DETAILED ACTION
This office action is in response to the claims filed 11/10/2022. Claims 1-20 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1, 4, 7, 15, and 17-18 are objected to because of the following informalities:
Claim 1, line 6; and claim 15, line 6 recites, “and an inflation and deflation unit”; it is suggested to amend to recite the claim to recite --an inflation unit, and a deflation unit-- in the claims so that it is clear that the inflation unit and deflation unit refer to two distinct structural elements and “an inflation and deflation unit” is not a single element capable of performing inflation and deflation.
Claim 4, lines 7-9 and claim 17, lines 7-9 recite, “wherein the outer pressure pipe and the inner pressure pipe pneumatically connect the outer cuff and the inner cuff to the outer pilot balloon and the inner pilot balloon, respectively”. It is suggested to amend the claim to recite --wherein the outer pressure pipe pneumatically connect the outer cuff to the outer pilot balloon--, as the feature of the inner pressure pipe pneumatically connecting the inner cuff to the inner pilot balloon is already recited in lines 6-7 of the respective claims (“wherein the inner pressure pipe pneumatically connects the inner cuff both to the deflation unit and the inflation unit via the inner pilot balloon”), and therefore would avoid redundancy to make the claim more clear.
Claim 7, line 1 and claim 18, line 2 recites “the shape of the cuff”; it is suggested to amend the claim to recite --a shape of the cuff-- as it is the first time the shape is being recited.
Claim 20, lines 1-2 recite, “wherein the inner cuff opening is circular, oval, square, and triangle in shape”; it is suggested to amend the claim to recite that either at least one of the plurality of inner cuff openings have the recited shapes or that the plurality of inner cuff openings have the recited shape, as line 1 recites that the inner cuff opening comprises a plurality of openings.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“an inflation unit” in line 7 of claim 1 and line 6 of claim 15, corresponding to an air container bag, syringe, electrical pump, a simple air inlet hole; “a deflation unit” in line 7 of claim 1 and line 6 of claim 15, corresponding to an opening hole, a release valve, or an electrical vacuum; and “a cuff control system” in lines 12-17 of claims 1 and 15, corresponding to a processor and components for analyzing data regarding cuff pressure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1-20 is/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 pre-AIA the applicant regards as the invention.
Regarding claim 1, lines 7-9 recite, “wherein the pilot balloon, balloon sensor, inflation and deflation units are disposed towards the distal end of the endotracheal tube” and line 13 recites, “a cuff control system disposed towards the distal end”. It is unclear how to determine the metes and bounds of the limitation “disposed towards the distal end” because applicant’s drawings and originally filed specification discloses that the pilot balloon, balloon sensor, inflation and deflation units, and cuff control system are located outside of the endotracheal tube and not located at the distal end of the endotracheal tube. For purposes of examination, the limitation “disposed towards the distal end” is interpreted to read on an element that is in communication (physical attachment, fluid communication, electrical communication, etc) with the distal end of the endotracheal tube. Line 13 recites “the power source”; there is insufficient antecedent basis for this limitation in the claim.
Regarding claim 2, lines 1-2 recites, “further comprising a power source disposed towards the distal end for energizing the endotracheal intubation apparatus”. As discussed above, it is unclear how the power source is “disposed towards the distal end” because applicant’s specification and drawings show the power source located outside of the endotracheal tube, and the limitation is interpreted to read on an element that is in communication with the distal end of the endotracheal tube. It is unclear whether the limitation “a power source” refers back to the previously recited power source in claim 1, or to an additional power source. For purposes of examination, the limitation is considered to refer back to the power source in claim 1, as applicant’s specification and drawings only disclose a single power source.
Regarding claim 5, lines 1-2 recite “the pressures of the inner cuff and the outer cuff are optimal and determined from the following steps”. It is unclear how to determine the metes and bounds of how to determine if a given pressure is “optimal”. Furthermore, how the steps in the claim relate to the device of claim 1 (for example, whether the cuff control system is configured to perform the steps, whether the cuff merely has to be capable of performing the steps to achieve the optimal pressures, etc.)
Regarding claim 11, lines 1-2 recite, “wherein the cuff control system is a fully automatic smart control system.” It is unclear how to determine how to determine the metes and bounds of how to determine whether a control system is a “smart” control system.
Regarding claim 14, lines 1-2 recite, “wherein the inner cuff opening is circular, oval, square, and triangle in shape”. It is unclear how a single opening can have a shape that both circular, oval, square, and triangular. For purposes of examination, it is considered that the inner cuff opening is circular, oval, square, or triangle in shape
Regarding claim 15, lines 7-8 recite, “wherein the pilot balloon, balloon sensor, inflation and deflation units are disposed towards the distal end of the endotracheal tube” and line 12 recites, “a cuff control system disposed towards the distal end”. As discussed above, it is unclear how to determine the metes and bounds of the limitation “disposed towards the distal end”, and the limitation is interpreted to read on an element that is in communication with the distal end of the endotracheal tube. Line 13 recites “the power source”; there is insufficient antecedent basis for this limitation in the claim.
Regarding claim 16, lines 1-2 recites, “further comprising a power source disposed towards the distal end for energizing the endotracheal intubation apparatus”. As discussed above, it is unclear how to determine the metes and bounds of the limitation “disposed towards the distal end”, and the limitation is interpreted to read on an element that is in communication with the distal end of the endotracheal tube. It is unclear whether the limitation “a power source” refers back to the previously recited power source in claim 15, or to an additional power source. For purposes of examination, the limitation is considered to refer back to the power source in claim 1, as applicant’s specification and drawings only disclose a single power source.
Regarding claim 17, lines 9-10 recite “the pressures of the inner cuff and the outer cuff are optimal and determined from the following steps”. It is unclear how to determine the metes and bounds of how to determine if a given pressure is “optimal”.
Regarding claim 19, lines 5-6 recite, “wherein the cuff control system is operable as a fully automatic smart control system.” It is unclear how to determine how to determine the metes and bounds of how to determine whether a control system is a “smart” control system.
Regarding claim 20, lines 1-2 recite, “wherein the inner cuff opening is circular, oval, square, and triangle in shape”. It is unclear how an opening can have a shape that both circular, oval, square, and triangular. For purposes of examination, it is considered that the inner cuff opening is circular, oval, square, or triangle in shape
Claims 3-4, 6-10, 11-13, and 18 are rejected for being either directly or indirectly depending from a rejected claim base.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6, 8-11, 15-16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calderoni et al (2011/0253137) in view of Muto (4,552,558).
Regarding claim 1, Calderoni in figs 1-2 discloses an endotracheal intubation apparatus for intubating a patient, comprising: an endotracheal tube (12) having a proximal end (end “A” shown in fig 2), a distal end (end adjacent to trachea “C” in fig 2), and a circumference (an endotracheal tube (12) has a circumference comprising an outer perimeter of the tube) (para [0030]), the distal end insertable into the patient's trachea (C) for intubating (fig 2, para [0030]); an expandable cuff (14) attached around the circumference of the endotracheal tube (12) towards the distal end (para [0030]); a pressure pipe (26) (conduit) (para [0034]), a balloon sensor (18) (pressure sensor senses fluid pressure in the cuff (14), and therefore is considered to be a balloon sensor because the cuff is inflatable) (para [0035]), and an inflation (16) (air pump) and deflation unit (20, 52) (dump valve, safety pressure relief switch) (para [0032]); the pressure pipe pneumatically (26) connects the cuff (14) to the deflation unit (20, 52) and inflation unit (16) (fig 2, para [0034]), the balloon sensor (18) measures the pneumatic pressure of the cuff (14) (para [0035]), the deflation (20, 52) and inflation units (16) are adaptable for respectively deflating and inflating the cuff (14) (para [0035]); a cuff control system (24) and is electrically connected to the balloon sensor (18) (fig 3, para [0035]), the power source (40) (power system) (para [0033]), deflation unit (20, 52) (para [0034]), and inflation unit (16) (para [0032]); wherein the cuff control system (24) controls the deflation unit (20, 52) and inflation unit (16) to achieve a predetermined pressure in the cuff (14) for sealing space between the patient's trachea and the circumference of the endotracheal tube (12) with the inflated cuff (14) based on the cuff air pressure sensed by the balloon sensor (18) according to a negative feedback control loop scheme (microprocessor (24) of the regulator and control system (10) measures the fluid pressure in the tube cuff (14) and automatically adjusts the air pressure inside the tube cuff (14) to the level selected by the technician, wherein the pressure level is constantly sensed by the pressure sensor (18) during the term of use of that cuff (14) within the patient's trachea "C"; and the pressure in the cuff (14) is regulated by microprocessor activation of either the air pump (16) or by microprocessor activation of the dump valve (20) to lower the pressure in the tube cuff (14), all as sensed, as necessary, by the microprocessor (24) and its attached reporting units (32)) (para [0035]).
Calderoni does not disclose the endotracheal tube intubation apparatus includes a pilot balloon, wherein the pressure pipe pneumatically connects the cuff to the deflation unit and inflation unit via the pilot balloon.
However, Muto teaches an endotracheal tube (20) including a cuff (23) attached to a distal end of the endotracheal tube (20) (col 2, ln 64-col 3, ln 3), a pressure pipe (26) (hollow tube), a pilot balloon (31), and an inflation unit (33) (syringe type balloon), wherein the pressure pipe (26) pneumatically connects the cuff (23) to the inflation unit (33) via the pilot balloon (33) (col 3, ln 4-18).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Calderoni by providing a pilot balloon, wherein the pressure pipe pneumatically connects the cuff to the deflation unit and inflation unit via the pilot balloon as taught by Muto in order to provide a visual indication to a surgeon of low side cuff pressure, medium cuff pressure, and high side cuff pressure based on the observed shape of the pilot balloon (Muto, abstract). The now-modified Calderoni’s device is considered that the pilot balloon, balloon sensor, inflation and deflation units, and cuff control system are disposed towards the distal end of the endotracheal tube, because, as discussed above, the limitation “disposed towards the distal end of the endotracheal tube” is interpreted to read on the pilot balloon, balloon sensor, inflation and deflation units, and cuff control system in communication with the distal end of the endotracheal tube, and Calderoni discloses that the balloon sensor, inflation and deflation units, and cuff control system are in communication with the distal end of the endotracheal tube to provide a pneumatic connection with the cuff to control cuff pressure (Calderoni, para [0034]), and Muto discloses that the pilot balloon is in pneumatic communication with the cuff to provide a visual indicator of cuff pressure (Muto, abstract).
Regarding claim 2, Calderoni discloses a power source (40) (system power) for energizing the endotracheal intubation apparatus (para [0034]), and is considered to be disposed towards the distal end as it energizes components of the pressure regulator and control system (10) that are in pneumatic communication with the cuff disposed at the distal end of the endotracheal intubation apparatus.
Regarding claim 3, modified Calderoni discloses the negative feedback control loop scheme for the cuff control system (24 of Calderoni) to maintain the cuff pressure within a predetermined range comprises: activating the deflation unit (20, 52 of Calderoni) if the pressure in the cuff increases above the predetermined range and activating the inflation unit (16 of Calderoni) if the pressure in the cuff falls below the predetermined range (the pressure in the cuff (14 of Calderoni) is regulated by microprocessor activation of either the air pump (16 of Calderoni) or by microprocessor activation of the dump valve (20 of Calderoni)) (Calderoni, para [0035]).
Modified Calderoni does not disclose the pressure pipe travels along the endotracheal tube.
However, Muto teaches an endotracheal tube (20) including a cuff (23) attached to a distal end of the endotracheal tube (20) (col 2, ln 64-col 3, ln 3), a pressure pipe (26) (hollow tube), a pilot balloon (31), and an inflation unit (33) (syringe type balloon), wherein the pressure pipe (26) pneumatically connects the cuff (23) to the inflation unit (33) via the pilot balloon (33) (col 3, ln 4-18), and as shown in figs 3-4, extends along the endotracheal tube (20) (hollow tubule (26) has its distal end (27) in communication with the interior (28) of the cuff (23) and thence extends along the tube (20) to a point (29) whence it emerges for connection outside the body of the patient to a pilot balloon (31)) (col 3, ln 4-8)
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Calderoni so that the pressure pipe travels along the endotracheal tube as taught by Muto, as the configuration of the pressure pipe traveling along the endotracheal tube is known in the art, and it appears that the pressure pipe of modified Calderoni would perform equally well to provide fluid communication with the pilot balloon and the cuff if the pressure pipe travels along the endotracheal tube. See MPEP 2143(I)(A).
Regarding claim 6, Calderoni discloses the cuff control system (24) monitors the balloon sensor (18) at predetermined intervals to maintain the predetermined pressure in the cuff (12) (pressure sensor is read every millisecond and averages are calculated over the previous 16 samples taken) (para [0040]).
Regarding claim 8, Calderoni discloses the cuff control system (24) activates the inflation unit (16) in discreet steps or in a continuous manner to achieve/maintain the predetermined pressure (microprocessor (24) activates the air pump (16) in a step shown in fig 4 when the pressure of the cuff is outside its required range) (para [0039]).
Regarding claim 9, Calderoni discloses the deflation unit (20, 52) and the inflation unit (16) are operable and mutually independent of each other (deflation unit (20) is a dump valve and inflation unit (20) is an air pump and are two distinct structural elements that can be separately controlled by the microprocessor (para [0035]).
Regarding claim 10, Calderoni discloses the cuff control system (24) simultaneously activates the deflation unit (20) and the air pump (16) to maintain the predetermined pressure (microprocessor (24) controls the air pump (16) and dump valve (20), and therefore is operable to simultaneously activate the air pump (16) and close the dump valve (20) to provide pressure to the cuff (14) (para [0014]).
Regarding claim 11, Calderoni discloses the cuff control system (14) is operable as a fully automatic smart control system (the pressure regulator and control system monitors the fluid pressure in the cuff and adjusts the cuff pressure automatically to the pressure preselected by the technician) (para [0015]).
Regarding claim 15, Calderoni discloses a device whose ordinary use comprises a method for intubating a patient with an endotracheal tube, comprising: providing an endotracheal tube (12) having a proximal end (end “A” shown in fig 2), a distal end (end adjacent to trachea “C” in fig 2), and a circumference (an endotracheal tube (12) has a circumference comprising an outer perimeter of the tube) (para [0030]), the distal end insertable into the patient's trachea (C) for intubating (fig 2, para [0030]); providing an expandable cuff (14) attached around the circumference of the endotracheal tube (12) towards the distal end (para [0030]); providing a pressure pipe (26) (conduit) (para [0034]), a balloon sensor (18) (pressure sensor senses fluid pressure in the cuff (14), and therefore is considered to be a balloon sensor because the cuff is inflatable) (para [0035]), and an inflation (16) (air pump) and deflation unit (20, 52) (dump valve, safety pressure relief switch) (para [0032]); the pressure pipe pneumatically (26) connects the cuff (14) to the deflation unit (20, 52) and inflation unit (16) (fig 2, para [0034]), the balloon sensor (18) measures the pneumatic pressure of the cuff (14) (para [0035]), the deflation (20, 52) and inflation units (16) are adaptable for respectively deflating and inflating the cuff (14) (para [0035]); and providing a cuff control system (24) and is electrically connected to the balloon sensor (18) (fig 3, para [0035]), the power source (40) (power system) (para [0033]), deflation unit (20, 52) (para [0034]), and inflation unit (16) (para [0032]); wherein the cuff control system (24) controls the deflation unit (20, 52) and inflation unit (16) to achieve a predetermined pressure in the cuff (14) for sealing space between the patient's trachea and the circumference of the endotracheal tube (12) with the inflated cuff (14) based on the cuff air pressure sensed by the balloon sensor (18) according to a negative feedback control loop scheme (microprocessor (24) of the regulator and control system (10) measures the fluid pressure in the tube cuff (14) and automatically adjusts the air pressure inside the tube cuff (14) to the level selected by the technician, wherein the pressure level is constantly sensed by the pressure sensor (18) during the term of use of that cuff (14) within the patient's trachea "C"; and the pressure in the cuff (14) is regulated by microprocessor activation of either the air pump (16) or by microprocessor activation of the dump valve (20) to lower the pressure in the tube cuff (14), all as sensed, as necessary, by the microprocessor (24) and its attached reporting units (32)) (para [0035]).
Calderoni does not disclose the providing a pilot balloon, wherein the pressure pipe pneumatically connects the cuff to the deflation unit and inflation unit via the pilot balloon.
However, Muto teaches an endotracheal tube (20) including a cuff (23) attached to a distal end of the endotracheal tube (20) (col 2, ln 64-col 3, ln 3), a pressure pipe (26) (hollow tube), a pilot balloon (31), and an inflation unit (33) (syringe type balloon), wherein the pressure pipe (26) pneumatically connects the cuff (23) to the inflation unit (33) via the pilot balloon (33) (col 3, ln 4-18).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of Calderoni by providing a pilot balloon, wherein the pressure pipe pneumatically connects the cuff to the deflation unit and inflation unit via the pilot balloon as taught by Muto in order to provide a visual indication to a surgeon of low side cuff pressure, medium cuff pressure, and high side cuff pressure based on the observed shape of the pilot balloon (Muto, abstract). The now-modified Calderoni’s device is considered that the pilot balloon, balloon sensor, inflation and deflation units, and cuff control system are disposed towards the distal end of the endotracheal tube, because, as discussed above, the limitation “disposed towards the distal end of the endotracheal tube” is interpreted to read on the pilot balloon, balloon sensor, inflation and deflation units, and cuff control system in communication with the distal end of the endotracheal tube, and Calderoni discloses that the balloon sensor, inflation and deflation units, and cuff control system are in communication with the distal end of the endotracheal tube to provide a pneumatic connection with the cuff to control cuff pressure (Calderoni, para [0034]), and Muto discloses that the pilot balloon is in pneumatic communication with the cuff to provide a visual indicator of cuff pressure (Muto, abstract).
Regarding claim 16, modified Calderoni discloses providing a power source (40) (system power) (para [0034]) disposed towards the distal end for energizing the endotracheal intubation apparatus (power source (40 of Calderoni) energizes components of the pressure regulator and control system (10) that are in pneumatic communication with the cuff disposed at the distal end of the endotracheal intubation apparatus., and therefore is considered to be disposed towards the distal end); wherein the negative feedback control loop scheme for the cuff control system (24 of Calderoni) to maintain the cuff pressure within a predetermined range comprises: activating the deflation unit (20, 52 of Calderoni) if the pressure in the cuff increases above the predetermined range and activating the inflation unit (16 of Calderoni) if the pressure in the cuff falls below the predetermined range (the pressure in the cuff (14 of Calderoni) is regulated by microprocessor activation of either the air pump (16 of Calderoni) or by microprocessor activation of the dump valve (20 of Calderoni)) (Calderoni, para [0035]).
Modified Calderoni does not disclose the pressure pipe travels along the endotracheal tube.
However, Muto teaches an endotracheal tube (20) including a cuff (23) attached to a distal end of the endotracheal tube (20) (col 2, ln 64-col 3, ln 3), a pressure pipe (26) (hollow tube), a pilot balloon (31), and an inflation unit (33) (syringe type balloon), wherein the pressure pipe (26) pneumatically connects the cuff (23) to the inflation unit (33) via the pilot balloon (33) (col 3, ln 4-18), and as shown in figs 3-4, extends along the endotracheal tube (20) (hollow tubule (26) has its distal end (27) in communication with the interior (28) of the cuff (23) and thence extends along the tube (20) to a point (29) whence it emerges for connection outside the body of the patient to a pilot balloon (31)) (col 3, ln 4-8)
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Calderoni so that the pressure pipe travels along the endotracheal tube as taught by Muto, as the configuration of the pressure pipe traveling along the endotracheal tube is known in the art, and it appears that the pressure pipe of modified Calderoni would perform equally well to provide fluid communication with the pilot balloon and the cuff if the pressure pipe travels along the endotracheal tube. See MPEP 2143(I)(A).
Regarding claim 19, Calderoni discloses the cuff control system (24) activates the inflation unit (16) in discreet steps or in a continuous manner to achieve/maintain the predetermined pressure (microprocessor (24) activates the air pump (16) in a step shown in fig 4 when the pressure of the cuff is outside its required range) (para [0039]); wherein the deflation unit (20, 52) and the inflation unit (16) are operable and mutually independent of each other (deflation unit (20) is a dump valve and inflation unit (20) is an air pump and are two distinct structural elements that can be separately controlled by the microprocessor (para [0035]); wherein the cuff control system (24) simultaneously activates the deflation unit (20) and the air pump (16) to maintain the predetermined pressure (microprocessor (24) controls the air pump (16) and dump valve (20), and therefore is operable to simultaneously activate the air pump (16) and close the dump valve (20) to provide pressure to the cuff (14) (para [0014])l and wherein the cuff control system (14) is operable as a fully automatic smart control system (the pressure regulator and control system monitors the fluid pressure in the cuff and adjusts the cuff pressure automatically to the pressure preselected by the technician) (para [0015]).
Claim(s) 7 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Calderoni et al and Muto as applied to claim 1 above, and further in view of Bateman et al (2017/0239435).
Regarding claim 7, modified Calderoni discloses a cuff.
Modified Calderoni does not disclose the shape of the cuff is a donut, triangular, square, or oval.
However, Bateman teaches a tracheal tube (1) including a cuff (10) attached to a distal end of the cuff (1) (para [0018]), and as shown in fig 1, is shown to have an oval shape and the cuff can be formed of a flexible plastics material moulded with a natural annular or doughnut shape that is inflated without stretching, to contact the wall of the trachea (para [0003]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Calderoni so that the shape of the cuff is a donut or oval so that the cuff can be inflated without stretching, to contact the wall of the trachea, by using a relatively low-pressure gas (Bateman, para [0003]).
Claim(s) 12 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Calderoni et al and Muto as applied to claim 1 above, and further in view of Levinson (5,235,973).
Regarding claim 12, modified Calderoni discloses a balloon sensor.
Modified Calderoni does not disclose the balloon sensor is adaptable to measure air volume, airflow, and/or temperature.
However, Levinson teaches an endotracheal tube (9) including a cuff (10) attached to a distal end of the endotracheal tube (19) (col 4, ln 31-51), and a balloon sensor (39) (flow transducer (39) continuously monitors flow into the cuff and out of the cuff) (col 8, ln 29-34).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Calderoni so that the balloon sensor is adaptable to measure airflow as taught by Levinson in order to track airflow in the cuff inflation line to indicate volume and detect cuff leakage (Levinson, abstract).
Claim(s) 18 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Calderoni et al and Muto as applied to claim 15 above, and further in view of Bateman et al and Levinson.
Regarding claim 18, modified Calderoni discloses the cuff control system (24 of Calderoni) monitors the balloon sensor (18 of Calderoni) at predetermined intervals to maintain the predetermined pressure in the cuff (12 of Calderoni) (pressure sensor is read every millisecond and averages are calculated over the previous 16 samples taken) (Calderoni, para [0040]).
Modified Calderoni does not disclose the shape of the cuff is a donut, triangular, square, or oval.
However, Bateman teaches a tracheal tube (1) including a cuff (10) attached to a distal end of the cuff (1) (para [0018]), and as shown in fig 1, is shown to have an oval shape and the cuff can be formed of a flexible plastics material moulded with a natural annular or doughnut shape that is inflated without stretching, to contact the wall of the trachea (para [0003]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Calderoni so that the shape of the cuff is a donut or oval so that the cuff can be inflated without stretching, to contact the wall of the trachea, by using a relatively low-pressure gas (Bateman, para [0003]).
The now-modified Calderoni’s method does not disclose the balloon sensor is adaptable to measure air volume, airflow, and/or temperature.
However, Levinson teaches an endotracheal tube (9) including a cuff (10) attached to a distal end of the endotracheal tube (19) (col 4, ln 31-51), and a balloon sensor (39) (flow transducer (39) continuously monitors flow into the cuff and out of the cuff) (col 8, ln 29-34).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Calderoni so that the balloon sensor is adaptable to measure airflow as taught by Levinson in order to track airflow in the cuff inflation line to indicate volume and detect cuff leakage (Levinson, abstract).
Allowable Subject Matter
Claim 4-5, 13-14, 17, and 20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement for reasons for allowance: The closest prior art of the record, Calderoni et al (2011/0253137) and Muto (4,552,558) disclose the limitations of claim 1; Clayton (2008/0078403) teaches an endotracheal tube including a cuff comprising an inner cuff (40) (inner layer) with an inner cuff opening (opening between inner cuff (40) and lumen (34)) and inflated with a first pressure pipe (34) and an outer cuff (38) (outer layer) encapsulating the inner cuff (40) and inflated with a second pressure pipe (36) (lumen) (para [0039]); and Georgilis et al (2021/0030984) teaches an endotracheal tube (106) including a first cuff (118) (proximal cuff) and a second cuff (120) (distal cuff), and a pair of lumen passageways (304) to connect the first cuff (118) with a first pilot balloon (114) and a second cuff (120) with a second pilot balloon (116) (para [0031]). However, neither Calderoni et al, Muto et al, Clayton, Georgilis et al, or the other prior art of record, disclose that the pilot balloon comprises an outer pilot balloon and an inner pilot balloon; wherein the balloon sensor comprises an outer balloon sensor and an inner balloon sensor for measuring the pneumatic pressure of the outer cuff and the inner cuff, respectively; and wherein the outer pressure pipe and the inner pressure pipe pneumatically connect the outer cuff and the inner cuff to the outer pilot balloon and the inner pilot balloon, respectively as recited in claims 4 and 17, as the prior art discloses two separate pilot balloons and therefore does not disclose a single pilot balloon comprising an outer pilot balloon and an inner pilot balloon.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Pesenti et al (2018/0126105) and Deutsch et al (2011/0197888) disclose endotracheal tubes with a cuff inflation control system; and Shapiro (4,791,923), Dunn (5,038,777), and Baran (3,173,418) disclose endotracheal tubes with an inner cuff and an outer cuff
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS YOUNG SUL whose telephone number is (571)270-5260. The examiner can normally be reached on Monday-Friday 8:30 am-5 pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached on 571-272-48354835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DOUGLAS Y SUL/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785