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 .
Drawings
The drawings are objected to because:
Fig. 37 has improper shading and the lighter shading is not sufficiently dense and darker enough for reproduction (see MPEP 608.02(V)(l) and MPEP 608.02(V)(m)).
Figs. 45-47 and 54 are photographs which are not ordinarily permitted in utility patent applications (see MPEP 608.02(V)(b)(1)).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 2 is objected to because of the following informality: claim 2 recites “a nasotracheal tubes” in line 2, and is suggested to read --a nasotracheal tube-- in order to be grammatically correct.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase "other tubes" in lines 1 and 17 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "other"), thereby rendering the scope of the claims unascertainable. See MPEP § 2173.05(d). Moreover, the limitation “one or more other tubes” in line 17 is confusing, as it is unclear as to whether this limitation is meant to be the same as or different from “one or more other tubes” in line 1. For the purposes of examination, they will be interpreted as the same limitation. Furthermore, the limitation “its” in line 22 is confusing, as it is unclear as to what limitation is being referenced.
Regarding claim 15, the phrase "other tubes" in lines 1 and 2 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "other"), thereby rendering the scope of the claims unascertainable. See MPEP § 2173.05(d). Moreover, the limitations “a nasal tube” in line 1, “a nose” in line 1, “a patient” in line 1, and “one or more other tubes” in lines 1 and 2 are confusing, as it is unclear as to whether these limitations are meant to be the same as or different from “a nasal tube” in claim 1, “a nose” in claim 1, “a patient” in claim 1, “one or more other tubes” in claim 1 and/or line 1, respectively. For the purposes of examination, they will be interpreted as the same respective limitations.
Regarding claim 17, the phrase "other tubes" in lines 1 and 23 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "other"), thereby rendering the scope of the claims unascertainable. See MPEP § 2173.05(d). Moreover, the limitation “one or more other tubes” in line 23 is confusing, as it is unclear as to whether this limitation is meant to be the same as or different from “one or more other tubes” in line 1. For the purposes of examination, they will be interpreted as the same limitation. Furthermore, the limitation “its” in line 28 is confusing, as it is unclear as to what limitation is being referenced.
Regarding claim 20, the phrase "other tubes" in lines 1 and 2 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "other"), thereby rendering the scope of the claims unascertainable. See MPEP § 2173.05(d). Moreover, the limitations “a nasal tube” in line 1, “a nose” in line 1, “a patient” in line 1, and “one or more other tubes” in lines 1 and 2 are confusing, as it is unclear as to whether these limitations are meant to be the same as or different from “a nasal tube” in claim 17, “a nose” in claim 17, “a patient” in claim 17, “one or more other tubes” in claim 17 and/or line 1, respectively. For the purposes of examination, they will be interpreted as the same respective limitations.
Any remaining claims are rejected based on their dependency on a rejected base claim.
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 patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson et al. (US 2013/0338521 A1) in view of Beran (US 4,114,626) and Flagler et al. (US 2008/0072911 A1).
Regarding claim 1, as best understood, Thompson discloses a nasal tube device for securing a nasal tube and one or more other tubes to a nose of a patient (nasal tube devices for placing and securing a nasal tube to a patient’s nose; the nasal tube can be comprised of multiple tubes) (Figs. 3, 5A; abstract; para. [0049]), the nasal tube device comprising:
(a) a nasal tube comprising, sequentially, a proximal end, a proximal-clip portion, a proximal-flange portion, a distal portion, and a distal end, the proximal end of the nasal tube having a proximal opening, the distal end of the nasal tube having a distal opening, and the nasal tube having a nasal tube lumen extending from the proximal opening of the nasal tube to the distal opening of the nasal tube (nasal tube 102 has a proximal end 130 with an opening for lumen 134, a flange 140/recessed portion 142 for securing device 110, a portion for retention flange 104, a distal portion behind the flange 104, and a distal end 132 with an opening; lumen 134 extends between the proximal end 130 opening and the distal end 132 opening) (Figs. 1A-5A; para. [0049]; para. [0052]; para. [0055]; para. [0059]);
(b) a flange having a proximal face and a distal face, the flange extending radially outwardly from the proximal-flange portion of the nasal tube, the nasal tube extending through the flange (retention flange 104 has proximal and distal faces, and extends radially outwards from the its portion of the nasal tube 102; nasal tube 102 extends through the retention flange 104) (Figs. 1A-5A; para. [0051]; para. [0054]);
(d) a clip for securing one or more other tubes to the nasal tube within the lumen of the nasal tube at the proximal-clip portion of the nasal tube (securing device 110 is a clip; securing device 110 can secure the portions 220, 222 of the bridle line 208 inside the lumen 134 at the portion of nasal tube 102 for the securing device 110) (Figs. 1A-5A; para. [0060]; para. [0062]), the clip being reversibly closeable about the proximal-clip portion of the nasal tube to reversibly compress the proximal-clip portion of the nasal tube about the one or more other tubes when closed (securing device 110 has a living hinge to allow it to switch between open and closed positions about its portion of the nasal tube 102; securing device 110 compresses about the nasal tube 102 and the tubes inside the lumen 134 when closed) (Figs. 1A-5A; paras. [0059-0060]), wherein:
the nasal tube has an elliptical tubular cross section that is noncircular (nasal tube cross section can be ovoid, elliptical, oval, or other non-circular shapes) (para. [0106]).
Thompson does not disclose (c) an adhesive tape comprising a base portion and one or more strip portions extending from the base portion, the base portion of the adhesive tape having a proximal side, a distal side, and a hole therethrough, each of the one or more strip portions having a proximal side and a distal side, the distal side of each of the one or more strip portions each having an adhesive surface, the nasal tube extending through the hole of the base portion of the adhesive tape, the adhesive tape being attached to the flange at the base portion of the adhesive tape.
However, Beran teaches an intubation set (Beran; abstract) including an adhesive tape comprising a base portion and one or more strip portions extending from the base portion (adhesive layers 118, 124 have respective tabs 122, 128 with strips extending from the sides of the tabs 122, 128) (Beran; Figs. 10, 13-17; col. 6 lines 14-29), the base portion of the adhesive tape having a proximal side, a distal side, and a hole therethrough (tabs 122, 128 have proximal and distal sides as well as tab openings 144, 150) (Beran; Figs. 10, 13-17; col. 6 lines 14-29), each of the one or more strip portions having a proximal side and a distal side, the distal side of each of the one or more strip portions each having an adhesive surface (the strips extending from the sides of the tabs 122, 128 have proximal and distal sides, with the adhesives of the respective adhesive layers 118, 124 on the distal sides facing flange 140) (Beran; Figs. 10, 13-17; col. 6 lines 14-29), the nasal tube extending through the hole of the base portion of the adhesive tape (tube 102 for insertion into a nostril extends through the tab openings 144, 150) (Beran; Fig. 10; col. 5 lines 51-60), the adhesive tape being attached to the flange at the base portion of the adhesive tape (adhesive layers 118, 124 are attached to the sleeves 112, 114 and retaining ring 116 at their respective tabs 122, 128) (Beran; Figs. 10, 13-17; col. 5 lines 51-60; col. 6 lines 14-29).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Thompson flange to include an adhesive tape comprising a base portion and one or more strip portions extending from the base portion, the base portion of the adhesive tape having a proximal side, a distal side, and a hole therethrough, each of the one or more strip portions having a proximal side and a distal side, the distal side of each of the one or more strip portions each having an adhesive surface, the nasal tube extending through the hole of the base portion of the adhesive tape, the adhesive tape being attached to the flange at the base portion of the adhesive tape, as taught by Beran, for the purpose of providing a more effective means of keeping the tube in position relative to the patient in terms of the strength of connection and the variety of physical situations that can be accommodated (Beran; col. 5 lines 20-25).
Thompson does not disclose the flange is highly compliant based on being thin and flexible and provides a barrier to moisture and heat based on its composition.
However, the Applicant’s specification para. [0145] recites, “The flange 124 is highly compliant based on being thin and flexible and provides a barrier to moisture and heat based on its composition… the flange 124 should be made from a material that provides for the flange 124 to be sufficiently flexible to conform to the anatomy of a patient. Suitable thicknesses for the flange 124 include, for example, 0.50 to 5.00 mm, 0.60 to 2.50 mm, or 0.75 to 1.00 mm… Suitable materials for making the flange 124, include, for example, silicone rubber elastomer, natural latex rubber, thermoplastic elastomer, styrene block copolymer, thermoplastic polyolefin, thermoplastic polyurethane, thermoplastic vulcanizate, ethylene-propylene-diene-monomer, copolymer derivatives of ethylene-propylene-diene-monomer, styrene-butadiene-rubber, copolymer derivatives of styrene-butadiene-rubber, flexible non-elastomeric polymer, or plasticized polyvinyl chloride”. Thus, a flange of suitable material and thickness would inherently be thin and flexible and be able to provide a barrier to moisture and heat as claimed. Flagler teaches a molded tracheostomy tube (Flagler; abstract) wherein the flange member 20 can be made of a thermoplastic elastomer with a thickness of 0.03-0.05 inches, i.e. 0.762-1.27 mm (Flagler; Figs. 1A-5; paras. [0030-0031]), and so teaches wherein the flange is highly compliant based on being thin and flexible and provides a barrier to moisture and heat based on its composition as claimed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Thompson flange to be highly compliant based on being thin and flexible and provides a barrier to moisture and heat based on its composition, as taught by Flagler, for the purpose of providing the flange with increased flexibility to allow for greater range of motion for the attached conduit or tube (Flagler; paras. [0030-0031]).
Regarding claim 2, the modified Thompson teaches wherein the nasal tube comprises a nasopharyngeal airway or a nasotracheal tubes (nasal tube can be a nasopharyngeal airway or pass into the trachea) (Thompson; para. [0036]).
Regarding claim 3, the modified Thompson teaches wherein the flange is formed integrally to the nasal tube at the proximal-flange portion of the nasal tube (retention flange 104 can be integral to the nasal tube 102 at that proximal-flange portion of the nasal tube 102) (Thompson; Figs. 1A-5A; para. [0036]).
Regarding claim 4, the modified Thompson teaches wherein the flange is formed separately from the nasal tube, the flange has a hole therethrough, and the nasal tube extends through the hole of the flange (retention flange 104 can be attached to the nasal tube 102, and so be separate pieces; when separate pieces, the flange 104 would have to have a hole through which the nasal tube 102 can extend) (Thompson; Figs. 1A-5A; para. [0036]).
Regarding claim 5, the modified Thompson teaches wherein the flange has a thickness of 0.50 to 5.00 mm (flange member 20 can have a thickness of 0.03-0.05 inches, i.e. 0.762-1.27 mm) (Flagler; para. [0031]).
Regarding claim 6, the modified Thompson teaches wherein the flange is made from a material having a tensile strength of 2.0 to 20 MPa, a tensile modulus of 0.5 to 10 MPa, and a hardness of 50 Shore-00 to 90 Shore A (as Flagler teaches the material and thickness of the flange having these properties of tensile strength, tensile modulus, and hardness as described in the Applicant’s specification para. [0145], the Flagler flange would thus also have these physical properties as claimed) (Flagler; Figs. 1A-5; paras. [0030-0031]).
Regarding claim 7, the modified Thompson teaches wherein the flange is made from thermoplastic elastomer (flange member 20 can be made of a thermoplastic elastomer) (Flagler; para. [0030]).
Regarding claim 8, the modified Thompson teaches wherein the one or more strip portions of the adhesive tape comprise two to four strip portions extending from the base portion of the adhesive tape (each of the adhesive layers 118, 124 has two strips extending from the sides of the tabs 122, 128) (Beran; Figs. 10, 13-17).
Regarding claim 9, the modified Thompson teaches wherein the adhesive tape is attached to the flange based on the distal side of base portion of the adhesive tape being adhered to the proximal face of the flange (adhesive layers 118, 124 are attached to the proximal face of the retaining ring 116 based on the distal sides of tabs 122, 128) (Beran; Figs. 10, 13-17; col. 5 lines 51-60; col. 6 lines 14-29).
Regarding claim 10, the modified Thompson teaches wherein the adhesive tape is attached to the flange based on the proximal side of base portion of the adhesive tape being adhered to the distal face of the flange (adhesive layers 118, 124 are attached to the distal face of the flange 140 based on the proximal sides of tabs 122, 128) (Beran; Figs. 10, 13-17; col. 5 lines 51-60; col. 6 lines 14-29).
Regarding claim 11, the modified Thompson teaches wherein the nasal tube device further comprises an adhesive liner, the adhesive liner covering the adhesive surfaces of the distal sides of the one or more strip portions of the adhesive tape (peel-away protective coverings 130, 132 and/or patch sheets 120, 126 cover the surfaces of the adhesive layer 118, 124 strips) (Beran; Figs. 10, 13-17; col. 5 lines 51-68; col. 6 lines 1-4, 14-29).
Regarding claim 12, the modified Thompson teaches wherein the clip and the proximal-clip portion of the nasal tube comprise structures that provide a complementary fit between the clip and the proximal-clip portion of the nasal tube when the clip is closed about the proximal-clip portion of the nasal tube (recessed portion 142 has a recessed outer wall surface or nest region for a complementary fit to the inner surface walls of the closed securing device 110) (Thompson; Figs. 1A-5A; para. [0055]).
Regarding claim 13, the modified Thompson teaches wherein the clip comprises one or more protrusions to reversibly compress the proximal-clip portion of the nasal tube about the one or more other tubes when the clip is closed about the proximal-clip portion of the nasal tube (securing device 110 has a tongue-and-groove style locking mechanism 412 to open and close the securing mechanism about the nasal tube 102 at the recessed portion 142, thereby compressing the nasal tube 102 and the tubes inside when closed) (Thompson; Figs. 1A-5A; paras. [0059-0060]).
Regarding claim 15, as best understood, the modified Thompson teaches a system for securing a nasal tube and one or more other tubes to a nose of a patient, the system comprising the nasal tube device according to claim 1 and one or more other tubes (see 35 U.S.C. 103 rejection of claim 1 above), wherein: the one or more other tubes are partially disposed in the nasal tube lumen of the nasal tube through the proximal opening of the nasal tube; and the clip is reversibly closed about the proximal-clip portion of the nasal tube, thereby reversibly compressing the proximal-clip portion of the nasal tube about the one or more other tubes (securing device 110 has a living hinge to allow it to switch between open and closed positions about its portion of the nasal tube 102; securing device 110 compresses the nasal tube 102 at the recessed portion 142 and the tubes inside the proximal opening of the nasal tube 102 lumen 134 when closed) (Thompson; Figs. 1A-5A; paras. [0059-0060]).
Regarding claim 16, the modified Thompson teaches wherein the nasal tube comprises a nasopharyngeal airway (nasal tube can be a nasopharyngeal airway) (Thompson; para. [0036]), and the one or more other tubes comprise a tube for oxygen delivery and a tube for carbon dioxide monitoring (oxygen delivery tube 308 and carbon dioxide monitoring tube 310) (Thompson; Fig. 3; para. [0049]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Thompson in view of Beran and Flagler as applied to claim 1 above, and further in view of Doshi et al. (US 2011/0067709 A1).
Regarding claim 14, the modified Thompson teaches the invention as previously claimed including wherein the nasal tube has an elliptical tubular cross section that is noncircular based on the elliptical tubular cross section having a major axis length and an interfocal length (nasal tube cross section can be ovoid, elliptical, oval, or other non-circular shapes; when an elliptical shape, there would be both a major axis length and an interfocal length within the major axis length) (Thompson; para. [0106]), but is silent on the interfocal length being 0.50 to 0.99 times the major axis length.
However, Doshi teaches a nasal respiratory device (Doshi; abstract) with an elliptical profile in which the ratio of the long axis to the short axis is between 1.2:1 and 3:1, and the long axis can between 8 and 20 mm (Doshi; para. [0092]). Moreover, one of ordinary skill in the art with knowledge of basic equations regarding ellipses would know that when one takes any point on the ellipse, the sum of the distances to the focus points is constant. Thus, to calculate an interfocal length: (Interfocal length of ellipse/2)2 = (major axis length/2)2 - (minor axis length/2)2 . In the case of Doshi, when the ratio between axes is 3:1 and the long axis is 12 mm, this means: (Interfocal length of ellipse/2)2 = (12/2)2 - (4/2)2 = (6)2 - (2)2 = 36 - 4 = 32. The square root of 32 is about 5.657, which is then multiplied by 2 to yield the interfocal length of 11.31, which is about 0.943 times the major axis length (i.e. 11.31 divided by 12 is about 0.943).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Thompson elliptical tubular cross section such that the interfocal length being 0.50 to 0.99 times the major axis length, as taught by Doshi, for the purpose of providing a specific elliptical size and shape for the nasal tube that would be suitable to fit inside a nostril.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson in view of Sheridan et al. (US 3,973,569), Beran, and Flagler.
Regarding claim 17, as best understood, Thompson discloses a nasal tube device for securing a nasal tube and one or more other tubes to a nose of a patient (nasal tube devices for placing and securing a nasal tube to a patient’s nose; the nasal tube can be comprised of multiple tubes) (Figs. 3, 5A; abstract; para. [0049]), the nasal tube device comprising:
(a) a nasal tube comprising, sequentially, a proximal end, a proximal-clip portion, a distal portion, and a distal end, the proximal end of the nasal tube having a proximal opening, the distal end of the nasal tube having a distal opening, and the nasal tube having a nasal tube lumen extending from the proximal opening of the nasal tube to the distal opening of the nasal tube (nasal tube 102 has a proximal end 130 with an opening for lumen 134, a recessed portion 142 for securing device 110, a portion for retention flange 104, a distal portion behind the flange 104, and a distal end 132 with an opening; lumen 134 extends between the proximal end 130 opening and the distal end 132 opening) (Figs. 1A-5A; para. [0049]; para. [0052]; para. [0055]; para. [0059]);
(c) a flange having a proximal face and a distal face, the flange extending radially outwardly from the nasal tube, the flange having a hole between the proximal face of the flange and the distal face of the flange, the flange being formed separately from the nasal tube, the nasal tube extending through the hole of the flange (retention flange 104 has proximal and distal faces, and extends radially outwards from the its portion of the nasal tube 102; retention flange 104 is attached to the nasal tube 102 and so is a separate piece; nasal tube 102 extends through the retention flange 104 via a hole in the flange 104) (Figs. 1A-5A; para. [0051]; para. [0054]);
(e) a clip for securing one or more other tubes to the nasal tube within the lumen of the nasal tube at the proximal-clip portion of the nasal tube (securing device 110 is a clip; securing device 110 can secure the portions 220, 222 of the bridle line 208 inside the lumen 134 at the portion of nasal tube 102 for the securing device 110) (Figs. 1A-5A; para. [0060]; para. [0062]), the clip being reversibly closeable to reversibly compress the proximal-clip portion of the nasal tube about the one or more other tubes when closed (securing device 110 has a living hinge to allow it to switch between open and closed positions about its portion of the nasal tube 102; securing device 110 compresses about the nasal tube 102 and the tubes inside the lumen 134 when closed) (Figs. 1A-5A; paras. [0059-0060]), wherein:
the nasal tube has an elliptical tubular cross section that is noncircular (nasal tube cross section can be ovoid, elliptical, oval, or other non-circular shapes) (para. [0106]).
Thompson does not disclose (b) a bolster comprising a proximal end, a bolster body, and a distal end, the proximal end of the bolster having a proximal opening, the distal end of the bolster having a distal opening, the bolster having a bolster lumen extending from the proximal opening of the bolster to the distal opening of the bolster, the bolster being formed separately from the nasal tube, the nasal tube extending through the bolster lumen; the flange being distal to the bolster on the nasal tube; the clip being reversibly closeable about the bolster.
However, Sheridan teaches a tracheostomy tube (Sheridan; abstract) including a bolster comprising a proximal end, a bolster body, and a distal end, the proximal end of the bolster having a proximal opening, the distal end of the bolster having a distal opening, the bolster having a bolster lumen extending from the proximal opening of the bolster to the distal opening of the bolster, the bolster being formed separately from the nasal tube, the nasal tube extending through the bolster lumen (the combination of ring members 40 teaching the bolster; a proximal ring 40 has a body with an opening for the tubular section 8, a distal ring 40 has a body with an opening for the tubular section 8; middle ring 40 forms the lumen extending between the proximal and distal rings 40 through which tubular section 8 extends; the rings are separate from the tubular portion 8) (Sheridan; Figs. 1-5; col. 2 lines 46-54); the flange being distal to the bolster on the nasal tube (flange 22 is distal to the distal ring 40 on the tubular section 8) (Sheridan; Figs. 1-5; col. 2 lines 46-54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Thompson to include a bolster comprising a proximal end, a bolster body, and a distal end, the proximal end of the bolster having a proximal opening, the distal end of the bolster having a distal opening, the bolster having a bolster lumen extending from the proximal opening of the bolster to the distal opening of the bolster, the bolster being formed separately from the nasal tube, the nasal tube extending through the bolster lumen; the flange being distal to the bolster on the nasal tube, as taught by Sheridan, for the purpose of providing a means by which a surgeon can help to adjust the size of the device to better fit the patient (Sheridan; col. 3 lines 17-33).
With this modification, the modified Thompson would thus teach the clip being reversibly closeable about the bolster (the Thompson securing device 110 would be able to be closed about the Sheridan rings 40, as both would be located proximal to the Thompson flange 108) (Thompson, Figs. 1A-5A, paras. [0059-0060]; Sheridan, Figs. 1-5, col. 2 lines 46-54).
Thompson does not disclose (d) an adhesive tape comprising a base portion and one or more strip portions extending from the base portion, the base portion of the adhesive tape having a proximal side, a distal side, and a hole therethrough, each of the one or more strip portions having a proximal side and a distal side, the distal side of each of the one or more strip portions each having an adhesive surface, the nasal tube extending through the hole of the base portion of the adhesive tape, the adhesive tape being attached to the flange at the base portion of the adhesive tape.
However, Beran teaches an intubation set (Beran; abstract) including an adhesive tape comprising a base portion and one or more strip portions extending from the base portion (adhesive layers 118, 124 have respective tabs 122, 128 with strips extending from the sides of the tabs 122, 128) (Beran; Figs. 10, 13-17; col. 6 lines 14-29), the base portion of the adhesive tape having a proximal side, a distal side, and a hole therethrough (tabs 122, 128 have proximal and distal sides as well as tab openings 144, 150) (Beran; Figs. 10, 13-17; col. 6 lines 14-29), each of the one or more strip portions having a proximal side and a distal side, the distal side of each of the one or more strip portions each having an adhesive surface (the strips extending from the sides of the tabs 122, 128 have proximal and distal sides, with the adhesives of the respective adhesive layers 118, 124 on the distal sides facing flange 140) (Beran; Figs. 10, 13-17; col. 6 lines 14-29), the nasal tube extending through the hole of the base portion of the adhesive tape (tube 102 for insertion into a nostril extends through the tab openings 144, 150) (Beran; Fig. 10; col. 5 lines 51-60), the adhesive tape being attached to the flange at the base portion of the adhesive tape (adhesive layers 118, 124 are attached to the sleeves 112, 114 and retaining ring 116 at their respective tabs 122, 128) (Beran; Figs. 10, 13-17; col. 5 lines 51-60; col. 6 lines 14-29).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Thompson flange to include an adhesive tape comprising a base portion and one or more strip portions extending from the base portion, the base portion of the adhesive tape having a proximal side, a distal side, and a hole therethrough, each of the one or more strip portions having a proximal side and a distal side, the distal side of each of the one or more strip portions each having an adhesive surface, the nasal tube extending through the hole of the base portion of the adhesive tape, the adhesive tape being attached to the flange at the base portion of the adhesive tape, as taught by Beran, for the purpose of providing a more effective means of keeping the tube in position relative to the patient in terms of the strength of connection and the variety of physical situations that can be accommodated (Beran; col. 5 lines 20-25).
Thompson does not disclose the flange is highly compliant based on being thin and flexible and provides a barrier to moisture and heat based on its composition.
However, the Applicant’s specification para. [0145] recites, “The flange 124 is highly compliant based on being thin and flexible and provides a barrier to moisture and heat based on its composition… the flange 124 should be made from a material that provides for the flange 124 to be sufficiently flexible to conform to the anatomy of a patient. Suitable thicknesses for the flange 124 include, for example, 0.50 to 5.00 mm, 0.60 to 2.50 mm, or 0.75 to 1.00 mm… Suitable materials for making the flange 124, include, for example, silicone rubber elastomer, natural latex rubber, thermoplastic elastomer, styrene block copolymer, thermoplastic polyolefin, thermoplastic polyurethane, thermoplastic vulcanizate, ethylene-propylene-diene-monomer, copolymer derivatives of ethylene-propylene-diene-monomer, styrene-butadiene-rubber, copolymer derivatives of styrene-butadiene-rubber, flexible non-elastomeric polymer, or plasticized polyvinyl chloride”. Thus, a flange of suitable material and thickness would inherently be thin and flexible and be able to provide a barrier to moisture and heat as claimed. Flagler teaches a molded tracheostomy tube (Flagler; abstract) wherein the flange member 20 can be made of a thermoplastic elastomer with a thickness of 0.03-0.05 inches, i.e. 0.762-1.27 mm (Flagler; Figs. 1A-5; paras. [0030-0031]), and so teaches wherein the flange is highly compliant based on being thin and flexible and provides a barrier to moisture and heat based on its composition as claimed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Thompson flange to be highly compliant based on being thin and flexible and provides a barrier to moisture and heat based on its composition, as taught by Flagler, for the purpose of providing the flange with increased flexibility to allow for greater range of motion for the attached conduit or tube (Flagler; paras. [0030-0031]).
Regarding claim 18, the modified Thompson teaches wherein the flange extends from the bolster at the distal end of the bolster (flange 22 extends from the distal ring 40 at its distal end) (Sheridan; Figs. 1-5; col. 2 lines 46-54).
Regarding claim 19, the modified Thompson teaches wherein the bolster is slidable along the nasal tube when the clip is not reversibly closed about the bolster, and the flange is slidable along the nasal tube (Sheridan rings 40 and flange 22 slideably encircle the tubular section 8, and so would be able to slide when the Thompson securing device 110 is open) (Thompson, Figs. 1A-5A, paras. [0059-0060]; Sheridan, Figs. 1-5, col. 2 lines 44-54).
Regarding claim 20, as best understood, the modified Thompson teaches a system for securing a nasal tube and one or more other tubes to a nose of a patient, the system comprising the nasal tube device according to claim 17 and one or more other tubes (see 35 U.S.C. 103 rejection of claim 17 above), wherein: the one or more other tubes are partially disposed in the nasal tube lumen of the nasal tube through the proximal opening of the nasal tube; and the clip is reversibly closed about the bolster, thereby reversibly compressing the proximal-clip portion of the nasal tube about the one or more other tubes (Thompson securing device 110 has a living hinge to allow it to switch between open and closed positions about its portion of the nasal tube 102; Thompson securing device 110 compresses about the nasal tube 102 and the tubes inside the proximal opening of the nasal tube 102 lumen 134 when closed, and so would also close about the modification with the Sheridan rings 40) (Thompson, Figs. 1A-5A, paras. [0059-0060]; Sheridan, Figs. 1-5, col. 2 lines 44-54).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 6,488,664 B1 by Solomon et al. is considered to be relevant as it discloses a clamp for a nose tube in front of a flange.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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