DETAILED ACTION
Response to Amendment
This Office Action is responsive to the amendment filed on 09/18/2025. As indicated by the amendment: claim 1 has been amended. Claims 1-13 are presently pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 6, which depends from claim 1, recites “wherein the endotracheal tube retainer has a longitudinally-extending channel formed there and defining a retainer sidewall”. However, independent claim 1, from which claims 6 depends, recites a longitudinally-extending channel formed in the endotracheal tube retainer and defines a sidewall. The specification, as originally filed, does not disclose the endotracheal tube retainer having two longitudinally-extending channels and two retainer sidewalls. Accordingly, the claims fail to comply with the written description requirement. .
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 6-7 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. Claim 6, which depends from claim 1, recites “wherein the endotracheal tube retainer has a longitudinally-extending channel formed there and defining a retainer sidewall”. However, independent claim 1, from which claims 6 depends, recites a longitudinally-extending channel formed in the endotracheal tube retainer and defines a sidewall. It is not clear how the endotracheal tube retainer has two longitudinally-extending channels and two retainer sidewalls or through which channel and sidewall the slot extends. Accordingly, the claims are rendered indefinite. For purposes of examination, the longitudinally-extending channel and retainer sidewall of claim 6 are interpreted as the same longitudinally-extending channel and retainer sidewall of claim 1. Appropriate correction is required.
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.
Claim(s) 1-3 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fujitani et al. (US 2015/0112139 A1) in view of Petersen et al. (US 2011/0295068 A1) in view of Chu (US 2019/0038113 A1).
Regarding claim 1, Fujitani discloses a steerable medical device (par. [0020]), comprising: a housing (3C/3M1/3R; Fig. 2; par. [0026]); an insertion tube (2; Fig. 1; par. [0019]); a rotary knob assembly (of 3; Fig. 1) rotatably mounted on and extending out of the housing and affixed to the insertion tube (30 extends out of 3C and is affixed to 2 via 3H and 12; Figs. 1-2; par. [0023]), the rotary knob assembly comprising: a bushing (3M2; Fig. 2) configured for rotatable mounting about a longitudinal axis of the housing (3M2 is rotatably mounted about axis 1a; Fig. 2; par. [0048]); a user-controllable knob (30/3H; Fig. 2; par. [0030]) affixed to the bushing (3M2) such that the bushing rotates in unison with the knob about the longitudinal axis (30 and 3M2 are affixed such that they rotate together; par. [0054]); and an endotracheal tube retainer (12; Fig. 2; par. [0028]) affixed to the knob (12 is affixed to 30 via 3H, Fig. 2) such that the knob rotates in unison with the tube retainer (30 rotates with 2 and 12; par. [0054]).
However, Fujitani does not specifically disclose wherein the tube retainer is fabricated from an elastomer material and an outer surface of the tube retainer is configured for frictional engagement with an inner surface of a tube connector of an endotracheal tube, wherein a longitudinally-extending channel is formed in the endotracheal tube retainer and defines a tube retainer sidewall. Petersen teaches an analogous steerable medical device (1; Fig. 1) having an analogous endotracheal tube retainer (11/12; Fig. 1; par. [0039]) that is fabricated from an elastomer material (par. [0039] – a suitable flexible material, for example rubber). Petersen also teaches that an outer surface of the tube retainer (11/12) is configured for frictional engagement with an inner surface of a tube connector of an endotracheal tube (par. [0005] and [0040]). The endotracheal tube retainer (11/12) also has a longitudinally-extending channel formed therein (interior of 11/12; Fig. 4) and defines a tube retainer sidewall (Fig. 4 – sidewalls of 11/12). Petersen teaches the structure of its endotracheal retainer tube allows the endoscope to connect to an endotracheal tube, such that the vision system of the endoscope allows the endoscope and endotracheal tube to be guided into place without danger to the patient (par. [0005]). It would have been obvious to one having ordinary skill in the art to modify the endotracheal tube retainer of Fujitani to include the elastomer material and outer surface configured for frictional engagement of Petersen in order to allow the endoscope to be used in procedures to establish artificial respiration wherein the endoscope and endotracheal tube can be guided into place without danger to the patient, as taught by Fujitani.
Modified Fujitani does not specifically disclose wherein at least one longitudinally extending slot is formed in the tube retainer sidewall
Regarding claim 2, Fujitani in view of Petersen in view of Chu disclose the steerable medical device of claim 1, wherein the bushing comprises a radially extending flange (32; Fig. 2; par. [0049]) configured for engagement with an annular channel formed in the housing (32 engages with 24 of 3M1; par. [0049]).
Regarding claim 3, Fujitani in view of Petersen in view of Chu disclose the steerable medical device of claim 1, wherein the housing and knob respectively comprise at least one detent (25p; Fig. 4) and at least one recess (37h; Fig. 4), or vice versa, configured for mutual engagement at least one defined-rotation position of the knob relative to the housing (25p and 37h engage at the neutral rotation position of the knob; par. [0083]).
Regarding claim 6, Fujitani in view of Petersen in view of Chu disclose the steerable medical device of claim 1, wherein the endotracheal tube retainer has a longitudinally-extending channel formed therein (Petersen: channel within 11; Fig. 2) and defining a tube retainer sidewall (Peterson: outer walls of 11; Fig. 2), and wherein the tube retainer sidewall comprises at least one outer surface taper angle (Petersen: Fig. 2 – distal tapering of 12).
Regarding claim 7, Fujitani in view of Petersen in view of Chu disclose the steerable medical device of claim 6, wherein the tube retainer sidewall comprises two outer surface taper angles different from each other (Petersen: Fig. 2 – different taper angles of 12 around 7 and around 1a).
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fujitani in view of Petersen in view of Chu as applied to claim 1 above, and further in view of Chu (US 2018/0117280 A1, hereinafter referred to as “Chu-2”).
Regarding claim 4, Fujitani in view of Petersen in view of Chu disclose the steerable medical device of claim 1, wherein the housing comprises a housing stop surface (26a/26b of 3M1; par. [0072]) and the knob comprises a knob stop surface (58 of 3H; Fig. 5; par. [0072]), but does not specifically disclose wherein the housing stop surface and the knob stop surface are configured to limit rotation of the knob when the housing stop surface contacts the knob stop surface. Fujitani discloses wherein the housing stop surface and the knob stop surface are configured to provide resistance for rotation beyond 90 degrees (38 and 26a abut when 30 has been rotated by 90 degrees and the amount of strength required to rotate increases; par. [0084]) in order to provide an indication of the rotation (par. [0084]).
Chu-2 teaches an endoscope handle (112B; Fig. 5) and a knob (164/112A; Fig. 5) which rotates relative to a housing portion (164 rotates 112A relative to 112B; par. [0040]), where the housing comprises a housing stop surface (172 of 112B; Fig. 6; par. [0040]) and the knob comprises a knob stop surface (170 of 164; Fig. 5; par. [0040]) configured to limit rotation of the knob when the housing stop surface contacts the knob stop surface (par. [0040]). It would have been obvious to one having ordinary skill in the art to modify the housing stop surface and knob stop surface of Fujitani such that they limit rotation of the knob when the housing stop surface contacts the knob stop surface as taught by Chu-2 in order to prevent the insertion tube from rotating too much.
Regarding claim 5, Fujitani in view of Petersen in view of Chu in view of Chu-2 disclose the steerable medical device of claim 4, wherein the housing stop surface and the knob stop surface are configured to permit no more than 90° of rotation of the knob away from a zero-rotation position of the knob relative to the housing (26a and 26b are 90 degrees from projection 38 to permit no more than 90 degree rotation in either direction from then neutral position; Fig. 5).
Allowable Subject Matter
As recited in the Non-Final Rejection of 05/05/2025, claim 8, and claims 9-13 dependent therefrom, are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Neither Fujitani, Petersen nor Boston disclose the steerable medical device comprising the control device as recited in dependent claim 8.
Humphrey et al. (US 2019/0117937 A1) teaches an analogous device having a control device (38; par. [0049]) comprising: a steering shaft (44; Fig. 5), a first steering cam (40; Fig. 5) and a second steering cam (42; Fig. 5). However, Humphrey does not teach the steering shaft having at least one end configured to extend out of at least one opening formed in the housing; the first steering cam affixed to the steering shaft such that the steering shaft rotates in unison with the first steering cam about the longitudinal axis of the steering shaft; the second steering cam mounted on the steering shaft and freely rotatable about the longitudinal axis of the steering shaft independent of the steering shaft, or a user-controllable lever disposed outside the housing and affixed to the at least one end of the steering shaft such that the steering shaft rotates in unison with the lever.
Do et al. (US 2019/0110661 A1) teaches an analogous device having a control device (abstract) with a latch assembly (1; Fig. 1) operable in an inactive configuration to maintain wires in an un-tensioned state (Fig. 4; par. [0091]) or an active configuration to maintain wires in a tensioned state (Fig. 5; par. [0092]). However, the steering mechanism of Do is tilted like a joystick and does not used a rotatable steering shaft with steering cams (par. [0060]). Like Do, Malkowski et al. (US 2015/0164524 A1) teaches an analogous device having a control device (abstract) with a latch assembly (1304; Fig. 65A) operable in an inactive configuration to maintain wires in an un-tensioned state (Fig. 65A; par. [0225]) or an active configuration to maintain wires in a tensioned state (Fig. 65B; par. [0228]). However, the steering mechanism of Malkowski uses a ball and cup mechanism and does not used a rotatable steering shaft with steering cams (par. [0157]).
The prior art of record does not teach, or otherwise render obvious, the latch assembly for a first steering cam affixed to the steering shaft such that the rotate in unison and a second steering cam mounted to the steering shaft and freely rotatable independent of the steering shaft or a user-controllable lever affixed to the steering shaft, in combination with the other elements of the claim.
Response to Arguments
Applicant’s arguments, see claim amendments and remarks, filed 09/18/2025, with respect to the rejection(s) of the claim(s) under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chu, as discussed above. Regarding Applicant’s argument that the bend prevention member of Fujitani could not serve as an endotracheal tube retainer (see Remarks at page 2), the Examiner respectfully disagrees and asserts that the bend prevention member of Fujitani is capable of being frictionally engaged with an inner surface of a tube connector of an endotracheal tube, as engagement would depend on the configuration of the surface of the tube connector of the endotracheal tube. Thus, it could be considered an endotracheal tube retainer. As is clear from the above rejection, the endotracheal tube retainer of Fujitani is modified by Petersen and Chu.
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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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
12/23/2025