DETAILED ACTION
This office action is responsive to the amendment filed February 2, 2026. By that amendment, claims 3, 5-15, 22, 23, and 27 were amended; and claim 30 was newly presented. Claims 1-30 are pending.
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 .
Response to Arguments
The outstanding rejections under 35 USC 112(b) of claims 3, 5-15, 22, 23, and 27-29 were overcome by the amendments to the claims of February 2, 2026.
Applicant's arguments filed February 2, 2026, related to the rejection of claim 1under 35 USC 102(a)(1) in view of Ramsay (US 2012/0271356 A1) have been fully considered but they are not persuasive. Dependent claims rejected under 35 USC 102(a)(1) or under 35 USC 103 were treated together with claim 1 in the arguments based on their dependence from an allegedly allowable claim, so will be treated together with claim 1 in this response.
Applicant argues that A) elements 102/104 are not “distance-spanning flexible coupling members”; that B) fig. 1E is an intermediate configuration; and that C) distance of 102/104 being relied upon as meeting the spanning limitation is improper. Examiner understands the arguments.
As an initial matter, Examiner quickly responds to B) by stating that he agrees the figure demonstrates an intermediate configuration, but that fig. 1E was relied upon only for the fact that it was the clearest presentation of the device in cross-section. The structures of 1E and the demonstration of the thickness of 102/104 through the head portions were what was considered of importance. The relationship between 102/104 and 106/126 will not be substantially changed when moving to the final locked position.
Regarding A) and C), Examiner disagrees that 102/104 does not function to distance-span and connect the fastener head and rod-receiving head in the manner claimed. To “span” is defined as “to extend across” (Merriam-Webster Dictionary 2026). Examiner respectfully takes the position that the thickness of 102/104 has ‘extended across’ the distance between the fastener head 160 and the rod-receiving head portions 106 and 126 as seen best in fig. 1E (chosen due to cross-sectional view). Examiner sees no issue with this understanding, and no reason that the thickness dimension of 102/104 reaching across the distance is not reading on the claimed spanning and coupling limitations.
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Examiner disagrees that the limitation is ‘read out of the claim’ and respectfully suggests a narrowing limitation as to how much this spanning must be; or a portion of the device which performs the spanning, which is not the same as what Ramsay is doing; or some other structural distinction between the Ramsay device and the instant invention; would overcome the rejection of record.
The dependent claims were argued with claim 1 so stand or fall therewith.
Claim Rejections - 35 USC § 102
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) 1-8, 18-21, 23-27 and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramsay et al. (US 2012/0271356 A1).
Regarding claim 1, Ramsay teaches a spinal bone fastener assembly as at figs. 1A-1F capable of being engaged to a posterior spinal bone fastener system, the spinal bone fastener assembly comprising
a bone fastener 108 having a bone fastener head portion 160, a bone engaging elongated shaft 162 and a first drive (unlabeled, formed in 160 as seen clearly in fig. 1E) for introducing the bone fastener 108 into a target bone,
a rod receiving head 106/116/126 configured to receive and at least partially encompass a spinal rod 110 in a first rod receiving opening 124 with a central pocket (a portion of surface of 124) having a clamping seat (portion of the surface of 118) which is configured to contact 110 (considered to be in the form of a clamping seat),
a tightening means 120 configured to exert a retaining and/or clamping force between the spinal rod 110 and the rod receiving head 106/116/126,
at least one flexible elongate member 102/104 [0042] connecting the rod receiving head 106/116/126 with the bone fastener 108 (by virtue of 102/104 being coupled to 108 at opening 172, and coupled to the receiving head 106/116/126 through slots 152/154/156/158 therein; best seen at fig. 1E and marked up figure),
wherein,
the bone fastener 108 further comprises at least one first flexible elongate member retaining means (at the configuration of the shaft and head, best seen in fig. 1E, which arrangement prevents the head from pulling through 172),
the rod receiving head 106/116/126 comprises at least one second flexible elongate member retaining means (slots 152/154/156/158) and a first tightening mechanism portion 122 [0037], [0038]
the tightening means 120 comprises a second drive (unlabeled, seen clearly in fig. 1E) to engage the tightening means 120 into the rod receiving head (for use of screwdriver [0037]),
the spinal bone fastener assembly has a second tightening mechanism at threads formed on 120 sized and shaped to engage with the first rod setting or tightening mechanism portion at the openings 122 [0037-0038], and
the flexible elongated member 102/104 comprises a long elongated flexible body which is sized and shaped to engage with first and second flexible elongate member retaining means (the enlarged head 60 and the slots 152/154/156/158) and of which at least a portion spans between the bone fastener head portion 160 and the rod receiving head 106/116/126 bottom end on 106(see fig. 1E), wherein the bone fastener head portion 160 is spaced at a distance from the rod receiving head bottom end (by the thickness of 102/104 within 106 as in fig. 1E – see the marked up figure in the response to arguments section).
Regarding claim 2, the assembly includes a locked configuration (120 tightened) and an unlocked configuration (120 loosened). In the locked configuration, the elongated flexible member 102/104 is biased against the clamping seat of 118. Translation of 102/104 through the second retaining means 152/154/156/158 is inhibited by being in the locked configuration. (see fig. 1E, [0039])
Regarding claim 3, the first rod setting or tightening mechanism 122 and the second tightening mechanism at the threads on 120 includes external threads. The first tightening mechanism at the slots formed in 102/104 are considered to be internal threads (e.g. partial threads).
Regarding claim 4, since the flexible member 102/104 can pass through the second flexible elongate member retaining means 152/154/156/158, those are considered oversized in comparison to the cross section of 102/104.
Regarding claim 5, the second flexible elongate member retaining means 152/154/156/158 is considered to fully encompass the flexible elongate member 102/104 (since it retains it on all sides). The arms are not permitted to move outwardly relative from the screw due to the structure of 152/154/156/158.
Regarding claim 6, the elongate member retaining means 152/154/156/158 extend parallel with an elongated axis of the bone fastener 108 as seen best at fig. 1A
Regarding claims 7 and 8, a tightening means on 120 is an inner tightening means, and 122 is an outer tightening means. 120 is considered to be a “main” tightening means. As noted above in rejecting claim 3, these are considered to be an inner and outer thread.
Regarding claim 18, it is examiner’s position that the structure of the head 160 and portion 106 being enlarged relative to the shank 162 of the screw will function as a depth stop preventing further insertion of the screw into the bone.
Regarding claim 19, the rod receiving head 106/116/126 includes a rod tightening means receiving extensions at the inner formation of 126 that project from the head top (e.g. from the top of 116 – when used with 122, this portion functions to secure the rod when 120 is tightened).
Regarding claim 20, the rod receiving head 106/116/126 includes a first drive shaped aperture 150 that extends through the head bottom end. See fig. 1A
Examiner does not interpret this limitation to mean that the aperture has the same shape as the first drive, but rather, has a shape that permits use of the first drive.
Regarding claim 21, the flexible elongated member 102/104 has a distal coupling end including aperture 172. There is no reason this end could not be attached to an appropriate inferentially claimed insertion device.
Regarding claim 23, the flexible elongated member 102/104 enters the rod receiving head 106/116/126 from the head bottom end and exits the head 106/116/126 from the head outer wall as seen in fig. 1E.
Regarding claim 24, the portion of 102/104 which includes the passage 172 will be designated a spacer, which is positioned between the fastener 108 and the rod receiving head 106/116/126 as seen at fig. 1E.
Regarding claims 25 and 26, the claim is substantially identical to claim 1, with exception of the insertion device. For the same reasons claim 1 was rejected, claim 25 is rejected, with additional identification of the insertion mechanism including a tensioning mechanism at a screwdriver for driving 120 (120 tightens 102/104 as it threads into 122) [0037]. The number of slots 122 visible, and/or the amount of force experienced by a user of the screwdriver through the screwdriver handle are considered to be tensioning force measurement devices.
Regarding claim 27, the claim requires providing the same structures as already rejected in claim 1, above. Further, the fastener is installed into a patient’s spine [0003], the receiving head 106/116/126 being located a predetermined distance from the bone fastener head portion 160 by structures of the device; introducing a rod 110; and tightening the tightening means 120 against the spinal rod (direct contact not required as claimed) in the central pocket blocking the position of 102/104 in the rod receiving head 106/116/126.
Regarding claim 30, there is no reason that a portion of 116 which is not seat 118 cannot be referred to as an ‘intermediate inlay”.
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.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramsay in view of Rice et al. (US 2018/0353217 A1).
Regarding claim 15, Ramsay teaches the limitations of claim 1, as above, but Ramsay fails to teach the bone fastener head portion 160 being predominantly non-circular.
Rice teaches a bone fastener head similar to the Ramsay head as at element 102. This head includes ridges [0045]. The ridged portion is considered to be non-circular.
It would have been obvious to one with ordinary skill in the art at the time of the invention o include ridges of Rice on the head 160 of the Ramsay screw. One would have done so in order to increase purchase between the screw head and the other structures of the assembly (Rice, [0045]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramsay in view of Greenhalgh et al. (US 2019/0167326 A1).
Regarding claim 16, Ramsay teaches the limitations of claim 1, as above, but fails to teach the first drive formed in 160 including an internal thread capable of use in attachment of an inferentially claimed bone cement insertion cannula.
Greenhalgh teaches a fastener including a first drive 20 including an internal thread 21a for engagement to a tool. A properly sized and configured bone cement insertion cannula is capable of interfacing with 21a.
It would have been obvious to one with ordinary skill in the art at the time of the invention to incorporate an internal thread 21a of Greenhalgh into the first drive of 160 of Ramsay. One would have done so in order to permit coupling of a tool to the screw 108. (Greenhalgh, [0212])
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramsay.
Regarding claim 17, Ramsay teaches the limitations of claim 1, as above, and further teaches the elongated member 102/104 being formed of biocompatible plastics [0055].
Ramsay has not taught the weaving or braiding of strands of plastic to form 102/104, and has not specified the particular types of plastics.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form 102/104 of one of the claimed types of plastics and braiding them as part of the forming process. It is examiner’s position that braided fibers would not be functionally distinct from an extruded or other known means for forming plastics in the art. One would have done so as a matter of selection of a known material to arrive at a material having desirable material properties for the task of spinal surgery. It is within the ordinary skill of one in the art to select a material based on its intended use.
Allowable Subject Matter
Claims 9-14, 22, 28 and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The claim cannot be allowed until such time as the outstanding rejections under 35 USC 112 are resolved.
Conclusion
THIS ACTION IS MADE FINAL. 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 David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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