Prosecution Insights
Last updated: April 19, 2026
Application No. 18/552,214

REINFORCED TUBES

Non-Final OA §102§103
Filed
Sep 25, 2023
Examiner
ZHANG, TINA
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Smiths Medical International Limited
OA Round
1 (Non-Final)
56%
Grant Probability
Moderate
1-2
OA Rounds
3y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allow Rate
46 granted / 82 resolved
-13.9% vs TC avg
Strong +47% interview lift
Without
With
+46.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
42 currently pending
Career history
124
Total Applications
across all art units

Statute-Specific Performance

§101
4.5%
-35.5% vs TC avg
§103
51.2%
+11.2% vs TC avg
§102
21.4%
-18.6% vs TC avg
§112
20.4%
-19.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 82 resolved cases

Office Action

§102 §103
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. Information Disclosure Statement The information disclosure statement(s) filed on 09/25/2023 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement (s) is /are being considered by the examiner. Claims This office action is in response to the preliminary amendment filed on 09/25/2023 . As directed by the preliminary amendments, claims 1-12 have been cancelled and claims 13-24 have been added. As such, claims 13-24 are being examined in this application. Claim Objections Claim 16 is/are objected to because of the following informalities: Claim 16, line 2, recites “…extending around it towards…” but should recite “…extending around it the tube towards …” for clarity. Appropriate correction is required. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. The term “ elongate member ” of claim ( s ) 1 5-16 invoke 112(f). The specification recites “ The tube may include an elongate member extending within the shaft along the path along the first region but not within the shaft along the second region (see page 3, lines 5-6)” and “ Towards its patient end 11 the shaft 10 supports a conventional inflatable sealing cuff 13 the interior of which connects with the patient end of a small-bore inflation line or tube 14 extending along the tube 1 (see page 5, lines 3-5) . ” For examination purposes, as best understood, the term “ elongate member ” refers to an inflation line or tube. The term “ inflatable sealing member ” of claim (s) 16 invoke 112(f). The specification recites “ The tube preferably includes an inflatable sealing member extending around it towards one end of the first region, the elongate member being an inflation line opening at one end into the sealing member (see page 3, lines 7-9 )” and “ Towards its patient end 11 the shaft 10 supports a conventional inflatable sealing cuff 13 the interior of which connects with the patient end of a small-bore inflation line or tube 14 extending along the tube 1 (see page 5, lines 3-5) . ” For examination purposes, as best understood, the term “ inflatable sealing member ” refers to a n inflatable sealing cuff. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claim (s) 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson ( US 20200246586 A1 ). Regarding claim 20, Anderson teaches a method of making a reinforced medico-surgical tube (elastic introducer 10, see Figs. 1 and 4-17 and [0065]) (Anderson teaches an elastic introducer 1 comprising a wire structure 100 and a liner 200 as seen in Figs. 1 and 16 and [0065]) , characterised in that the method includes the steps of: forming a flat coil of a stiff material having multiple loops arranged side by side along the length of the coil ( Anderson teaches wire structure 100 to have a repeating longitudinal pattern of multiple loops in a flat or uncurved state as seen in Figs. 2-4 and then further teaches wire structure 100 to be curved in circumferential loops as seen in Figs. 5-6 and 16 ) , the coil including at least a first region ( expandable section 90 , see Fig. 16) and a second region ( full diameter section 70 , see Fig. 16) where the width of the coil is different along the two regions (Anderson teaches full diameter section 70 to be of a different diameter than expandable section 90 as seen in Fig. 16 and [0065]) ; bending the coil along its longitudinal axis into a tubular form such as to form a longitudinal gap between the ends of the loops along at least the first region ( Anderson teaches wire structure 100 to be curved in circumferential loops in a tubular form as seen in Fig. 16, wherein there is a longitudinal gap between the ends of the loops in the expandable section 90 as seen in Fig. 16 and [0065]) ; and subsequently forming a shaft by embedding the coil within a flexible plastics material ( Anderson teaches wire structure 100 to be within liner 200 as seen in Figs. 1 and 7 and [0065], wherein liner 200 is made out of Teflon or polyethylene (see [0068])) . 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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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. Clai m(s) 13 -14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson ( US 20200246586 A1 ) in view of Cabiri ( US 20130304034 A1 ). Regarding claim 13, Anderson teaches a reinforced medico-surgical tube (elastic introducer 10, see Figs. 1 and 4-17 and [0065]) including a shaft (liner 200, see Figs. 1 and 12-14) of a flexible plastics material reinforced along a major part of its length by a reinforcement in the form of a coil of a filament of stiff material (wire structure 100, see Figs. 1-16 and [0070]) embedded within the plastics (Anderson teaches liner 200 to be made out of Teflon or polyethylene (see [0068]), wherein along a major part of the length of liner 200 is reinforced by wire structure 100 made out of Nitinol or stainless steel as seen in Figs. 12-13 and [0070]) , characterised in that the coil has multiple turns formed by loops of the filament (wire structure 100 is bent to form a series of loops as seen in Figs. 5-7 and 16 and [0075]-[0076]) , that the loops have opposite closed ends extending around the shaft in opposite directions towards one another and towards a longitudinal locus (longitudinal locus, see Anderson’s Annotated Fig. 16 ) between the closed ends of the loops (Anderson teaches the series of loops in wire structure 100 to have the opposite closed ends of full diameter section 70 and expandable section 90 extend around liner 200 in opposite directions towards one another (expandable section 90 and full diameter section 70 are coiling in an opposite direction towards the other section as seen in Fig. 16) and towards a longitudinal locus between the closed ends of the loops as seen in Anderson’s Annotated Fig. 16 ) , and a first region of the tube ( expandable section 90 , see Fig. 16) and a second region ( full diameter section 70 , see Fig. 16) along the tube (see Fig. 16). But does not teach the longitudinal locus along a first region of the tube defines a path wider than that along a second region along the tube . Anderson further teaches the wire structure 100 can include a sinusoidal pattern without a wire overlap region 114 as shown in Fig. 7 and [0071] and [0076]. Therefore, i t would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tube taught by Anderson to have a sinusoidal pattern without a wire overlap region as Anderson teaches wire structure 100 can include different patterns (see Figs. 2-7 and [0071]). Anderson’s Annotated Fig. 16 However, Cabiri teaches slots 16 to increase the flexibility towards the distal end of the tube for steerability of the device and controlled manipulation thereof as seen in Fig. 6 and [0025]. Cabiri further teaches the amount of flexibility can be controlled by the number of slots, spacing therebetween, shape of the slot and the angle subtended by the slo t as seen in [0025], wherein Fig. 6 shows the slots are circumferentially phase shifted with respect to each other about the circumference of the tube (see [0032]). Anderson teaches the number, shape and pattern of projections 1104 can affect expansion stress, flexibility and bending compliance of elastic introducer 1010 as seen in Fig. 19 and [0089]. As such, Anderson understands the wire structure 100 and the projections 1104 of elastic frame 1100 affect the properties of the elastic introducer 10/1010. Therefore, i t would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tube taught by Anderson to have wider slots/gaps on the distal portion of the tube as taught by Cabiri for increased flexibility towards the distal end of the tube for steerability of the device and controlled manipulation (see [0025]). Anderson in view of Cabiri teaches the longitudinal locus along a first region of the tube defines a path wider than that along a second region along the tube (Anderson teaches expandable section 90 (taken as first region of the tube) and full diameter section 70 (taken as second region) as seen in Fig. 16 and further wire structure 100 can include a sinusoidal pattern without a wire overlap region 114 as shown in Fig. 7 and [0071] and [0076]. Cabiri teaches the path to be wider towards the distal end of the tube as seen in [0025]. Therefore, Anderson in view of Cabiri teaches the longitudinal locus along the expandable section 90 is a path wider (taught by Cabiri) than that along the full diameter section 70). Regarding claim 14, Anderson in view of Cabiri teaches the tube of claim 13, and Anderson further teaches characterised in that the loops in the coil are longer along the second region than along the first region (Anderson teaches the loops in the coil of full diameter section 70 to have a bigger diameter than the loops in the coil of the expandable section 90 as seen in Fig. 16 and [0065], and therefore the loops in the coil of the full diameter section 70 will be longer). Regarding claim 17, Anderson in view of Cabiri teaches the tube of claim 13, and Anderson further teaches characterised in that the filament is of a metal selected from a group including stainless steel, high tensile steel, amalgams, alloys, and Nitinol (Wireless structure 100 can be made out of Nitinol or stainless steel as seen in [0070]) . Clai m(s) 15 -16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson ( US 20200246586 A1 ) in view of Cabiri ( US 20130304034 A1 ), as applied to claim 13 above, and further in view of Koorn ( US 20110061658 A1 ). Regarding claim 15, Anderson in view of Cabiri teaches the tube of claim 13, but does not teach characterised in that the tube includes an elongate member extending within the shaft along the path along the first region but not within the shaft along the second region. However, Koorn teaches characterised in that the tube (tube portion 16, see Fig. 3 ) includes an elongate member (air channel 38, see Fig. 3 ) extending within the shaft along the path along the first region but not within the shaft along the second region ( Koorn teaches air channel 38 coupled to balloon cuff 32 as seen in Fig. 3 and therefore, extends within the shaft of tube portion 16 along the first region (where reference numeral 20 is pointing towards) and not along the second region (where reference numeral 28 (left closer to reference numeral 30) is pointing towards)) . Anderson teaches an introducer system for a transcatheter medical device as seen in [0065]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tube taught by Anderson in view of Cabiri to include the balloon cuff, air channel and male adaptor as taught by Koorn to be integrated into the tube to communicate ventilating gas into the trachea of a patient to perform another useful function (see [0080]). Regarding claim 16, modified Anderson teaches the tube of claim 15, and further teaches characterised in that the tube includes an inflatable sealing member ( balloon cuff 32 , see Fig. 1) extending around it towards one end of the first region (Cabiri teaches balloon cuff 32 extending around one end of the first region (where reference numeral 20 is pointing towards) as seen in Fig. 3. Therefore, modified Anderson teaches balloon cuff 32 to extend around one end of expandable section 90) , and that the elongate member is an inflation line opening at one end into the sealing member (Cabiri teaches balloon cuff 32 to be supplied with air or other inflation gas via air channel 38 and further teaches the air channel to be mounted on the tube wall of the endotracheal tube as seen in [0082]. Therefore, air channel 38 is connected to one end of balloon cuff 32 to supply inflation gas). Clai m(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson ( US 20200246586 A1 ) in view of Cabiri ( US 20130304034 A1 ), as applied to claim 13 above, and further in view of Lawrence ( US 20040087932 A1 ). Regarding claim 18, teaches the tube of claim 13, but does not teach characterised in that outer arms of loops at opposite ends of the coil are wider than along the remainder of the coil and have smoothly rounded ends. However, Lawrence teaches “ Collar 34 anchors malleable member 30 into place within wall 20 such that when cannula 10 is bent, twisted, and otherwise manipulated by a surgeon, malleable member 30 remains in place rather than sliding within wall 20, which can lead to undesired damage to wall 20. ” Anderson teaches an introducer system for a transcatheter medical device with an expandable section 90 as seen in Fig. 16 and [0065]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tube taught by Anderson in view of Cabiri to include the collar as taught by Lawrence to keep the malleable member/wire structure in place when the cannula/sheath is bent, twisted and otherwise manipulated by a surgeon (see [0065]). Furthermore, it would be obvious to one of ordinary skill in the art to have the collar on both ends of wire structure 100 to aid in keeping wire structure 100 in place and to prevent undesired damage to the sheath on both ends. As such, modified Anderson teaches that outer arms of loops at opposite ends of the coil are wider than along the remainder of the coil (collar 34 at opposite ends of the coil are wider than the remainder of the coil as seen in Fig. 2 of Lawrence). With respect to Claim 18, modified Anderson does not explicitly teach the outer arms of loops at opposite ends of the coil to have smoothly rounded ends. However, it has been held that the mere change in shape does not constitute a patentable improvement in the art when said change in shape does not result in a non-obvious change in functionality (see MPEP § 2144.04. IV. B .). In this case, it is unclear why changing the shape of the outer arms to have smoothly rounded ends would substantially change the functionality of the device in a non-obvious way . It is known in the art to use rounded/atraumatic ends to prevent the ends from harming the tube and/or user. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify modified Anderson to have the outer arms of loops at opposite ends of the coil to have smoothly rounded ends, since it has been held that th e change in shape involves only routine skill in the art. Clai m(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson ( US 20200246586 A1 ) in view of Cabiri ( US 20130304034 A1 ), as applied to claim 13 above, and further in view of Vidlund ( US 6033394 A ). Regarding claim 19, Anderson in view of Cabiri teaches the tube of claim 13, but does not teach characterised in that an outer arm of an end loop of the coil is linked to an adjacent arm by a bridging piece midway along the length of the outer arm. However, Vidlund teaches characterised in that an outer arm of an end loop (first end 74, see Fig. 3) of the coil (support structure 70, see Fig. 3) is linked to an adjacent arm (support 78 (the support closest to first end 74), see Fig. 3) by a bridging piece (strut 72b, see Fig. 3) midway along the length of the outer arm ( Vidlund teaches first end 74 of support structure 70 is linked to support 78 by strut 72b midway along the length of first end 74 as seen in Fig. 3) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tube taught by Anderson in view of Cabiri to include bridging pieces as taught by Vidlund for enhanced geometric integrity and improving torque response (see Col. 4, lines 60-67). Clai m(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson ( US 20200246586 A1 ). Regarding claim 23, Anderson teaches a coil (wire structure 100, see Figs. 1-16 and [0070]) for use in reinforcing a medico-surgical tube (elastic introducer 10, see Figs. 1 and 4-17 and [0065]) (Anderson teaches wire structure 100 embedded in jacket 300 to provide kink resistance as seen in [0065]) , characterised in that the coil has multiple turns formed by loops of a filament of a stiff material (wire structure 100 is bent to form a series of loops and is made out of Nitinol or stainless steel as seen in Figs. 5-7 and 16 and [0070] and [0075]-[0076]) , that loops along a first region of the coil are shorter than loops along a second region (Anderson teaches the loops of full diameter section 70 to have a bigger diameter than the loops of the expandable section 90 as seen in Fig. 16 and [0065], and therefore the loops of the expandable section 90 will be shorter) But does not teach that the loops have opposite closed ends, such that when the coil is bent into a tubular form along its longitudinal axis to bring the closed ends of the loops of the second region close to one another the closed ends of the loops of the first region are spaced from one another by a gap along the length of the first region. However, Anderson further teaches that the loops have opposite closed ends ( Anderson further teaches the wire structure 100 can include a sinusoidal pattern without a wire overlap region 114 as shown in Fig. 7 and [0071] and [0076]). Therefore, i t would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tube taught by Anderson to have a sinusoidal pattern without a wire overlap region as Anderson teaches wire structure 100 can include different patterns (see Figs. 2-7 and [0071]). Anderson teaches such that when the coil is bent into a tubular form along its longitudinal axis to bring the closed ends of the loops of the second region close to one another the closed ends of the loops of the first region are spaced from one another by a gap along the length of the first regio n (Anderson teaches the closed ends of the loops of the expandable region 90 to be spaced by a gap as seen in Fig. 7). Clai m(s) 21 -22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson ( US 20200246586 A1 ) in view of Ageel ( GB 2552250 A ). Regarding claim 21, Anderson teaches the method of claim 20, but does not teach a tracheostomy tube, characterised in that the tube includes a sealing cuff towards its patient end, a neck flang e at a location between a patient end portion of the tube and a machine end portion of the tube, that the first region of the coil extends along the patient end region of the tube leaving a gap along the coil along the patient end region, that the tube includes an inflation tube opening at one end into the sealing cuff, that the inflation tube is embedded within the plastics material and extends along the gap, and that the inflation tube extends externally of the shaft on the machine side of the flange. However, Ageel teaches a tracheostomy tube ( tracheostomy tube 1, see Figs. 1-2) , characterised in that the tube includes a sealing cuff ( sealing cuff 13, see Figs. 1-2 ) towards its patient end ( patient end 32, see Fig. 2 ) ( Ageel teaches a sealing cuff 13 towards its patient end 32 as seen in Figs. 1-2) , a neck flange ( neck flange 20, see Figs. 1-2 ) at a location between a patient end portion of the tube and a machine end portion of the tube ( neck flange 20 is between patient end 32 and machine end 14 of shaft 10 of tube 1 as seen in Figs. 1-2 ) , that the first region of the coil extends along the patient end region of the tube leaving a gap along the coil along the patient end region (the region of helical reinforcement member 30 between patient end 32 and neck flange 20 (taken as the first region of the coil as seen in Fig. 2) extends along the patient end region of tube 1 and leaves a gap along the coil as seen in Fig. 3 where inflation line 31 is also coiled alongside helical reinforcement member 30) , that the tube includes an inflation tube (inflation line 31 and inflation tube 34, see Figs. 1-3) opening at one end into the sealing cuff (tube 1 comprises an opening for the embedded inflation tube 31 at one end into sealing cuff 13 as seen in Figs. 1-2 and page 6, lines 23-24, to allow the inflation tube 31 to inflate the sealing cuff 13) , that the inflation tube is embedded within the plastics material and extends along the gap ( Ageel teaches inflation line 31 to be embedded into the plastic material and extends along the gap as seen in Fig. 3 and page 6, lines 11-16) , and that the inflation tube extends externally of the shaft (shaft 10, see Figs. 1-2) on the machine side of the flange (inflation tube 34 extends externally of shaft 10 on the machine end 14 of neck flange 20 as seen in Fig. 2) . Anderson teaches an introducer system for a transcatheter medical device as seen in [0065] comprising wire structure 100 and a liner 200 as seen in Fig. 1. Similarly, Ageel teaches a tracheostomy tube 1 comprising helical reinforcement member 30 and a shaft 10 as seen in Figs. 1-2. Therefore, it would be obvious to one of ordinary skill in the art to apply wire structure 100 and introducer system from Anderson to be of a tracheostomy tube as taught by Ageel , as they are both medical tubes being introduced into a patient’s body. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Anderson to include the sealing cuff, neck flange and inflation tube as taught by Ageel for a known alternative function to allow a patient to be ventilated (see page 1, second paragraph and page 5, second paragraph). Regarding claim 22, Anderson in view of Ageel teaches the method of claim 21, and Anderson further teaches characterised in that the external diameter of the shaft is greater along the machine end portion of the tube than along the patient end portion of the tube (Anderson teaches the loops in the coil of full diameter section 70 to have a bigger external diameter than the loops in the coil of the expandable section 90 as seen in Figs. 16-17 and [0065], and therefore the external diameter of liner 200 is greater along the full diameter section (taken as machine end portion) than along the expandable section 90 (taken as the patient end portion)). Regarding claim 24, Anderson teaches a tube (elastic introducer 10, see Figs. 1 and 4-17 and [0065]) including a shaft (liner 200, see Figs. 1 and 12-14) of a flexible plastics material ( Anderson teaches liner 200 to be made out of Teflon or polyethylene (see [0068]) ) , characterised in that the tube includes a coil (wire structure 100, see Fig. 16) according to Claim 23 embedded in the shaft. But does not teach a tracheostomy tube. However, Ageel teaches a tracheostomy tube ( tracheostomy tube 1, see Figs. 1-2) comprising helical reinforcement member 30 and a shaft 10 as seen in Figs. 1-2. Anderson teaches an introducer system for a transcatheter medical device as seen in [0065] comprising wire structure 100 and a liner 200 as seen in Fig. 1. Therefore, it would be obvious to one of ordinary skill in the art to apply wire structure 100 and introducer system from Anderson to be of a tracheostomy tube as taught by Ageel , as they are both medical tubes being introduced into a patient’s body. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Cully ( US 20140276599 A 1) teaches a sinusoidal reinforcement member for a endoluminal device. Anderson ( US 20180303610 A1 ) teaches an elastic introducer sheath with a first loop portion, a second loop portion and a gap in between. Phythyon ( US 7918227 B1 ) teaches an endotracheal tube with a spirally-wound coil. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Tina Zhang whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-6956 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 9:00AM-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, FILLIN "SPE Name?" \* MERGEFORMAT Brandy Lee can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-7410 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /TINA ZHANG/ Examiner, Art Unit 3785 /BRANDY S LEE/ Supervisory Patent Examiner, Art Unit 3785
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Prosecution Timeline

Sep 25, 2023
Application Filed
Mar 24, 2026
Non-Final Rejection — §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
56%
Grant Probability
99%
With Interview (+46.7%)
3y 6m
Median Time to Grant
Low
PTA Risk
Based on 82 resolved cases by this examiner. Grant probability derived from career allow rate.

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