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 .
Notice of Amendment
The Amendment filed 11/19/2025 has been entered.
Response to Arguments
Applicant argues the annotated Fig. 3 provided is for Cho and not Cheng and therefore invalidates the current rejections.
The examiner acknowledges Fig. 3 of Cheng was inadvertently not included in the previous final rejection. However, this mistake has been corrected so that annotated Figures for Cho and Cheng are provided to help illustrate how Cho and Cheng read on Claim 1.
Applicant argues A) “Cheng is a bendable ureteral access sheath for navigation in the soft-tissue urinary tract; its objective is atraumatic steering through a narrow, delicate lumen. The present invention targets endoscopic interbody spinal fusion inside a bony intervertebral space. A person of ordinary skill in spinal endoscopy/fusion would not reasonably consult ureteral sheath art to solve this different biomechanical and surgical problem”, B) “Introducing a bendable segment in Applicant’s invention would undermine working space stability, axial/torsional stiffness, force transmission, and fluid-mediated visualization—all critical for spinal fusion—thereby teaching away from the claimed rigid architecture rather than suggesting it”, AND C) “A ureteral sheath is engineered for soft tissue and small instruments, not for maintaining large cross-sectional clearance under tool contact forces common in fusion (endplate preparation, graft packing, cage deployment). Even if combined, a POSITA would have no reasonable expectation that the hybrid would form the claimed large, stable therapeutic corridor or withstand operative loads.”
The examiner disagrees since the claim merely states the preamble that an intended use of the device is for endoscopic interbody spinal fusion, however this language is not very limiting since the intended use the preamble is not reinforced within the body of the claim. Furthermore, merely generically stating “for endoscopic interbody spinal fusion” provide little patentable weight without further specifying further details regarding how the device is being used within an endoscopic interbody spinal fusion (i.e. specifying the route of insertion and function being performed). Additionally, most of the arguments provided are not directly required by the claim and should be positively recited OR more language should be provided regarding the use of the device within the spine to overcome the use of the devices of Cho and Cheng.
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, 3, 5, 6, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Cho (US Patent No. 4,802,461) in view of Cheng et al. (US Patent Application Publication No. 2020/0315445, hereinafter Cheng).
In regard to claim 1, Cho discloses a structure for endoscopic interbody spinal fusion (19, Fig. 2), characterized by comprising:
an endoscope component (23) and a mounting seat component (21) fixedly connected to the endoscope component (23), wherein
the endoscope component (21) comprises an endoscope outer tube (23), as well as a water inlet pipe piece (33), a camera pipe piece (35) in close proximity to the water inlet pipe piece (33), and a water outlet pipeline (37) in close proximity to the camera pipe piece (35) that are arranged side by side in the endoscope outer tube (23); a water inlet pipe connector (53) is connected to the water inlet pipe piece (33), and a water outlet pipe connector (57) is connected to the water outlet pipeline (37);
the water inlet pipe connector (53) and the water outlet pipe connector (57) are symmetrically arranged at two sides of the mounting seat component (21), and an eyepiece component (39) is fixedly connected to the mounting seat component (21) and is arranged corresponding to the camera pipe piece (Fig. 2); and
the mounting seat component (21) comprises an open mounting base (via bore (39)) and an extended flat seat integrally connected to the mounting base (see annotated Fig. 2 below), wherein three through holes (25, 25, 26) are provided in a middle of the extended flat seat, and the through holes are in one-to-one correspondence with the water inlet pipe piece, the camera pipe piece and the water outlet pipeline piece, respectively (Col. 4, Lines 13-24, Fig. 2).
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Cho does not expressly teach an implantation sleeve, with the endoscope component closely fitting an inner wall of the implantation sleeve with an endoscope outer tube extending along a length of the implantation sleeve. the implantation sleeve comprises a working sleeve, an endoscope transition sleeve fixedly connected to the working sleeve, and an endoscope outer tube guide sleeve, wherein an endoscope outer tube guide sleeve closely fits a lower end of an endoscope transition sleeve, wherein the endoscope outer tube extends through the endoscope outer tube guide sleeve and into the endoscope transition sleeve and the working sleeve in sequence.
Cheng teaches a bendable ureteral access sheath for use with a flexible ureteroscope (Fig. 3). The ureteral access sheath includes in sequence a endoscope outer tube guide sleeve, an endoscope transition sleeve and a working sleeve (see annotated Fig. 3 below). The ureteral access sheath further includes a bendable tube section (12) enabling a distal end of the access sheath to change direction aiding in navigating a ureteroscope through the ureter without puncturing or damaging walls of the ureter (Par. 56).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope of Cho with the access sheath of Cheng aiding advancement of the endoscope within a body cavity while preventing puncturing of luminal walls of the body cavity by bending of the bendable tube section of the access sheath.
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In regard to claim 3, Cho and Cheung teaches wherein an end surface of the endoscope outer tube has an arc-shaped section (the cross-section of the outer tube is circular and therefore can be considered arc-shaped, Figs. 2-3), and the endoscope component closely fits the inner wall of the implantation sleeve so that the working sleeve and the endoscope outer tube form a working space (the endoscope component closely fits the working sleeve).
In regard to claim 5, Cho teaches wherein a water inlet port channel and a water outlet port channel are respectively opened on two opposite sides of the mounting base, and the water outlet pipe connector and the water inlet pipe connector are fixedly connected to the water inlet port channel and the water outlet port channel, respectively (Figs. 2-3).
In regard to claim 6, Cho teaches wherein a cover plate (via eyepiece at the proximal end of the mounting base (21), Fig. 2) is fixedly connected to an opening of the mounting base (Fig. 2), and an optical fiber interface (41) is fixedly connected to an end face of the mounting base away from the cover plate (Fig. 2).
In regard to claim 8, Cho teaches characterized in that a total length of the endoscope outer tube plus the mounting seat component ranges from 100 cm to 300 cm (Col., 3, Lines 37-40, wherein the length of the outer tube (23) and mounting seat (21) would be greater than 100 cm and within the range of 100-300cm).
In regard to claim 9, Cho teaches characterized in that wherein the endoscope outer tube is configured to isolate the water inlet pipe piece, the camera pipe piece, and the water outlet pipeline from the working channel for visualizing endoscopic operation (Figs. 2-3).
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 December 2, 2025