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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Species D, readable on claims 1-16, 23, 24 in the reply filed on 12/22/2025 is acknowledged.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-14, 16, 23 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Motai et al. (US Patent Application Publication No. 2008/0249356, hereinafter Motai).
In regard to claim 1, Motai discloses an apparatus (121, Fig. 27) for accessing a body lumen or a body cavity, the apparatus comprising:
a hollow shaft (123, Fig. 27 formed from a single piece of flexible material (Par. 123 teaches of the hollow shaft is formed of a resin material), the hollow shaft comprising a proximal end, a distal end and a lumen extending from the proximal end to the distal end (Fig. 27), wherein the lumen of the hollow shaft is configured to receive an endoscope (13x, Fig. 28), and further wherein the distal end of the hollow shaft comprises an adjustable portion (141B) which is configured to be articulated between (i) a straight configuration in which the adjustable portion is parallel to a longitudinal axis of the hollow shaft (Fig. 27), and (ii) an angled configuration in which the adjustable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft (Fig. 28), whereby to bend the endoscope disposed within the lumen of the hollow shaft (Fig. 28);
a sleeve (122) having a proximal end, a distal end and a lumen extending from the proximal end to the distal end, wherein the lumen of the sleeve is configured to receive the hollow shaft and the endoscope disposed therein (Figs. 27,28); and
a balloon mounted to the sleeve (Par. 136).
In regard to claim 2, Motai teaches wherein the proximal end of the hollow shaft comprises an actuator (143) for articulating the adjustable portion between the straight configuration and the angled configuration (Fig. 27, Par. 130).
In regard to claim 3, Motai teaches wherein the proximal end of the hollow shaft comprises a handle (142), and further wherein the actuator comprises two cables extending from the adjustable portion to the handle (Fig. 27, Par. 130).
In regard to claim 4, Motai teaches wherein each of the two cables comprise a proximal end mounted to the actuator and a distal end mounted to the adjustable portion (Par. 130).
In regard to claim 6, Motai teaches wherein the distal end of the hollow shaft is configured to be longitudinally movable relative to the distal end of the sleeve (Figs. 27-28).
In regard to claim 7, Motai teaches wherein the hollow shaft comprises at least one visual marker (M4) for indicating how far the distal end of the hollow shaft extends beyond the distal end of the sleeve (Fig. 29).
In regard to claim 8, Motai teaches wherein the lumen of the hollow shaft is sized to be larger than an outer diameter of an endoscope such that when the endoscope is disposed within the lumen the hollow shaft, a gap large enough to pass an instrument therethrough exists between the inner wall of the lumen of the hollow shaft and the exterior surface of the endoscope (the endoscope is movably disposed in the lumen of the hollow shaft (Figs. 28a-28d), additionally Fig. 31 shows the lumen having a larger size enabling an instrument such as a sheath or other tools are capable of being inserted between the inner wall of the lumen and the exterior surface of the endoscope).
In regard to claim 9, Motai teaches wherein the lumen of the sleeve is sized to be larger than an outer diameter of the hollow shaft such that when the hollow shaft is disposed within the lumen the sleeve, a gap large enough to pass an instrument therethrough exists between the inner wall of the lumen of the sleeve and the exterior surface of the hollow shaft (the hollow shaft (123) is movably disposed within the lumen of the sleeve (Figs. 28a-28d) and therefore the lumen of the sleeve would have a larger diameter than an outer diameter of the hollow shaft and a sheath, sleeve, wire or other surgical instruments would be capable of being advanced between an inner wall of the lumen of the sleeve and the exterior surface of the hollow shaft, Par. 128).
In regard to claim 10, Motai teaches wherein the hollow shaft comprises a plurality of slits formed in the flexible material (via slits formed in the adjustable portion (141B), Fig. 27).
In regard to claim 11, Motai teaches wherein the hollow shaft is configured to pivot relative to the distal end of the sleeve (the adjustable portion (141B) of the hollow shaft (123) is able to pivot relative to the distal end of the sleeve (122) after the adjustable portion (141B) extends distally beyond the distal end of the sleeve, Figs. 27-28).
In regard to claim 12, Motai teaches wherein the hollow shaft is steerable relative to the distal end of the sleeve (the adjustable portion (141B) of the hollow shaft (123) is able to deflect relative to the distal end of the sleeve (122) after the adjustable portion (141B) extends distally beyond the distal end of the sleeve, Figs. 27-28).
In regard to claim 13, Motai teaches wherein the hollow shaft is configured to be steered by articulating an endoscope disposed within the lumen of the hollow shaft (the hollow shaft is capable of being steered by articulating an endoscope disposed within the lumen of the hollow shaft).
In regard to claim 14, Motai teaches wherein the hollow shaft is configured to be steered by moving the two cables secured to the adjustable portion (Par. 130, Fig. 27).
In regard to claim 16, Motai teaches wherein the adjustable portion comprises a distal end, a proximal end, and a plurality of pivot points disposed therebetween (Figs. 27-28 illustrates a plurality of pivot points for deflecting the adjustable portion).
In regard to claim 23, Motai teaches wherein the sleeve further comprises at least one instrument lumen (via lumen to receive the hollow shaft (123), Figs. 27-28).
In regard to claim 24, Motai teaches wherein the distal end of the sleeve comprises an atraumatic tip (Fig. 27 illustrates the distal end of the sleeve having a blunt tip).
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 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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Motai et al. (US Patent Application Publication No. 2008/0249356, hereinafter Motai) in view of Wang et al. (US Patent Application Publication 2017/0325659, hereinafter Wang).
In regard to claim 5, Motai teaches wherein the handle comprises a locking mechanism for locking the adjustable portion at a desired angle.
Wang teaches an analogous endoscope having an insertion section (4) and handle (3) and a self-locking rotation mechanism disposed within the handle. The self-locking rotation mechanism comprising a rotation shaft (7), a spring (14), a rotation shaft (2), the rotation shaft (7) is located within the endoscope handle (3) and supported by positioning holes in inner walls of the endoscope handle (3), the positioning holes are provided in a locking cover plate (1), and the locking cover plate (1) is inserted and fixed to the inner wall of the endoscope handle (3); two ends of the rotation shaft are respectively located in the positioning holes in the locking cover plate (1) at two opposite inner walls of the endoscope handle (3), and the rotation shaft has a gap along an axial direction thereof in each of the positioning holes (Par. 29). While assembling, firstly, the steel wire wheel 11 and the outer conical surface are sleeved and fixed to the rotation shaft 7 through the pin 13; and then one end of the adjustment steel wire 5 is fixed and wound to the positioning groove on the external circle of the steel wire wheel 11; and then the spring 14, the planar bearing 12 and the spring adjustment nut 9 are installed to the rotation shaft 7 in sequence, the rotation shaft is installed in the positioning holes; through the gaps between the rotation shaft and the positioning holes, the inner conical surface of the conical cylinder is corresponding to and slightly contacts the outer conical surface fixed on the rotation shaft (contacts without pressure); through adjusting an engagement depth of the spring adjustment nut 9 and the locking cover plate 1, a compression degree and a restoring force of the spring 14 are adjusted, so as to closely engage the above mentioned outer conical surface with the inner conical surface (namely, the outer conical surface contacts the inner conical surface with pressure), for balancing a friction force therebetween and the restoring force of the spring 14, thereby achieving self-locking. As a result, while operating the rotation handle 2 to drive the rotation shaft 7 to rotate, not only easy driving but also no rebound is achieved. Finally, the rotation handle 2 is installed and fixed (Par. 35).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the rotation actuator (143) of Motai with the self-locking rotation mechanism of Wang enabling the bending state of the insertion section to be automatically locked without requiring the physician to maintain control of the rotation actuator, thereby negating the need for a surgeon to retain the rotation actuator at a desired position and increasing surgical precision (Par. 42).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Motai et al. (US Patent Application Publication No. 2008/0249356, hereinafter Motai) in view of Cruz et al. (US Patent Application Publication No. 2018/0035872, hereinafter Cruz).
In regard to claim 15, Motai does not expressly teach wherein the balloon comprises at least one radiopaque marker.
Cruz teaches an analogous endoscope assembly (5) comprising a sleeve (15) and endoscope (10). The sleeve (15) comprises a balloon (20) for engaging a body lumen, wherein the balloon (20) has a radiopaque marker so that a physician can ascertain a position of the balloon within the surgical site (Par. 131).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the balloon of Motai with a radiopaque marker as taught by Cruz enabling a physician to ascertain the position of the balloon within the surgical site (Par. 131).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 January 10, 2026