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 .
Priority
Claims 1-4, 6-7, 9 have support going back to the original parent application 12/875,818 filed September 3, 2010 and thus these claims have an effective filing date of September 3, 2010.
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application:
Claim 1 requites first and second tools, with the central ramp “guided by the first tool and the second tool,” where these specific steps were only ever shown and described in Figs 11-14, which uses the embodiment shown in Figs 2-10. While Fig 2 shows the central ramp with an opening #32, opening #32 was never disclosed as being threaded. Claim 5 requires the central ramp having “a threaded opening”, where claim 5 (in view of claim 1) was not disclosed in the original parent.
Claim 8 claims an “extension with a threaded opening.” The examiner notes that while the specification contains other embodiments with an extension with a threaded opening (for example, as seen in Fig 25 with extension #250 and Fig 52 with extension #416), they do not disclose passing the central ramp guided by the first tool and the second tool. The embodiment of Fig 25 specifically discloses the central installed first (see Fig 28 and paragraph 96-97 in the current specification) and not guided by first and second tools as claimed in claim 1. The embodiment of Fig 52 only discloses installing the implant down an endoscopic tube (see paragraph 116 of the current specification) and does not discuss using any sort of tools. Likewise it is also not clear how the central ramp of Fig 52 is able to be guided using first and second tools as claimed.
In short, the steps in Claim 1 is only ever disclosed as being able to be carried out by the embodiment Figs 2-10. Claims 5 and 8 require the central ramp comprising “a threaded opening” which was never disclosed in the embodiment of Figs 2-10. As such, Claims 5, 8 (in view of claim 1) was not supported in the parent applications. Thus Claim 5, 8 have an effective filing date of the filing of the current application, Feb 11, 2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “end gap” (in claim 4) and “threaded opening” (in claim 5 in view of claim 1), and “extension comprising a threaded opening” (in claim 8 in view of claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “66” has been used to designate both a lower ramped surface (as seen in Fig 6-7 and paragraph 79) and an opening (as seen in Fig 4). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The limitation of claim 4, in particular the “end gap” was not disclosed in the original specification.
The limitations of Claim 5 in view of claim 1 was not disclosed in the original specification (see Priority section above).
The limitations of Claim 8 in view of claim 1 was not disclosed in the original specification (see Priority section above and 112 rejection below).
Claim Objections
Claim 4 objected to because of the following informalities:
Claim 4 line 3 should recite “[[the]] a proximal end”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 8 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 recites the limitation "the first side surface of the inferior endplate" in line 1 and “the first side surface of the superior endplate” in line 3-4. There is insufficient antecedent basis for these limitations in the claim. Examiner will treat with art as best understood.
As discussed in the Priority section above, the last clause of claim 1 was only ever disclosed in the embodiment shown in Fig 2-14. Claim 8 recites an “extension with a threaded opening, where when looking at Fig 13-14, it is not clear how the central ramp can have a configuration with an extension with a threaded opening as claimed in claim 8. The examiner notes that while the specification contains other embodiments with an extension with a threaded opening (for example, as seen in Fig 25 with extension #250 and Fig 52 with extension #416), they do not disclose passing the central ramp guided by the first tool and the second tool. The embodiment of Fig 25 specifically discloses the central installed first (see Fig 28 and paragraph 96-97 in the current specification) and not guided by first and second tools as claimed in claim 1. The embodiment of Fig 52 only discloses installing the implant down an endoscopic tube (see paragraph 116 of the current specification) and does not discuss using any sort of tools. As such, it is also not clear how the central ramp (having an extension) of Fig 52 as well as Fig 25 are able to be guided using first and second tools as claimed.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-7, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Shepard US 4,863,476 in view of Winslow US 5,885,299.
Regarding Claim 1, Shepard discloses a method of inserting an expandable fusion device (#22, #23 and #31) into an intervertebral disc space (col 5 lines 20-30), the method comprising:
passing a superior endplate of an expandable fusion device into an intervertebral disc space (see Fig below, Col 5 lines 20-30);
passing an inferior endplate of the expandable fusion device into the intervertebral disc space such that the inferior endplate is inferior to the superior endplate (see Fig below, Col 5 lines 20-30); and
with a first tool releasably mounted to the superior endplate and a second tool still releasably mounted to the inferior endplate (see Fig below, releasably mounted via threaded connection #27, #28, Col 4 lines 22-30), passing a central ramp (#31, having a ramp #34) through the endoscopic tube guided by the first tool and the second tool and between the superior endplate and the inferior endplate (see Fig below, Col 4 lines 31-50, see also Fig 7, where grooves #35, #36 allow the central ramp to be guided along the first and second tools).
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Shepard discloses the claimed invention as discussed above where the superior endplate is threadably coupled with the first tool and the inferior endplate is threadably coupled to the second tool (see Fig above, Col 4 lines 22-30) but does not disclose passing the superior endplate releasably mounted to the first elongate tool through the endoscopic tube and into an intervertebral disc space; passing the inferior endplate releasably mounted to the second elongate tool through the endoscopic tube.
Winslow discloses an implant (#100, Fig 3) threadably coupled to an elongate tool (#132, which has threads #144, Fig 8a, Col 4 lines 66 – Col 5 line 2), passing the implant releasably mounted to the elongate tool through an endoscopic tube (#300, Fig 11) and into an intervertebral disc space (Fig 11, Col 6 lines 66 – Col 7 line 8), the tool used to place the implant into the disc space where the endoscopic tube providing a guide into the disc space through which the implant and tool can pass through (Col 6 line 66- Col 7 line 8).
It would have been obvious to one having ordinary skill in the at a time before the effective filing date of the claimed invention to modify Shepard and have the first and second tools used to pass the super and inferior endplates through the endoscopic tube in view of Winslow above because the tools help place the endplates into the disc space where the endoscopic tube providing a guide into the disc space through which the endplates and tool can pass through. Examiner notes with the modification, the endoscopic tube of Shepard would be sufficiently sized to allow the passage of the superior and inferior endplates as well as the central ramp, where the first and second tools would be able to pass their respective endplate through the endoscopic tube and into the disc space.
Regarding Claim 2, Shepard as modified discloses removing the first tool from the superior endplate and the second tool from the inferior endplate (Col 5 lines 40-42 in Shepard).
Regarding Claim 4, Shepard as modified discloses the inferior endplate comprises a first surface (an upper surface, see Fig below), a second surface (see Fig below, a lower surface), a first side surface, and a second side surface (not identified but the endplate would have first and second side lateral surfaces), wherein the first surface of the inferior endplate includes an end gap (see Fig below, where there is an endgap that receives a proximal portion of the central ramp) at the proximal end (see Fig below where at where the first surface has a recess to receive the central ramp, where the recess has a proximal end as seen in Fig below) positioned medially between the first side surface and the second side surface, and the superior endplate comprises a first surface (see Fig below, a lower surface), a second surface (an upper surface, see Fig below), a first side surface, and a second side surface (not identified but the endplate would have first and second side lateral surfaces).
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Regarding Claim 6, Shepard as modified discloses the first side surface of the inferior endplate includes at least one ramped portion (see Fig below where an upper first side of the inferior endplate has a ramped portion) that engages the central ramp during movement of the expandable fusion device from a collapsed position to an expanded position (as seen in Fig 6, 8, Col 4 lines 30-50 in Shepard), and the first side surface of the superior endplate includes at least one ramped portion (see Fig below where an lower first side of the inferior endplate has a ramped portion) that engages the central ramp during movement of the expandable fusion device from the collapsed position to the expanded position (as seen in Fig 6, 8, Col 4 lines 30-50 in Shepard).
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Regarding Claim 7, Shepard as modified discloses the central ramp is configured to move in a first direction (see Fig above in claim 1, first direction is a rightward movement towards the endplate, Col 5 lines 20-30 in Shepard) and cause the inferior endplate and the superior endplate to move away from one another as the expandable fusion device shifts from a collapsed position (Fig 6 in Shepard) to an expanded position (Fig 8 in Shepard, Col 5 lines 20-30).
Regarding Claim 9, Shepard as modified discloses the central ramp has a first ramped surface and a second ramped surface (see Fig below), the first ramped surface is configured for engaging a portion of the inferior endplate and the second ramped surface is configured for engaging a portion of the superior endplate (see Fig below and Fig 8 where the ramped surfaces engage respective portions of the inferior and superior endplate, Col 4 lines 30-40 in Shepard).
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Regarding Claim 3, Shepard as modified discloses the claimed invention as discussed above but does not disclose passing the superior endplate of the expandable fusion device through the endoscopic tube occurs prior to passing the inferior endplate of the expandable fusion device through the endoscopic tube.
However, it would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the steps of Shepard to pass the superior endplate through the endoscopic tube occurs prior to passing the inferior endplate of the expandable fusion device through the endoscopic tube since this provides one of only three finite possibilities (passing the superior endplate first, passing the inferior endplate first or passing both endplates simultaneously) to obtain predictable results of passing the superior and inferior endplates into the disc space. Examiner notes that it has been held that it would have been “obvious to try” try one of the possible three finite possibilities to obtain predictable results of placing a fusion device into the disc space, where applicant has not disclosed that the order of the placement of the endplates solves any stated problem or is anything more than one of finite possibilities a person ordinary skill in the art would find obvious for the purpose of implanting endplates of a fusion device. [see MPEP 2144.05 (B)].
Regarding Claim 5, Shepard as modified discloses the claimed invention as discussed above but does not disclose the central ramp comprises a threaded opening having an open proximal end and a closed distal end, the threaded opening extending partially through the central ramp.
However, Shepard as modified discloses the endplates each have a threaded opening (#27, #28, Fig 6 in Shepard) having an open proximal end (to receive tools #27, #39, Fig 6 in Shepard) and a closed distal end (as seen in Fig 6 in Shepard), the threaded opening extending partially through the endplates (Fig 6 in Shepard), the threaded openings used to couple to respective tools (#27, #39) to hold and insert the endplates (see Fig above, Col 4 lines 22-30 in Shepard and with the modification in view of Winslow, Col 6 line 66- Col 7 line 8 in Winslow).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the central ramp of Shepard as modified to include a threaded opening in view of Shepard and Winslow above so that the central ramp can receive its own tool to hold and insert the central ramp. Examiner notes that with the inclusion of the threaded opening to the central ramp, where looking at Fig 7 of Shepard, the threaded opening would be located in one of the left or right portions of the central ramp so as to not interfere with the grooves (#35, #36 in Shepard).
Claims 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiman US 2012/0059475 in view of Gray US 2021/0378836.
Regarding Claim 8, Weiman discloses a method (Fig 11-14) of inserting an expandable fusion device (#10, Fig 1-14) into an intervertebral disc space, the method comprising:
passing a superior endplate (#16) of an expandable fusion device releasably mounted to a first elongate tool (#70) through an endoscopic tube and into an intervertebral disc space (Fig 11, paragraph 83, where the tool would be removed after the procedure);
passing an inferior endplate (#14) of the expandable fusion device releasably mounted to a second elongate tool (#72) through the endoscopic tube and into the intervertebral disc space such that the inferior endplate is inferior to the superior endplate (Fig 12, paragraph 83 where the tool would be removed after the procedure); and
with the first tool still releasably mounted to the superior endplate and the second tool still releasably mounted to the inferior endplate (Fig 13-14, paragraph 83), passing a central ramp (#18) through the endoscopic tube guided by the first tool and the second tool and between the superior endplate and the inferior endplate (paragraph 83),
wherein the central ramp comprises a first end, a second end (see Fig below).
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Weiman discloses a driving ramp (#260) with an opening (#262), where the driving ramp is moved towards the first end to expand the device (paragraph 77, 79) but does not disclose how the driving ramp is moved towards the first end and does not disclose an extension comprising a threaded opening, wherein the extension extends beyond the second end along a horizontal plane.
Gray discloses a central ramp (#708, see Fig below) with a first end (see Fig below), a second end (see Fig below), an extension (#728, see Fig below) comprising a threaded opening (#750, Fig 77, paragraph 209), wherein the extension extends beyond the second end along a horizontal plane (see Fig below, Fig 77, where the a threaded #752 couples to the central ramp such that the extension #728 extends beyond the second end along a horizontal plane that extends along the length of the extension), a driving ramp (#710, see Fig below), which receives a screw (#706), where the screw is received in the threaded opening (paragraph 209) where rotation of the screw moves the driving ramp towards the first end of the central ramp to expand the device (paragraph 206, 207, 74a-74b).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the central ramp of Weiman to include an extension threadably attached to the second end of the central ramp with a threaded opening, and a screw in view of Gray above because this provides a known alternative way of moving the driving ramp towards the first end of the central ramp to expand the implant. With the modification, the screw is able to extend through the driving ramp and engage the threaded opening such that rotation of the screw moves the driving ramp towards the first end of the central ramp to expand the implant. Likewise with the modification and looking at Fig 14 of Weiman, the extension would be attached after removal of tools #70, #72 and prior to installation of driving ramp #260.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for art of cited interest, showing other implants installed with tools.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
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