflation ports are each at least one of: a valve (see Col. 5, line 66-Col. 6, line 24 of Nissen which discloses “When air system 50 is set for inflation, deflate valve 54 is closed in the closed position and inflate valve 60 is set to the open position) a gauge cock, a plug, a tap, or a spigot.
Regarding Claim 7: Nissen in view of Wilhoit make obvious the device of claim 1, further comprising: a fourth inflatable chamber disposed in the body and substantially oriented along the longitudinal direction (see annotated copy of Fig. 3 of Nissen showing annotated numbers 1-6 representing the first through sixth chambers) the fourth inflatable chamber disposed in a contiguous position relative to the second inflatable chamber (as shown in annotated copy of Fig. 3 of Nissen); a fifth inflatable chamber disposed in the body and substantially oriented along the longitudinal direction (see annotated copy of Fig. 3 of Nissen showing annotated numbers 1-6 representing the first through sixth chambers), the fifth inflatable chamber disposed in a contiguous position relative to the fourth inflatable chamber (as shown in annotated copy of Fig. 3 of Nissen); and a sixth inflatable chamber disposed in the body and substantially oriented along the longitudinal direction, the sixth inflatable chamber disposed in a contiguous position relative to the fourth inflatable chamber (see annotated copy of Fig. 3 of Nissen).
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Regarding Claim 8: Nissen in view of Wilhoit make obvious the device of claim 7. Nissen does not explicitly disclose further comprising: a fourth inflation port coupled to the fourth inflatable chamber, the fourth inflation port configured to permit the fluid to enter the fourth inflatable chamber, the controller being coupled to the fourth inflation port, wherein the controller is further configured to: selectively permit entrance of the fluid into the fourth inflatable chamber, and selectively transition the fourth inflatable chamber, independently from the first inflatable chamber, the second inflatable chamber, the third inflatable chamber, the fifth inflatable chamber, and the sixth inflatable chamber, between an inflated shape and a deflated shape.
Nissen does disclose “the number of inflatable sections and how they are grouped together for inflation and deflation purposes can be as varied as the differences in human anatomy dictate” (Col. 4, lines 38-41 of Nissen) such that a spine of the patient is aligned with an orientation of the head and the neck of the patient (see annotated copy of Fig. 3, Col. 1, lines 15-23, and Claim 15 of Nissen which discusses inflating portions of the pillow for aligning and adjusting the head of a patient for intubation). Wilhoit teaches “The control system 12 selectively controls the independent inflation and deflation of each of the chambers 16, 18, 20, as will be discussed below, via interconnecting inflation and deflation tubes, respectively 40, 42, and 44” – (Col. 5, lines 9-12 of Wilhoit) and “While the control system 12 is shown in combination with an inflatable pillow 10 having a plurality of inflatable chambers therein, it will be understood that the control system may be used with other configurations of inflatable pillows, having one or more selectively inflatable and deflatable chambers therein” – (Col. 4, lines 35-40 of Wilhoit).
Accordingly, it would have been obvious to one of ordinary skill in the art before the claimed invention was effectively filed to have combined Nissen (directed to an inflatable intubation support) and Wilhoit (directed to an inflatable support with individually and separately inflatable supports/controls) and arrived at an inflatable intubation support with a controller enabling storage of different desired recall positions and individually and separately inflatable supports. One of ordinary skill in the art would have been motivated to make such a combination because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods (replacing the manual controls of Nissen with a controller comprising memory recall and including ports/valves at each inflatable chamber) with no change in their respective functions (the control would still enable inflation and deflation of the support for positioning a user for intubation) with a reasonable expectation of success and one of ordinary skill in the art would have recognized that the results of the combination were predictable (the controller could be used to store and recall positions for different users and position a user with more control due to the ability to individually operate each chamber).
Although Nissen does not teach a fourth inflation port as claimed and Wilhoit only shows an embodiment with three inflation chambers, the combination of Nissen and Wilhoit make obvious a fourth inflation port coupled to the fourth inflatable chamber, the fourth inflation port configured to permit the fluid to enter the fourth inflatable chamber, the controller being coupled to the fourth inflation port, wherein the controller is further configured to: selectively permit entrance of the fluid into the fourth inflatable chamber, and selectively transition the fourth inflatable chamber, independently from the first inflatable chamber, the second inflatable chamber, the third inflatable chamber, the fifth inflatable chamber, and the sixth inflatable chamber, between an inflated shape and a deflated shape.
Regarding Claim 9: Nissen in view of Wilhoit make obvious the device of claim 7. Nissen does not disclose a fifth inflation port coupled to the fifth inflatable chamber, the fifth inflation port configured to permit the fluid to enter the fifth inflatable chamber, the controller being coupled to the fifth inflation port, wherein the controller is further configured to: selectively permit entrance of the fluid into the fifth inflatable chamber, and selectively transition the fifth inflatable chamber, independently from the first inflatable chamber, the second inflatable chamber, the third inflatable chamber, the fourth inflatable chamber, and the sixth inflatable chamber, between an inflated shape and a deflated shape.
Nissen does disclose “the number of inflatable sections and how they are grouped together for inflation and deflation purposes can be as varied as the differences in human anatomy dictate” (Col. 4, lines 38-41 of Nissen) such that a spine of the patient is aligned with an orientation of the head and the neck of the patient (see annotated copy of Fig. 3, Col. 1, lines 15-23, and Claim 15 of Nissen which discusses inflating portions of the pillow for aligning and adjusting the head of a patient for intubation). Wilhoit teaches “The control system 12 selectively controls the independent inflation and deflation of each of the chambers 16, 18, 20, as will be discussed below, via interconnecting inflation and deflation tubes, respectively 40, 42, and 44” – (Col. 5, lines 9-12 of Wilhoit) and “While the control system 12 is shown in combination with an inflatable pillow 10 having a plurality of inflatable chambers therein, it will be understood that the control system may be used with other configurations of inflatable pillows, having one or more selectively inflatable and deflatable chambers therein” – (Col. 4, lines 35-40 of Wilhoit).
Accordingly, it would have been obvious to one of ordinary skill in the art before the claimed invention was effectively filed to have combined Nissen (directed to an inflatable intubation support) and Wilhoit (directed to an inflatable support with individually and separately inflatable supports/controls) and arrived at an inflatable intubation support with a controller enabling storage of different desired recall positions and individually and separately inflatable supports. One of ordinary skill in the art would have been motivated to make such a combination because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods (replacing the manual controls of Nissen with a controller comprising memory recall and including ports/valves at each inflatable chamber) with no change in their respective functions (the control would still enable inflation and deflation of the support for positioning a user for intubation) with a reasonable expectation of success and one of ordinary skill in the art would have recognized that the results of the combination were predictable (the controller could be used to store and recall positions for different users and position a user with more control due to the ability to individually operate each chamber).
Although Nissen does not teach a fifth inflation port as claimed and Wilhoit only shows an embodiment with three inflation chambers, the combination of Nissen and Wilhoit make obvious a fifth inflation port coupled to the fifth inflatable chamber, the fifth inflation port configured to permit the fluid to enter the fifth inflatable chamber, the controller being coupled to the fifth inflation port, wherein the controller is further configured to: selectively permit entrance of the fluid into the fifth inflatable chamber, and selectively transition the fifth inflatable chamber, independently from the first inflatable chamber, the second inflatable chamber, the third inflatable chamber, the fourth inflatable chamber, and the sixth inflatable chamber, between an inflated shape and a deflated shape.
Regarding Claim 10: Nissen in view of Wilhoit make obvious the device of claim 7. Nissen does not disclose further comprising: a sixth inflation port coupled to the sixth inflatable chamber, the sixth inflation port configured to permit the fluid to enter the sixth inflatable chamber, the controller being coupled to the sixth inflation port, wherein the controller is further configured to: selectively permit entrance of the fluid into the sixth inflatable chamber, and selectively transition the sixth inflatable chamber, independently from the first inflatable chamber, the second inflatable chamber, the third inflatable chamber, the fourth inflatable chamber, and the fifth inflatable chamber, between an inflated shape and a deflated shape.
Nissen does disclose “the number of inflatable sections and how they are grouped together for inflation and deflation purposes can be as varied as the differences in human anatomy dictate” (Col. 4, lines 38-41 of Nissen) such that a spine of the patient is aligned with an orientation of the head and the neck of the patient (see annotated copy of Fig. 3, Col. 1, lines 15-23, and Claim 15 of Nissen which discusses inflating portions of the pillow for aligning and adjusting the head of a patient for intubation). Wilhoit teaches “The control system 12 selectively controls the independent inflation and deflation of each of the chambers 16, 18, 20, as will be discussed below, via interconnecting inflation and deflation tubes, respectively 40, 42, and 44” – (Col. 5, lines 9-12 of Wilhoit) and “While the control system 12 is shown in combination with an inflatable pillow 10 having a plurality of inflatable chambers therein, it will be understood that the control system may be used with other configurations of inflatable pillows, having one or more selectively inflatable and deflatable chambers therein” – (Col. 4, lines 35-40 of Wilhoit).
Accordingly, it would have been obvious to one of ordinary skill in the art before the claimed invention was effectively filed to have combined Nissen (directed to an inflatable intubation support) and Wilhoit (directed to an inflatable support with individually and separately inflatable supports/controls) and arrived at an inflatable intubation support with a controller enabling storage of different desired recall positions and individually and separately inflatable supports. One of ordinary skill in the art would have been motivated to make such a combination because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods (replacing the manual controls of Nissen with a controller comprising memory recall and including ports/valves at each inflatable chamber) with no change in their respective functions (the control would still enable inflation and deflation of the support for positioning a user for intubation) with a reasonable expectation of success and one of ordinary skill in the art would have recognized that the results of the combination were predictable (the controller could be used to store and recall positions for different users and position a user with more control due to the ability to individually operate each chamber).
Although Nissen does not teach a sixth inflation port as claimed and Wilhoit only shows an embodiment with three inflation chambers, the combination of Nissen and Wilhoit make obvious the device of claim 7. Nissen does not disclose further comprising: a sixth inflation port coupled to the sixth inflatable chamber, the sixth inflation port configured to permit the fluid to enter the sixth inflatable chamber, the controller being coupled to the sixth inflation port, wherein the controller is further configured to: selectively permit entrance of the fluid into the sixth inflatable chamber, and selectively transition the sixth inflatable chamber, independently from the first inflatable chamber, the second inflatable chamber, the third inflatable chamber, the fourth inflatable chamber, and the fifth inflatable chamber, between an inflated shape and a deflated shape.
Regarding Claim 11: Nissen in view of Wilhoit make obvious the device of claim 7, wherein the third inflatable chamber, the fourth inflatable chamber, the fifth inflatable chamber, and the sixth inflatable chamber are configured to independently transition between a fully-deflated shape, a partially inflated shape, and a fully- inflated shape (see Col. 7, lines 6-23 of Nissen which discloses “Preferably, pillow 10 is partially inflated on the operating table before placing the patient thereon. Alternatively, it would not be outside the scope of the present invention if pillow 10 was completely deflated before placing the patient on it. After the patient is positioned on pillow 10, back support inflatable sections 36 and 38, base support inflatable sections 40 and 42 and head rest inflatable sections 46 and 48 are slowly inflated to properly align the upper body so that the pinna and sternum are in the same horizontal plane. Back support inflatable sections 36 and 38, base support inflatable sections 40 and 42 and head rest inflatable sections 46 and 48 are inflated by setting deflate valve 54 to the closed position and inflate valve 60 to the open position. On/off switch 62 for base support inflatable sections 40 and 42 and head rest inflatable sections 46 and 48 is placed in the on position. On/off switch 66 for back support inflatable sections 36 and 38 is placed in the on position. Air is supplied to pillow 10 until the "sniffing" position 82 is achieved.”). Additionally, Wilhoit teaches “The control system 12 selectively controls the independent inflation and deflation of each of the chambers 16, 18, 20, as will be discussed below, via interconnecting inflation and deflation tubes, respectively 40, 42, and 44” – (Col. 5, lines 9-12 of Wilhoit) and “While the control system 12 is shown in combination with an inflatable pillow 10 having a plurality of inflatable chambers therein, it will be understood that the control system may be used with other configurations of inflatable pillows, having one or more selectively inflatable and deflatable chambers therein” – (Col. 4, lines 35-40 of Wilhoit).
Regarding Claim 12: Nissen in view of Wilhoit make obvious the device of claim 1, wherein the first inflatable chamber and the second inflatable chamber define at least a portion of the outer casing (see the side view of the inflatable chambers in Fig. 4 of Nissen).
Regarding Claim 13: Nissen in view of Wilhoit make obvious the device of claim 1, wherein the body has a length that extends along the longitudinal direction from the superior end to the inferior end, a width that extends from a first lateral side of the at least two lateral sides to a second lateral side of the at least two lateral sides along a transverse direction that is perpendicular to the longitudinal direction and the vertical direction, wherein the length is greater than the width when the body is positioned on the surgical table in preparation to receive the patient (see Fig. 4 of Nissen and Col. 4, lines 11-15 of Nissen which disclose “he apparatus 10 (referred to hereinafter as a "pillow") is preferably about 16 to 18 inches wide and preferable about 20 to 24 inches long. This measurement may be varied depending on whether the patient is an adult, male or female, or a pediatric patient. Pillow 10 comprises several sections 12, 14 and 16 that are independently inflatable/deflatable using pressurized air delivered through inlets/outlets 20 and 22. In one embodiment of the present invention three inflatable sections 12, 14 and 16 are present. In an alternative embodiment, additional sections may be added depending on whether pillow 10 will be used with a male, female or pediatric patient”).
Regarding Claim 15: Nissen in view of Wilhoit make obvious the device of claim 1, wherein the superior end defines a first height that extends from the bottom to the top along the vertical direction, and the inferior end defines a second height that extends from the bottom to the top along a vertical direction, the first height being greater than the second height upon at least a partial inflation of at least one of: the first inflatable chamber or the second inflatable chamber (see annotated copy of Fig. 4 of Nissen below showing annotated heights of the ends of the support).
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Regarding Claim 16: Nissen in view of Wilhoit make obvious the device of claim 7, wherein the body is configured such that: the first inflatable chamber is disposed substantially contiguous to the second inflatable chamber the first inflatable chamber being disposed closer to the superior end relative to the third inflatable chamber (as shown in Fig. 3 and Fig. 10 of Nissen); the third inflatable chamber is disposed substantially contiguous to the fourth inflatable chamber (see annotated copy of Fig. 10 of Nissen which shows the third and fourth chambers being contiguous with one another in at least the use position of Fig. 10); the fourth inflatable chamber is disposed relative to the second inflatable chamber (any chamber of Nissen is considered disposed relative to any other chamber since there is no further description such as “contiguous,” “adjacent,” “vertically,” etc.); the fifth inflatable chamber is disposed substantially contiguous to the sixth inflatable chamber (as shown in annotated copies of Figs. 3 and 10 of Nissen); and the sixth inflatable chamber is disposed relative to the third inflatable chamber (any chamber of Nissen is considered disposed relative to any other chamber since there is no further description such as “contiguous,” “adjacent,” “vertically,” etc.).
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Regarding Claim 18: Nissen in view of Wilhoit make obvious the device of claim 1, wherein the body is configured such that: the first inflatable chamber is disposed substantially contiguous to the second inflatable chamber in at least one of: a position above the second inflatable chamber relative to the vertical direction, or a position beneath the second inflatable chamber relative to the vertical direction (as shown in annotated copies of Figs. 3 and 10 of Nissen), the first inflatable chamber being disposed closer to the superior end relative to the third inflatable chamber (see annotated copy of Fig. 10 of Nissen); and the third inflatable chamber is disposed substantially contiguous to at least one of: the first inflatable chamber, or the second inflatable chamber (as shown in annotated copies of Figs. 3 and 10 of Nissen), the third inflatable chamber being disposed closer to the inferior end relative to the first inflatable chamber (see annotated copy of Fig. 3 of Nissen).
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Regarding Claim 20: Nissen in view of Wilhoit make obvious the device of claim 1, wherein the body is configured such that: the first inflatable chamber is disposed substantially contiguous to the second inflatable chamber in at least one of: a position above the second inflatable chamber relative to the vertical direction, or a position beneath the second inflatable chamber relative to the vertical direction (see annotated copies of Figs. 3 and 10 of Nissen); and the first inflatable chamber being disposed in at least one of: a position closer to the bottom relative to the second inflatable chamber, or a position closer to the top relative to the second inflatable chamber (see annotated copy of Fig. 3 of Nissen).
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Regarding Claim 22: Nissen discloses a method for positioning at least a head of a patient lying on a surgical table (see claim 15 of Nissen), the method comprising: positioning an intubation device beneath at least the head of the patient lying on the surgical table (see claim 15 of Nissen), the intubation device including a body having a superior end, an inferior end, a bottom, and a top (see annotated copy of Fig. 3 of Nissen), wherein the superior end is configured to position at least the head of the patient along the top of the intubation device such that inferior end is proximate to at least one of: a neck of the patient, or an upper back of the patient (see Claim 15 of Nissen); [….] until a spine of the patient is aligned with an orientation of the head and the neck of the patient (see annotated copy of Fig. 3, Col. 1, lines 15-23, and Claim 15 of Nissen).
Nissen does not disclose receiving, with a user interface of the intubation device, a user input selecting a preconfigured inflation position out of a plurality of preconfigured inflation positions, each of the plurality of preconfigured inflation positions defining a different combinations of a first inflation state for the first inflatable chamber and a second inflation state for the second inflatable chamber, wherein at least one of the first inflation state and the second inflation state is a partially-inflatable state; and causing, with a controller of the intubation device, an inflation state of all of the first inflatable chamber to independently change to the first inflation state based on the user input and the second inflatable chamber to independently change to the second inflation state based on the user input until a spine of the patient is aligned with an orientation of the head and the neck of the patient.
However, in the same field of endeavor, inflatable supports (see the abstract of Wilhoit), Wilhoit teaches receiving, with a user interface of the intubation device (control system 12 of Wilhoit), a user input (selection of one of the three memory buttons of the control system 12 of Wilhoit) selecting a preconfigured inflation position out of a plurality of preconfigured inflation positions (the selection of one of the three memory buttons of the control system 12 of Wilhoit), each of the plurality of preconfigured inflation positions (Col. 6, lines 42-49 of Wilhoit – “In addition to the above, modern electronics permits the addition of an inexpensive memory unit 82, which will retain inflation pressure settings, heat level, and/or massage operation settings for more than a single individual user of the present pillow 10. While three different memory settings are shown, it will be seen that more or fewer such settings may be incorporated within the present control system 12, as desired.”) defining a different combinations of a first inflation state for the first inflatable chamber and a second inflation state for the second inflatable chamber (Col. 5, lines 9-15 of Wilhoit – “The control system 12 selectively controls the independent inflation and deflation of each of the chambers 16, 18, 20, as will be discussed below, via interconnecting inflation and deflation tubes, respectively 40, 42, and 44. Air (or other gas or liquid, hereinafter described as a fluid) is selectively pumped to or from each of the chambers 16, 18, 20 by pump means, described further below, through the tubes 40, 42, and 44” and Col. 6, lines 42-48 of Wilhoit - “In addition to the above, modern electronics permits the addition of an inexpensive memory unit 82, which will retain inflation pressure settings, heat level, and/or massage operation settings for more than a single individual user of the present pillow 10. While three different memory settings are shown, it will be seen that more or fewer such settings may be incorporated within the present control system 12, as desired.”) wherein at least one of the first inflation state and the second inflation state is a partially-inflatable state (see the Examiner’s note below); and causing, with a controller of the intubation device (control system 12 of Wilhoit), an inflation state of all of the first inflatable chamber to independently change to the first inflation state based on the user input and the second inflatable chamber to independently change to the second inflation state based on the user input (Col. 5, lines 9-15 of Wilhoit – “The control system 12 selectively controls the independent inflation and deflation of each of the chambers 16, 18, 20, as will be discussed below, via interconnecting inflation and deflation tubes, respectively 40, 42, and 44. Air (or other gas or liquid, hereinafter described as a fluid) is selectively pumped to or from each of the chambers 16, 18, 20 by pump means, described further below, through the tubes 40, 42, and 44” and Col. 7, line 61- Col. 8, line 6 of Wilhoit - In the event of a pillow 10 incorporating memory means 82, the above functions could be programmed into the memory 82, thus allowing all of the above inflation, heating, and/or massage functions to be activated as desired with the press of a single button.”) until a spine of the patient is aligned with an orientation of the head and the neck of the patient.
Examiner’s note: The original disclosure of the current application does not provide a definition of the “partially inflatable state” (claims 1 and 22), “partially inflated shape” (claims 3 and 11) or “a partial inflation” (claim 15). Since Wilhoit teaches selecting different levels of inflation for each chamber for different users, the partially inflatable state or partially inflated shape are considered any state with some level of inflation below a maximum pressure level/fully inflated state).
See that Nissen teaches 50,42, 46 and 38 grouped separately from 44, 36 and 38. Therefore the first and second inflatable bladders are inflatable independently of one another as shown in the annotated copy of Fig. 3 below.
One having ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine Nissen (method of using an inflatable intubation support) and Wilhoit (inflation support with independently adjustable balloons and with memory for storing desired settings) with a reasonable expectation of success by replacing the manual controls of Nissen with a controller as taught by Wilhoit operable in the method claimed above. One having ordinary skill would have been motivated to make such a combination because a controller with a memory “enabl[es] different users to select a preset optimum setting of inflation pressures for multiple chambers” (Col. 1, lines 46-51 of Wilhoit).
Regarding Claim 23: Nissen and Wilhoit make obvious the method of claim 22, wherein the causing further comprises causing at least a third inflatable chamber disposed in the body to independently expand (via the combination of Nissen and Wilhoit) until the spine of the patient is aligned with an orientation of the head and the neck of the patient (see the Examiner’s note below).
Examiner’s note: Although Nissen discusses the alignment of the patient’s neck for intubation there is not a discussion of the spine aligning with the neck however, the alignment of the spine of the patient would be a result of the preconfigured positions being selected by a user which is taught by the combination of Nissen and Wilhoit.
Regarding Claim 24: Nissen and Wilhoit make obvious the method of claim 22, wherein the causing further comprises causing one or more of: a fourth inflatable chamber or a fifth inflatable chamber disposed in the body to independently expand (via the combination of Nissen and Wilhoit) until a cervical spine of the patient is aligned with an orientation of the head and the neck of the patient (see Col. 7, lines 33-36 of Nissen which discloses “similarly, back support inflatable sectio