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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/10/2025 has been entered.
Response to Amendment
The amendment filed 06/10/2025 has been entered. Claim 1-6, 10-14 are pending in the application. Applicant’s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Final Office Action mailed 12/10/2024/2023.
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 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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Runnels (US 2018/0110950) in view of Machold (US 2018/0092647) and further in view of Nguyen (US 2002/0143378) and further in view of Mccormick (US 2014/0123976) and further in view of Sjostedt (US 2009/0248035).
Regarding claim 1, Runnels discloses a laryngoscopy tool (1460, Fig 63) for assisting in placement of an endotracheal tube (Para 0006), the laryngoscopy tool comprising: a) a stylet having a proximal end (end near tabs 1466, Fig 63) and a distal end (1482, Fig 63), the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal end, the articulating distal end being configured to articulate between more than one shape (Para 0260); an upper control wire (portion of wire 1310 between tab 1466B and connection point 1470) and a lower control wire (portion of wire 1310 between tab 1466A and connection point 1468); and a steering control base (1466A-B, Fig 63) slidable along the stylet to articulate the distal end of the stylet (Para 0260).
Runnels is silent regarding a transition segment located intermediate the less stiff distal end of the stylet and a more stiff proximal portion of the stylet, the transition segment having a distal portion and proximal portion, the transition segment having two parallel openings along its length, a medial portion with a diameter greater than a distal portion and proximal portion of the transition segment, with the distal portion and proximal portion each having an outer diameter less than the outer diameter of each of the distal end of the stylet and the less flexible proximal portion of the stylet and fitting within the distal end and proximal portion of the stylet such that the distal end and proximal portion of the stylet and the medial portion of the transition segment have substantially the same dimeter; and an upper sheath portion and a separate lower sheath portion, the upper sheath portion and the lower sheath portion comprising pathways for an upper control wire and a lower control wire, the upper control wire and lower control wire located in separate openings in the transition segment; wherein the upper and lower sheath portions are mostly proximal to the transition segment and terminate within the transition segment; b) a handle removably secured to the proximal end of the stylet; having a single steering control base; and wherein the steering control base comprises a slidable tube surrounding a portion of the proximal end of the stylet configured to move forward and backward to articulate the distal end of the stylet.
The embodiment of Fig 49 of Runnels discloses a handle (1200, Fig 49) removably secured to the proximal end of the stylet (Para 0241); wherein a steering control base (802, Fig 49) is positioned on an extension (portion of 804 between the control base 802 and the handle 1200, Fig 49) from the handle.
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 stylet disclosed by Runnels to further include a handle as further taught by Runnels in order to improve handling and control of the stylet (Para 0241).
The modified invention of Runnels discloses all of the elements of the invention as discussed above, however, is silent regarding a transition segment located intermediate the less stiff distal end of the stylet and a more stiff proximal portion of the stylet, the transition segment having a distal portion and proximal portion, the transition segment having two parallel openings along its length, a medial portion with a diameter greater than a distal portion and proximal portion of the transition segment, with the distal portion and proximal portion each having an outer diameter less than the outer diameter of each of the distal end of the stylet and the less flexible proximal portion of the stylet and fitting within the distal end and proximal portion of the stylet such that the distal end and proximal portion of the stylet and the medial portion of the transition segment have substantially the same dimeter; and an upper sheath portion and a separate lower sheath portion, the upper sheath portion and the lower sheath portion comprising pathways for an upper control wire and a lower control wire, the upper control wire and lower control wire located in separate openings in the transition segment; wherein the upper and lower sheath portions are mostly proximal to the transition segment and terminate within the transition segment; having a single steering control base; and wherein the steering control base comprises a slidable tube surrounding a portion of the proximal end of the stylet configured to move forward and backward to articulate the distal end of the style.
Machold teaches an introducer tube (device of Fig 3) having a transition segment (42, Fig 3) located intermediate the less stiff distal end (44, Fig 3) of the tube and a more stiff proximal portion (40, Fig 3) of the tube (Para 0034), the transition segment having a medial portion (48, Fig 5) with a diameter greater than a distal portion (50, Fig 5) and proximal portion (52, Fig 5) of the transition segment, with the distal portion and proximal portion each having an outer diameter less than the outer diameter of each of the distal end of the stylet and the less flexible proximal portion of the stylet (Para 0034) and fitting within the distal end and proximal portion of the stylet such that the distal end and proximal portion of the stylet and the medial portion of the transition segment have substantially the same diameter (Para 0034 and See Fig 3).
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 stylet disclosed by Runnels to comprise a transition segment as taught by Machold in order to a stylet that can have a proximal portion and a distal portion with varying physical properties to allow for more accurate control of the distal end (Para 0005 and 0009).
Examiner notes that the modified invention of Runnels and Machold would have the transition segment having two parallel openings along its length and have the upper control wire and lower control wire located in separate openings in the transition segment as Machold teaches the transition section having a hole 61 for a single wire (Para 0036) and Runnel teaches that the wires have their respective routes through the length of the stylet from the proximal end to the distal end (Para 0197) and thus, one of ordinary skill would understand that the transition section would necessarily require two holes within the transition section for the wires to traverse the transition section.
The modified invention of Runnels and Machold disclose all of the elements of the invention as discussed above, however, is silent regarding an upper sheath portion and a separate lower sheath portion, the upper sheath portion and the lower sheath portion comprising pathways for an upper control wire and a lower control wire; wherein the upper and lower sheath portions are mostly proximal to the transition segment and terminate within the transition segment; and wherein the steering control base is a single steering control base that comprises a slidable tube surrounding a portion of the proximal end of the stylet configured to move forward and backward to articulate the distal end of the style.
Nguyen teaches a steerable tube having an upper sheath portion (one of sheaths 48, Fig 2) and a separate lower sheath portion (the other one of sheaths 48, Fig 2), the upper sheath and the lower sheath comprising pathways for an upper control wire and a lower control wire (wires 32, Fig 2) (Para 0046); the upper and lower sheath portions are proximal to the transition section (36, Fig 2) and terminate within the transition segment (Para 0049 and See Fig 2)
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 stylet disclosed by Runnels to include an upper sheath, a lower sheath, and compression coils as taught by Nguyen in order to have a proximal portion that can resist compression while preventing unintended contact between the coils and other elements of the stylet (Para 0046).
The modified invention of Runnels, Machold, and Nguyen discloses all of the elements of the invention as discussed above, however, is silent regarding wherein the steering control base is a single steering control base that comprises a slidable tube surrounding a portion of the proximal end of the stylet configured to move forward and backward to articulate the distal end of the style.
Mccormick teaches a stylet (10, Fig 1) comprising a single slidable steering control base (20, Fig 8) is slidable along the stylet to articulate the distal end of the stylet (Para 0035); and wherein the steering control base comprises a slidable tube (channel 44 for receiving the wire 22, Fig 8) surrounding a portion of the proximal end of the stylet (as the wire is a portion of the stylet, the channel surrounding the wire can be interpreted as surrounding a portion of the stylet) configured to move forward and backward to articulate the distal end of the stylet (Para 0035); the steering control base having a diameter narrow enough to pass through an endotracheal tube (Para 0036).
Sjostedt teaches a stylet (1 and 2, Fig 1) comprising a single slidable steering control base (4, Fig 1) that completely surrounds the stylet and is slidable along the stylet to articulate the distal end of the stylet (Para 0025); and wherein the steering control base comprises a slidable tube surrounding a portion of the proximal end of the stylet configured to move a wire forward and backward to articulate the distal end of the stylet (See Fig 6).
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 control base disclosed by Runnels, Machold, and Nguyen to be the slidable control base taught by Mccormick in order to allow for the stylet and steering control base to be slidably disposed in a conventional endotracheal tube (Para 0036). Further, the slidable control base can be a slidable tube completely surrounding the stylet as taught by Sjostedt in order to be able to rotate the stylet and still have access to the steering control base (Para 0027).
Regarding claim 2, the modified invention of Runnels, Machold, Nguyen, Mccormick, and Sjostedt discloses the handle (1200, Fig 49 -Runnels) is removable from the proximal end of the stylet (Para 0241 -Runnels).
Regarding claim 3, the modified invention of Runnels, Machold, Nguyen, Mccormick, and Sjostedt discloses the handle (1200, Fig 49 -Runnels) is removable from the proximal end of the stylet to allow placement of an endotracheal tube in place (Para 0241 -Runnels).
Regarding claim 4, the modified invention of Runnels, Machold, Nguyen, Mccormick, and Sjostedt discloses the stylet (1460, Fig 63 -Runnels) articulates in a plane (Para 0260 -Runnels).
Regarding claim 5, the modified invention of Runnels, Machold, Nguyen, Mccormick, and Sjostedt discloses the stylet (1460, Fig 63 -Runnels) includes an internal mechanism for articulating the distal end (Para 0260 -Runnels; Para 0051 -Mccormick).
Regarding claim 6, the modified invention of Runnels, Machold, Nguyen, Mccormick, and Sjostedt discloses the stylet (1460, Fig 63 -Runnels as modified by Machold, Nguyen, and Mccormick) further comprises a flexible intermediate portion (portion of flexible articulating end 44 between or intermediate the distal tip and the transition segment 42, See Fig 3 of Machold).
Claims 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Runnels (US 2018/0110950) in view of Bon (US 2003/0171736) and further in view of Machold (US 2018/0092647) and further in view of Mccormick (US 2014/0123976) and further in view of Sjostedt (US 2009/0248035).
Regarding claim 10, Runnels discloses a method for placement of an endotracheal tube, the method comprising: a) providing a laryngoscopy tool for assisting in placement of an endotracheal tube, the laryngoscopy tool comprising: i) a stylet having a proximal end and an articulating distal end, the stylet configured for receiving an endotracheal tube, the articulating distal end being configured to articulate between more than one shape; ; an upper control wire (portion of wire 1310 between tab 1466B and connection point 1470) and a lower control wire (portion of wire 1310 between tab 1466A and connection point 1468); b) inserting the distal end of the stylet of the laryngoscopy tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx (See Figs 10-13; Para 0174-0177); d) inserting an endotracheal tube over the proximal end of the stylet and down toward the distal end of the stylet (See Fig 14; Para 0178); and e) removing the stylet from the patient's trachea while keeping the endotracheal tube in place (Para 0094, lines 9-15).
Runnels is silent regarding a transition segment located intermediate the articulating distal end of the stylet and a less flexible proximal portion of the stylet, the transition segment having a distal portion and proximal portion, the transition segment having a diameter greater than each of the articulating distal end of the stylet and the less flexible proximal portion of the stylet; and an upper sheath portion and a separate lower sheath portion, the upper sheath and lower sheath comprising pathways for an upper control wire and a lower control wire; the upper and lower sheet portions proximal to the transition segment; and ii) a handle secured to the proximal end of the stylet; c) removing the handle from the proximal end of the stylet; and wherein the control base comprises a tube surrounding a portion of the proximal end of the stylet; the steering control base having a diameter narrow enough to pass through an endotracheal tube; the tube slidable on the stylet to articulate the articulating distal end of the stylet.
The embodiment of Fig 49 of Runnels discloses a handle (1200, Fig 49) removably secured to the proximal end of the stylet (Para 0241); and a step of removing the handle from the proximal end of the stylet (Para 0241, lines 8-13).
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 stylet disclosed by Runnels to further include a removable handle as further taught by Runnels in order to improve handling and control of the stylet while still allowing removal of the handle to facilitate insertion of the endotracheal tube over the stylet (Para 0241).
The modified invention of Runnels discloses all of the elements of the invention as discussed above, however, is silent regarding a transition segment located intermediate the articulating distal end of the stylet and a less flexible proximal portion of the stylet, the transition segment having a distal portion and proximal portion, the transition segment having a diameter greater than each of the articulating distal end of the stylet and the less flexible proximal portion of the stylet; and an upper sheath portion and a separate lower sheath portion, the upper sheath and lower sheath comprising pathways for an upper control wire and a lower control wire; the upper and lower sheet portions proximal to the transition segment; and wherein the control base comprises a tube surrounding a portion of the proximal end of the stylet; the steering control base having a diameter narrow enough to pass through an endotracheal tube; the tube slidable on the stylet to articulate the articulating distal end of the stylet.
Bon teaches a steerable tube having an upper sheath portion (one of stiffeners 30, Fig 1) and a separate lower sheath portion (the other one of stiffeners 30, Fig 1), the upper sheath and the lower sheath comprising pathways (20, Fig 1) for an upper control wire and a lower control wire (Para 0022); the upper and lower sheath portions proximal to a flexible distal segment (Para 0025, “one or more positive stiffeners 30 are preferably embedded within a proximal segment 14a of the shaft 14, and stiffeners are omitted from a distal segment 14b of the shaft”).
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 stylet disclosed by Runnels to include an upper sheath and a lower sheath as taught by Bon in order to maintain the overall stiffness of the shaft and resist socking (Para 0009).
The modified invention of Runnels and Bon disclose all of the elements of the invention as discussed above, however, is silent regarding a transition segment located intermediate the articulating distal end of the stylet and a less flexible proximal portion of the stylet, the transition segment having a distal portion and proximal portion, the transition segment having a diameter greater than each of the articulating distal end of the stylet and the less flexible proximal portion of the stylet; and wherein the control base comprises a tube surrounding a portion of the proximal end of the stylet; the steering control base having a diameter narrow enough to pass through an endotracheal tube; the tube slidable on the stylet to articulate the articulating distal end of the stylet.
Machold teaches an introducer tube (device of Fig 3) having a transition segment (42, Fig 3) located intermediate the articulating distal end (44, Fig 3) of the tube and a less flexible proximal portion (40, Fig 3) of the tube (Para 0034), the transition segment having a distal portion (50, Fig 5) and proximal portion (52, Fig 5), the transition segment having a diameter greater than either the distal portion or proximal portion (See Fig 5).
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 stylet disclosed by Runnels and Bon to comprise a transition segment as taught by Machold in order to a stylet that can have a proximal portion and a distal portion with varying physical properties to allow for more accurate control of the distal end (Para 0005 and 0009).
Examiner notes that the combined invention of Runnels, Bon, and Machold discloses that the upper and lower sheath portions are proximal to the transition segment as Bon teaches that the sheath portions (stiffeners 30) are embedded within a proximal portion but are omitted from the flexible distal portion (Para 0025) and Machold teaches that the transition segment is between the proximal portion and flexible distal portion (Para 0034).
The modified invention of Runnels, Bon, and Machold discloses all of the elements of the invention as discussed above, however, is silent regarding wherein the control base comprises a tube surrounding a portion of the proximal end of the stylet; the steering control base having a diameter narrow enough to pass through an endotracheal tube; the tube slidable on the stylet to articulate the articulating distal end of the stylet.
Mccormick teaches a stylet (10, Fig 1) comprising a single steering control base (20, Fig 8) is slidable along the stylet to articulate the distal end of the stylet (Para 0035); and wherein the steering control base comprises a slidable tube (channel 44 for receiving the wire 22, Fig 8) surrounding a portion of the proximal end of the stylet (as the wire is a portion of the stylet, the channel surrounding the wire can be interpreted as surrounding a portion of the stylet) configured to move forward and backward to articulate the distal end of the stylet (Para 0035); the steering control base having a diameter narrow enough to pass through an endotracheal tube (Para 0036).
Sjostedt teaches a stylet (1 and 2, Fig 1) comprising a single slidable steering control base (4, Fig 1) that completely surrounds the stylet and is slidable along the stylet to articulate the distal end of the stylet (Para 0025); and wherein the steering control base comprises a slidable tube surrounding a portion of the proximal end of the stylet configured to move a wire forward and backward to articulate the distal end of the stylet (See Fig 6).
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 control base disclosed by Runnels, Machold, and Nguyen to be the slidable control base taught by Mccormick in order to allow for the stylet and steering control base to be slidably disposed in a conventional endotracheal tube (Para 0036). Further, the slidable control base can be a slidable tube completely surrounding the stylet as taught by Sjostedt in order to be able to rotate the stylet and still have access to the steering control base (Para 0027).
Regarding claim 11, the modified invention of Runnels, Bon, Machold, Mccormick, and Sjostedt discloses the laryngoscopy tool for assisting in placement of the endotracheal tube is removable from the proximal end of the endotracheal tube (Para 0094 -Runnels; after proper placement of the distal end of the endotracheal tube, the stylet is removed by sliding it out of the proximal end of the endotracheal tube to allow an external ventilator to be connected to the proximal end of the endotracheal tube).
Regarding claim 12, the modified invention of Runnels, Bon, Machold, Mccormick, and Sjostedt discloses the stylet (1460, Fig 63 -Runnels) articulates in a plane (Para 0260 -Runnels).
Regarding claim 13, the modified invention of Runnels, Bon, Machold, Mccormick, and Sjostedt discloses the stylet (1460, Fig 63 -Runnels) includes an internal mechanism for articulating the distal end (Para 0260 -Runnels; Para 0051 -Mccormick).
Regarding claim 14, the modified invention of Runnels, Bon, Machold, Mccormick, and Sjostedt discloses the stylet (1460, Fig 63 -Runnels as modified by Bon, Machold, and Mccormick) further comprises a flexible intermediate portion (portion of flexible articulating end 44 between or intermediate the distal tip and the transition segment 42, See Fig 3 of Machold).
Response to Arguments
Applicant’s arguments regarding Runnels, Bon, Machold, Mccormick failing to teach a single slidable steering control base completely surrounds the stylet have been fully considered but are moot in view of the current rejection that relies on Sjostedt to teach the amended limitations.
Applicant’s arguments regarding the embodiments of Figure 49 and Figure 63 are not combinable have been fully considered but are not persuasive. Applicant asserts that adding the handle from Figure 49 would likely cover the tabs of Figure 63 making the system inoperable. Examiner disagrees as one of ordinary skill in the art would understand and be able to position the elements as to not overlap in the same way that the handle doesn’t overlap the lever 802 in Figure 49. One would simply place the elements at different axial locations along the stylet.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/
Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783