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 .
Response to Amendment
Applicant has canceled claim 9 which was previously rejected under 35 U.S.C. §112(d).
The Specification was previously objected to and has been amended; Examiner accordingly withdraws the objections to the Specification.
Claims 3 and 9-25 have been cancelled. Claims 26-27 have been added. Claims 1-2, 4-8, and 26-27 remain pending. No new matter has been entered.
Claim Objections
Claims 1 and 26 are objected to because of the following informalities:
Each of claims 1 and 26 is objected for a typographical error wherein the claims have improper antecedent basis where they recite “a maximum diameter adjacent each of the proximal and distal cuff portions to a minimum diameter intermediate the proximal and distal cuff portions; a distal cuff portion disposed opposite the at least one divot portion from the proximal cuff portion” and should instead recite “a maximum diameter adjacent each of the proximal cuff portion and a distal cuff portion to a minimum diameter intermediate the proximal and distal cuff portions; the distal cuff portion disposed opposite the at least one divot portion from the proximal cuff portion”.
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).
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 (see annotated fig. 9) and distal cuff portions (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); a 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]), at least one of the proximal cuff portion or the distal cuff portion having a uniform diameter (see annotated fig. 10, each of the proximal cuff portion and the distal cuff portion have short regions immediately adjacent to the divot portion when the cuff is deflated which have uniform outer diameters) along an axially-extending region of the inflatable cuff (see lengths L1 in annotated fig. 10) at least as long as an axially-extending length of the divot portion (see length L2 in annotated fig. 10; lengths L1 are each longer than length L2 as shown); 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.
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Annotated fig. 9 from Bracken
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Annotated fig. 10 from Bracken calling out the claimed lengths with uniform diameters
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 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 (see annotated fig. 9) and distal cuff portions (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); a 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])), both the proximal cuff portion and the distal cuff portion having a uniform diameter (see annotated fig. 10, each of the proximal cuff portion and the distal cuff portion have short regions immediately adjacent to the divot portion when the cuff is deflated which have uniform outer diameters) along an axially-extending region of the inflatable cuff (see lengths L1 in annotated fig. 10); 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.
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 filed 01/06/2026 have been fully considered but they are not persuasive.
Applicant has argued that Bracken does not disclose the new limitations regarding a uniform diameter along an axially extending-region of the proximal and/or distal cuff portion. Examiner respectfully disagrees. As shown in fig. 10 of Bracken and called out specifically in annotated fig. 10 provided above, the deflated cuff of Bracken has a region of each of the proximal and distal cuff portions which are closest to the deflated divot portion which have a uniform outer diameter before the outer diameter decreases as the distance from the from the divot portion increases. The claim does not require that the inflatable cuff be inflated when it has the claimed uniform length regions, and thus the deflated state of Bracken as shown in fig. 10 applies to meet the claim limitations. The divot portion in Bracken tapers inwardly as claimed where it has a smaller maximum radius in its middle as called out in annotated fig. 9 compared to the proximal and distal cuff portions which have larger maximum outer radii in their respective inflated states.
Additionally, Examiner notes that Applicant’s argument pertaining to the presence of an air pocket between the divot portion and the surrounding tissue due to the tapering of the divot portion is not a claimed feature. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the presence of an air pocket due to the amount of tapering of the divot portion relative to the distal and proximal cuff portions) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Thus, Examiner respectfully finds Applicant’s arguments unpersuasive and rejects the claims as indicated in the rejection above.
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.
Additionally, Examiner notes that figs. 4 and 5 of Applicant’s Drawings show screenshots of ultrasound images at different positions, with the first position of fig. 4 being along the distal cuff portion and the second position of fig. 5 being along the divot portion; the Drawings are relied upon to show the visible and discernible differences between the positioning of the medical tube and cuff structures, and it is not abundantly clear where in figs. 4 and 5 these differences are shown. No objection is made to the Drawings, however an annotated copy of figs. 4 and 5 provided in the next set of Applicant’s Remarks pointing out the differences between these figures and highlighting the different structures could be helpful to facilitate further understanding.
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-Th 7:00a-5:00p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783