DETAILED ACTION
This office action is in response to the amendment dated 11/18/2025. As directed by the amendment, claims 15-24 have been amended, claims 1-14 and 25-26 have been cancelled, and no claims have been newly added. Thus, claims 15-24 and 27-29 are presently pending in this application, which claims 15-24 presented on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 15 is objected to because of the following informalities:
Claim 15, line 8 recites “the thickness of the elongate member”; it is suggested to amend the claim to recite --a thickness-- as it is the first time the thickness limitation is being recited.
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.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Field (2016/0287826) in view of Miller (2004/0221853), with Jackson (4,020,849) provided as evidence.
Regarding claim 15, Field in figs 1-3 discloses a reinforced medico-surgical tube having a shaft (1) (tubular shaft) of a first, plastics material (tube is made of a second component (29) made of a plastics material) (para [0024]) reinforced along at least a part of its length by a helical member (20) (machine end component (20) includes a reinforcement member (23) which is shown in figs 2-3 to have a helical shape) of a second, stiffer material (machine end component (20) is made from a stiffer material such as a hard plastic, Kevlar, or metal reinforcement) (para [0023]) and embedded with the first material (29) (second component (29) is overmoulded over the first material (20) which forms the helical member (23)) (para [0024]), characterised in that the helical member (20) has a longitudinal path along a part at least of its length extending transversely of the turns of the helical member (20) (as shown in fig 3, reinforcement member (23) includes a longitudinal path extending along the moulded clips (24)) (para [0023]), and that the tube includes an elongate member (12) (inflation line) (para [0020]) extended along a part at least of the length of the longitudinal path so that a part at least of the thickness of the elongate member (12) is received in the longitudinal path (moulded clip (24) of horse-shoe section on its outer surface and aligned with one another forming a longitudinal path so that the elongate member (12) can be retained by the clips during the moulding process) (para [0023]).
Field does not disclose the longitudinal path is adapted to receive the thickness of the elongate member sufficiently to ensure that the elongate member does not form a projection at an outside wall of the shaft.
However, Miller in figs 1-2 teaches an endotracheal tube (10) (tubular apparatus) forming a shaft formed by tube wall (30) and including a longitudinal path (longitudinal opening within tube wall (30)) and an elongate member (24) (first inflation lumen) disposed withing the longitudinal path, wherein the longitudinal path is adapted to receive the thickness of the elongate member (24) sufficiently to ensure that the elongate member (24) does not form a projection at an outside wall of the tube (30) (as shown in fig 2, the first inflation lumen (24) is disposed within tube wall (30) but does not provide a projection) (para [0032]), and Jackson teaches an endotracheal tube forming a shaft (10) (curved breathing tube) and including an inflation lumen (16) (filling passage) disposed within the shaft (10) such that no projection is formed at an outside wall of the shaft (as shown in fig 3, no projection is formed by the filling passage) for providing a smooth surface for insertion of the trachea of the patient (col 3, ln 45-50).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Field so that longitudinal path is adapted to receive the thickness of the elongate member sufficiently to ensure that the elongate member does not form a projection at an outside wall of the shaft, as the feature of a tracheal tube configured so that a longitudinal path is adapted to receive the thickness of the elongate member sufficiently to ensure that the elongate member does not form a projection at an outside wall of the shaft is known in the art, and as evidenced by Jackson, not forming a projection at an outside surface of a shaft of an endotracheal would provide a smooth surface suitable for insertion of the trachea of the patient (Jackson, col 3, ln 45-50).
Regarding claim 16, Field discloses that the longitudinal path is provided by an indentation (horse-shoe section) in the helical member (20) (first component (20) includes moulded clips (24) which has an indent (concave surface of horseshoe shape) which are aligned with one another to form the longitudinal path) (para [0023]).
Regarding claim 17, Field discloses that the longitudinal path is provided by notches in the helical member (first component (20) includes moulded clips (24) which has notches (concave surface of horseshoe shape) which are aligned with one another to form the longitudinal path) (para [0023]).
Regarding claim 18, Field discloses that the longitudinal path is provided by a gap in the helical member (20) (as shown in fig 3, longitudinal path includes a gap in the helical member (20) between adjacent turns of the helical member (20)) (fig 3).
Regarding claim 19, Field discloses that the elongate member (12) is a small-bore tube (inflation line) extending longitudinally along a part at least of the length of the longitudinal path so that a part at least of a thickness of the small-bore tube (12) is received in the longitudinal path (inflation line (12) can be retained by the clips (24), and therefore at least part of a thickness of the inflation line (12) is received in a longitudinal path formed by the clips) (para [0023]).
Regarding claim 20, Field discloses that the tube (1) has an inflatable sealing cuff (11) towards its patient end (10), and that a patient end (10) of a small-bore tube (12) opens into the sealing cuff (11)) (para [0020]).
Regarding claim 21, Field discloses that the helical member (20) is of a metal wire (helical member can include metal reinforcement in wire form) (para [0023]).
Regarding claim 22, Field discloses that the metal wire is of titanium (metal wire can be made of Nitinol (para [0023]), and Nitinol is a nickel-titanium alloy).
Regarding claim 23, Field discloses that the plastics material includes silicone (plastics material can be a silicone material) (para [0024]).
Regarding claim 24, Field discloses the tube is a tracheostomy tube (para [0020]).
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
Applicant argues on page 5, third full paragraph of applicant’s remarks, that Field as shown in fig 8 discloses a bulge, and therefore does not disclose that the longitudinal path is adapted to receive the thickness of the elongate member sufficiently to ensure that the elongate member does not form a projection at an outside wall of the shaft. However, applicant’s argument is moot in view of the new grounds of rejection further in view of Miller, which in figs 1-2 teaches an endotracheal tube (10) (tubular apparatus) forming a shaft formed by tube wall (30) and including a longitudinal path (longitudinal opening within tube wall (30)) and an elongate member (24) (first inflation lumen) disposed withing the longitudinal path, wherein the longitudinal path is adapted to receive the thickness of the elongate member (24) sufficiently to ensure that the elongate member (24) does not form a projection at an outside wall of the tube (30) (as shown in fig 2, the first inflation lumen (24) is disposed within tube wall (30) but does not provide a projection) (para [0032]), and Jackson, which teaches an endotracheal tube forming a shaft (10) (curved breathing tube) and including an inflation lumen (16) (filling passage) disposed within the shaft (10) such that no projection is formed at an outside wall of the shaft (as shown in fig 3, no projection is formed by the filling passage) for providing a smooth surface for insertion of the trachea of the patient (col 3, ln 45-50). Therefore, it would have been obvious to one of ordinary skill to the skilled artisan, upon seeing the disclosures of Miller and Jackson, to modify the device of Field so that longitudinal path is adapted to receive the thickness of the elongate member sufficiently to ensure that the elongate member does not form a projection at an outside wall of the shaft, as the feature of a tracheal tube configured so that a longitudinal path is adapted to receive the thickness of the elongate member sufficiently to ensure that the elongate member does not form a projection at an outside wall of the shaft is known in the art, and as evidenced by Jackson, not forming a projection at an outside surface of a shaft of an endotracheal would provide a smooth surface suitable for insertion of the trachea of the patient (Jackson, col 3, ln 45-50). Although not relied upon in the current rejection, Howat (2010/0057051) teaches that a reinforcing member (40) can be embedded in an outer polymeric layer or material (44) such that the reinforcing member (40) does not form a projection (para [0022]), Casey (7,018,372) discloses that a reinforcing member (5) may be embedded in a shaft of a catheter body (4) such that the no projection is formed on an outer wall of the catheter body (see figs 10a-c and 14), and Davies (4,977,594) and Geraghty (2016/0296719) disclose that a lumen can project inwardly from an inner surface of a shaft so that no projection is formed on an outer wall of the shaft (see fig 2 of Davies and figs 1--b of Geraghty). Therefore, the rejection is maintained.
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.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785