DETAILED ACTION
This Office Action is in response to the filing of an amendment to the claims on 4/20/2026. As per the amendment, claims 11-14, 32-38, and 40-45 have been amended, claims 31 and 39 have been cancelled, and no claims have been added. Thus, claims 11-14, 32-38, and 40-45 are pending in the application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 11 and 34 are objected to because of the following informalities:
Claim 11 recites the term “can be” in line 9. Examiner suggests changing to read --is-- in order to clarify that the following limitation is a required feature.
Claim 34 recites the term “can be” in line 9. Examiner suggests changing to read --is-- in order to clarify that the following limitation is a required feature.
Appropriate correction is required.
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 11, and 32-33 rejected under 35 U.S.C. 103 as being unpatentable over Guerra et al. (US Pub. 2014/0128902) in view of Wood et al. (US Pub. 2011/0315147).
Regarding claim 11, Guerra discloses a tracheostomy tube assembly (tracheostomy tube system 2 as seen in Fig. 1) having at a distal end of a tracheostomy tube a resilient retention element (see Figs. 1 and 12A-12F where a balloon 7 is at a distal end of the tracheostomy tube 2, and acts as a retention element), the retention element being radially outwardly biased with respect to the tracheostomy tube (see Figs. 1 and 12A-12F where the balloon 7 extends radially outward from tube 2) and configured to cause an outer part thereof to expand radially away from the tracheostomy tube when the distal end of the tracheostomy tube extends into a patient's trachea (see Figs. 1 and 12A-12F where the balloon 7 has an outer surface that expands radially away from tube 2, which occurs when the distal end of the tube 2 extends into the patient’s trachea), wherein the tracheostomy tube has a wall defining a principal interior lumen breathable through by a patient when the tube is inserted into the patient's trachea (the lumen of tracheostomy tube 2 in Fig. 1).
Guerra lacks a detailed description of one or more subsidiary interior lumens extending through the interior of the wall from one end of the tracheostomy tube to the other end of the tracheostomy tube whereby fluid communication can be made to the interior of the patient's trachea when the tube is inserted therein.
However, Wood teaches a tracheal tube device, where a tracheal tube (which can be a tracheostomy tube as seen in [0023]) has one or more subsidiary interior lumens extending through the wall from one end of the tube to the other (see Fig. 1 where tube 10 has multifunctional lumen 34 extending through the length of the tube; and see Fig. 9 where an embodiment of a multifunctional lumen has three lumens 34/ 34’/ 34’’; see [0044]-[0046]) whereby fluid communication can be made to the interior of the patient's trachea when the tube is inserted therein (see Figs. 1 and 9 and [0044]-[0046] where the lumens 34/ 34’/ 34’’ reach and are in fluid communication with the trachea).
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 lumen of Guerra to have additional subsidiary lumens as taught by Wood, as it would allow for additional devices and/or sensors to be used while the tracheostomy tube is in place.
Regarding claim 33, the modified Guerra device has an incision guide for a tracheostomy tube (Guerra; see Fig. 1 and Figs. 12A-12F including guide wire tube 23 and peelable insertion element 25 to guide the tube 2), the guide comprising an incision sleeve and two or more wings extending from one end of the sleeve in opposing directions (Guerra; see Figs. 11A-12F and [0071] where peelable insertion element 25 has two arms 25A and 25B which are half-tube members forming an incision sleeve, each arm having an extension on the proximal end that protrude in opposite directions from one another), the incision sleeve having two or more zones of weakness along its length whereby it can be drawn apart to detach it from a tracheostomy tube passing through the sleeve (Guerra; see [0071] and Figs. 11B-11D where the two arms 25A and 25B are detachable from one another, having two zones of weakness that allow the two arms to peel apart from one another).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Guerra in view of Wood as applied to claim 11 above, and further in view of Curley et al. (US Pub. 2012/0304984).
Regarding claim 12, the modified Guerra device has wherein the retention element, when expanded, has the form of a conical wall extending about the tube (Guerra; see Figs. 1 and 12A-12F; see also [0061] where balloon 7 is understood to have a conical shape).
The modified Guerra device lacks a detailed description of the radially larger end of the conical wall being more proximal relative to the tube than the radially smaller end of the conical wall.
However, Curley teaches a tracheal stoma dilation device, where a tracheal cuff member on a tracheostomy tube is shaped such that the radially larger end of a conical wall is more proximal relative to the tube than the radially smaller end of the conical wall (see Fig. 11, where a reverse tapered cuff 76 can be shaped such that the radially larger end is proximal and the radially smaller end is distal).
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 cuff of the modified Guerra device to be a reverse tapered cuff as taught by Curley, as it would be a simple substitution of one cuff member for another, to yield the predictable result of providing a cuff to help hold the tube in place, with the added benefit of applying more pressure near the proximal end of the tracheal passageway to re-open the stoma (Curley; see [0039]).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Guerra in view of Wood in view of Curley as applied to claim 12 above, and further in view of Wondka et al. (US Pat. 10,058,668).
Regarding claim 13, the modified Guerra device has a wall of the retention element.
The modified Guerra device lacks a detailed description of wherein the wall of the retention element is perforate.
However, Wondka teaches a tracheostomy tube device, where a retention element can be perforate (see Figs. 24-26 and see Col. 18 line 66 to Col. 19 line 8 and see also the description of Figs. 24-26 on Col. 19 line 9 to Col. 20 line 22, where a shield member can be a cuff and is fenestrated and airflow permeable).
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 cuff of the modified Guerra device to be fenestrated and airflow permeable as taught by Wondka, as it would allow for sensor to be included and able to receive information through the cuff, while the cuff is still able to retain the tube in place.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Guerra in view of Wood as applied to claim 11 above, and further in view of Guo et al. (CN 110548204; see attached translated copy).
Regarding claim 14, the modified Guerra device has the retention element interacts with the interior of the patient's trachea (cuff presses against tracheal tissues).
The modified Guerra device lacks a detailed description of wherein the retention element is provided with suckers on its proximal face for attachment to the interior of the patient's trachea.
However, Guo teaches a tracheal tube device, where a cuff member of the tube is provided with a plurality of suction cups are arranged on the exterior of the cuff to face and interact with the tracheal tissues to form a tight and comfortable seal (see Figs. 1 and 5-8 where suction cups 33 are arranged on a surface of a cuff 30; see also page 4 paragraphs 3-5).
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 cuff of the modified Guerra device to include a plurality of outwardly arranged exterior suction cups as taught by Guo, as it would be a simple substitution of one means for holding the cuff in place for another, with the benefit of providing a good and comfortable seal (Guo; see page 4 paragraphs 3-5).
Regarding claim 32, the modified Guerra device has multiple such subsidiary lumens, each subsidiary lumen being separated from the others by material of the wall (Wood; see Fig. 9 where each of lumens 34/ 34’/ 34’’ are separate from one another by the wall of the tube 10).
Claims 34, 36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Roberson, Jr. et al. (US Pat. 7,267,124; hereinafter “Roberson”) in view of Guerra in view of Wood et al. (US Pub. 2011/0073115; hereinafter Wood ‘115) in view of Wood et al. (US Pub. 2011/0315147; hereinafter Wood ‘147).
Regarding claim 34, Roberson discloses a tracheostomy kit (see abstract) comprising a neck brace configured to be secured around a patient's neck (see Fig. 1 guide 10, and Col. 2 lines 1-9 where the substrate 16 holds the guide around at least a portion of the neck area), the neck brace defining an aperture arranged to be located at a tracheostomy incision site when the neck brace is secured around the patient's neck (see aperture 20 in Fig. 1), a tracheostomy tube slidably guidable through the aperture (breathing tube 14 in Fig. 3), and an introducer to make an incision at the tracheostomy incision site (see cutting instrument 12 in Fig. 2).
Roberson lacks a detailed description of an introducer guidable through the tracheostomy tube to make an incision at the tracheostomy incision site.
However, Guerra teaches a tracheostomy device, where an introducer is guidable through the tracheostomy tube to make an incision at the tracheostomy incision site (see Figs. 2-4 and [0072]-[0073] where a dilator 19 is passed through the tracheostomy tube 2 in order to produce the incision).
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 cutting instrument of Roberson to be designed to be a guided dilator through the tracheostomy tube as taught by Guerra, as it would be a simple substitution of one type of tracheotomy incision device for another, to yield the predictable result of providing an incision for a tracheostomy.
The modified Roberson device lacks a detailed description of a flexible, funnelshaped drogue, arranged around the tracheostomy tube, for retaining the tracheostomy tube in the trachea.
However, Wood ‘115 teaches a tracheal tube device, where a flexible, funnelshaped drogue, arranged around the tracheal tube, for retaining the tracheal tube in the trachea (see Figs. 2 and 5 cuff assembly 14 which is a funnelshaped cuff (drogue) that holds against the tracheal walls (see [0019])).
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 shape of the cuff of the modified Roberson device to be a funnelshaped drogue as taught by Wood ‘115, as it would be a simple substitution of one shape of cuff for another, to yield the predictable result of holding the cuff and tube against the tracheal walls.
The modified Roberson device has wherein the tracheostomy tube has a wall defining a principal interior lumen through which a patient may breathe when the tube is inserted into the patient's trachea (Guerra; the lumen of tracheostomy tube 2 in Fig. 1).
The modified Roberson device lacks a detailed description of one or more subsidiary interior lumens extending through the wall from one end of the tube to the other whereby fluid communication can be made to the interior of the patient's trachea when the tube is inserted therein.
However, Wood ‘147 teaches a tracheal tube device, where a tracheal tube (which can be a tracheostomy tube as seen in [0023]) has one or more subsidiary interior lumens extending through the wall from one end of the tube to the other (see Fig. 1 where tube 10 has multifunctional lumen 34 extending through the length of the tube; and see Fig. 9 where an embodiment of a multifunctional lumen has three lumens 34/ 34’/ 34’’; see [0044]-[0046]) whereby fluid communication can be made to the interior of the patient's trachea when the tube is inserted therein (see Figs. 1 and 9 and [0044]-[0046] where the lumens 34/ 34’/ 34’’ reach and are in fluid communication with the trachea).
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 lumen of the modified Roberson device to have additional subsidiary lumens as taught by Wood ‘147, as it would allow for additional devices and/or sensors to be used while the tracheostomy tube is in place.
Regarding claim 36, the modified Roberson device has an introducer.
The modified Roberson device lacks a detailed description of an incision sleeve configured to guide the tracheostomy tube though the sleeve and into the incision.
However, Guerra further teaches an incision sleeve through which the tracheostomy tube can be guided into the incision (Guerra; see Figs. 11A-12F and [0071] where insertion element 25 is an incision sleeve about the tube 2).
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 introducer of the modified Roberson device to include an incision sleeve as taught by Guerra, as it would be a simple substitution of one type of dilation system for another, to yield the predictable result of dilating the incision.
Regarding claim 38, the modified Roberson device has wherein the incision sleeve comprises two half-sleeves, each forming half of a circumference of the sleeve (Guerra; see Figs. 11A-12F where the insertion elements 25 has arms 25A/25B which are half sleeves around a half-circumference of the tube).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra in view of Wood ‘115 in view of Wood ‘147 as applied to claim 34 above, and further in view of Christopher (US Pub. 2001/0035185).
Regarding claim 35, the modified Roberson device has wherein the neck brace comprises a plate locatable at the front of the patient's neck (Roberson; see Fig. 1 guide 10 being a plate located on the front of a patient’s neck).
The modified Roberson device lacks a detailed description of two flexible elements attached laterally to the plate, the flexible elements being attachable to each other at the back of the neck.
However, Christopher teaches a head-mounted respiratory device, where each end of the device has a flexible element that extends around to the back of the head to connect with the other flexible element (see Figs. 3-5 where each end of delivery tube 20 has a strap 25 which extends out from the head and connects at the back of the patient’s head; see also [0030]).
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 adhesive of the modified Roberson device to be a pair of straps that extend around the head as taught by Christopher, as it would be a simple substitution of one mechanism for holding the guide against the patient’s neck for another, to yield the predictable result of holding the guide steady and in position.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra in view of Wood ‘115 in view of Wood ‘147 as applied to claim 36 above, and further in view of Schnell (US Pat. 8,251,068).
Regarding claim 37, the modified Roberson device has the incision sleeve.
The modified Roberson device lacks a detailed description of wherein the incision sleeve has a sharp distal end for widening the incision.
However, Schnell teaches a tracheotomy device, where a dilation member is conically shaped and has a sharp distal end (see Figs. 2-3 and Col. 6 lines 15-22 where the tip of insertion aid 2 is conical and sharp).
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 shape of the incision sleeve of the modified Roberson device to be conical and sharp at a distal end as taught by Schell, as it would allow for the distal end of the incision sleeve to fit into smaller incisions before dilating them.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra in view of Wood ‘115 in view of Wood ‘147 as applied to claim 34 above, and further in view of Guo.
Regarding claim 40, the modified Roberson device has the drogue.
The modified Roberson device lacks a detailed description of wherein the drogue includes suckers for securing the drogue to the inside of the trachea.
However, Guo teaches a tracheal tube device, where a cuff member of the tube is provided with a plurality of suction cups are arranged on the exterior of the cuff to face and interact with the tracheal tissues to form a tight and comfortable seal (see Figs. 1 and 5-8 where suction cups 33 are arranged on a surface of a cuff 30; see also page 4 paragraphs 3-5).
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 drogue of the modified Roberson device to include a plurality of outwardly arranged exterior suction cups as taught by Guo, as it would be a simple substitution of one means for holding the cuff in place for another, with the benefit of providing a good and comfortable seal (Guo; see page 4 paragraphs 3-5).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra in view of Wood ‘115 in view of Wood ‘147 as applied to claim 34 above, and further in view of Idemoto et al. (US Pat. 4,832,683).
Regarding claim 41, the modified Roberson device has the introducer includes a cutting tip.
The modified Roberson device lacks a detailed description of wherein the introducer includes a ceramic cutting tip.
However, Idemoto teaches a cutting device for surgical use, where the cutting tip can be ceramic (see Col. 2 lines 49-52 where a blade for cutting tissue is ceramic).
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 cutting tip of the modified Roberson device to be a ceramic cutting tip as taught by Idemoto, as it would be a simple matter of design choice for a person of ordinary skill in the art to choose a well-known and biocompatible cutting tip material, such as ceramic.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra in view of Wood ‘115 in view of Wood ‘147 as applied to claim 34 above, and further in view of Smith et al. (US Pat. 5,139,019).
Regarding claim 42, the modified Roberson device has the introducer makes the incision.
The modified Roberson device lacks a detailed description of wherein the introducer comprises a laser for making the incision.
However, Smith teaches a tracheal device, where an incision can be done by laser (see Col. 1 lines 15-23 and Col. 5 lines 8-12).
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 introducer that performs the incision of the modified Roberson device to be a laser that performs the incision as taught by Smith, as it would be a simple substitution of one cutting mechanism for another, to yield the predictable result of being able to cut an incision into the tissue of the patient.
Claims 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra in view of Wood ‘115 in view of Wood ‘147 as applied to claim 34 above, and further in view of Masury et al. (US Pub. 2007/0088374).
Regarding claim 43, the modified Roberson device has wherein the introducer includes a proximal end, for advancing the introducer with respect to the tracheostomy tube (Guerra; see Fig. 1 where a proximal end of guide wire 6 is manually advanced within the tracheostomy tube 2).
The modified Roberson device lacks a detailed description of wherein the introducer includes a manually actuatable part at a proximal end.
However, Masury teaches a medical device for performing incisions, where a proximal end of an introducer system is manually actuatable (see Figs. 5-6 where actuator 16 is proximal the central portion 72, and includes a spring 66 for blade retraction; see [0025]).
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 introducer of the modified Roberson device to have an actuator and retraction spring as taught by Masury, as it would allow for the practitioner to manually choose when to make the incision by using an actuator, to better ensure that the patient is prepped and ready.
Regarding claim 44, the modified Roberson device has a spring for returning the introducer to a retracted state (Masury; see spring 66 in Fig. 5 and [0025]).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson in view of Guerra in view of Wood ‘115 in view of Wood ‘147 as applied to claim 34 above, and further in view of Wondka.
Regarding claim 45, the modified Roberson device has the tracheostomy tube and kit.
The modified Roberson device lacks a detailed description of an ultrasonic attachment for scanning the trachea.
However, Wondka teaches a tracheostomy tube device, which can include ultrasonic sensors for intra-airway sensing (see Col. 3 lines 35-40).
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 tracheostomy tube of the modified Roberson device to include ultrasonic sensors attached to it as taught by Wondka, as it would provide sensing of the airway and breathing characteristics to better monitor patient condition.
Response to Arguments
Applicant's arguments filed 4/20/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 7-8 of the remarks that claim 11 (and claim 34 for similar reasons) does not have the subsidiary lumens which open to the trachea as required in the claim language. The argument is not well-taken. Wood ‘147 which is relied upon to teach this limitation shows a plurality of multifunctional lumens that can extend at least some length through a tracheostomy tube. As clear from Fig. 1 and [0026], at least one of the additional subsidiary lumens can be used for passing a camera 36 through it, which is shows to go all the way through the length of the tube and exiting out the distal end. Thus, this additional lumen that carries the camera must be capable of being exposed to and in fluid communication with the trachea, particularly when the camera is not currently employed. By virtue of being a lumen that is open on both ends to allow travel of a device (e.g. camera), the lumen is in fluid communication with the trachea.
Applicant further argues that Guerra does not disclose a retention element that collects fluid in the trachea, as the balloon of Guerra is deflated once the tube is in position. However, this is not a function recited by the claim language, and it is unclear how this retention element would affect or prevent the use of a lumen that goes through the body of the tube for delivering a device to the distal end, such as taught by Wood ‘147.
For the above reasons, the rejections hold.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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