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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21-24, 31-33, 35-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jackson et al. (U.S. Pub. No. 2014/0214084 A1, hereinafter “Jackson I”).
Jackson I discloses, regarding claim 21, an assembly (see Fig. 93) couplable to bone (via 3100), the assembly comprising: an anchor comprising: a shank (3004) including distal threading (3024) that is securable to bone (see Fig. 93, see para. [0218]); and a head (3008) at a proximal end (see Fig. 93, see para. [0217]); a housing (3010) including an anchor bore (3061) extending distally into the housing along a longitudinal axis of the housing (e.g. long axis of 3010, see Fig. 93), wherein the anchor bore is at least a diameter of the head of the anchor at a proximal end of the housing (see Fig. 97, note that diameter of anchor bore at proximal end is wide enough to receive 3012, which has a larger diameter than 3008), wherein the anchor bore is configured to retain at least a portion of the head of the anchor therein (via 3012 and 3100, see Fig. 99), and wherein the head of the anchor is insertable into the anchor bore at a distal end of the housing (see Fig. 97); and a saddle (3014) receivable within the housing and configured to receive a connecting member (3021) thereon (see Fig. 99, see para. [0217]), wherein a distal end (3184) of the saddle is configured to engage a proximal end of the head of the anchor (see Fig. 99, see para. [0222]).
Regarding claim 22, wherein the head comprises: a proximal first threaded portion (3040) of the shank (see Fig. 97), wherein the proximal first threaded portion of the shank is insertable into the anchor bore at the distal end of the housing (see Fig. 97); and a donut (3012) including a second threaded portion (3126), wherein the donut is threadably securable to the shank via threaded engagement of the proximal first threaded portion and the second threaded portion (see Figs. 93 and 99, see para. [0221]), wherein the anchor bore is configured to retain the donut therein (see Figs. 97 and 99), and wherein the distal end of the saddle is configured to engage a proximal end of the donut (see Fig. 99).
Regarding claim 23, wherein the anchor includes a necked portion (3026, see Fig. 94, see para. [0219]) between the proximal first threaded portion of the shank and the distal threading of the shank (see Fig. 94), wherein the necked portion has a smaller diameter than the proximal first threaded portion of the shank (see Fig. 94), and wherein the anchor further includes a distally tapered transition surface (3035, see Fig. 94, see para. [0219]) between the proximal first threaded portion of the shank and the necked portion (see Fig. 94, see para. [0219]).
Regarding claim 24, wherein the housing includes a tapered outer diameter (3108) at the distal end of the housing (see Fig. 97, see para. [0220]), wherein the necked portion of the anchor corresponds to the tapered outer diameter at the distal end of the housing (see Fig. 91), and wherein the tapered outer diameter of the housing and the necked portion of the anchor provides a high degree of angulation for a position of the anchor relative to the longitudinal axis of the housing (see paras. [0220] and [0142]).
Regarding claim 31, further comprising: a set screw (3018, see Fig. 93) configured to be inserted into the housing following the insertion of the head at the proximal end of the anchor and following the insertion of the saddle into the housing (see Fig. 99), wherein the set screw threadably engages an interior surface (3072) of the housing to secure the set screw within the housing (see Fig. 99, see para. [0217]).
Regarding claim 32, wherein a proximal end of the set screw includes a tool notch (3240) configured to receive a tool for applying a first torque on the proximal end of the set screw to threadably engage the set screw to the housing (see Fig. 93, see para. [0223]).
Regarding claim 33, wherein when a connecting member (3021) is inserted between the saddle and the set screw (see Fig. 99, see para. [0217]), threadably engaging the set screw to the housing compresses the connecting member between the saddle and the set screw following an application of a second torque on the proximal end of the set screw by the tool (see para. [0217]).
Jackson I discloses, regarding claim 35, an anchor assembly (see Fig. 93) couplable to bone (via 3100), the assembly comprising: an anchor (3100) comprising: a shank (3004) including distal threading (3024) that is securable to bone (see Fig. 93, see para. [0218]); and a head (3008) at a proximal end (see Fig. 93, see para. [0217]); a housing (3010) including an anchor bore (3061) extending distally into the housing along a longitudinal axis of the housing (e.g. long axis of 3010, see Fig. 93), wherein the anchor bore is configured to retain at least a portion of the head of the anchor therein (via 3012 and 3100, see Fig. 99), wherein the head of the anchor is insertable into the anchor bore at a distal end of the housing (see Fig. 97), and a saddle (3014) receivable within the housing and configured to receive a connecting member (3021) thereon (see Fig. 99, see para. [0217]), wherein a distal end (3184) of the saddle is configured to engage a proximal end of the head of the anchor (see Fig. 99, see para. [0222]).
Regarding claim 36, wherein a first threaded portion (3126) of the head is couplable to a proximal second threaded portion (3040) of the shank (see Fig. 97), wherein the anchor includes a necked portion (3026, see Fig. 94, see para. [0219]) between the proximal second threaded portion of the shank and the distal threading of the shank (see Figs. 93-94 and 99, see para. [0221]), wherein the necked portion has a smaller diameter than the proximal second threaded portion of the shank (see Fig. 94), and wherein the anchor further includes a distally tapered transition surface between the head and the necked portion (3035, see Fig. 94, see para. [0219]) between the proximal first threaded portion of the shank and the necked portion (see Fig. 94, see para. [0219]).
Regarding claim 37, wherein the anchor bore is at least a diameter of the head of the anchor at a proximal end of the housing (see Fig. 97, note that diameter of anchor bore at proximal end is wide enough to receive 3012, which has a larger diameter than 3008).
Claim(s) 38-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jackson et al. (U.S. Pub No. 2015/0119940 A1, hereinafter “Jackson II”).
Jackson II discloses, regarding claim 38, an assembly (see Fig. 1) couplable to bone (via 1), the assembly comprising: an anchor (1) comprising: a shank (4) including distal threading that is securable to bone (see para. [0066] “threaded shank body”); and a head (8) at a proximal end (see Fig. 1); a housing (10) including an anchor bore (91) extending distally into the housing along a longitudinal axis of the housing (see Fig. 8), wherein the anchor bore is configured to retain at least a portion of the head of the anchor therein (via 11-12 and 14, see para. [0060]), and wherein the head of the anchor is insertable into the anchor bore at the distal end of the housing (see Figs. 30-32, see para. [0093]); and a turret (12) couplable to the distal end of the housing (see Fig. 25) and comprising a plurality of fingers (150, 152, 154, 156, 158, 160, 162 and 163, see Figs. 12-14, see para. [0075]) receivable within the distal end of the housing to attach the turret to the housing (see Fig. 25).
Regarding claim 39, wherein the turret includes a tapered outer diameter (171, see Fig. 7, see Figs. 22-23, see para. [0076] “frusto-conical”) at a distal end of the turret that corresponds to a necked portion of the anchor (see Fig. 45), and wherein the tapered outer diameter of the turret and the necked portion of the anchor provides a high degree of angulation for a position of the anchor relative to the longitudinal axis of the housing (via 180, see Fig. 45), and wherein the turret is rotatable with respect to the housing to allow the anchor to be positioned at the high degree of angulation relative to the longitudinal axis of the housing (see Fig. 45, see para. [0076]).
Regarding claim 40, further comprising: a saddle (14) receivable within the housing (see Fig. 48) and configured to receive a connecting member thereon (21, see Fig. 48, note that surface 183 receives connecting member 21 thereon), wherein a distal end (190) of the saddle is configured to engage a proximal end of the head of the anchor (see Fig. 48, see para. [0078]).
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.
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson I, as applied to claim 21 above, and in view of Jackson (US Pub No. 2006/0100622 A1, hereinafter “Jackson III”).
Jackson I discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 25, wherein the proximal end of the donut includes one or more tool notches configured to receive a tool for applying a torque on the proximal end of the donut to secure the first threaded portion to the second first proximal threaded portion; and regarding claim 26, wherein engagement of the one or more tool notches by the tool causes deformation of the second threaded portion when the second threaded portion is secured to the first proximal threaded portion.
Jackson III discloses an assembly (see Figs. 12-15) with an anchor (201) with shank (204), a head (238) and a donut (212), wherein the donut includes one or more tool notches (296, see Figs. 12-13) configured to receive a tool (231) for applying a torque on the proximal end of the donut to secure the first threaded portion to the second first proximal threaded portion (see para. [0103]); wherein engagement of the one or more tool notches by the tool causes deformation of the second threaded portion when the second threaded portion is secured to the first proximal threaded portion (see para. [0104]) in order to enable the donut to be engaged by a driving tool and rigidly secure the donut to the head in a manner that prevents relative rotation therebetween (see paras. [0103]-[0104]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the proximal end of the donut in Jackson I to include one or more tool notches in view of Jackson III in order to enable the donut to be engaged by a driving tool and rigidly secure the donut to the head in a manner that prevents relative rotation therebetween.
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson I, as applied to claim 21 above, and in view of Leff et al. (U.S. Pub. No. 2017/0049484 A1, hereinafter “Leff”).
Jackson I discloses all of the features of the claimed invention, as previously set forth above in the embodiment shown in Figure 99, except regarding claim 27, wherein the saddle includes one or more ridges that extend at least one of radially inward and distally from the saddle and toward the proximal end of the donut, and wherein the one or more ridges are configured to engage the proximal end of the donut to limit movement between the donut and the saddle; regarding claim 28, wherein the saddle includes a plurality of engagement teeth configured to engage the connecting member when received by the saddle to limit movement of the connecting member within the housing.
Leff discloses an assembly (see Fig. 1) with a saddle (6, see Figs. 2-3), wherein the saddle includes one or more ridges that extend at least one of radially inward (42, see Fig. 3), and wherein the one or more ridges are configured to engage the proximal end of the bone screw to limit movement between the bone screw and the saddle (see para. [0054]); wherein the saddle includes a plurality of engagement teeth (42, see Fig. 3) configured to engage the connecting member when received by the saddle to limit movement of the connecting member within the housing (see para. [0054]) by improving engagement with the bone screw (see para. [0054]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the saddle in Jackson I to include ridges that extend radially inward / engagement teeth in view of Leff in order to limit movement of the connecting member within the housing by improving engagement with the bone screw.
Claim(s) 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson I, as applied to claim 21 above.
Jackson I discloses all of the features of the claimed invention, as previously set forth above in the embodiment shown in Figure 99, except regarding claim 29, wherein the saddle includes one or more ledges that extend radially outward from a radially outer surface of the saddle and that are configured to engage an interior surface of the housing to limit movement of the saddle within the housing; and regarding claim 30, wherein the one or more ledges are tapered distally to create a proximal-facing flat face for retaining the saddle within the housing via engagement of the one or more ledges and the housing.
Jackson I discloses in an alternative embodiment shown in Figure 91, wherein the saddle includes one or more ledges (2188, see Fig. 89) that extend radially outward from a radially outer surface of the saddle (see Fig. 89) and that are configured to engage an interior surface of the housing to limit movement of the saddle within the housing; and wherein the one or more ledges are tapered distally to create a proximal-facing flat face (2195 / 2167) for retaining the saddle within the housing via engagement of the one or more ledges and the housing (see paras. [0211] and [0215]) in order to provide greater surface area of contact with the set screw for locking of the bone screw (see paras. [0211] and [0173]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify saddle in the embodiment shown in Figure 99 of Jackson I to include one or more ledges in view of an alternative embodiment shown in Figure 91 of Jackson in order to provide greater surface area of contact with the set screw for locking of the bone screw.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson I, as applied to claims 21-22 above, and in view of Errico et al. (US Pub No. 2020/0253655 A1, hereinafter “Errico”).
Jackson I discloses all of the features of the claimed invention, as previously set forth above. Jackson I further discloses, regarding claim 34, wherein a diameter of the proximal first threaded portion is less than a diameter of the anchor bore of the housing (see Fig. 97), however fails to disclose, regarding claim 34, and wherein a diameter of the shank is greater than the diameter of the anchor bore of the housing.
Errico discloses an assembly (see Fig. 6) with a bone anchor (100) wherein the shank has a greater diameter than anchor bore (24, see Fig. 6, see para. [0037]) in order to provide better cutting / retaining of the bone anchor into osseous tissue (see paras. [0035]-[0036]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the diameter of the shank in Jackson I to be greater than the diameter of the anchor bore in view of Errico in order to provide better cutting / retaining of the bone anchor into osseous tissue.
Response to Arguments
Applicant’s arguments, see page 7, filed 10/16/2025, with respect to the nonstatutory double patenting rejection have been fully considered and are persuasive. The nonstatutory double patenting rejection has been withdrawn.
Applicant's arguments filed 10/16/2025 have been fully considered, with respect to the rejection of claims 21 and 35 under 35 U.S.C 102(a)(1) as being anticipated by Jackson et al. (U.S. Pub. No. 2014/0214084 A1), but they are not persuasive.
The Applicant asserts that claim Jackson fails to disclose, regarding claims 21 and 35, engagement of the saddle to the proximal end of the head of the anchor. The Applicant asserts that Fig. 99 of Jackson shows an outer substantially spherical surface 3127 of the retainer 3012 engages the lower curved or radiused surface portion 3184 of the saddle 3178, the applicant further asserted with an amended Fig. 99 showing that neither the shank head top surface 3036 nor the shank cylindrical surface 3038 engage the curved surface portion 3184 of the saddle 3178.
The Office respectfully disagrees. Claims 21 and 35 only require that “a distal end of the saddle is configured to engage a proximal end of the head of the anchor”, not that the distal end of the saddle is configured to directly engage a proximal end of the head of the anchor. Therefore, Jackson shows in Fig. 99 that the lower curved or radiused surface portion 3184 of the saddle 3178 engages a proximal end of the head of the anchor (3008) via engagement with donut (3012) that is threadably attached to the proximal end of the head of the anchor (3008).
Applicant’s arguments with respect to claim(s) 38-40 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773