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 Amendment
Applicant’s amendments, filed 03/02/2026, has been entered. Claims 1, 3, 4, 6, 9-16, 18, 20, 22, 26-31, 34-40 remain pending.
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) 26, 27, 15, 29, 30, 31, 34, 35, 36, 39, 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barodka (US20100300450) in view of Nelson et al. (US20070295337), hereafter Nelson.
Regarding Claim 26, Barodka discloses a nasal tracheal device (Abstract, “an nasal airway management device”), comprising: a cuff having respective open channels at proximal and distal end portions (Fig. 2, inflatable cuff 14, see Fig. A below, the cuff has open channels at opening 24 and channel that coupled to the airway tube).
Barodka is silent on the open channels being coaxial with each other along an axis and in alignment with each other, so that their respective centerpoints are coaxial.
However, Nelson teaches a tracheal tube device (Abstract), comprising of a cuff (Fig. 7, tapered cuff 12) having respective open channels at proximal and distal end portions (See Fig. 7, the cuff 12 has open channels at proximal and distal end coupled to the tracheal tube), the open channels being coaxial with each other along an axis and in alignment with each other, so that their respective centerpoints are coaxial (See Fig. 7, the cuff 12 has the claimed geometry). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known nasal tracheal device of Barodka, with the cuff of Nelson, to provide patient comfort and minimize tracheal tissue irritation as taught by Nelson (Nelson, par. 0044-0045).
The modified Barodka further discloses the cuff being inflatable into an inflated state with axial symmetry (Nelson, Fig. 7 shows the cuff in an inflated state with axial symmetry) and being deflatable into a the deflated state (Nelson par. 0038, “The tapered cuff 12 may be inflated and deflated via a lumen 14 in communication with the tapered cuff 12”), the cuff being configured to have a curvilinear, oblong elongate shape (Nelson par. 0036, “A cuff may exhibit a continuous rate of tapering… In other embodiments, the taper may have a nonlinear rate of tapering...”; Nelson teaches that the tapered cuff can have non-linear tapering, representing a curvilinear, oblong elongated shape, see Nelson Fig. 1 for example of non-linear/continuous rate of tapering. Fig. 7 of Nelson merely shows an example of tapering direction and does not indicate the tapering must be linear) having a full length along the axis between the respective open channels (Nelson Fig. 7) and having an exterior surface curvature that tapers in the inflated state in the inflated state and tapering in a direction away from the distal end portion of the cuff toward the proximal end portion of the cuff (Nelson Fig. 7 shows the claimed tapering direction, par. 0036 indicated the cuff can have a curved exterior surface), the distal end portion of the cuff in the inflated state and the proximal end portion of the cuff in the inflated state each having a respective width that is perpendicular to the axis (See Fig. B, annotated below), the respective width of the distal end portion of the cuff in the inflated state being wider than the respective width of the proximal end portion of the cuff in the inflated state (See Fig. B, annotated below); positioning means for positioning the cuff supraglottic (Barodka, Fig. 2, airway tube 12), the positioning means including a tube that extends into the cuff from outside the cuff via the respective open channel at the proximal end portion of the cuff (Barodka Fig. 2, Nelson Fig. 7, after the modification, the airway tube will extend into the cuff via the openings), the tube extending the full length of the cuff between the respective open channels of the cuff (See Fig. B below), the tube having an axis that coincides with the axis of the cuff (See Fig. B below), the proximal end portion of the cuff being integral with or coupled to the tube (Barodka, Fig. 2, par. 0008, “The inflatable cuff may be attached at or near the distal end of the airway tube”), the tube being sized and configured to insert though a nasal insertion path in a nasal cavity and into a trachea until positioning the cuff supraglottic (Barodka, par. 0008, “At least the distal end of the airway tube may be configured to be inserted through a patient's nasopharyngeal passageway… When in an inflated state the inflatable cuff may expand to form a seal around the patient's supraglottic laryngeal inlet.”); and means for sealing the cuff that is positioned supraglottic against an inner wall of the trachea by inflating the cuff (Barodka, par. 0008, “an inflated state the inflatable cuff may expand to form a seal around the patient's supraglottic laryngeal inlet”) and for unsealing the cuff from the inner wall of the trachea by deflating the cuff to enable subsequent withdrawal of the cuff (Barodka, par. 0009, “The inflatable cuff may include a flexible material densely packed about the distal end of the airway tube when the inflatable cuff is in the deflated state to facilitate insertion of the distal end of the airway tube through the patient's nasopharyngeal passageway”) (Examiner Notes: deflating the cuff to unseal and withdraw from the trachea is the intended mode of operation of the prior art, such functionality is implicitly disclosed in the prior art).
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Fig. A, Adapted from Barodka Fig. 2
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Fig. B, Adapted from Nelson Fig. 7
Regarding Claim 27, the modified Barodka discloses the nasal tracheal device of claim 26, wherein the tube has a plurality of lumens selected from the group consisting of a lumen in fluid communication with the cuff and a pressurized fluid source to inflate the cuff, a lumen having an open delivery path for delivering oxygen from a ventilator to a trachea and then to lungs of the patient or alternately connected to an anesthesia circuit for providing anesthesia, and a sight bore lumen (Barodka, par. 0019, “The airway tube 12 defines a lumen… configured to be coupled to a ventilator”; par. 0023, inflation passage 16).
Regarding Claim 15, the modified Barodka discloses the intubation system with the nasal tracheal device of claim 27, comprising: a ventilator or anesthesia circuit in fluid communication with one of the plurality of lumens (Barodka, par. 0019, “The airway tube 12 defines a lumen… configured to be coupled to a ventilator”); and an inflation fluid source in fluid communication with a further one of the plurality of lumens to inflate the cuff (Barodka, par. 0023, “the cuff 14 may be inflated via the inflation passage 16 by, for example, a 10-20 cc syringe filled with air or another suitable gas or liquid substance”).
Regarding Claim 29, the modified Barodka discloses the nasal trachea device of claim 26, wherein the tapering of the cuff allows for reduced drag at withdrawal of the cuff in comparison to conventional cuffs that are cylindrical or elliptical instead of tapered (Examiner Notes: The prior art discloses a structure that is identical to the claimed invention, therefore it is inherently capable of performing the claimed function).
Regarding Claim 30, the modified Barodka discloses the nasal trachea device of claim 26, wherein the tapering of the cuff allows for inducing less inflammation after deflation at the withdrawal in comparison to conventional cuffs that are cylindrical or elliptical instead of tapered (Examiner Notes: The prior art discloses a structure that is identical to the claimed invention, therefore it is inherently capable of performing the claimed function).
Regarding Claim 31, the modified Barodka discloses the nasal trachea device of claim 26, wherein the tapering of the cuff allows for providing positive pressure directed in a manner that prevents travel of the cuff over vocal cords (Examiner Notes: The prior art discloses a structure that is identical to the claimed invention, therefore it is inherently capable of performing the claimed function).
Regarding Claim 34, the modified Barodka discloses the nasal trachea device of claim 26, wherein the cuff lacks a collection portion that comprises a channel with a recess that faces the proximal end portion of the cuff and lacks the channel extending circumferentially about at least a portion of the tube (See Nelson Fig. 7, the cuff does not have the recited features).
Regarding Claim 35, the modified Barodka discloses the nasal trachea device of claim 26, wherein the surface curvature of the cuff in the inflated state tapers from the distal end portion of the cuff toward the proximal end portion of the cuff (Nelson Fig. 7 shows the cuff tapers from the distal end to the proximal end, par. 0036 discloses surface curvature).
Regarding Claim 36, the modified Barodka discloses the nasal trachea device of claim 35, wherein the surface curvature of the cuff in the inflated state is concave between the distal and proximal end portions of the cuff (Nelson, par. 0036 discloses the cuff has a surface curvature, see Fig. 1 for example of a concaved curvature of the cuff).
Regarding Claim 39, the modified Barodka discloses the nasal trachea device of claim 26, wherein the cuff is configured to inflate in a manner that is symmetric about the axis of the cuff (Nelson, Fig. 7) and results in an exterior surface of the cuff having both concave curvature and convex curvature, the concave curvature being between the proximal and distal ends of the cuff, the convex curvature being closer to the distal end of the cuff than is the concave curvature (See Nelson Fig. 1, 7, par. 0036, Fig. 7 shows an example of cuff tapering towards the proximal end, par. 0036 discloses the cuff can have non-linear curved surface and Fig. 1 shows an example. One of ordinary skilled in the art would understand that in case of a cuff tapering towards the proximal end with a curved surface will have the claimed shape).
Regarding Claim 40, the modified Barodka discloses the nasal trachea device of claim 26, wherein the tube terminates at the respective open channel at the distal end portion of the cuff (See Barodka Fig. 2, the airway tube terminates at the distal end open channel of the cuff).
Claim(s) 1, 3, 4, 6, 10, 13, 14, 18, 37, 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barodka in view of Nelson, in view of Adams (US20140230823), in view of Juan Camilo Gómez, Lina Paola Melo, Yuliana Orozco, Gustavo Adolfo Chicangana, Diana Carolina Osorio, Estimation of the optimum length of endotracheal tube insertion in adults, Colombian Journal of Anesthesiology, Volume 44, Issue 3, 2016, Pages 228-234, ISSN 2256-2087, hereafter Gomez.
Regarding Claim 1, the modified Barodka discloses the nasal tracheal device of claim 26, but is silent on the tube has a segment with visual indicia of insertion depth correlated to patient height, the tube extending by the insertion depth in correlation with an estimated height of the patient so that with the cuff positioned supraglottic, the segment is visible at least partially external to an intake zone of the intranasal insertion path through which extends the tube.
However, Adams teaches a tracheal tube (Fig. 1, tube 100), wherein the tube has a segment with visual indicia of insertion depth (Fig. 1, colored rings 110A-110F). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known device of Barodka, with the visual indicia of Adams, to provide quick and accurate determination of the intubation depth as taught by Adams (Adams, Abstract).
The modified Barodka further teaches that the visual indicia and insertion depth is correlated with the patient size (Adams, Table 1), but is silent on that the visual indicia is correlated to patient height, the tube extending by the insertion depth in correlation with an estimated height of the patient.
However, Gomez teaches a method of estimating optimal length of tracheal tube insertion (Introduction), wherein the insertion depth is correlated to patient height, the tube extending by the insertion depth in correlation with an estimated height of the patient (See results section, Table 2). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Barodka, and have the visual indicia determined in correlation with an estimated height of the patient, for optimal insertion depth to prevent complications as taught by Gomez (Gomez, introduction).
The modified Barodka further teaches with the cuff positioned supraglottic (Barodka, par. 0008, “an inflated state the inflatable cuff may expand to form a seal around the patient's supraglottic laryngeal inlet”), the segment is visible at least partially external to an intake zone of the intranasal insertion path through which extends the tube (Examiner Notes: See Adams, par. 0018, an example is given where the segment externally visible at the patient’s mouth; par. 0005, an endotracheal tube can be inserted through the nose; the segment would also be visible externally in for a nasal insertion).
Regarding Claim 3, the modified Barodka discloses the nasal tracheal device of claim 1, wherein the visual indicia of insertion depth comprises a plurality of bands of different colors (Adams, par. 0009, “color coded markings such as colored rings… correlates each colored marking to a specific intubation depth”).
Regarding Claim 4, the modified Barodka discloses the nasal tracheal device of claim 3, wherein the plurality of bands comprises at least three bands of different colors (See Adams Fig. 1, six bands are shown in the figure).
Regarding Claim 6, the modified Barodka discloses the nasal tracheal device of claim 1, wherein the cuff is configured as pear-shaped (Nelson, Fig. 7, par. 0036, the embodiment in Fig. 7 with curved surface disclosed by par. 0036 has a pear shape).
Regarding Claim 10, the modified Barodka discloses the nasal tracheal device of claim 1, wherein the tube has a proximal end portion spaced away from the cuff and has a bend (See Fig. C below), the visual indicia being closer to the bend than the proximal end portion of the tube is to the bend (Examiner Notes: See Fig. 3 of Barodka, the visual indicia must be in the claimed position to be visible externally as taught by Adams).
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Fig. C, adapted from Barodka Fig. 3
The modified Barodka does not specifically disclose that the bend has a degree of curvature of between 90-120 degrees. However, Barodka discloses that the airway tube is curved and have a U-shape (Barodka, par. 0023, “the airway tube 12 may include a curved shaped such as, for example, a U-shape to mimic nasal airway anatomy and add a second dimension to allow only one position for insertion.”). It would have been obvious for one of ordinary skilled in the art to modify the known device of Barodka, and have the bend to be between 90-120 degrees, as applicant appears to have placed no criticality on the claimed range (See applicant’s disclosure, par. 00088, “The bent segment15b can have an angle p in a range of 100-120 degrees”). In this case, the U-shape bend disclosed by the prior art combines with the Figure (Barodka, Fig. 3) renders the bend angle to be close to the claimed range. The courts have held a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985), MPEP 2144.05.
Furthermore, Barodka discloses and illustrates Fig. 3. The description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977). See MPEP 2125. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the angle within applicant' s claimed range as Barodka reasonably teaches it off the drawing.
Regarding Claim 13, the modified Barodka discloses the nasal tracheal device of claim 1, wherein the cuff comprises a neck at an upper end thereof that transitions into a bottom portion that defines a maximal lateral extent of the inflatable cuff when inflated, and wherein the maximal lateral extent is 2-3 times greater than a lateral extent of the neck when the cuff is inflated (Examiner Notes: See Fig. B above, based on the figure from the prior art, the maximal lateral extent is 2-3 times larger than the neck, see MPEP 2125).
Regarding Claim 14, the modified Barodka discloses the nasal tracheal device of claim 13, but does not specifically disclose wherein the cuff has a radius of curvature that extends between the neck and the bottom portion that is in a range of 1-1.5 inches over 0.5-1 inch. However, the prior art already discloses a cuff having a neck and a bottom portion having a radius of curvature. The difference between the claimed invention and the prior art is only the specific numerical limitation on the dimension. The recited radius does not reflect any criticality or improvement over the prior art (See applicant’s disclosure, par. 00094). Therefore, the claimed dimension would have been obvious over the prior at, see In re Gardner.
Regarding Claim 18, Barodka discloses the intubation system of claim 15, but is silent on wherein the tube has a segment that has visual indicia of insertion depth that comprises a plurality of bands of different colors that are color coded based on percentile height distribution data for males and females.
However, Adams teaches a tracheal tube (Fig. 1, tube 100), wherein the tube has a segment with visual indicia of insertion depth that comprises a plurality of bands of different colors (Fig. 1, colored rings 110A-110F). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known device of Barodka, with the visual indicia of Adams, to provide quick and accurate determination of the intubation depth as taught by Adams (Adams, Abstract).
The modified Barodka is still silent on the colors are color coded based on percentile height distribution data for males and females.
However, Gomez teaches a method of estimating optimal length of tracheal tube insertion (Introduction), wherein the insertion depth is estimated based on percentile height distribution data for males and females (See results section, Table 2). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Barodka, and have the visual indicia determined based on percentile height distribution data, for optimal insertion depth to prevent complications as taught by Gomez (Gomez, introduction).
Regarding Claim 37, the modified Barodka discloses the nasal trachea device of claim 3, further comprising: correlating means for correlating color band placement based on height of a patient (Gomez, Table 2, see rejection for claim 1), the color band being indicative of the bands of different colors (Adams, par. 0009).
Regarding Claim 38, the modified Barodka discloses the nasal trachea device of claim 3, wherein the tube has axially spaced apart proximal and distal ends, the proximal end of the tube being further from the cuff than is the distal end of the tube (Barodka, Fig. 2, distal end at 22 and proximal end at 20), further comprising: correlating means for correlating color band placement based on length of markers from a distal end of the tube, the color band being indicative of the bands of different colors that are the markers for the visual indica in the segment (Adams Fig. 1, par. 0009).
Claim(s) 22, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barodka in view of Nelson, in view of Adams.
Regarding Claim 22, the modified Barodka discloses the nasal tracheal device of claim 26, wherein the tube has a proximal end spaced away from the cuff (See Fig. C above), further comprising: plurality of branches that extend from the tube from locations between a bend of the tube and the proximal end portion of the tube (Fig. 1, element 16, element 22 are branches). Barodka further discloses the bend having a curvature (Barodka, par. 0023).
However, Barodka does not specifically disclose the bend having a curvature with an angle of inclination within a range of 90 to 120 degrees. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Barodka to have an angle of inclination within a range of 90 to 120 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Barodka would not operate differently with the claimed angle of inclination and since Barodka already teaches that there is a bend in the tube (Barodka Fig 1, par. 0023), the device would function appropriately having the claimed angle of inclination. Further, applicant places no criticality on the range claimed, indicating simply that the angle of inlication “may” be within the claimed ranges (Applicant's disclosure, par. 00088).
Furthermore, Barodka discloses and illustrates Fig. 3. The description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977). See MPEP 2125. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the angle within applicant' s claimed range as Barodka reasonably teaches it off the drawing.
Barodka is silent on the tube having a segment with visual indicia, the visual indicia being closer to the bend than the proximal end portion of the tube is to the bend.
However, Adams teaches a tracheal tube (Fig. 1, tube 100), wherein the tube has a segment with visual indicia (Fig. 1, colored rings 110A-110F). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known device of Barodka, with the visual indicia of Adams, to provide quick and accurate determination of the intubation depth as taught by Adams (Adams, Abstract).
The modified Barodka discloses the visual indicia being closer to the bend than the proximal end portion of the tube is to the bend (Examiner Notes: See Fig. 3 of Barodka, the visual indicia must be in the claimed position to be visible externally as taught by Adams).
Regarding Claim 20, the modified Barodka discloses the nasal tracheal device of claim 22, wherein the visual indicia is color-coded (Adams, par. 0009)
Claim(s) 9, 11, 12, 16, 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barodka in view of Nelson, in view of Wang et al. (US9327091).
Regarding Claim 9, Barodka discloses The nasal tracheal device of claim 26, wherein the tube has one lumen configured to connect to a ventilator (par. 0019, “The airway tube 12 defines a lumen… configured to be coupled to a ventilator”), a further lumen (Fig. 2, the inflation passage 16) configured to connect to an inflation fluid source (par. 0023, “the cuff 14 may be inflated via the inflation passage 16 by, for example, a 10-20 cc syringe filled with air or another suitable gas or liquid substance”) whereby the further lumen defines an inflation path (Fig. 2, path defined by inflation passage 16 and the fluid source), the one lumen defines an oxygen path (Fig. 2, path defined by airway tube 12 and ventilator).
Barodka is silent on another lumen configured to connect to a vacuum source, another lumen defines an aspiration path.
However, Wang teaches a tracheal tube device (device shown in Fig. 1) comprising of one lumen (Fig. 1, primary channel 107) is configured to connect to a ventilator (col. 4 line 3-4, “The connector 102 is a connection adapted to connect to a mechanical ventilator”), a further lumen (Fig. 1, inflation tube lumen 114) configured to connect to an inflation fluid source (col. 4, line 36-38, “The inflation tube 110A may be connected to the inflation fluid supply device 110C by way of pilot balloon 110B”) and another lumen (Fig. 1, suction tube lumen 112) configured to connect to a vacuum source (Wang, col. 5 line 23, suction device 108A) whereby the further lumen defines an inflation path, the one lumen defines an oxygen path and the another lumen defines an aspiration path (See Fig. A, ventilator connector, suction device, inflation fluid supply). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known device of Barodka, with the lumen of Wang, to connect to a vacuum source to create negative pressure to prevent movement of secretion into the lower trachea as taught by Wang (Wang, col. 2 line 59 – col. 3 line 4).
Regarding Claim 11, the modified Barodka discloses the nasal tracheal device of claim 9, wherein the another lumen is provided at least in part by a conduit (Wang, Fig. 1, col. 8, line 23-24, the conduit formed by suction line 120, suction tube 108E, suction tube lumen 112) that extends external to the tube (Wang, col. 6 line 57-59, “the suction tube lumen 112 may attach to the exterior surface of the catheter 106 and extend along the length of the catheter”) with a free end that resides adjacent the cuff (Wang, Fig. 1, col. 19, line 52-56, “Further, the suction line 120 may removably positioned on a surface of balloon 118 via a simple placement of suction line 120 on the surface of the balloon 118 (i.e., no bond, or only a friction bond, between the surface of the balloon 118 and the suction line 120)”; the suction line is simply placed adjacent to the cuff and is hence free).
Regarding Claim 12, the modified Barodka discloses the nasal tracheal device of claim 11, wherein the conduit is configured to reside against a wall of the cuff when the cuff is in a non-inflated state (Wang, col. 19, line 52-56), and wherein the conduit is configured to be pushed outward in response to inflation of the cuff (Wang, col. 19, line 62-64, “Additionally, in some circumstances, a portion of suction line 120 may be held in place by a tracheal wall in which the tracheal tube system 1200 is placed.”).
Regarding Claim 16, Barodka discloses the intubation system of claim 15, but is silent on further comprising a vacuum in fluid communication with another of the plurality of lumens and defining an aspiration path.
However, Wang teaches a tracheal tube device (device shown in Fig. 1) comprising of a vacuum in fluid communication with another of the plurality of lumens and defining an aspiration (Fig. 1, suction tube lumen 112; col. 5 line 23, suction device 108A) Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known device of Barodka, with the lumen of Wang, to connect to a vacuum source to create negative pressure to prevent movement of secretion into the lower trachea as taught by Wang (Wang, col. 2 line 59 – col. 3 line 4).
Regarding Claim 28, Barodka discloses the nasal tracheal device of claim 27, but is silent on further comprising a further lumen that extends between a suction source to at least one suction intake port that resides adjacent to the cuff.
However, Wang teaches a tracheal tube device (device shown in Fig. 1), comprising of a further lumen (Fig. 1, col. 8, line 23-24, suction tube lumen 112) that extends between a suction source (Fig. 1, suction device 108A) to at least one suction intake port that resides adjacent to the cuff (Fig. 1, col. 19, line 52-56, “Further, the suction line 120 may removably positioned on a surface of balloon 118 via a simple placement of suction line 120 on the surface of the balloon 118 (i.e., no bond, or only a friction bond, between the surface of the balloon 118 and the suction line 120)”). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known device of Barodka, with the lumen of Wang, to connect to a vacuum source to create negative pressure to prevent movement of secretion into the lower trachea as taught by Wang (Wang, col. 2 line 59 – col. 3 line 4).
Response to Arguments
Applicant’s arguments, see Applicant’s Remark, filed 03/02/2026, with respect to the rejection(s) of claim(s) 26 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nelson. Specifically, Nelson discloses a symmetrical cuff with a curved surface, that tapers toward the proximal end of the cuff.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRIS HANYU GONG whose telephone number is (703)756-5898. The examiner can normally be reached M-F 8:30-4:30.
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/KRIS HANYU GONG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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