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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 31, 2025 has been entered.
Response to Amendment
The following section is in reference to the Applicant’s Arguments, filed December 31, 2025
The Applicant’s amendments to Claims 1, 3, 4, 6, and 9 have been acknowledged.
The previous objections to Claims 1, 3-6, and 9 have been withdrawn in light of the Applicant’s amended corrections.
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, 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 and 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Herrick et al. (US 20050092328 A1, hereinafter “Herrick”) in view of Visconti et al. (US 20140261463 A1 , hereinafter “Visconti”), further in view of Roger et al. (US 5555881 A, hereinafter “Roger”).
Regarding Claim 1, Herrick discloses: An endotracheal tube stabilization device (Annotated Figure 1, endotracheal tube holder 10) for retention of an endotracheal tube (Paragraph 0020, It is an object of the present invention to provide a method and apparatus for holding an endotracheal tube stationary relative to a mouth of a neo-natal patient), said stabilization device comprising:
an endotracheal tube holder (ETH) having an elongated, straight generally tubular, body (Paragraph 0058, The tube holding member 22 is designed to open along its length, allowing an endotracheal tube 24 to be disposed therein, and to then be closed tightly around the endotracheal tube 24, leaving sufficient space for air or other fluids to pass therethrough. The tube holding member 22 is then disposed within the U-shaped receptacle 14 and held securely), with an axial bore of a predetermined diameter sized to directly receive said endotracheal tube (Paragraph 0065, FIG. 4A is an end elevational profile view of the tube holding member 22 as seen from the perspective A-A shown in FIG. 3. The tube holding member 22 has a top half 32, a bottom half 34, a hinge 36, and the hole 38 for the endotracheal tube 24)
said endotracheal tube holder having a proximal portion, an intermediate bite block of generally square outer shape and protects said endotracheal tube, and a distal portion (Annotated Figure 5, Paragraph 0071, FIG. 5 is a top elevational view which shows that an end of the tube holding member now extends into the mouth of the patient. This extension or bite block 44 is then covered by a sleeve of soft rubber. The bite block functions as a pacifier for the neo-natal infant. It also protects the gums from the harder material of the endotracheal tube that is inserted through the tube holding member 22);
a removable wing plate (Figure 2A, faceplate 12) having at least two wings (Figure 2A, attaching ends 16) and a center opening (Figure 2A, receptacle 14), which is adapted to fit onto said endotracheal tube holder between said proximal portion and said intermediate bite block (Paragraph 0056, The first component is the arcuate face plate 12 of the endotracheal tube holder 10 which forms the framework of the endotracheal tube holding system. The face plate 12 is comprised of a semi-flexible arcuate material which conforms to the curvature of a patient's face at the mouth, and extends backwards along the patient's cheeks. The face plate 12 has a U-shaped receptacle 14 centered in a midpoint of the face plate 12. The open end of the U-shaped receptacle 14 is open upwards relative to the face plate 12), with said at least two wings extending on the sides of said endotracheal tube holder (Annotated Figure 1); each of said at least two wings has a peripheral slot (Figure 1, slots 20), (Paragraph 0063, FIG. 2C is a side profile elevational view of face plate 12. The slots 20 are clearly visible. It should be remembered that the slanting of the slots is provided to assist in attaching the attachment straps 18 to the face plate 12. However, these slots 18 can be slanted in any preferable direction, in accordance with the requirements of the particular attachment straps 18 being used);
and a strap assembly (Figure 1, attachment straps 18), which engages the at least two wings through its peripheral slot and is configured to hold the endotracheal tube holder in place by tightening straps around the patient's head (Paragraph 0073, Finally, the details of the attachment straps 18 illustrated in FIGS. 6 and 7 should only be considered to be some examples of the possible configurations that they can form. In this preferred embodiment, however, they provide a distinct advantage over the prior art. Specifically, the attachment straps 18 are constructed of a soft and non-elastic material. The material is formed from strips so that the material is padded inside for added comfort as the patient lays on them. Preferably, the strips are sewn together at stress joints, thus only requiring the hook and loop fastening system of VELCRO™ in order to tighten the whole attachment structure. Constructing the strips from a non-elastic material is important for reducing unwanted stresses on the cranial bones of the neo-natal patient).
As seen in Figure 1, the overall shape of the tube holding member disclosed by Herrick is generally square/rectangular, with distinct flat sides and angles. However, if the Applicant is not convinced, Visconti more explicitly disclosed an intermediate bite block of generally square outer shape (Figure 55, Paragraph 0143, The through bores 624 and bite block 602 can be the same as the bite block 572 shown in FIGS. 51-53 or can be of a different construction. In this example, the bite block 602 is different in that the tubular side wall forms a somewhat square cross-section shape on the exterior of the block while a central opening 628 through the bite block can be round or even non-round in cross-section).
Both Herrick and Visconti disclose endotracheal tube holding devices that include bite blocks. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal tube stabilization device of Herrick to include the generally square bite block as taught by Visconti for the purpose of providing a surface for the teeth of the user to rest while biting down on the bite block. Additionally, because the stabilization device of Herrick already teaches a bite block, modification to include the square cross-section as taught by Visconti would involve a mere adjustment to the existing structure, which would yield predictable results and fail to distinguish the invention over the prior art.
Herrick teaches an axial bore through the ETH, but does not explicitly teach wherein said axial bore has a slot along its length that is wider on the proximal portion of the ETH and sized to receive an endotracheal tube from its side
However, Visconti teaches an endotracheal tube holding device with a variety of structural arrangements, including embodiments (Figures 5 and 26) wherein said axial bore has a slot along its length and sized to receive an endotracheal tube from its side (Paragraph 0117, FIGS. 26 and 27 show still another alternate example of a tube holder 290 with most features similar to earlier described bite block features. In this example, the tube holder 290 has a bite block 292 with an insertion slot 294 similar to the slot 128 of the bite block 46 with a wide slot width. This bite block 282 also has a blind slot 296 similar to the blind slot 134 on the bite block 46 and positioned opposite the insertion slot 294. The bite block 292 has a groove 298 formed along a length of the bite block and recessed into an inner surface 300 of the bite block wall 302. The groove 298 creates an accessory line channel that is recessed into the wall 302, instead of using protrusions to create space between the inner wall and an ET tube in the bite block, as in prior examples. The groove can be V-shaped in cross-section or can have a rounded, semispherical, or other shape as well. The groove 298 creates a thinner wall segment of the wall 302 as shown in FIG. 27. This thinner wall segment can provide dual functions of creating an accessory line channel as well as creating flex relief in the wall to aid in inserting the ET tube into the bite block)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal tube holder disclosed by Herrick to include the slot within the axial bore as disclosed by Visconti for the purpose of providing an opening through which the ET tube can be retained (Paragraph 0103, In the disclosed example, the bite block 46 has an insertion slot 128 through the wall 120. The insertion slot 128 extends along the entire length of the bite block 46. The wall 120 can be formed of a suitable plastic material so that the bite block 46 is sufficiently flexible to allow an ET tube 44 to be inserted laterally into the central opening 122 through the insertion slot 128. The flexibility of the wall 120 can allow the width of the slot 128, and thus the diameter of the wall, to expand when inserting the tube and then to spring back to the normal at rest slot width and wall diameter once the ET tube 44 is fully inserted). Being that the stabilization device of Herrick already teaches an axial bore within the device, the modification to include the slot as taught by Visconti would involve a mere adjustment to the existing structure, which would yield predictable results and fail to distinguish the invention over the prior art.
Furthermore, the prior art of Rogers teaches a similar tube holder where the axial bore has a slot along its length that is wider on the proximal portion of ETH (Figures 13 and 17, clamping body members 336 A,B), (Column 5, lines 9-11, The clamping members 336A,B are flexible as shown in FIG. 17 to expand and contract in order to accommodate tubing of differing diameters). The figures illustrate the clamping body members gradually widening as they reach the proximal end of the apparatus.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal tube stabilization device of Herrick comprising the axial bore, as well as the flexible slot for an endotracheal tube from Visconti, to further include that the slot is wider on the proximal portion as taught by Rogers. Adjusting the axial bore to be wider on the proximal portion would allow for expanding and contracting the clamping members to accommodate differing tube diameters and ensure a tight hold on the tube without occluding the tube (Columns 4-5, lines 66-11, The body portions 322A,B include clamping members 336A,B which extend from the body members 322A,B to form a clamping orifice 338 axially aligned with the central orifice 332. The clamping members 336A,B are engaged on each side by a clamping clasp or snap member 346 which holds the clamping members in position about an endotracheal tube of small diameter. The clamping members 336A, 336B further include a ridge 340 of gripping members designed to engage and hold the endotracheal tube in position without occluding the tube. The clamping members 336A,B are flexible as shown in FIG. 17 to expand and contract in order to accommodate tubing of differing diameters).
Additionally, because the modified stabilization device of Herrick in view of Visconti already teaches a slot within the axial bore of the device, modification to include widening of the slot as taught by Rogers would involve a mere adjustment to the existing structure, which would yield predictable results and fail to distinguish the invention over the prior art.
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Regarding Claim 3, Herrick in view of Visconti and Rogers discloses all of the limitations of Claim 1. Herrick further discloses: wherein said intermediate bite block is an integrated portion of the ETH or a separate bite block fitted onto a intermediate portion of the ETH (Paragraph 0071, An alternative embodiment of the tube holding member 22 is shown in FIG. 5. FIG. 5 is a top elevational view which shows that an end of the tube holding member now extends into the mouth of the patient. This extension or bite block 44 is then covered by a sleeve of soft rubber. The bite block functions as a pacifier for the neo-natal infant. It also protects the gums from the harder material of the endotracheal tube that is inserted through the tube holding member 22)
Regarding Claim 4, Herrick in view of Visconti and Rogers discloses all of the limitations of Claim 1. Visconti further discloses: wherein said distal portion comprises:
an inside surface, which is lined with a grip pattern (Paragraph 0115, FIGS. 22 and 23 show yet another example of a tube holder 270 with features similar to earlier described bite block features. In this example, the tube holder 270 has a bite block 272 with two sets of ribs 274 forming two accessory line channels, one above the ET tube and one below the ET tube. The ribs 274 are otherwise similar to the ribs 142 described previously. The bite block 272 also has a living hinge 276 similar to the living hinge 266 in the previous example. Also in this example, free edges 278 of the bite block 272 along an insertion slot 279 can be configured to contact one another upon compression of the bite block. In this example, the free edges 278 can also be configured so that one of the free edges slips past the other until it contacts one of the ribs 274, which can act as a stop to prevent further compression);
a fastener secured onto an outside of said distal portion of the ETH (Paragraph 0094, In this example, a latching means is also provided to lock and hold the clamping lever 76 in the locked or clamped condition of FIG. 1. The latching means in one example can have a flexible, resilient catch 84 provided on the top side 75 and near the front end of the arm 62. When the clamping lever 76 is lowered onto the top side 75 of the arm 62, the catch 84 will flex forward to permit the front edge 86 of the clamping lever 76 to snap past the catch 84. The catch 84 then captures and retains the clamping lever 76 in the closed or clamped position of FIG. 1 to tightly engage the tube strap 62. To release the ET tube 44, a person can pull the catch 84 forward away from the clamping lever 76 until the front edge 86 can clear the catch. The clamping lever 76 can then be raised to release the tube strap 62. This type of latching means allows one to release the ET tube 44, readjust its position, and then re-secure the tube again without having to replace any components, tape, straps, and the like.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal tube holder disclosed by Herrick to incorporate the inner grip pattern and adjustable fastener disclosed by Visconti. Being that the stabilization device of Herrick already teaches grip members (Herrick, Paragraph 0061, FIG. 2A is a front profile elevational view of the face plate 12. It is apparent that the U-shaped receptacle 14 has two upper lips 26 which help to retain the tube holding member 22 (FIG. 1) after it is inserted), the modification to include the ribs as taught by Visconti would involve a mere adjustment to the existing structure, which would yield predictable results and fail to distinguish the invention over the prior art. Furthermore, incorporating an fastening means allows for ease in readjustment and positioning of the device in accordance with a user’s needs (Visconti, Paragraph 0094, This type of latching means allows one to release the ET tube 44, readjust its position, and then re-secure the tube again without having to replace any components, tape, straps, and the like)
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Herrick (US 20050092328 A1) in view of Visconti (US 20140261463 A1 ) in view of Roger (US 5555881 A), further in view of Waldeck (US 7699055 B2)
Regarding Claim 5, Herrick in view of Visconti and Rogers discloses all of the limitations of Claim 1. Herrick does not disclose whether the said removable wing plate is configured to freely rotate radially around the ETH
However, Waldeck does disclose wherein said removable wing plate is configured to freely rotate radially around the ETH (Columns 4-5, lines 66-12, the shield plate comprises two separate wings which are movable relative to each other and which each have a respective ring portion having an opening and fitted on to the cylindrical projection. In that case the ring portions, on their mutually facing surfaces, preferably have a tooth configuration or grooving which prevent relative rotation of the ring portions and thus the wings forming the shield plate. It will be appreciated that the relative rotary movement is still to be possible, by overcoming a corresponding resistance force, so that it is possible substantially fixedly to set the wings in the different relative positions which are predetermined by the grooving or toothed configuration).
Both Herrick and Waldeck disclose similar tracheal tube holding apparatuses. It would have been obvious to one skilled in the art before the effective filing date to incorporate the adjustable shield plate taught by Waldeck (Column 2, lines 19-21, That object is attained in that the shield plate of the tracheotomy cannula is mounted to the cannula fixably in various positions in the longitudinal direction of the cannula) with the assembly disclosed by the modified Herrick so as to provide an additional degree of comfort for a user (Column 1, lines 27-37, Particularly when cannulae of that kind are intended for prolonged use, that is to say for example in intensive care medicine or for a patient who has to breathe continuously with such a cannula, a certain degree of wearing comfort is of major significance from the point of view of the patient, in order for example to avoid a feeling of pressure, pressure points or wound chaffing and soreness. The position of the shield plate on a tracheotomy cannula is an aspect of significance in that respect insofar as the shield plate serves to define the final position of the tracheotomy cannula at its condition of being inserted into the trachea).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Herrick (US 20050092328 A1) in view of Visconti (US 20140261463 A1 ) in view of Roger (US 5555881 A), further in view of Sharaiha (US 20190388303 A1)
Regarding Claim 6, Herrick in view of Visconti and Rogers discloses all of the limitations of Claim 1. Herrick further discloses: wherein said straps further comprises an inner lining (Paragraph 0073, the attachment straps 18 are constructed of a soft and non-elastic material. The material is formed from strips so that the material is padded inside for added comfort as the patient lays on them. Preferably, the strips are sewn together at stress joints, thus only requiring The hook and loop fastening system of VELCRO(.TM.) in order to tighten the whole attachment structure. Constructing the strips from a non-elastic material is important for reducing unwanted stresses on the cranial bones of the neo-natal patient). However, Herrick does not disclose an inner lining made of a burn-compatible material.
Sharaiha teaches a similar endotracheal stabilization device and wherein said straps further comprises an inner lining made of a burn-compatible material (Paragraph 0045, Each one of straps 112, 114, 116, 118, 119, and/or base 110b may be made of any suitable material, including, but not limited to, nylon, cloth, mesh, foam, and/or the like, and may include any suitable comfort material provided on an inner surface of one or more of the straps or base that may interface with a portion of patient's head PH (e.g., a foam layer that may be adhered to an inner surface of each strap for providing a comfortable interface between strap subassembly 110 and patient's head PH when tube holding assembly 100 is held in an appropriate position on patient's head PH).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal stabilizer to include the strap assembly as taught by Sharaiha for the purpose of providing a comfortable interface between the strap assembly and patient's head when the stabilization device is held in an appropriate position on the patient's face. Additionally, because the stabilization device of Herrick already teaches a strap assembly, modification to include that the strap assembly is made of burn-compatible material as taught by Sharaiha would involve a mere adjustment to the existing structure, which would yield predictable results and fail to distinguish the invention over the prior art.
Regarding Claim 7, Herrick in view of Visconti, Rogers, and Sharaiha discloses all of the limitations of Claim 6. Sharaiha further discloses: wherein said burn-compatible material is a nonadherent film, a fine mesh gauze, a foam, an alginate, a hydrocolloid, or a hydrogel (Paragraph 0045, Each one of straps 112, 114, 116, 118, 119, and/or base 110b may be made of any suitable material, including, but not limited to, nylon, cloth, mesh, foam, and/or the like, and may include any suitable comfort material provided on an inner surface of one or more of the straps or base that may interface with a portion of patient's head PH (e.g., a foam layer that may be adhered to an inner surface of each strap for providing a comfortable interface between strap subassembly 110 and patient's head PH when tube holding assembly 100 is held in an appropriate position on patient's head PH)
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Herrick (US 20050092328 A1) in view of Visconti (US 20140261463 A1 ) in view of Roger (US 5555881 A), in view of Sharaiha (US 20190388303 A1), further in view of Holyoake et al. (US 20180078728 A1, hereinafter “Holyoake”).
Regarding Claim 8, Herrick in view of Visconti, Rogers, and Sharaiha discloses all of the limitations of Claim 6. However, none of the references disclose: wherein said inner lining further comprises a topical antimicrobials agent. However, Holyoake teaches wherein said inner lining further comprises a topical antimicrobials agent (Paragraphs 0280-0281, The breathing circuit may comprise a collar around an end or connection point of the breathing circuit where a patient interface is attached or attachable, the collar formed from said material with one or more antimicrobial additives. The or an entire breathing circuit may be made with antimicrobial additives, for example a breathing tube or conduit may be made from a plastics material including antimicrobial additives)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal tube as taught by a combination of Herrick and Sharaiha to further include the antimicrobial additives as taught by Holyoake for the purpose of preventing contamination and upholding user's health (Paragraph 0001, The present disclosure generally relates to methods and/or structures for preventing contamination of breathing circuits by patients).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Herrick (US 20050092328 A1) in view of Visconti (US 20140261463 A1 ) in view of Roger (US 5555881 A), further in view of Yang et al. (CN 106075686 A, hereinafter “Yang”).
Regarding Claim 9, Herrick in view of Visconti and Rogers discloses all of the limitations of Claim 1. Herrick further discloses: A method for securing an endotracheal tube to a patient using the endotracheal tube stabilization device of claim 1 (Paragraph 0020, It is an object of the present invention to provide a method and apparatus for holding an endotracheal tube stationary relative to a mouth of a neo-natal patient), comprising
inserting an endotracheal tube through a patient's oral cavity in to upper airway (Paragraph 0059, The endotracheal tube 24 is inserted into the patient's trachea, and the endotracheal tube holder 10 is positioned on the patient's face in front of the mouth);
orienting the proximal portion of the ETH toward the patient's oral cavity (Paragraph 0059, The endotracheal tube 24 is inserted into the patient's trachea, and the endotracheal tube holder 10 is positioned on the patient's face in front of the mouth);
d. wrapping the strap assembly around the back of the patient's head (Paragraph 0059, The attachment straps 18 are then coupled to the face plate 12 and adjusted so as to pull the face plate 12 gently but firmly against the patient's mouth so that the endotracheal tube 24 cannot be dislodged from the patient's trachea);
securing the strap assembly to the wing plate (Paragraph 0063, FIG. 2C is a side profile elevational view of face plate 12. The slots 20 are clearly visible. It should be remembered that the slanting of the slots is provided to assist in attaching the attachment straps 18 to the face plate 12. However, these slots 18 can be slanted in any preferable direction, in accordance with the requirements of the particular attachment straps 18 being used);
Visconti further discloses:
guiding the ETH onto the endotracheal tube by pressing the endotracheal tube through the slot beginning from proximal portion and into the axial bore (Paragraph 0117, FIGS. 26 and 27 show still another alternate example of a tube holder 290 with most features similar to earlier described bite block features. In this example, the tube holder 290 has a bite block 292 with an insertion slot 294 similar to the slot 128 of the bite block 46 with a wide slot width. This bite block 282 also has a blind slot 296 similar to the blind slot 134 on the bite block 46 and positioned opposite the insertion slot 294. The bite block 292 has a groove 298 formed along a length of the bite block and recessed into an inner surface 300 of the bite block wall 302. The groove 298 creates an accessory line channel that is recessed into the wall 302, instead of using protrusions to create space between the inner wall and an ET tube in the bite block, as in prior examples. The groove can be V-shaped in cross-section or can have a rounded, semispherical, or other shape as well. The groove 298 creates a thinner wall segment of the wall 302 as shown in FIG. 27. This thinner wall segment can provide dual functions of creating an accessory line channel as well as creating flex relief in the wall to aid in inserting the ET tube into the bite block);
sliding the endotracheal tube stabilization device (ETSD) down the endotracheal tube and positioning the bite block between the patient's incisors (Paragraph 0088, The device 30 also incorporates a bite block 46 that is carried by the tube holder 40 and slidable therewith along the track 32. Details of the bite block 46 are described in greater detail below. The bite block 46 in this example is positioned and spaced vertically below the track 32 so that the bite block extends between the teeth within a patient's mouth during use);
tightening an adjustable fastener and engaging the endotracheal tube with a grip pattern (Paragraph 0115, FIGS. 22 and 23 show yet another example of a tube holder 270 with features similar to earlier described bite block features. In this example, the tube holder 270 has a bite block 272 with two sets of ribs 274 forming two accessory line channels, one above the ET tube and one below the ET tube. The ribs 274 are otherwise similar to the ribs 142 described previously. The bite block 272 also has a living hinge 276 similar to the living hinge 266 in the previous example. Also in this example, free edges 278 of the bite block 272 along an insertion slot 279 can be configured to contact one another upon compression of the bite block. In this example, the free edges 278 can also be configured so that one of the free edges slips past the other until it contacts one of the ribs 274, which can act as a stop to prevent further compression) within the distal portion of the ETH, locking the endotracheal tube in place in relation to the endotracheal tube holder (Paragraph 0094, In this example, a latching means is also provided to lock and hold the clamping lever 76 in the locked or clamped condition of FIG. 1. The latching means in one example can have a flexible, resilient catch 84 provided on the top side 75 and near the front end of the arm 62. When the clamping lever 76 is lowered onto the top side 75 of the arm 62, the catch 84 will flex forward to permit the front edge 86 of the clamping lever 76 to snap past the catch 84. The catch 84 then captures and retains the clamping lever 76 in the closed or clamped position of FIG. 1 to tightly engage the tube strap 62. To release the ET tube 44, a person can pull the catch 84 forward away from the clamping lever 76 until the front edge 86 can clear the catch. The clamping lever 76 can then be raised to release the tube strap 62. This type of latching means allows one to release the ET tube 44, readjust its position, and then re-secure the tube again without having to replace any components, tape, straps, and the like).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal tube holder disclosed by Herrick to incorporate the inner grip pattern and adjustable fastener disclosed by Visconti. Being that the stabilization device of Herrick already teaches grip members (Herrick, Paragraph 0061, FIG. 2A is a front profile elevational view of the face plate 12. It is apparent that the U-shaped receptacle 14 has two upper lips 26 which help to retain the tube holding member 22 (FIG. 1) after it is inserted), the modification to include the ribs as taught by Visconti would involve a mere adjustment to the existing structure, which would yield predictable results and fail to distinguish the invention over the prior art. Furthermore, incorporating an fastening means allows for ease in readjustment and positioning of the device in accordance with a user’s needs (Visconti, Paragraph 0094, This type of latching means allows one to release the ET tube 44, readjust its position, and then re-secure the tube again without having to replace any components, tape, straps, and the like)
However, the combination of Herrick in view of Visconti and Rogers does not disclose rotating the wing plate.
Yang does disclose: rotating the wing plate 90 degrees, either clockwise or counter clockwise around the endotracheal tube allowing the rotating wing plate to close the slot on the proximal portion (Paragraphs 30-31, fixation device. The openings are aligned. The fixation device is inserted into the oral cavity directly below the endotracheal tube through the opening. The endotracheal tube is then embedded in the opening. The external fixator is rotated counterclockwise by 0–120° until the biting mechanism on the external fixator engages with the groove on the dental pad, thus fixing the endotracheal tube longitudinally. At this point, the sagittal openings of the external fixator and the protective plate face different directions, thus fixing the endotracheal tube laterally. Preferably, after rotating the external fixation plate counterclockwise by 0 to 120°, the protective plate is rotated clockwise to fix the trachea in the concentric holes formed by the opening. Here, the external fixation can be done by first rotating clockwise, and then rotating the protective plate counterclockwise. Of course, they can rotate simultaneously in opposite directions, thus fixing the trachea in the device. When it is necessary to remove the trachea, you can reverse the operation described above to make the openings of the external fixation, bite block, and protective plate in a straight line, so that the trachea can be removed)
Yang teaches a similar stabilization device configured for guiding the endotracheal tube holder onto the endotracheal tube by pressing the endotracheal tube through the slot beginning from proximal portion and into the axial bore (Paragraph 0073, The external fixation includes a structure that is larger at the top and smaller at the bottom, forming a neck at the junction of the upper and lower parts. The diameter of the through hole in the protective plate is smaller than the diameter of the upper part of the fixation. During assembly, the protective plate and the external fixation are snapped together to form a structure that can rotate relative to each other but can be fixed (Figure 1, Figure 4)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stabilization device of Herrick, Visconti, and Roger to include the method of rotating the wing plate from Yang into a closed position for the purpose of closing the slot on the proximal portion allowing the plate to rotate and lock to fix the air tube within the holder. Furthermore, the structure of Yang also provides an additional degree of user comfort in addition to securing the tube as needed (Paragraph 0013, In summary, to further improve endotracheal tube fixation methods, increase patient comfort, reduce postoperative complications, and lower the probability of retrograde infection, this invention provides a novel endotracheal tube fixation device and a method for fixing the endotracheal tube using this device. This device not only effectively protects the endotracheal tube from displacement and dislodgement, but also eliminates the need for external fixation with elastic tape, thus avoiding pressure on the patient's face and mouth area, reducing pressure sores on the lips, oral ulcers, and facial skin damage. Furthermore, the device has a simple structure, is easy to replace, and occupies a small space, facilitating nursing procedures such as oral care, suctioning, and repositioning. This reduces postoperative complications, lowers the probability of retrograde infection, increases patient comfort, and facilitates overall treatment).
Response to Arguments
Applicant’s arguments with respect to the rejections of Claims 1 and 3-9 under have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of the amended claim language, specifically the addition of “sized to directly receive said endotracheal tube” and “generally square outer shape”. Please refer to the section above for further explanation regarding the Examiner’s rejection of the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure
Crosbie (US 5069206 A) discloses a rotatable endotracheal tube clutch
Pagan (US 5746202 A) discloses a securing device for introducing oral tubes
Thomson et al. (US 20090255538 A1) discloses an endotracheal tube holder
Nieuwstad (US 5009227 A) discloses an endotracheal tube holder
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL Z HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S. Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785