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 .
Claim Objections
Applicant is advised that should claim 52 be found allowable, claim 53 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim(s) 50-58, 60-61 and 63-64 is/are rejected under 35 U.S.C. 102()a)1) as being anticipated by Jung et al. (US pub 2019/0142407).
With respect to claim 50, Jung discloses a multi-portal method (see figs 1 and 20 below) for treating a subject, comprising: positioning an endoscopic visualization instrument (fig 1, 70) at a first entrance located along the subject to view an intervertebral disc between adjacent vertebral bodies of the subject (Fig 20 120); endoscopically viewing abstract), using the endoscopic visualization instrument at the first entrance, removal the intervertebral disc using one or more instruments delivered through a second entrance located along the subject (paragraph 83, removing disc with probe 40); and after removal of the intervertebral disc, delivering an implant to an interverbal space between the adjacent vertebral bodies (paragraph 77, seating a cage), and endoscopically viewing, using the endoscopic visualization instrument at the first entrance and spaced apart from the interverbal space, the implant positioned at the interverbal space (abstract monitoring during surgery). With respect to claim 51, Jung discloses further comprising distracting the adjacent vertebral bodies to enlarge the interverbal space prior to delivering the implant into the interverbal space (paragraph 72, decompression). With respect to claim 52, Jung discloses further comprising viewing endplates (abstract viewing the site during the procedure) of the adjacent vertebral bodies using the endoscopic visualization instrument positioned outside of the interverbal space (fig 1). With respect to claim 53, Jung discloses further comprising viewing endplates (abstract viewing the site during the procedure) of the adjacent vertebral bodies using the endoscopic visualization instrument positioned outside of the interverbal space (fig 1). With respect to claim 54, Jung discloses further comprising viewing, using the endoscopic visualization instrument, removal of tissue adjacent a spine of the subject using the one or more instruments (paragraph 23, remove tissue while endoscope is located therein). With respect to claim 55, Jung discloses further comprising viewing, using the endoscopic visualization instrument, removal of tissue adjacent a spine of the subject using a surgical instrument (paragraph 23). With respect to claim 53, Jung discloses further comprising viewing, using the endoscopic visualization instrument, removal of tissue adjacent a spine of the subject while viewing non-targeted nerve tissue (paragraph 72, images of site while ensuring nerves are not damaged). With respect to claim 50, Jung discloses further comprising: using the one or more instruments to remove at least a portion of a facet and surrounding tissue of the subject to define a transforaminal path to the interverbal space; and delivering the implant along the transforaminal path and into the interverbal space (paragraph 12). With respect to claim 58, Jung discloses further comprising: positioning the endoscopic visualization instrument to view non-targeted tissue at or near a working region in the subject; and removing the tissue from the working region while viewing and leaving non- targeted nerves intact (paragraphs 23 and 72). With respect to claim 60, Jung discloses further comprising performing, under endoscopic viewing of the endoscopic visualization instrument, at least one of: a decompression procedure (paragraph 72), a discectomy, a microdiscectomy (paragraph 83, removing the disc), or a laminotomy.
With respect to claim 61, Jung discloses multi-portal method (see fig 1 and 20 below) for treating a subject, comprising: endoscopically viewing (abstract and fig 1), using an endoscopic instrument positioned in a first port (paragraph 127, endoscope is in a guide tube) located along the subject, vertebrae adjacent to one another (fig 1); enlarging an intervertebral space between the adjacent vertebrae using a distraction instrument (paragraph 72) positioned in a second port located along the subject (see fig 1 below) ,wherein the second port is spaced apart from the first port (fig 1); and after enlarging the intervertebral space, moving an implant into the enlarged intervertebral space (paragraph 77), and endoscopically viewing (abstract), using the endoscopic instrument positioned outside of the intervertebral space, the implant in the enlarged intervertebral space and the adjacent vertebrae (fig 1 and fig 20). With respect to claim 63, Jung discloses further comprising endoscopically viewing, using the endoscopic instrument, one or more nerve roots and opposing side regions of the intervertebral space (abstract and paragraph 72). With respect to claim 64, Jung discloses wherein the implant is an intervertebral cage (paragraph 77).
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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) 59 and 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung et al. (US Pub 2019/0142407) in view of McGuire et al. (US Pub 2014/0303730).
With respect to claim 59, Jung disclose using endoscopic viewing instruments to view the reduction of nerve compression attributed to tissue removal (paragraph 72, decompression, paragraph 160 continuously monitoring) and discloses using imaging (paragraph 105) but does not disclose viewing using fluoroscopy.
McGuire disclose viewing using fluoroscopy (paragraph 7) to verify proper positioning (paragraph 7).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jung to include viewing using fluoroscopy in view of McGuire in order to verify proper positioning.
With respect to claim 62, Jung discloses the claimed invention except for further comprising using fluoroscopy to view: the implant prior to releasing the implant from a delivery instrument, the implant during expansion of the implant in the subject, and the implant after completing expansion of the implant.
McGuire discloses further comprising using fluoroscopy to view (paragraph 7): the implant prior to releasing the implant from a delivery instrument (paragraph 7, during insertion), the implant during expansion of the implant in the subject (paragraph 7, during insertion and paragraph 35, viewing desired endplate of separation while the implant is inflated with fluid), and the implant after completing expansion of the implant (paragraph 7 after insertion) to verify proper positioning (paragraph 7).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jung to include further comprising using fluoroscopy to view: the implant prior to releasing the implant from a delivery instrument, the implant during expansion of the implant in the subject, and the implant after completing expansion of the implant in view of McGuire in order to verify proper positioning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20010005796 A1 discloses a method of inserting a cage and removing the disc
US 20200383675 A1 discloses a method of spinal surgery with multiple ports
US 20140121774 A1 discloses a method of inserting a cage and removing the disc
US 20190142408 A1 discloses a method of spinal surgery with multiple ports
US 20030028251 A1 discloses a method of spinal surgery with multiple ports
US 20160199194 A1 discloses a method of inserting a cage and removing the disc
US 12226319 B2 is a parent application and it is noted that amendments may lead to a double patenting rejection
US 5735290 A discloses a method of surgery with multiple ports
US 10327912 B1 discloses a method of inserting a cage and removing the disc
US 6348058 B1 discloses a method of spinal surgery with multiple ports
US 20170065269 A1 discloses a method of spinal surgery with multiple ports
US 9901457 B2 discloses a method of spinal surgery with multiple ports
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773