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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/23/2026 has been entered.
Response to Amendment
Claims 1-2, 4-8, and 26-27 remain pending. No new matter has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, the claim is objected to for having a typographical error wherein the claim recites “at least as long as an axially-extending length of the divot portion” and should instead recite “at least as long as the axial length of the divot portion” such that the language and antecedent basis is consistent between that element and the previously established “the divot portion having an axial length” claim element.
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.
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.
Claim(s) 1-2, 4-8, and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bracken et al. (WO 2012087841, henceforth Bracken) in view of Miller (US 20040221853, henceforth Miller) and Gobel (US 20030066532, previously made of record), and as evidenced by Sato (“Functional Histoanatomy of the Human Larynx”, Kiminori Sato, published 23 January 2018).
Regarding claim 1, Bracken discloses a repositionable endotracheal medical tube (the chosen embodiment is shown in figs. 6-13, however an alternative embodiment showing the endotracheal tube 1 as a whole is shown in fig. 1; the disclosure of Bracken is generally drawn to an endotracheal tube which can be moved between positions, see [00011] and [00012]) having an inflatable cuff (cuff 18, figs. 8 and 9), the inflatable cuff comprising: a proximal end (see annotated fig. 9); a proximal cuff portion (proximal section or area 18c, fig. 9) adjacent to the proximal end (see fig. 9, the proximal end and proximal section 18c are immediately adjacent to each other); at least one divot portion (the indented space radially surrounding center section or area 18a, fig. 9, which extends radially from the third maximum outer diameter as shown in annotated fig. 9 to the second maximum outer diameter as shown in annotated fig. 9 and extends longitudinally between cuff portions 18b and 18c as shown) disposed distal to the proximal cuff portion (see fig. 9) the divot portion tapering inwardly from a maximum diameter adjacent each of the proximal cuff portion (see annotated fig. 9) and a distal cuff portion (see annotated fig. 9) to a minimum diameter (see third maximum outer diameter of annotated fig. 9) intermediate the proximal and distal cuff portions (see annotated fig. 9, the minimum diameter which is the third maximum outer diameter is located between the proximal and distal cuff portions), the divot portion having an axial length measured from a first end at which the proximal cuff portion meets the maximum diameter of the divot portion adjacent to the cuff portion (see annotated fig. 9, the point at which the cuff portion meets the divot portion is the first end as claimed), to a second end at which the distal cuff portion meets the maximum diameter of the divot portion adjacent the distal cuff portion (see annotated fig. 9, the point at which the cuff portion meets the divot portion is the second end as claimed); the distal cuff portion (distal section or area 18b, fig. 9) disposed opposite the at least one divot portion from the proximal cuff portion (see fig. 9); the proximal cuff portion, the divot portion, and the distal cuff portion being contiguous with one another (see [00052] and see fig. 8) and defining a shared fluid bladder (this is understood to be true in view of [00050]-[00052] where it is disclosed that there is a pressure increase within cuff 18; since this is one pressure increase, it is understood that the cuff is all one shared fluid bladder and there are no internal walls separating the cuff 18 into separate fluid bladders; additionally see fig. 8 which shows no such internal walls), with the proximal cuff portion and the distal cuff portion being inflatable to a greater extent than the divot portion (this is shown in fig. 9 and disclosed in [00052]); and a distal end (see annotated fig. 9) adjacent the distal cuff portion (see fig. 9, the distal end and distal section 18b are immediately adjacent to each other). Bracken additionally discloses that its cuff portions must be inflated ([00050]-[00052] discloses inflation with a gas) and that the medical tube has a radiopaque stripe ([0008]). {Examiner notes that radiopaque stripes are known to be usable with radiography as an imaging modality.}
Bracken does not disclose the medical tube wherein the divot portion has an acoustic impedance sufficiently different from an acoustic impedance of the proximal and distal cuff portions so as to achieve an acoustical mismatch that, when scanned using an ultrasonic sensor to produce an ultrasonic image, in the ultrasonic image produced by the ultrasound sensor positioned over at least one of the proximate cuff portion and the distal cuff portion, a signal indicative of the presence of the inflatable cuff is visually discernible such that a precise location of the inflatable cuff, and the medical tube, in situ, may be directly determined by viewing the ultrasonic image. Miller teaches a medical tube (tubular apparatus 10, figs. 1 and 3) having an inflatable cuff (sleeve 42, main balloon cuff 38, sleeve 40, and leader balloon cuff 46, fig. 3, make up an inflatable cuff because the structures of the main balloon cuff 38 and leader balloon cuff 46 can be inflated by air or saline as in [0035] and the structures make up a cuff at the distal section 32 of tubular apparatus 12) having a proximal cuff portion (main balloon cuff 38, fig. 3) and a distal cuff portion (leader balloon cuff 46, fig. 3) with a divot portion located between the cuff portions (see fig. 3, the divot portion is the indented space surrounding sleeve 40 which extends radially from the maximum outer diameter of sleeve 40 to the maximum outer diameter of sleeve 46 and extends longitudinally between cuff portions 46 and 38 as shown) wherein the divot portion has an acoustic impedance (since there is no structure present at the divot portion, its acoustic impedance would be that of the hollow body cavity in which it is placed, see Abstract) sufficiently different from an acoustic impedance of the distal cuff portion (see [0039], [0058], and [0059], leader balloon cuff 46 can be inflated with an acoustically transmissive fluid; this fluid can be saline or other materials as taught in [0059]) so as to achieve an acoustical mismatch when scanned using an ultrasonic sensor to produce an ultrasonic image (see [0058] and [0059], the selected fluid in the cuff causes back scattering of ultrasonic waves because of its acoustic mismatch when scanned using an ultrasonic transducer), in the ultrasonic image produced by the ultrasound sensor positioned over the distal cuff portion, a signal indicative of the presence of the inflatable cuff is visually discernible such that a precise location of the inflatable cuff, and the medical tube, in situ, may be directly determined by viewing the ultrasonic image as a result of an acoustical mismatch between the divot portion and the cuff portions (See [0058]-[0062], the positioning of tubular apparatus 10, and especially leader balloon cuff 46 as a part of tubular apparatus 10, can be determined via an ultrasonic monitor and transducer – which is a sensor as [0009] – because the structures of the leader balloon cuff 46 can be seen on the ultrasonic monitor. This is understood to mean that a signal indicating the presence and location of leader balloon cuff 46 is discernible when the cuff is inflated as in [0061] in particular when viewed by an ultrasonic monitor and image produced therein because the fluid inside of cuff 46 has an acoustic impedance mismatch with the air or other gas in the hollow body cavity which surrounds it and the divot portion and allows for the cuff 46 to be located relative to the divot portion to give a precise location). Miller additionally teaches that radiography and ultrasonic techniques are known to be used to determine placement of endotracheal tubes (see [0008]-[0009]), and that material selection in proximal and distal cuff portions can be used to provide for ultrasonic imaging appearing visually on ultrasonic monitors ([0060]-[0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the materials and fluids with acoustic impedances in the distal cuff portion of the medical tube of Miller in the cuff portions of Bracken to allow for ultrasonic imaging to be able to be used instead of radiographic imaging as it is an equivalent method of imaging in the placement of endotracheal tubes (see Miller [0008] and [0009]) and because the use of such materials allows for easy visual detection as claimed (see Miller [0060]-[0061]). Since both of the proximal and distal cuff portions of Bracken inflate using the same gas ([00050]-[00052]), and since this gas would be replaced with the fluid of Miller in the modified device, this would further mean that the divot portion of Bracken would be different from both cuff portions to achieve the acoustical mismatch as claimed.
Bracken as modified by Miller does not disclose the divot portion having an axial length, measured from a first end at which the proximal cuff portion meets the maximum diameter of the divot portion adjacent to the proximal cuff portion, to a second end at which the distal cuff portion meets the maximum diameter of the divot portion adjacent the distal cuff portion, of at least 5mm wherein at least one of the proximal cuff portion or the distal cuff portion, when the inflatable cuff is in an inflated condition, has a uniform diameter along an axially–extending region of the inflatable cuff at least as long as an axially–extending length of the divot portion. Gobel teaches a repositionable endotracheal medical tube (tracheal tube 1 of fig. 6) having an inflatable cuff (balloon 24, fig. 6), the inflatable cuff comprising: a proximal end (see annotated fig. 6 below, the proximal end is the end closer to filling balloon 33); a proximal cuff portion (see the portion of the balloon 24 which is between incision 27 and balloon 33) adjacent to the proximal end (see annotated fig. 6); at least one divot portion (incision 27, fig. 6) disposed distal to the proximal cuff portion (see fig. 6, the distal direction is the direction towards the tapered end of ventilating cannula 3 as shown), the divot portion tapering inwardly from a maximum diameter adjacent each of the proximal cuff portion and a distal cuff portion (see annotated fig. 6, incision 27 tapers inwardly from a maximum, uniform outer diameter of each of the cuff portions as shown at the first and second end of the divot portion as called out) to a minimum diameter (see annotated fig. 6, the minimum diameter is called out within incision 27) intermediate the proximal and distal cuff portions (see annotated fig. 6), the divot portion having an axial length (see annotated fig. 6, the axial length of incision 27 is measured from the called out first end to the called out second end and is shown as the length along tube 3 which has cross hatched shading as opposed to straight lines), measured from a first end at which the proximal cuff portion meets the maximum diameter of the divot portion adjacent to the proximal cuff portion (see annotated fig. 6, the first end as claimed is called out), to a second end at which the distal cuff portion meets the maximum diameter of the divot portion adjacent the distal cuff portion (see annotated fig. 6, the second end as claimed is called out); the distal cuff portion disposed opposite the at least one divot portion from the proximal cuff portion (see annotated fig. 6), with the proximal cuff portion and the distal cuff portion being inflatable to a greater extent than the divot portion ([0080), at least one of the proximal cuff portion or the distal cuff portion, when the inflatable cuff is in an inflated condition, having a uniform diameter (see annotated fig. 6, the uniform diameter sections are called out along the cuff portions) along an axially- extending region of the inflatable cuff (see annotated fig. 6) at least as long as an axially-extending length of the divot portion (see annotated fig. 6, the called out uniform portions extend further along cannula 3 than incision 27). While Gobel does not explicitly teach the axial length of the divot portion to be at least 5 mm as claimed, Gobel does disclose that the incision 27 is formed approximately correspondingly with the glottis. Sato evidences that the glottis is, on average, more than 5 mm long (pg. 92, “The Dimensions and Morphological Characteristics of the Human Adult Glottis” section, “The average length of the glottis (Fig. 9.4, Lag + Lpg) is 24.5 ± 1.9 (average ± SD) mm in males and 16.3 ± 1.4 mm in females ”), and thus Gobel is considered to teach the axial length of the incision to be at least 5 mm long as claimed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the inflatable cuff of Bracken as modified as in Gobel for allowing the tube to be positionable at a different part of the patient anatomy by lining up the divot portion with an anatomic structure as in Gobel (see at least Gobel [0080]). Since the devices of Bracken as modified and Gobel are both endotracheal tubes, and since Bracken as modified is for configured for sealing the trachea in the endotracheal tract (see at least Bracken [0002]) and the configuration of Gobel is for sealing a different part of the endotracheal tract around the glottis (Gobel [0080]), and since the configuration of Gobel is such that it is configured to seal the glottis at the incision, it is the Examiner’s position that the re-shaped cuff of the modified device would have the claimed configuration for providing sealing to the different area of the endotracheal tube should the practitioner want to seal the endotracheal tube at the glottis as in Gobel.
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Annotated fig. 9 from Bracken
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Annotated fig. 6 from Gobel
Regarding claim 2, Bracken as modified discloses the medical tube wherein in the inflatable cuff, the proximal cuff portion has a first maximum outer diameter (see annotated fig. 9), the distal cuff portion has a second maximum outer diameter (see annotated fig. 9), and the divot portion has a third outer diameter (see annotated fig. 9) that is less than the first and second maximum outer diameters (as shown in annotated fig. 9, this is true; note also [00052]).
Regarding claim 4, Bracken as modified discloses the medical tube wherein when scanned using an ultrasonic sensor to produce an ultrasonic image, in the ultrasonic image produced by the ultrasound sensor positioned over the at least one divot portion, the presence of the inflatable cuff is not visible (if the ultrasonic sensor were to be positioned over the divot portion in the modified device of Bracken, the divot portion, and thus the presence of the inflatable cuff, would not be visible as claimed because there is no structure which is present to differentiate the divot portion from the hollow cavity in which the medical tube resides, which is typically the trachea; in particular, since the divot portion lacks the fluid which causes backscattering of light for detection of structural features of the tube as a result of acoustical mismatching as taught in Miller [0013], [0039], and [0059]-[0060] in the modified device, the structures of the medical tube would not be visible as claimed since no backscattering of ultrasonic waves would occur).
Regarding claim 5, Bracken as modified discloses the medical tube further including an inflation lumen in fluid communication with an interior of the inflatable cuff (see [0008], [00023], [00050]).
Regarding claim 6, Bracken as modified discloses the medical tube wherein the inflatable cuff is configured to be filled with air (see [00050], the disclosed gas is air as in [0004]; note that while the modified device relies on the use of fluid of Miller to provide backscattering and acoustical mismatch as claimed, the cuff of Bracken is still structurally capable of being filled with air, and since the limitation is functional where it recites that the cuff is configured to be filled with air and thus requires only that the cuff is capable of being filled with air, the claim limitation is met).
Regarding claim 7, Bracken as modified discloses the medical tube wherein the inflatable cuff is configured to be filled with saline or water (see Miller [0059], the fluid which is used to fill the cuff is a saline solution in the modified device).
Regarding claim 8, Bracken as modified discloses the medical tube wherein the at least one divot portion is generally toroidal (since the divot portion has a rounded exterior where it follows the same tubular exterior shape as the proximal and distal cuff portions, a hollow interior which is filled by portion 18a as shown in annotated fig. 9, and extends longitudinally over the length of portion 18a, it is generally donut-shaped and is thus generally toroidal as claimed).
Regarding claim 26, Bracken discloses a repositionable endotracheal medical tube (the chosen embodiment is shown in figs. 6-13, however an alternative embodiment showing the endotracheal tube 1 as a whole is shown in fig. 1; the disclosure of Bracken is generally drawn to an endotracheal tube which can be moved between positions, see [00011] and [00012]) having an inflatable cuff (cuff 18, figs. 8 and 9), the inflatable cuff comprising: a proximal end (see annotated fig. 9); a proximal cuff portion (proximal section or area 18c, fig. 9) adjacent to the proximal end (see fig. 9, the proximal end and proximal section 18c are immediately adjacent to each other); at least one divot portion (the indented space radially surrounding center section or area 18a, fig. 9, which extends radially from the third maximum outer diameter as shown in annotated fig. 9 to the second maximum outer diameter as shown in annotated fig. 9 and extends longitudinally between cuff portions 18b and 18c as shown) disposed distal to the proximal cuff portion (see fig. 9), the divot portion tapering inwardly from a maximum diameter adjacent each of the proximal cuff portion (see annotated fig. 9) and a distal cuff portion (see annotated fig. 9) to a minimum diameter (see third maximum outer diameter of annotated fig. 9) intermediate the proximal and distal cuff portions (see annotated fig. 9, the minimum diameter which is the third maximum outer diameter is located between the proximal and distal cuff portions), the divot portion having an axial length measured from a first end at which the proximal cuff portion mees the maximum diameter of the divot portion adjacent to the proximal cuff portion (see annotated fig. 9, the point at which the cuff portion meets the divot portion is the first end as claimed), to a second end at which the distal cuff portion meets the maximum diameter of the divot portion adjacent the distal cuff portion (see annotated fig. 9, the point at which the cuff portion meets the divot portion is the second end as claimed); the distal cuff portion (distal section or area 18b, fig. 9) disposed opposite the at least one divot portion from the proximal cuff portion (see fig. 9), the proximal cuff portion, the divot portion, and the distal cuff portion being contiguous with one another (see [00052] and see fig. 8) and defining a shared fluid bladder (this is understood to be true in view of [00050]-[00052] where it is disclosed that there is a pressure increase within cuff 18; since this is one pressure increase, it is understood that the cuff is all one shared fluid bladder and there are no internal walls separating the cuff 18 into separate fluid bladders; additionally see fig. 8 which shows no such internal walls), with the proximal cuff portion and the distal cuff portion being inflatable to a greater extent than the divot portion (this is shown in fig. 9 and disclosed in [00052]); and a distal end (see annotated fig. 9) adjacent the distal cuff portion (see fig. 9, the distal end and distal section 18b are immediately adjacent to each other). Bracken additionally discloses that its cuff portions must be inflated ([00050]-[00052] discloses inflation with a gas) and that the medical tube has a radiopaque stripe ([0008]). {Examiner notes that radiopaque stripes are known to be usable with radiography as an imaging modality.}
Bracken does not disclose the medical tube wherein the divot portion has an acoustic impedance sufficiently different from an acoustic impedance of the proximal and distal cuff portions so as to achieve an acoustical mismatch that, when scanned using an ultrasonic sensor to produce an ultrasonic image, in the ultrasonic image produced by the ultrasound sensor positioned over at least one of the proximate cuff portion and the distal cuff portion, a signal indicative of the presence of the inflatable cuff is visually discernible such that a precise location of the inflatable cuff, and the medical tube, in situ, may be directly determined by viewing the ultrasonic image. Miller teaches a medical tube (tubular apparatus 10, figs. 1 and 3) having an inflatable cuff (sleeve 42, main balloon cuff 38, sleeve 40, and leader balloon cuff 46, fig. 3, make up an inflatable cuff because the structures of the main balloon cuff 38 and leader balloon cuff 46 can be inflated by air or saline as in [0035] and the structures make up a cuff at the distal section 32 of tubular apparatus 12) having a proximal cuff portion (main balloon cuff 38, fig. 3) and a distal cuff portion (leader balloon cuff 46, fig. 3) with a divot portion located between the cuff portions (see fig. 3, the divot portion is the indented space surrounding sleeve 40 which extends radially from the maximum outer diameter of sleeve 40 to the maximum outer diameter of sleeve 46 and extends longitudinally between cuff portions 46 and 38 as shown) wherein the divot portion has an acoustic impedance (since there is no structure present at the divot portion, its acoustic impedance would be that of the hollow body cavity in which it is placed, see Abstract) sufficiently different from an acoustic impedance of the distal cuff portion (see [0039], [0058], and [0059], leader balloon cuff 46 can be inflated with an acoustically transmissive fluid; this fluid can be saline or other materials as taught in [0059]) so as to achieve an acoustical mismatch when scanned using an ultrasonic sensor to produce an ultrasonic image (see [0058] and [0059], the selected fluid in the cuff causes back scattering of ultrasonic waves because of its acoustic mismatch when scanned using an ultrasonic transducer), in the ultrasonic image produced by the ultrasound sensor positioned over the distal cuff portion, a signal indicative of the presence of the inflatable cuff is visually discernible such that a precise location of the inflatable cuff, and the medical tube, in situ, may be directly determined by viewing the ultrasonic image as a result of an acoustical mismatch between the divot portion and the cuff portions (See [0058]-[0062], the positioning of tubular apparatus 10, and especially leader balloon cuff 46 as a part of tubular apparatus 10, can be determined via an ultrasonic monitor and transducer – which is a sensor as [0009] – because the structures of the leader balloon cuff 46 can be seen on the ultrasonic monitor. This is understood to mean that a signal indicating the presence and location of leader balloon cuff 46 is discernible when the cuff is inflated as in [0061] in particular when viewed by an ultrasonic monitor and image produced therein because the fluid inside of cuff 46 has an acoustic impedance mismatch with the air or other gas in the hollow body cavity which surrounds it and the divot portion and allows for the cuff 46 to be located relative to the divot portion to give a precise location). Miller additionally teaches that radiography and ultrasonic techniques are known to be used to determine placement of endotracheal tubes (see [0008]-[0009]), and that material selection in proximal and distal cuff portions can be used to provide for ultrasonic imaging appearing visually on ultrasonic monitors ([0060]-[0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the materials and fluids with acoustic impedances in the distal cuff portion of the medical tube of Miller in the cuff portions of Bracken to allow for ultrasonic imaging to be able to be used instead of radiographic imaging as it is an equivalent method of imaging in the placement of endotracheal tubes (see Miller [0008] and [0009]) and because the use of such materials allows for easy visual detection as claimed (see Miller [0060]-[0061]). Since both of the proximal and distal cuff portions of Bracken inflate using the same gas ([00050]-[00052]), and since this gas would be replaced with the fluid of Miller in the modified device, this would further mean that the divot portion of Bracken would be different from both cuff portions to achieve the acoustical mismatch as claimed.
Bracken as modified by Miller does not disclose the divot portion having an axial length, measured from a first end at which the proximal cuff portion meets the maximum diameter of the divot portion adjacent to the proximal cuff portion, to a second end at which the distal cuff portion meets the maximum diameter of the divot portion adjacent the distal cuff portion, of at least 5mm wherein at least one of the proximal cuff portion or the distal cuff portion, when the inflatable cuff is in an inflated condition, has a uniform diameter along an axially–extending region of the inflatable cuff at least as long as an axially–extending length of the divot portion. Gobel teaches a repositionable endotracheal medical tube (tracheal tube 1 of fig. 6) having an inflatable cuff (balloon 24, fig. 6), the inflatable cuff comprising: a proximal end (see annotated fig. 6 below, the proximal end is the end closer to filling balloon 33); a proximal cuff portion (see the portion of the balloon 24 which is between incision 27 and balloon 33) adjacent to the proximal end (see annotated fig. 6); at least one divot portion (incision 27, fig. 6) disposed distal to the proximal cuff portion (see fig. 6, the distal direction is the direction towards the tapered end of ventilating cannula 3 as shown), the divot portion tapering inwardly from a maximum diameter adjacent each of the proximal cuff portion and a distal cuff portion (see annotated fig. 6, incision 27 tapers inwardly from a maximum, uniform outer diameter of each of the cuff portions as shown at the first and second end of the divot portion as called out) to a minimum diameter (see annotated fig. 6, the minimum diameter is called out within incision 27) intermediate the proximal and distal cuff portions (see annotated fig. 6), the divot portion having an axial length (see annotated fig. 6, the axial length of incision 27 is measured from the called out first end to the called out second end and is shown as the length along tube 3 which has cross hatched shading as opposed to straight lines), measured from a first end at which the proximal cuff portion meets the maximum diameter of the divot portion adjacent to the proximal cuff portion (see annotated fig. 6, the first end as claimed is called out), to a second end at which the distal cuff portion meets the maximum diameter of the divot portion adjacent the distal cuff portion (see annotated fig. 6, the second end as claimed is called out); the distal cuff portion disposed opposite the at least one divot portion from the proximal cuff portion (see annotated fig. 6), with the proximal cuff portion and the distal cuff portion being inflatable to a greater extent than the divot portion ([0080), at least one of the proximal cuff portion or the distal cuff portion, when the inflatable cuff is in an inflated condition, having a uniform diameter (see annotated fig. 6, the uniform diameter sections are called out along the cuff portions) along an axially- extending region of the inflatable cuff (see annotated fig. 6) at least as long as an axially-extending length of the divot portion (see annotated fig. 6, the called out uniform portions extend further along cannula 3 than incision 27). While Gobel does not explicitly teach the axial length of the divot portion to be at least 5 mm as claimed, Gobel does disclose that the incision 27 is formed approximately correspondingly with the glottis. Sato evidences that the glottis is, on average, more than 5 mm long (pg. 92, “The Dimensions and Morphological Characteristics of the Human Adult Glottis” section, “The average length of the glottis (Fig. 9.4, Lag + Lpg) is 24.5 ± 1.9 (average ± SD) mm in males and 16.3 ± 1.4 mm in females ”), and thus Gobel is considered to teach the axial length of the incision to be at least 5 mm long as claimed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the inflatable cuff of Bracken as modified as in Gobel for allowing the tube to be positionable at a different part of the patient anatomy by lining up the divot portion with an anatomic structure as in Gobel (see at least Gobel [0080]). Since the devices of Bracken as modified and Gobel are both endotracheal tubes, and since Bracken as modified is for configured for sealing the trachea in the endotracheal tract (see at least Bracken [0002]) and the configuration of Gobel is for sealing a different part of the endotracheal tract around the glottis (Gobel [0080]), and since the configuration of Gobel is such that it is configured to seal the glottis at the incision, it is the Examiner’s position that the re-shaped cuff of the modified device would have the claimed configuration for providing sealing to the different area of the endotracheal tube should the practitioner want to seal the endotracheal tube at the glottis as in Gobel.
Regarding claim 27, Bracken as modified discloses the medical tube of claim 26, wherein the inflatable cuff is configured to be filled with saline or water (see Miller [0059], the fluid which is used to fill the cuff is a saline solution in the modified device).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
With respect to Gobel, Applicant's arguments filed 03/23/2026 have been fully considered but they are not persuasive. Applicant argued that it would not have been obvious to have combined the teachings of Gobel with the teachings of Bracken and Miller as previously relied upon; Examiner respectfully disagrees as Gobel teaches an arrangement with a shape beneficial for sealing against a portion of the laryngeal anatomy with dimensions and uniform portions of maximum diameter as claimed, and it would have been obvious to have shaped the modified assembly of Bracken and Miller as in Gobel for the benefit of providing sealing to the glottis should that be an area that a practitioner were like to isolate in a patient’s anatomy.
Thus, Examiner respectfully finds Applicant’s arguments unpersuasive and rejects the claims as indicated in the rejection above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Prosecution Insights