DETAILED ACTION
This office action is in response to the amendment dated 4/2/2026. As directed by the amendment, claim 15 has 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/2/2026 has been entered.
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 outside the helical member (23) along a part at least of the length of the longitudinal path (as shown in figs 2-3, portions of the inflation line (12) are disposed outside the helical member (23) at locations between adjacent moulded clips (24) of the helical member (23)) so that a part at least of a 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 4/2/2026 have been fully considered but they are not persuasive.
Applicant argues on page 6, fourth full paragraph-page 15, second full paragraph of applicant’s remarks, that the features of claim 15 include:
a. helical member of a second, stiffer material and embedded with the first
material [of the shaft];
b. the helical member has a longitudinal path along a part at least of its length;
c. an elongate member extended outside the helical member along a part at
least of the length of the longitudinal path and is received in the longitudinal
path;
d. the longitudinal path is adapted to receive the thickness of the elongate
member sufficiently to ensure the elongate member does not form a
projection at an outside wall of the shaft.
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Applicant argues on page 7, third full paragraph, that Fields does not have the features of b, c, and d. However, as discussed above, Field discloses that (b) the helical member has a longitudinal path along a part at least of its length, because, as shown in the annotated fig 3 above, reinforcement member (23) includes a longitudinal path extending along the moulded clips (24), into which the inflation line (12) is disposed (para [0023]); and further discloses an elongate member (12) (inflation line) (para [0020]) extended outside the helical member (23) along a part at least of the length of the longitudinal path (as shown in the annotated fig 3, portions of the inflation line (12) would be disposed outside the helical member (23) at locations between adjacent moulded clips (24) of the helical member (23) when the inflation line is disposed in the clips (24) as shown in fig 2 so that a part at least of a thickness of the elongate member (12) is received in the longitudinal path). Therefore, Fields discloses the features of b and c, and as discussed below, the modified Field’s device, modified with the teaching of Miller and Jackson, additionally discloses the features of d.
Applicant argues on page 7, fourth full paragraph, that examiner alleges that it would be obvious for an artisan to reconfigure the reinforcement member of Field into feature b, which is impermissible hindsight. However, as discussed above, Fields discloses the limitations of feature b, and the proposed modification does not involve modifying the reinforcement member, but modifying the configuration of the elongate member and the first plastics material covering the elongate member so that the elongated member does not form a projection an outside wall of the shaft, because 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). Therefore, the rejection is maintained.
Applicant argues on page 7, fifth full paragraph, that Miller does not require a reinforcement member, as the rigidity of the tube is built into the molding process, and the lumen formed by the fluid through path is not the same as the elongate member recited in claim c of claim 15. However, the elongate member of claim 15 may correspond to an inflation line (elongate member is preferably a small-bore tube extending longitudinally along a part at least of the length of the longitudinal path so that a part at least of the thickness of the small-bore tube is received in the longitudinal path (page 3, first full paragraph), which can correspond to an inflation line (32) (page 5, second full paragraph)) and as discussed above, Field discloses the limitations of feature c. Miller’s inflation lumen (24) is considered to be analogous to the claimed elongate member, as it is a small-bore tube received in a longitudinal path along a shaft of an endotracheal tube, and therefore, because Miller teaches that a small-bore tube forming an elongated member may be embedded in a first plastics material of the endotracheal tube such that elongate member does not form a projection at an outside wall of the shaft of the endotracheal tube, and Jackson teaches the benefit of providing a smooth surface for insertion of the trachea of the patient, the device of Fields modified with the teaching of Miller and Jackson additionally discloses the features of d. Therefore, because Fields discloses features of a-c, and Miller and Jackson teach the benefit of providing feature d to an endotracheal tube, the rejection is maintained.
Conclusion
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/DOUGLAS Y SUL/Examiner, Art Unit 3785
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