DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 the 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/13/25 has been entered.
Accordingly, claims 1, 17 are amended.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-3, 5-10, 15, 17-20 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Harvey (US 20100145394 A1).
Harvey discloses a method of assembling a receiver assembly fig. 24e intended to secure an elongate rod to a capture head of a bone anchor with tooling, the method comprising: aligning an insert 628 with a receiver 626 such that a second channel of the insert is in non- alignment with a first channel of the receiver figs 24a-24c, the first and second channels being configured to receive the elongate rod when the second channel is in alignment with the first channel fig. 24d, para. 131; loading the insert into a through-space of the receiver with the second channel in the non-aligned position with the first channel figs 24a-24c, the receiver including an upper opening 648, the first channel extending downward from the upper opening, a bottom opening 652 opposite the upper opening fig. 24, and a base cavity 658 extending upward from the bottom opening into communication with the first channel to form the through- space extending between the bottom opening and the upper opening fig. 24a, the through-space including a helically wound guide and advancement structure 662 extending along an upper portion of the first channel and configured for rotatable engagement with a closure top (para. 130), at least one internal recess 661 beneath the helically wound guide and advancement structure, and at least one non-resilient internal ridge (upper end of recess 661) projecting inwardly below the at least one internal recess, the insert including top surfaces fig. 23 adjacent the second channel, side structures 657 (includes a pair of opposing vertical ribs 707, para. 131) protruding laterally outward and spaced below the top surfaces, and opposed lower extensions 669 extending downwardly below the second channel configured to engage the capture head of the bone anchor; and rotating the insert in the through-space of the receiver from the non-aligned position to an aligned position fig. 24d so as to align the second channel with the first channel fig. 24e and to rotate the side structures 657 into an overlapping arrangement within the at least one internal recess 661 with the side structures being adjacent to and above the at least one internal ridge fig. 24c, wherein upon a forced downward displacement fig. 24d of the insert within the through-space of the receiver with the tooling and prior to rotatably engaging the closure top with the guide and advancement structure, the side structures 657 are configured to engage the at least one internal ridge fig. 24e so as to inhibit the insert from moving back upward within the through-space of the receiver, wherein the opposed lower extensions 669 of the insert further comprise a plurality of downwardly extending resilient panels separated by a plurality of slots or gaps fig. 23, the plurality of resilient panels having curvate inner surfaces operable to engage at least an upper portion of the capture head of the bone anchor fig. 24c, wherein the receiver further comprises a base and a pair of upright arms 642 extending upward from a base to define the first channel 648, and wherein the helically wound guide and advancement structure 662 is a discontinuous helically wound guide and advancement structure, further comprising engaging inwardly-protruding internal surfaces 711 of the through-space of the receiver within side recesses or notches 709 formed into outer surfaces of the insert to inhibit further rotation of the insert within the receiver (para. 136), wherein the side recesses or notches 709 (gap between ribs 707) further comprises opposite shallow slots formed into outer surfaces of the insert fig. 23; and wherein engaging internal surfaces of the through-space of the receiver with the opposite shallow slots further comprises crimping opposed thin wall surfaces into the opposite shallow slots by tooling fig. 21a, further comprising forcibly displacing the insert downwardly within the through-space of the receiver until the side structures of the insert engage the at least one internal ridge to inhibit the insert from moving upward within the through-space of the receiver fig. 24e, wherein forcibly displacing the insert downwardly within through-space of the receiver further comprises forcibly displacing the side structures of the insert downwardly into an increasingly frictional interference engagement with the at least one internal ridge of the receiver fig. 24e, further comprising positioning the capture head of the bone anchor within the base cavity of the receiver prior to forcibly displacing the insert downwardly within the through-space of the receiver fig. 24c, the bone anchor including an anchor portion 630 opposite the capture head 633 implantable into the bone of the patient, wherein forcibly displacing the insert downwardly within the through-space of the receiver further comprises engaging the capture head of the bone anchor with the opposed lower extensions of the insert with a frictional engagement operable to inhibit the bone anchor from pivoting with respect to the receiver fig. 24c, further comprising: positioning the rod into the second channel of the insert that is in the aligned position with the first channel of the receiver (para. 131); positioning the closure into the upper opening of the receiver above the rod; and rotating the closure downwardly along the helically wound guide and advancement structure so as to forcibly displace the insert downwardly within the through space of the receiver into frictional engagement with the capture head of the bone anchor to lock an orientation of the bone anchor relative to the receiver (para. 130).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4, 11-14 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Harvey in view of Hammer et al. (US. 20100094349).
Harvey fail to teach that the pair of upright arms includes upwardly-extending break-off extensions, and positioning a retainer within the base cavity of the receiver prior to the capture head of the bone anchor, the retainer being configured to capture and pivotably secure the capture head of the bone anchor in the base cavity of the receiver, wherein positioning the retainer within the base cavity of the receiver further comprises uploading the retainer into the base cavity through the bottom opening of the receiver, wherein the retainer further comprises a ring- shaped body having at least one slit or slot extending at least partially through the body of the retainer, wherein the base cavity is sized and shaped to allow for expansion of the retainer when the capture head of the bone anchor is uploaded via the bottom opening, so as to capture the capture head in the base cavity.
Hammer teaches pair of upright arms includes upwardly-extending break-off extensions 1560, fig. 15, and positioning a retainer 1107 within the base cavity of the receiver prior to the capture head of the bone anchor, the retainer being configured to capture and pivotably secure the capture head of the bone anchor in the base cavity of the receiver (para. 94), wherein positioning the retainer within the base cavity of the receiver further comprises uploading the retainer 107 into the base cavity through the bottom opening of the receiver fig. 1, wherein the retainer 107 further comprises a ring- shaped body having at least one slit or slot extending at least partially through the body of the retainer fig. 1, wherein the base cavity is sized and shaped to allow for expansion of the retainer when the capture head of the bone anchor is uploaded via the bottom opening, so as to capture the capture head in the base cavity (para. 60 and 94).
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the pair of upright arms of Harvey with a removable extensions in view of Hammer in order to facilitating guiding the insertion of the insert into the receiver to place it in the position on the top of screw head.
Also, It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the system of Harvey with a retainer ring in view of Hammer in order to facilitating and enhancing retaining the screw head inside the bottom portion of the receiver.
Claims 16 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Harvey in view of Jackson (US 20040039383).
Harvey fail to teach that the closure is a two-piece threaded closure with an outer threaded ring and an inner threaded set screw; and wherein rotating the closure downwardly along the helically wound guide and advancement structure further comprises rotatably engaging the outer threaded ring with the helically wound guide and advancement structure.
Jackson (US 20040039383) teaches closure is a two-piece threaded closure with an outer threaded ring 2, fig. 1 and an inner threaded set screw 3; and wherein rotating the closure downwardly along the helically wound guide and advancement structure further comprises rotatably engaging the outer threaded ring 2 with the helically wound guide and advancement structure fig. 2.
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the closure of Harvey with a two-piece threaded closure in view of Jackson (US 20040039383) in order to effectively securely engage and lock the spinal rod in place relative to the bone screw.
Response to Arguments
Applicant’s arguments with respect to claim(s) 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
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/SAMEH R BOLES/Primary Examiner, Art Unit 3775