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 .
Priority
Acknowledgment is made of applicant’s claim for priority to Application No. (65/235,256) filed on August 20, 2021.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first inflatable tube in claims 5, 7-8, and the second inflatable tube in claim 8 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "115" and "114" have both been used to designate tubular member in para. 0036. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5, 9-13, 17-19, 23-26, and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morgan et al. (US 20170340216 A1), hereafter as Morgan.
Regarding Claim 1, Morgan discloses an endotracheal tube (Fig. 1, 11; para. 0018; abstract), comprising:
a tubular member (Fig. 11; 1100) extending from a proximal end to a distal end (Fig. 11 is showing the distal end; Fig. 1; proximal end 12 distal end is 13), and defining an outer surface(Fig. 11; outside of 1100) and an inner surface (Fig. 11; 1102) of the tubular member;
a first cuff (Fig. 11; 1103) positioned about a portion of the outer surface of the tubular member (Fig. 11; 1103 is attached to the outside of the tube 1100), the first cuff defining an inner surface and an outer surface of the first cuff (Fig. 11; 1103; Examiner notes: there is inner surface facing the tube and there is an outer surface facing away);
a sensor (Fig. 11; 1101; para. 0080) disposed on or adjacent to the outer surface of the first cuff (Fig. 11); and
a second cuff (Fig. 11; 1105) positioned over the sensor and at least partially over the first cuff, wherein the sensor is disposed between the first and second cuffs (Fig. 11; para. 0080, 0081).
Regarding Claim 2, Morgan discloses the endotracheal tube of claim 1, wherein the inner surface of the first cuff (Fig. 11; 1103) faces towards the outer surface of the tubular member (Fig. 11), and the outer surface of the first cuff (Fig. 11; 1103) faces away from the tubular member (Fig. 11).
Regarding Claim 3, Morgan discloses the endotracheal tube of claim 1, wherein the first cuff (Fig. 11; 1103) is coupled to the outer surface of the tubular member at or near the distal end of the tubular member (Fig. 1, 11).
Regarding Claim 4, Morgan discloses the endotracheal tube of claim 1, wherein the first cuff (Fig. 11; 1103) is inflatable (para. 0080, 0081).
Regarding Claim 5, Morgan discloses the endotracheal tube of claim 2, comprising a first inflation tube extending through the tubular member (para. 0020) and in communication with an interior of the first cuff (Fig. 11, 1103) for selectively inflating and deflating the first cuff(para. 0020-0022, 0080, 0081).
Regarding Claim 9, Morgan discloses the endotracheal tube of claim 1, wherein the second cuff (Fig. 11; 1105; para. 008) defines an inner surface and an outer surface of the second cuff (Fig. 11; 1105 has surface that towards the tube and there is outer surface facing away), and wherein the sensor is disposed between the first (Fig. 11, 1103) and second cuffs(Fig. 11; 1105) such that the inner surface of the second cuff (Fig. 11; 1105) is positioned immediately adjacent to the sensor (Fig. 11; 1101 is in between 1003 and 1105).
Regarding Claim 10, Morgan discloses the endotracheal tube of claim 1, wherein the sensor (Fig. 11; 1101) is physically attached to the outer surface of the first cuff (Fig. 11, 1103) without physical attachment to the second cuff (Fig. 11; 1105) (Fig. 11; para. 0081; the sensor can be attached to either the first cuff or the second cuff).
Regarding Claim 11, Morgan discloses the endotracheal tube of claim 1, wherein the sensor (Fig. 11; 1101) is physically attached to the inner surface of the second cuff without physical attachment to the first cuff (Fig. 11, 1103) (Fig. 11; para. 0081; the sensor can be attached to either the first cuff or the second cuff).
Regarding Claim 12, Morgan discloses the endotracheal tube of claim 1, wherein the sensor (Fig. 11; 1101) is physically attached to the outer surface of the first cuff (Fig. 11, 1103) and the inner surface of the second cuff(Fig. 11; 1105) (Fig. 11; para. 0081; the sensor can be attached to either the first cuff or the second cuff or both).
Regarding Claim 13, Morgan discloses the endotracheal tube of claim 1, wherein the second cuff (Fig. 11; 1105) is disposed over an entire surface area of the outer surface of the first cuff(Fig. 11; 1103).
Regarding Claim 17, Morgan discloses the endotracheal tube of claim 1, wherein the sensor (Fig. 11; 1101, 1104) comprises multiple different types of sensors (para. 0021, 0080; Examiner notes: optical fibre pressure sensor and optical fibre).
Regarding Claim 18, Morgan discloses the endotracheal tube of claim 1, wherein the sensor (Fig. 11; 1101, 1104) is configured to move radially outward away from the tubular member (Fig. 11; 1101) during inflation of the first cuff (Fig. 11; 1103; Examiner notes: when the first inflatable cuff is inflated this will cause the sensor to move outwardly; para. 0080; This limitation is functional).
Regarding Claim 19, Morgan discloses the endotracheal tube of claim 18, wherein the distal end of the tubular member (Fig. 1, 11; 1100; para. 0001) is configured to be positioned within a trachea of a patient (para. 0001, 0011, 0014, 0019), and inflation of the first cuff moves the sensor radially outward away from the tubular member and against a wall of the trachea (para. 0080; the cuff is inflatable and move the cuff outward away from 1102).
Regarding Claim 23, Morgan discloses a method of measuring one or more vital signs or physiological parameters of a patient, the method comprising (abstract):
inserting a distal end of an endotracheal tube (Fig. 11, 1100) into a trachea of a patient (para. 0018, 0080), the endotracheal tube including
(i) a tubular member (Fig. 11; 1100) extending from a proximal end to a distal end (Fig. 11 is showing the distal end; Fig. 1; proximal end 12 distal end is 13), and defining an outer surface(Fig. 11; outside of 1100) and an inner surface (Fig. 11; 1102) of the tubular member,
(ii) a first cuff (Fig. 11; 1103) positioned about a portion of the outer surface of the tubular member (Fig. 11; 1103 is attached to the outside of the tube 1100), the first cuff defining an inner surface and an outer surface of the first cuff (Fig. 11; 1103; Examiner notes: there is inner surface facing the tube and there is an outer surface facing away)
(iii) a sensor (Fig. 11; 1101; para. 0080) disposed on or adjacent to the outer surface of the first cuff (Fig. 11), and
(iv) a second cuff (Fig. 11; 1105) positioned over the sensor and at least partially over the first cuff, wherein the sensor is disposed between the first and second cuffs (Fig. 11; para. 0080, 0081); expanding the first cuff of the endotracheal tube to move the sensor radially outward away from the tubular member and against a wall of the trachea (Fig. 1, 11; para. 0002, 0080, 0081);
and measuring one or more vital signs or physiological parameters of the patient with the sensor (para. 0030, 0081).
Regarding Claim 24, Morgan discloses the method of claim 23, comprising inflating the first cuff with a fluid to move the sensor radially outward away from the tubular member and against the wall of the trachea (Fig. 1, 11; 0002, 0030, 0050, 0080-0081), the first cuff (Fig. 11; 1103) forming a seal with the wall of the trachea.
Regarding Claim 25, Morgan discloses the method of claim 23, comprising inflating the second cuff (Fig. 11; 1105) with a fluid to move the sensor radially outward away from the tubular member and against the wall of the trachea (para. 0080; the cuff is inflatable and move the cuff outward away from 1102).
Regarding Claim 26, Morgan discloses the method of claim 23, wherein the second cuff (Fig. 11; 1105; para. 008) defines an inner surface and an outer surface of the second cuff (Fig. 11; 1105 has surface that towards the tube and there is outer surface facing away), and wherein the sensor is disposed between the first (Fig. 11, 1103) and second cuffs(Fig. 11; 1105) such that the inner surface of the second cuff (Fig. 11; 1105) is positioned immediately adjacent to the sensor (Fig. 11; 1101 is in between 1003 and 1105).
Regarding Claim 28, Morgan discloses a tracheostomy tube (para. 0018; abstract), comprising:
a tubular member (Fig. 11; 1100) extending from a proximal end to a distal end (Fig. 11 is showing the distal end; Fig. 1; proximal end 12 distal end is 13), and defining an outer surface(Fig. 11; outside of 1100) and an inner surface (Fig. 11; 1102) of the tubular member;
a first cuff (Fig. 11; 1103) positioned about a portion of the outer surface of the tubular member (Fig. 11; 1103 is attached to the outside of the tube 1100), the first cuff defining an inner surface and an outer surface of the first cuff (Fig. 11; 1103; Examiner notes: there is inner surface facing the tube and there is an outer surface facing away);
a sensor (Fig. 11; 1101; para. 0080) disposed on or adjacent to the outer surface of the first cuff (Fig. 11); and
a second cuff (Fig. 11; 1105) positioned over the sensor and at least partially over the first cuff, wherein the sensor is disposed between the first and second cuffs (Fig. 11; para. 0080, 0081).
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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan, as applied to claim 1, in view of Nasir (US 20100288289 A1).
Regarding Claim 6, Morgan discloses the endotracheal tube of claim 1,
Morgan does not disclose wherein the second cuff is non-inflatable.
Nasir teaches wherein the second cuff is non-inflatable (para. 0018-0019; Fig. 4a-4b; soft barrier 28).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the second cuff of Morgan to include it not to be inflatable as taught by Nasir for the purpose of a protective layer to protect the patient and to improve the seal formed between the device and the airway (para. 0019).
Claim(s) 7, 21, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan, as applied to claim 1.
Regarding Claim 7, Morgan discloses the endotracheal tube of claim 5, wherein the second cuff is inflatable,
Morgan does not disclose specifically that the first inflation tube is in communication with an interior of the second cuff for selectively inflating and deflating the second cuff.
However, Morgan teaches that the second cuff is inflatable, and a tube is in communication with an interior of the second cuff for selectively inflating and deflating the second cuff (para. 0028).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Morgan to include the that the first inflation tube is in communication with an interior of the second cuff for selectively inflating and deflating the second cuff as taught by Morgan for the purpose of inflating the cuff to a set pressure, maintain a set pressure within the cuff and/or provide a modulated pressure to the cuff (para. 0028).
Regarding Claim 21, Morgan discloses the endotracheal tube of claim 1, wherein the first cuff (Fig. 11; 1103) and the second cuff (Fig. 11; 1103)
Morgan does not specifically disclose that the cuffs are fabricated from a biocompatible material.
However, Morgan teaches in different embodiment that the inflatable cuffs could be made from biocompatible materials (para. 0058).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cuffs of Morgan in Fig. 11 Smith to include the is made from biocompatible material as taught by Morgan Fig. 3 for the purpose of these materials being transparent to visible light, enabling the optical sensor to function if provided within the cuff (para. 0058).
Regarding Claim 27, Morgan discloses the method of claim 23,
Morgan does not disclose specifically wherein measuring the one or more vital signs or physiological parameters of the patient with the sensor comprises measuring an oxygen saturation of a patient when the first cuff is inflated and the sensor is positioned against the wall of the trachea.
However, Morgan teaches a sensor that measures blood flow and pulse oximeter sensor (para. 0080-0081).
Therefore, due to the absence of the limitations of measuring the one or more vital signs or physiological parameters of the patient with the sensor comprises measuring an oxygen saturation of a patient when the first cuff is inflated and the sensor is positioned against the wall of the trachea, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that sensor would measure a parameter when the first cuff is inflated and the sensor is closes to the wall of the trachea. The sensor that sandwich in between would reasonably encompass the absent limitation measuring the one or more vital signs or physiological parameters of the patient with the sensor comprises measuring an oxygen saturation of a patient when the first cuff is inflated and the sensor is positioned against the wall of the trachea (para. 0080-0081; Fig. 11).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan, as applied to claim 5, in view of Daher et al. (US 20140128672 A1), hereafter as Daher.
Regarding Claim 8, Morgan discloses the endotracheal tube of claim 5, wherein the second cuff is inflatable,
Morgan does not disclose specifically that the endotracheal tube comprises a second inflation tube extending through the tubular member and in communication with an interior of the second cuff for selectively inflating and deflating the second cuff independently from the first cuff.
However, Daher teaches that the endotracheal tube comprises a second inflation tube (Fig. 3; 128) extending through the tubular member and in communication with an interior of the second cuff (Fig. 3; 122) for selectively inflating and deflating the second cuff independently from the first cuff (Fig. 3; 112) (para. 0115).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the tube of Morgan to include a second inflation tube extending through the tubular member and in communication with an interior of the second cuff for selectively inflating and deflating the second cuff independently from the first cuff as taught by Daher for the purpose of individually controlling the two cuffs (para. 0115).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan, as applied to claim 1, in view of Singvogel et al. (US 20120279500 A1), hereafter as Singvogel.
Regarding Claim 14, Morgan discloses the endotracheal tube of claim 1,
Morgan does not disclose specifically wherein the second cuff is disposed over only a portion of a surface area of the outer surface of the first cuff, and wherein the portion of the surface area is less than 50%.
However, Morgan teaches wherein the second cuff provides protection to the sensor (para. 0081, Fig. 11).
Therefore, due to the absence of the limitations of the second cuff is disposed over only a portion of a surface area of the outer surface of the first cuff, and wherein the portion of the surface area is less than 50%, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that second cuff would cover the location of the sensor in order to provide protection to the sensor, so the limitation would reasonably encompass the absent limitation of second cuff is disposed over only a portion of a surface area of the outer surface of the first cuff, and wherein the portion of the surface area is less than 50%.
Although Morgan does not specifically teach the size of sensor, one skilled in the art would reasonably expect the sensor to be over only a surface area less than 50% because as shown in Singvogel, the prior art teaches a sensor (Fig. 2-4; 13) disposed over a portion of a surface area of the outer surface of the first cuff (para. 0024).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the second cuff of Morgan to cover a surface area less than 50% as taught by modification for the purpose of providing protection to the sensor.
Regarding Claim 15, Morgan discloses the endotracheal tube of claim 14,
Morgan does not disclose specifically and wherein the portion of the surface area is less than 25%.
However, Morgan teaches wherein the second cuff provides protection to the sensor (para. 0081, Fig. 11).
Therefore, due to the absence of the limitations of the second cuff is disposed over only a portion of a surface area of the outer surface of the first cuff, and wherein the portion of the surface area is less than 25%, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that second cuff would cover the location of the sensor in order to provide protection to the sensor, so the limitation would reasonably encompass the absent limitation of second cuff is disposed over only a portion of a surface area of the outer surface of the first cuff, and wherein the portion of the surface area is less than 25%.
Although Morgan does not specifically teach the size of sensor, one skilled in the art would reasonably expect the sensor to be over only a surface area less than 25% because as shown in Singvogel, the prior art teaches a sensor (Fig. 2-4; 13) disposed over a portion of a surface area of the outer surface of the first cuff (para. 0024).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the second cuff of Morgan to cover a surface area less than 25% as taught by modification for the purpose of providing protection to the sensor.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan, as applied to claim 1, in view of Melker (US 20030236452 A1), hereafter as Melker.
Regarding Claim 16, Morgan discloses the endotracheal tube of claim 1,
Morgan does not disclose specifically wherein the sensor comprises a single pulse oximeter.
However, Melker teaches wherein the sensor comprises a single pulse oximeter.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify sensor of Morgan to include the sensor comprises a single pulse oximeter as taught by Melker for the purpose of continuously measuring blood oxygen saturation values and/or blood pressure and/or pulse values, wherein the system detects and monitors changes in vascular perfusion and resistance in a patient. The overall system particularly assesses differences in peripheral blood flow which may be impaired in certain illnesses and accident conditions (para. 0025).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan, as applied to claim 1, in view of Guilermo (US 20200030557 A1), hereafter as Guilermo.
Regarding Claim 20, Morgan discloses the endotracheal tube of claim 1,
Morgan does not disclose wherein the first cuff, and the second cuff are fabricated from a same material.
However, Guilermo teaches wherein the first cuff, and the second cuff are fabricated from a same material (para. 0042).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the first and second cuff of Morgan to be fabricated from a same material as taught by Guilermo because these are material that are commonly known in the art (para. 0045).
Claim(s) 22 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan, as applied to claim 1 and 28, in view of Finneran et al. (US 8568316 B2), hereafter as Finneran.
Regarding Claim 22, Morgan discloses the endotracheal tube of claim 1,
Morgan does not disclose comprising an electrical conductor coupled to the sensor and extending through a portion of the tubular member.
However, Finneran teaches comprising an electrical conductor (48, 50) coupled to the sensor (36) and extending through a portion of the tubular member (best shown in Fig. 5; 48, 55; Col 4 lns. 4-21).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Morgan to include the an electrical conductor coupled to the sensor and extending through a portion of the tubular member as taught by Finneran for the purpose of facilitating bidirectional communication between the sensor 36 located within the patient and the support system positioned outside the patient via the conductors (Col.4 lns 4-21).
Regarding Claim 29, Morgan discloses the tracheostomy tube of claim 28,
Morgan does not specifically disclose the tube comprising a tracheal collar coupled to the proximal end of the tubular member.
However, Finneran teaches the tube comprising a tracheal collar (18, 14) coupled to the proximal end of the tubular member (Fig. 1-8; 18, and 14, Col. 3 lns 36-48; Col. 8 lns 3-32).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the tube of Morgan to include a tracheal collar coupled to the proximal end of the tubular member as taught by Finneran for the purpose of connector may be attached to a mechanical ventilator during operation (Col. 3 lns 36-48).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAAP A ELLABIB whose telephone number is (571)272-5879. The examiner can normally be reached 8-5.
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MAAP A. ELLABIB
Examiner
Art Unit 3785
/M.A.E./Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights