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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/10/2026 has been entered.
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. 2011/0015683 A1, hereinafter “Jackson I”).
Jackson I discloses, regarding claim 21, an assembly (see Fig. 1) couplable to bone (via 6), the assembly comprising: an anchor (4, see Fig. 5) comprising: a shank (6) including distal threading (22) that is securable to bone (see Fig. 5, see para. [0035]); and a head (8 and 12) at a proximal end (see Fig. 7); a housing (10) including an anchor bore (e.g. bore formed within cylindrical inner surface 80) extending distally into the housing along a longitudinal axis of the housing (“B”, see Fig. 8), wherein the anchor bore is at least a diameter of the head of the anchor at a proximal end of the housing (see para. [0044] “inner diameter between the arms 52 measured between crests of the guide and advancement structure 62”), wherein the anchor bore is configured to retain at least a portion of the head of the anchor therein (via shoulder 81, see paras. [0044]-[0045]), and wherein the head of the anchor is insertable into the anchor bore at a distal end of the housing (see para. [0045] “the retaining and articulating structure could be compressible (such as where such structure has a missing section) and could be loaded through the neck 83 and then allowed to expand and fully seat in the spherical seating surface 82” and para. [0062] “bottom-loaded”); and a saddle (14) receivable within the housing and configured to receive a connecting member (21) thereon (see Fig. 12, see para. [0053]), wherein a distal end (126) of the saddle is configured to directly engage a proximal end of the head of the anchor (see Fig. 11, see para. [0053]).
Regarding claim 22, wherein the head (8 and 12) comprises: a proximal first threaded portion (8) of the shank (see Fig. 5), wherein the proximal first threaded portion of the shank is insertable into the anchor bore at the distal end of the housing (36, see Fig. 5, see paras. [0046] and [0062]); and a donut (12) including a second threaded portion (98, see Fig. 7, see para. [0046]), wherein the donut is threadably securable to the shank via threaded engagement of the proximal first threaded portion and the second threaded portion (see Fig. 7, see para. [0046]), wherein the anchor bore is configured to retain the donut therein (see paras. [0044]-[0045]), and wherein the distal end of the saddle is configured to engage a proximal end of the donut (see Fig. 11).
Regarding claim 23, wherein the anchor includes a necked portion (see annotated Fig. 5 below) between the proximal first threaded portion (36) of the shank and the distal threading of the shank (22), wherein the necked portion has a smaller diameter than the proximal first threaded portion of the shank (see Fig. 5), and wherein the anchor further includes a distally tapered transition surface (26, see Fig. 5) between the proximal first threaded portion of the shank and the necked portion (see Fig. 5).
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Regarding claim 24, wherein the housing includes a tapered outer diameter (87) at the distal end of the housing (see Fig. 9, see para. [0045]), wherein the necked portion of the anchor corresponds to the tapered outer diameter at the distal end of the housing (see Fig. 13, see para. [0045]), 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 para. [0045]).
Regarding claim 31, further comprising: a set screw (18, see Fig. 14, see para. [0054]) 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. 14), wherein the set screw threadably engages an interior surface (62) of the housing to secure the set screw within the housing (see Fig. 14, see para. [0053]).
Regarding claim 32, wherein a proximal end of the set screw includes a tool notch (168) 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. 14, see para. [0060]).
Regarding claim 33, wherein when a connecting member (21) is inserted between the saddle and the set screw (see Fig. 14), 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 Figs. 12-14).
Jackson I discloses, regarding claim 35, an anchor assembly (see Fig. 1) couplable to bone (via 6), the assembly comprising: an anchor (4, see Fig. 5) comprising: a shank (6) including distal threading (22) that is securable to bone (see Fig. 5, see para. [0035]); and a head (8 and 12) at a proximal end (see Fig. 7); a housing (10) including an anchor bore (e.g. bore formed within cylindrical inner surface 80) extending distally into the housing along a longitudinal axis of the housing (“B”, see Fig. 8) extending distally into the housing along a longitudinal axis of the housing (“B”, see Fig. 8), wherein the anchor bore is configured to retain at least a portion of the head of the anchor therein (via shoulder 81, see paras. [0044]-[0045]), wherein the head of the anchor is insertable into the anchor bore at a distal end of the housing (see para. [0045] “the retaining and articulating structure could be compressible (such as where such structure has a missing section) and could be loaded through the neck 83 and then allowed to expand and fully seat in the spherical seating surface 82” and para. [0062] “bottom-loaded”), and a saddle (14) receivable within the housing and configured to receive a connecting member (21) thereon (see Fig. 12, see para. [0053]), wherein a distal end (126) of the saddle is configured to directly engage a proximal end of the head of the anchor (see Fig. 11, see para. [0053]).
Regarding claim 36, wherein a first threaded portion (98) of the head is couplable to a proximal second threaded portion (36) of the shank (see Fig. 7), wherein the anchor includes a necked portion (see annotated Fig. 5 above) between the proximal second threaded portion of the shank (36) and the distal threading of the shank (22, see Fig. 5), wherein the necked portion has a smaller diameter than the proximal second threaded portion of the shank (see Fig. 5), and wherein the anchor further includes a distally tapered transition surface between the head and the necked portion (26) between the proximal first threaded portion of the shank and the necked portion (see Fig. 5).
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 para. [0044] “inner diameter between the arms 52 measured between crests of the guide and advancement structure 62”).
Claim(s) 38 and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murabayashi et al. (U.S. Pub No. 2018/0243010 A1, hereinafter “Murabayashi”).
Murabayashi discloses, regarding claim 38, an assembly (see Fig. 13) couplable to bone (via 7), the assembly comprising: an anchor (7) comprising: a shank (7a) including distal threading that is securable to bone (see Fig. 13); and a head (7b) at a proximal end (see Fig. 13); a housing (8) including an anchor bore (see annotated Fig. 17B below) extending distally into the housing along a longitudinal axis of the housing (see annotated Fig. 17B below), wherein the anchor bore is configured to retain at least a portion of the head of the anchor therein (via 9, see Fig. 24C), and wherein the head of the anchor is insertable into the anchor bore at the distal end of the housing (see Fig. 24A); and a turret (9) couplable to the distal end of the housing (see Figs. 24A-B) and comprising a plurality of fingers (22a, see Fig. 18B) receivable within the distal end of the housing to attach the turret to the housing (see Fig. 24B); wherein a proximal end of the turret is configured to pass over the shank in a distal-to-proximal direction toward the head at the proximal end of the anchor (see annotated Figs. 19 below, note that since the proximal opening of the turret is wider than the opening of the turret at the distal end, it would be capable of inserting the shank in a distal-to-proximal direction toward the head at the proximal end of the anchor, before the turret is attached to the housing, see also Fig. 24A).
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Regarding claim 40, further comprising: a saddle (10) receivable within the housing (see Fig. 14) and configured to receive a connecting member thereon (R, see Fig. 13), wherein a distal end (34a) of the saddle is configured to engage a proximal end of the head of the anchor (see Fig. 15).
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 II”).
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 II 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 II 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.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murabayashi, as applied to claim 38 above, and in view of Biedermann et al. (U.S. Pub. No. 2013/0110178 A1, hereinafter “Biedermann”).
Murabayashi discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 39, wherein the turret includes a tapered outer diameter at a distal end of the turret that corresponds to a necked portion of the anchor, 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, 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.
Biedermann discloses an assembly (see Fig. 1), with a housing (4) and a turret (6), wherein the turret includes a tapered outer diameter at a distal end of the turret (17, see Fig. 1, see para. [0040]) that corresponds to a necked portion of the anchor (see Fig. 2) in order to enable the anchor to pivot at a larger angle relative to the housing (see para. [0040]) and enable the assembly to be used for sacral fixation (see para. [0010]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the turret in Murabayashi to include a tapered outer diameter at a distal end of the turret that corresponds to a necked portion of the anchor, in view of Biedermann in order to in order to enable the anchor to pivot at a larger angle relative to the housing and enable the assembly to be used for sacral fixation.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-40 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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