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 .
Claim Objections
Claims 12 and 18 are objected to because of the following informalities:
Claim 12 recites “wherein the cleaning system includes a a fluid injection assembly”, but should read ---wherein the cleaning system includes a fluid injection assembly---.
Claim 18 recites “a physical agitator and a fluid injection port”, but should read ---a physical agitator and a fluid injection assembly---.
Appropriate correction is required.
Claim Interpretation
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 limitations are:
The recitation of “visualization device” in claims 1, 15, 16, and 20. Using broadest reasonable interpretation, a visualization device is understood to be either a port, that is capable of having such device, or the actual visualization device (a bronchoscope).
The recitation of “cleaning system” in claims 1, 9-13, and 18-20. Using broadest reasonable interpretation, a cleaning system is understood to be any device or tube that removes debris and helps to suction moisture in the tube or lungs.
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 U.S.C. § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 recites the limitation “a diameter of the tube body distal to the junction is less than a diameter of the tube body proximal to the junction” and depends from claim 4. Claim 4 recites the limitation “tube body includes a junction where the second tube merges into the first tube”. Since, the second tube merging into the first tube would inherently reduce the diameter of the tube body distal to the junction, claim 7 fails to further limit claim 4.
Claim Rejections – 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under 35 U.S.C. 103 as obvious over Wallace (EP 0092618 A1) in view of Vazales (US 20130104884 A1).
Regarding claim 1, Wallace discloses an endotracheal tube, configured to:
be inserted in an airway of a patient and the endotracheal tube (Wallace Figure 6);
comprising: a tube body having a distal end configured to be disposed in the airway and a proximal end configured to remain outside the airway (Wallace Figure 6; ‘12’ distal end in the airway, Figure 1; ‘9d’ proximal end outside of airway);
the tube body including a first tube and a second tube (Wallace Figure 10; ‘21’ and ‘9’ different tubes, e.g. first and second tube respectively);
and a flexible tip member disposed on the distal end of the tube body (Wallace pg. 4 lines 33-35, tube ‘11’ has a hole ‘8’, that makes the distal end more flexible, tube is also flexible in general, pg. 4 line 10);
Wallace fails to disclose a ventilator and a visualization device, and is silent to disclose a cleaning system.
Vazales discloses an endotracheal tube comprising:
and cooperate with a ventilator and a visualization device (Vazales [0017]; oxygen line port ‘131’ can be connected to a ventilator and Figure 3A; ‘133’, is a visualization port (operably receiving) for a visualization device to go into and [0051]; where the visualization member can be a bronchoscope);
the first tube configured to be operably coupled to the ventilator (Vazales Figure 5B; ‘131’ (first tube) is the oxygen port that can be connected to a ventilator [0017]);
and the second tube configured to operably receive and have the visualization device advanced therethrough (Vazales Figure 3A; ‘133’, is a visualization port (operably receiving) for a visualization device to go into (this tube body would be a ‘second tube’) and [0051]; where the visualization member can be a bronchoscope);
a cleaning system disposed in the second tube (Vazales Figure 14A; the airway cleaning device, where the suction catheter ‘1510’ can be a part of the airway cleaning device and remove debris from within the patient or tube, [0024]; the airway cleaning device can comprise an irrigation channel to deliver fluid for debris removal, [0025]; an expandable endotracheal tube cleaning member can be disposed on the outer surface of the suction catheter, [0371]; where a removeable member can be connected to the suction catheter within the airway cleaning device, [0369]; where the removable member can include bristles, [0536]; airway cleaning device can go into the visualization port ‘133’, and the visualization port down through tube body is a ‘second tube’ -thereby making a cleaning system, the visualization port ‘133’ goes into the second tube where the cleaning system goes toward distal tip end).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the endotracheal tube of Wallace to include a cleaning system, a visualization device, and a ventilator as taught by Vazales, since, a cleaning device helps to rejuvenate endotracheal tubes that are contaminated or clogged, a visualization device allows for the visualization of the airway/ correct insertion placement within the airway, and because a ventilator can provide assisted breathing for days or weeks with an endotracheal tube (Vazales; [0025], [0007], [0003]).
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Figure 1: Annotated Figure 3A of Vazales.
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Figure 2: Annotated Figure 10 of Wallace.
Regarding claim 2, Wallace discloses the endotracheal tube of Claim 1, but fails to disclose wherein the flexible tip member has a plurality of holes formed therethrough.
Vazales discloses the endotracheal tube of Claim 1, wherein the flexible tip member has a plurality of holes formed therethrough (Vazales Figure 16A and [0298]; where multiple holes are arranged at the distal tip end with an array pattern, and there can be multiple more holes).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the endotracheal tube of Wallace with the multiple holes in an array structure at the distal flexible tip as disclosed by Vazales-, since holes at the distal of an endotracheal tube are well known in the art as a murphy eye that are advantageous for increasing the total open area, allowing for better clearance of any blockages in an endotracheal tube (Nave: US 20170232216 A1 [0099]; murphy eyes).
Regarding claim 3, modified Wallace further discloses the endotracheal tube of Claim 2, wherein the plurality of holes are arranged in an array across an entire surface of the flexible tip member (Vazales Figure 16A and [0298]; where multiple holes are arranged at the distal tip end with an array pattern, and there can be multiple more holes).
Regarding claim 4, Wallace further discloses the endotracheal tube of Claim 1, wherein the tube body includes a junction where the second tube merges into the first tube (Wallace Figure 8; where the junction of the two tubes diameter narrows into the one tube at about ‘15b’).
Regarding claim 5, Wallace further discloses the endotracheal tube of Claim 4, wherein the second tube extends into the first tube distal to the junction (Wallace Figure 8; where the junction of the two tubes diameter narrows into the one tube at about ‘9a’, and Figure 10; where the second tube ‘10’ extends into the first tube the first tube ‘21’ distal to the junction point (about ‘15b’) at about the cross-section of ‘11’).
Regarding claim 6, Wallace further discloses the endotracheal tube of Claim 4, wherein an inflatable cuff is disposed between the distal end of the tube body and the junction (Wallace Figure 10; ‘15b’ is an inflatable member (cuff), that is between the distal end and the junction section)
Regarding claim 7, Wallace further discloses the endotracheal tube of Claim 4, wherein a diameter of the tube body distal to the junction is less than a diameter of the tube body proximal to the junction (Wallace Figure 10; where after ‘15b’, the diameter of the tube is less than the proximal side of the junction).
Regarding claim 8, Wallace further discloses the endotracheal tube of Claim 7, wherein the first tube circumscribes the second tube distal to the junction (Wallace figure 10; where inside the tube ‘21’ joins tube ‘10’, and distal to the junction, everything is one tube, also ‘21’/’11’ is the first tube that goes into the second tube ‘9’ distal (far) to the junction (‘15b’)).
Regarding claim 9, modified Wallace further discloses the endotracheal tube of Claim 4, wherein the cleaning system is disposed in the second tube proximal to the junction (Vazales Figure 14A; the airway cleaning device, where the suction catheter ‘1510’ can be a part of the airway cleaning device and remove debris from within the patient or tube, [0024]; the airway cleaning device can comprise an irrigation channel to deliver fluid for debris removal, [0025]; an expandable endotracheal tube cleaning member can be disposed on the outer surface of the suction catheter, [0371]; where a removeable member can be connected to the suction catheter within the airway cleaning device, [0369]; where the removable member can include bristles, [0536]; airway cleaning device can go into the visualization port ‘133’, and the visualization port down through tube body is a ‘second tube’ -thereby making a cleaning system, the visualization port ‘133’ goes into the second tube where the cleaning system goes toward distal tip end, proximal to the distal tip end away from a junction reference point).
Regarding claim 10, modified Wallace further discloses the endotracheal tube of Claim 9, wherein the cleaning system includes a physical agitator (Vazales Figure 14A; the airway cleaning device, where the suction catheter ‘1510’ can be a part of the airway cleaning device and remove debris from within the patient or tube, [0024]; the airway cleaning device can comprise an irrigation channel to deliver fluid for debris removal, [0025]; an expandable endotracheal tube cleaning member can be disposed on the outer surface of the suction catheter, [0371]; where a removeable member can be connected to the suction catheter within the airway cleaning device, [0369]; where the removable member can include bristles (physical agitator), [0536]; airway cleaning device can go into the visualization port ‘133’, and the visualization port down through tube body is a ‘second tube’ -thereby making a cleaning system, the visualization port ‘133’ goes into the second tube where the cleaning system goes toward distal tip end).
Regarding claim 11, modified Wallace further discloses the endotracheal tube of Claim 10, wherein the physical agitator includes bristles (Vazales Figure 14A; the airway cleaning device, where the suction catheter ‘1510’ can be a part of the airway cleaning device and remove debris from within the patient or tube, [0024]; the airway cleaning device can comprise an irrigation channel to deliver fluid for debris removal, [0025]; an expandable endotracheal tube cleaning member can be disposed on the outer surface of the suction catheter, [0371]; where a removeable member can be connected to the suction catheter within the airway cleaning device, [0369]; where the removable member can include bristles (physical agitator), [0536]; airway cleaning device can go into the visualization port ‘133’, and the visualization port down through tube body is a ‘second tube’ -thereby making a cleaning system, the visualization port ‘133’ goes into the second tube where the cleaning system goes toward distal tip end).
Regarding claim 12, modified Wallace further discloses the endotracheal tube of Claim 9, wherein the cleaning system includes a a fluid injection assembly (Vazales [0032]; irrigation channel (fluid injection assembly) for cleaning the distal end of the tube, included in the airway cleaning device, delivers fluid (fluid injection) and Figure 14A; the airway cleaning device, where the suction catheter ‘1510’ can be a part of the airway cleaning device and remove debris from within the patient or tube, [0024]; the airway cleaning device can comprise an irrigation channel to deliver fluid for debris removal, [0025]; an expandable endotracheal tube cleaning member can be disposed on the outer surface of the suction catheter, [0371]; where a removeable member can be connected to the suction catheter within the airway cleaning device, [0369]; where the removable member can include bristles (physical agitator), [0536]; airway cleaning device can go into the visualization port ‘133’, and the visualization port down through tube body is a ‘second tube’ -thereby making a cleaning system, the visualization port ‘133’ goes into the second tube where the cleaning system goes toward distal tip end).
Regarding claim 13, modified Wallace further discloses the endotracheal tube of Claim 1, wherein a sealing member is disposed adjacent to the cleaning system on the second tube and provides an air-tight seal of the second tube (Vazales [0066]; device insertion sealing member provides a seal when a cleaning device introduced within the tube).
Regarding claim 14, modified Wallace further discloses the endotracheal tube of Claim 1, wherein a stylet is disposed in the first tube through the proximal end (Vazales [0017]; oxygen port ‘131’ of Figure 3A, can be configured to include a stylet (malleable obturator)).
Regarding claim 15, modified Wallace further discloses the endotracheal tube of Claim 1, further comprising the visualization device, wherein the visualization device is disposed in the second tube at the proximal end (Vazales Figure 3A; ‘133’, is a visualization port (operably receiving) for a visualization device to go into (this tube body would be a ‘second tube’) and [0051]; where the visualization member can be a bronchoscope, it is on the proximal end of Figure 3A as well).
Regarding claim 16, modified Wallace further discloses the endotracheal tube of Claim 15, wherein the visualization device is a bronchoscope (Vazales Figure 3A; ‘133’, is a visualization port (operably receiving) for a visualization device to go into (this tube body would be a ‘second tube’) and [0051]; where the visualization member can be a bronchoscope, it is on the proximal end of the tube in Figure 3A as well).
Regarding claim 17, modified Wallace further discloses the endotracheal tube of Claim 16, wherein a stylet is disposed in the first tube at the proximal end (Vazales [0017]; oxygen port ‘131’ of Figure 3A, can be configured to include a stylet (malleable obturator), where the oxygen port ‘131’ is, is the ‘first tube’ and at the proximal end).
Regarding claim 18, modified Wallace further discloses the endotracheal tube of Claim 1,
wherein the flexible tip member has a plurality of holes formed therethrough and the plurality of holes are arranged in an array across an entire surface of the flexible tip member (Vazales Figure 16A and [0298]; where multiple holes are arranged at the distal tip end with an array pattern, and there can be multiple more holes).
and the cleaning system includes a physical agitator and a fluid injection port (Vazales [0032]; irrigation channel (fluid injection assembly) for cleaning the distal end of the tube, included in the airway cleaning device, delivers fluid (fluid injection) and Figure 14A; the airway cleaning device, where the suction catheter ‘1510’ can be a part of the airway cleaning device and remove debris from within the patient or tube, [0024]; the airway cleaning device can comprise an irrigation channel to deliver fluid for debris removal, [0025]; an expandable endotracheal tube cleaning member can be disposed on the outer surface of the suction catheter, [0371]; where a removeable member can be connected to the suction catheter within the airway cleaning device, [0369]; where the removable member can include bristles (physical agitator), [0536]; airway cleaning device can go into the visualization port ‘133’, and the visualization port down through tube body is a ‘second tube’ -thereby making a cleaning system, the visualization port ‘133’ goes into the second tube where the cleaning system goes toward distal tip end).
Regarding claim 19, modified Wallace further discloses the endotracheal tube of Claim 18, wherein a sealing member is disposed adjacent to the cleaning system on the second tube and provides an air-tight seal of the second tube (Vazales [0066]; device insertion sealing member provides a seal when a cleaning device introduced within the tube).
Regarding claim 20, Wallace further discloses the endotracheal tube configured to be inserted in an airway of a patient and cooperate with a ventilator (Wallace Figure 10, endotracheal tube is inserted into the airway, Vazales Figure 5B; ‘131’ (first tube) is the oxygen port that can be connected to a ventilator [0017]);
the method comprising: providing the endotracheal tube including a tube body having a distal end configured to be disposed in the airway and a proximal end configured to remain outside the airway (Wallace Figure 10; where the distal end is in the airway and the proximal end is outside the airway and the endotracheal tube is provided to be in the patient);
the tube body including a first tube and a second tube (Wallace Figure 10; ‘21’ and ‘9’ different tubes, e.g. second and first tube respectively);
and a flexible tip member disposed on the distal end of the tube body (Wallace pg. 4 lines 33-35, tube ‘11’ has a hole ‘8’, that makes the distal end more flexible, tube is also flexible in general, pg. 4 line 10);
inserting the endotracheal tube into the airway (Wallace Figure 10, endotracheal tube is inserted into the airway);
Wallace fails to disclose a ventilator and a visualization device, and is silent to disclose a cleaning system and securing the endotracheal tube to a desired location in the airway.
Vazales further discloses a method of utilizing an endotracheal tube (Vazales [0019]; using an endotracheal tube);
the first tube configured to be operably coupled to the ventilator (Vazales Figure 5B; ‘131’ (first tube) is the oxygen port that can be connected to a ventilator [0017]);
and a visualization device disposed in the second tube configured to be advanced therethrough (Vazales [0037]; method for visualizing the patient’s distal airway, introducing a visualization member into the tube, Figure 3A; ‘133’, is a visualization port (operably receiving) for a visualization device to go into (this tube body would be a ‘second tube’) and [0051]; where the visualization member can be a bronchoscope);
a cleaning system disposed in the second tube (Vazales [0038]; where there is a device for removing debris or secretions from the lungs, [0205]; the airway cleaning device can comprise an accessory channel, or irrigation line, Figure 14A, where the suction catheter ‘1510’ can be in the airway cleaning device and remove debris from within the patient or tube, airway cleaning device can go into the visualization port ‘133’, and the visualization port down through tube body is a ‘second tube’);
securing the endotracheal tube at a desired location in the airway (Vazales [0017]; where the stylet can be on the oxygen port ‘131’, that is a malleable obturator, helps with securing position in airway);
and cleaning the visualization device with the cleaning system (Vazales [0024]; the cleaning device can clean the visualization channel that removably receives a visualization device – thereby cleaning the visualization device with the cleaning system).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the endotracheal tube of Wallace to include a cleaning system, a visualization device, the securing of the endotracheal tube to a desired location in the airway and a ventilator as taught by Vazales, since, a cleaning device helps to rejuvenate endotracheal tubes that are contaminated or clogged, a visualization device allows for the visualization of the airway/ correct insertion placement within the airway, securing the location in the airway allows for the clinician to better maintain a patient’s airway and detect issues regarding the tube and patient’s health and because a ventilator can provide assisted breathing for days or weeks with an endotracheal tube (Vazales; [0025], [0007], [0003]).
Conclusion
The following prior art were considered but not used on a 35 U.S.C. § 102 or 103 rejection: WO 2020210327 A1, US 20200113427 A1, CN 110743071 A, KR 20160024096 A, CN 204972582 U, CN 105214188 A, US 20150151063 A1, US 20150101598 A1, CN 202951092 U, WO 2011126812 A1, US 20110023885 A1, US 20060090761 A1, US 6520183 B2.
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/AISLINN M JONES/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785