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 Species I, Figs. 1-5 in the reply filed on 12/31/2025 is acknowledged.
Claims 1-29 are pending. Claims 14-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Species 2, there being no allowable generic or linking claim.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the drawings are illegible and fail to show the claimed invention in a manner that would enable one of ordinary skill in the art to understand the structural connections and operation. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show track 136, slot 134, pin 138, plunger 135, keyed feature 126, keyed feature 142, spring 137, screw 139, keyed feature 152, keyed feature 146, body 154, threads 156, biasing member 159, threaded aperture 157 and slider body 158 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
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 1-29 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.
Claims 1-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are due to an inability to differentiate, determine, and understand the separate structural components due to the illegible nature of the drawings. The claimed structure can’t be identified in the Figures and therefore it is unclear how the structures connect or operate.
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) 1, 6, 8 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sweeney, III (U.S. 10,478,313 B1) as cited in the IDS filed 05/02/2024.
Concerning claim 1, as best understood, Sweeney discloses an inserter for inserting a spinal fusion implant, the inserter comprising: a housing (see Fig. 13, element 122) having a proximal member and a housing shaft (see Fig. 14, element 106) extending distally therefrom; an inner shaft (see Fig. 14, element 108) having a distal end and a proximal end, wherein the inner shaft is configured to be disposed at least partially within the housing shaft, and to translate relative to the housing shaft (see Figs. 17A-18B), and the distal end is configured to releasably engage the spinal fusion implant (see Fig. 16); a thumbwheel (see Fig. 13, element 128) configured to be rotatably fixed to the proximal end of the inner shaft, and to rotate about a longitudinal axis of the inserter, thereby causing the inner shaft to rotate (see col. 9, lines 12-21); a lock (see Fig. 15B, element 138) engaged with the inner shaft, wherein the lock is configured to move between a locked position and an unlocked position, wherein in the locked position, the inner shaft is rotatably fixed to the thumbwheel (see col. 10, lines 43-46), and in the unlocked position, the inner shaft and the thumbwheel are separable from one another (see col. 12, lines 39-43); and a soft stop (see col. 14, line 65 – col. 15, line 4; “unlock position” and collapse of distal insertion members 126) configured to provide one or more of audible and or tactile feedback to a user to indicate that the spinal fusion implant is fully disengaged from the distal end of the inner shaft.
Concerning claim 6, wherein the proximal end of the inner shaft comprises a keyed
feature (threads) which provides a complementary fit with a corresponding keyed feature (threads) on the thumbwheel (see Fig. 15A).
Concerning claim 8, wherein the inner shaft (see Fig. 15A, element 108) has a first diameter, and wherein the lock (138) further comprises: a portion of the inner shaft having a second diameter that is reduced relative to the first diameter; and a lock button (138) disposed on the housing and movable in a direction substantially perpendicular to the longitudinal axis, the lock button comprising a slot configured to engage the portion of the inner shaft having the reduced diameter, wherein the slot has an irregular cross sectional shape, such that: in the locked position (see Fig. 15A below), an outer surface of the lock button is substantially flush with an outer surface of the housing, and a first end of the slot provides a close fit with the portion of the inner shaft having the reduced diameter, and in the unlocked position (see Fig. 18A below), the outer surface of the lock button is raised relative to the outer surface of the housing, and a second end of the slot accommodates the inner shaft at a portion not having the reduced diameter, allowing the inner shaft to translate.
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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.
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.
Claim(s) 2-5, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney, III (U.S. 10,478,313 B1) in view of Pimenta (U.S. 8,673,005 B1).
Sweeney discloses the invention substantially as described above. However, Sweeney does not explicitly disclose that the distal end of the inner shaft comprises threads configured to engage complementary threads on the spinal fusion implant.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to simply substitute threads for the inner shaft and spinal fusion implant engagement, the concept of which is disclosed by Pimenta, being doing so is a simple substitution of one known connecting element for another in order to obtain the predictable result of temporarily securing the implant to the inserter during the insertion process.
Concerning claim 3, wherein rotation of the thumbwheel in a first direction is configured to cause the distal end of the inner shaft to engage the spinal fusion implant, and rotation of the thumbwheel in a second direction is configured to cause the distal end of the inner shaft to disengage from the spinal fusion implant (see col. 8, lines 23-28).
Concerning claim 4, the inner shaft is configured to translate distally, causing the proximal end thereof to disengage from the thumbwheel, and the inner shaft is further configured to be removed from a distal end of the housing shaft (see Fig. 11). It is noted that the ability for spinal fusion inserters to have a releasable inner shaft form the outer body offers several practical surgical benefits such as easier cage placement and positioning, better visualization, reduced risk of implant displacement, versatility with implant designs, and accommodation of surgical techniques. For example, one the cage is properly positioned in the disc space, the surgeon can detach the inner shaft while leaving the outer sleeve or body in place temporarily. This allows them to verify positioning, check alignment, or make find adjustments without the bulk of the entire instrument in the way.
Concerning claim 5, wherein the thumbwheel further comprises a biasing element (see Fig. 13, element 134) configured to bias the thumbwheel in a distal direction, wherein in the unlocked position, the thumbwheel is configured to translate proximally against a force of the biasing element (see col. 10, lines 48-52), and when the proximal end of the inner shaft is disengaged from the thumbwheel, a distal
end of the thumbwheel is configured to move radially outward relative to the longitudinal
axis to initiate disassembly of the thumbwheel from the inserter.
Concerning claim 7, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to simply substitute a hex feature for the threaded feature, because doing so is a simple substitution of one known connecting element for another. Additionally, a hex feature provides quicker engagement and disengagement, is simple and reliable, provides excellent torque transfer, and is often used for inserters when secure engagement and rapid assembly or disassembly is required during a procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, 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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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773