DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/14/2026 has been entered.
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.
Claim 17 is 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.
The term “about” in claim 17is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination the term “about” will be interpreted to mean a +/- 10% of the given value.
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 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 1 – 3, 5 – 8 and 10 - 15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jackson et al. (US 2011/0098755 A1) in view of DeLange et al. (US 5,092,635) and in view of Jackson (US 6,454,772 B1) and in view of Jackson (US 2005/0182410 A1).
Regarding claim1, Jackson discloses a pivotal bone anchor assembly (Abstract) comprising:
a receiver housing (Fig. 1, ref. 10) including a pair of arms and a channel between the arms (ref. 62) for receiving an elongate rod (Fig. 29), each of the pair of arms including an inner surface with a portion of a mating helically wound thread formed therein (ref. 72) with a receiver load flank having a downwardly facing linear surface (downward surface of the threading);
a closure (Fig. 1, ref. 18) having a central axis (Fig. 1, ref. B), a top end having a top surface (ref. 164, Fig. 29), a bottom end having a bottom surface opposite the top surface (ref. 168), a central internal drive structure extending into the top end (ref. 166), and a cylindrical body defining a root surface on which an outer mating continuous helically wound thread is formed thereon (see remarked Fig. 29 below), the thread comprising a closure load flank having an upwardly facing linear loading surface extending radially outwardly with respect to the root surface (see remarked Fig. 29 below), the upwardly facing linear loading surface having a slope angle sloping upwardly toward the top end of the cylindrical body or extending radially outward substantially perpendicular to the central axis (Fig. 29), the outer mating continuous helically wound thread further comprising a stab flank having a downwardly facing linear clearance surface extending radially outwardly with respect to the root surface (see remarked Fig. 29 below), the outer mating continuous helically wound thread further comprising a thread pitch defined as a distance a location on the mating discontinuous helically wound thread to a same location on an adjacent thread, a thread crest having a cylindrical surface extending parallel with respect to the central axis of the closure (see remarked Fig. 29 below), and a thread depth as a horizontal distance between the root surface on the cylindrical body to the cylindrical surface on the thread crest and;
a shank having a partially spherically shaped shank head (ref. 8) positionable within the receiver housing (Fig. 24); and
a non-pivoting retainer (ref. 12) positionable within the receiver housing prior to the shank head so as to contain the shank head therein with the shank being pivotal with respect to the receiver housing prior to locking the assembly with the closure (Fig. 18).
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Jackson is silent that the thread pitch ranges between 0.04 to 0.120 inches and wherein the thread depth ranges between 0.2 mm to 2.0 mm.
Jackson (‘772) teaches a set screw for a medical implant (Abstract) having a pitch ratio of 0.5 and a diameter of 6 mm (0.24 inches). Therefore, a pitch of approximately 0.12 inches. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the thread such that the thread has a pitch between 0.04 to 0.120, as taught by Jackson (‘772), for the purpose of providing substantially strength and resisting slippage (Summary (6)).
DeLange teaches a buttress thread form (Abstract) comprising a thread depth between 0.2 mm to 2.0 mm (L3 is disclosed as 0.050 inches). It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the thread such that the thread depth ranges between 0.2 mm to 2.0 mm, as taught by DeLange, for the purpose of better resisting splaying and pulling mating threads together (Abstract).
Jackson is also silent regarding the thread crest of the closure is spaced apart from the helically wound thread in the receiver housing when the closure is rotatably tightened down to between 70 and 125 inch pounds of applied torque to the closure within the receiver housing (a torque of between 70 and 125 is disclosed in paragraph [0434]), and wherein the assembly is configured to control outwardly splaying of the pair of arms of the receiver housing relative to each other with an axial loading from the closure resulting from the applied torque range so as to allow a controlled splaying of the pair of arms with respect to each other.
Jackson (2005) discloses an anallgous bone anchor assembly (Abstract) wherein the closure is spaced apart from the helically wound thread in the receiver housing when the closure is rotatably tightened within the receiver housing (Fig. 3), and wherein the assembly is configured to control outwardly splaying of the pair of arms of the receiver housing relative to each other with an axial loading from the closure resulting from the applied torque range so as to allow a controlled splaying of the pair of arms with respect to each other (paragraph [0057]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the assembly of Jackson (2011) such that the thread crest of the closure is spaced apart from the helically wound thread in the receiver housing when the closure is rotatably tightened down within the receiver housing, and wherein the assembly is configured to control outwardly splaying of the pair of arms of the receiver housing relative to each other with an axial loading from the closure resulting from the applied torque range so as to allow a controlled splaying of the pair of arms with respect to each other, as taught by Jackson (2005) for the purpose of limiting splaying to prevent unwanted loosening without losses to structural rigidity.
Regarding claim 2, Jackson (2011) in view of DeLange and in view of Jackson (‘772) and in view of Jackson (2005) discloses the bone anchor assembly of claim 1, wherein the shank head is bottom loaded into the receiver (Jackson 2011, Fig. 23).
Regarding claim 3, Jackson (2011) in view of DeLange and in view of Jackson (‘772) and in view of Jackson (2005) discloses the bone anchor assembly of claim 1, wherein each of the portions of the mating helically wound thread in the receiver housing includes an upwardly facing stab flank and an inwardly facing root surface spaced apart from the stab flank and the cylindrical surface on the thread crest of the closure, respectively, when the elongate rod is locked in the channel by the closure (Jackson 2005, Fig. 3).
Regarding claim 5, Jackson (2011) in view of DeLange and in view of Jackson (‘772) and in view of Jackson (2005) discloses the bone anchor assembly of claim 1, wherein the root surface is parallel with respect to the central axis of the closure and helically wound around the cylindrical body of the closure (Jackson 2011, Fig. 29).
Regarding claim 6, Jackson (2011) in view of DeLange and in view of Jackson (‘772) and in view of Jackson (2005) discloses the bone anchor assembly of claim 1, wherein the outer mating continuous helically wound thread further comprises a toe defined between the upwardly facing linear surface of the closure load flank and the cylindrical surface on the thread crest, the toe angling upward from the upwardly facing linear surface of the closure load flank (Jackson 2011, Fig. 29).
Regarding claim 7, Jackson (2011) in view of DeLange and in view of Jackson (‘772) and in view of Jackson (2005) discloses the bone anchor assembly of claim 1, wherein the bottom surface of the bottom end of the closure end includes a central nub protruding downward therefrom (Jackson 2011, Fig. 29, ref. 164).
Regarding claim 8, Jackson (2011) in view of DeLange and in view of Jackson (‘772) and in view of Jackson (2005) discloses the bone anchor assembly of claim 1, wherein the shank is canulated along an entire length thereof (Jackson 2011, Fig. 29).
Regarding claim10, Jackson discloses a pivotal bone anchor assembly (Abstract) comprising:
a receiver housing (Fig. 1, ref. 10) including a pair of arms and a channel between the pair of upwardly extending arms (ref. 62) for receiving an elongate rod (Fig. 29), each of the pair of upwardly extending arms including an inner surface with a portion of a mating helically wound thread formed therein (ref. 72) with a receiver load flank having a downwardly facing linear surface (downward surface of the threading) and a receiver base having an internal spherical seating surface adjacent to a lower opening communicating with a bottom surface of the receiver (Fig. 24);
a closure (Fig. 1, ref. 18) having a central axis (Fig. 1, ref. B), a top end having a top surface (ref. 164, Fig. 29), a bottom end having a bottom surface opposite the top surface (ref. 168), a central internal drive structure extending into the top end (ref. 166), and a cylindrical body defining a root surface on which an outer mating continuous helically wound thread is formed thereon (see remarked Fig. 29 below), the thread comprising a closure load flank having an upwardly facing linear loading surface extending radially outwardly with respect to the root surface (see remarked Fig. 29 below), the upwardly facing linear loading surface having a slope angle sloping upwardly toward the top end of the cylindrical body or extending radially outward substantially perpendicular to the central axis (Fig. 29), the outer mating continuous helically wound thread further comprising a stab flank having a downwardly facing linear clearance surface extending radially outwardly from the root surface (see remarked Fig. 29 below), the outer mating continuous helically wound thread further comprising a thread pitch defined as a distance a location on the mating discontinuous helically wound thread to a same location on an adjacent thread, a thread crest having a cylindrical surface extending parallel with respect to the central axis of the closure (see remarked Fig. 29 below), and a thread depth as a horizontal distance between the root surface on the cylindrical body to the cylindrical surface on the thread crest and;
a shank having a partially spherically shaped shank head (ref. 8) top loadable into the receiver with the shank head engaged with the internal spherical seating surface and the shank extending down the lower opening (as shown in Fig. 24, the diameter of the receiver is such that the shank may be top or bottom loaded).
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Jackson is silent that the thread pitch ranges between 0.04 to 0.120 inches and wherein the thread depth ranges between 0.2 mm to 2.0 mm.
Jackson (‘772) teaches a set screw for a medical implant (Abstract) having a pitch ratio of 0.5 and a diameter of 6 mm (0.24 inches). Therefore, a pitch of approximately 0.12 inches. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the thread such that the thread has a pitch between 0.04 to 0.120, as taught by Jackson (‘772), for the purpose of providing substantially strength and resisting slippage (Summary (6)).
DeLange teaches a buttress thread form (Abstract) comprising a thread depth between 0.2 mm to 2.0 mm (L3 is disclosed as 0.050 inches). It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the thread such that the thread depth ranges between 0.2 mm to 2.0 mm, as taught by DeLange, for the purpose of better resisting splaying and pulling mating threads together (Abstract).
Jackson is also silent regarding the thread crest of the closure is spaced apart from the helically wound thread in the receiver housing when the closure is rotatably tightened down to between 70 and 125 inch pounds of applied torque to the closure within the receiver housing (a torque of between 70 and 125 is disclosed in paragraph [0434]), and wherein the assembly is configured to control outwardly splaying of the pair of arms of the receiver housing relative to each other with an axial loading from the closure resulting from the applied torque range so as to allow a controlled splaying of the pair of arms with respect to each other.
Jackson (2005) discloses an anallgous bone anchor assembly (Abstract) wherein the closure is spaced apart from the helically wound thread in the receiver housing when the closure is rotatably tightened within the receiver housing (Fig. 3), and wherein the assembly is configured to control outwardly splaying of the pair of arms of the receiver housing relative to each other with an axial loading from the closure resulting from the applied torque range so as to allow a controlled splaying of the pair of arms with respect to each other (paragraph [0057]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the assembly of Jackson (2011) such that the thread crest of the closure is spaced apart from the helically wound thread in the receiver housing when the closure is rotatably tightened down within the receiver housing, and wherein the assembly is configured to control outwardly splaying of the pair of arms of the receiver housing relative to each other with an axial loading from the closure resulting from the applied torque range so as to allow a controlled splaying of the pair of arms with respect to each other, as taught by Jackson (2005) for the purpose of limiting splaying to prevent unwanted loosening without losses to structural rigidity.
Regarding claim 11, Jackson (2011) in view of DeLange and in view of Jackson (‘772) and in view of Jackson (2005) discloses bone anchor assembly of claim 10, wherein the shank head is bottom loaded into the receiver (Jackson 2011, Fig. 23).
Regarding claim 12, Jackson (2011) in view of DeLange and in view of Jackson (‘772) and in view of Jackson (2005) discloses the bone anchor assembly of claim 10, wherein each of the portions of the mating helically wound thread in the receiver housing includes an upwardly facing stab flank and an inwardly facing root surface spaced apart from the stab flank and the cylindrical surface on the thread crest of the closure, respectively, when the elongate rod is locked in the channel by the closure (Jackson 2005, Fig. 3).
Regarding claim 13, Jackson (2011) in view of DeLange and in view of Jackson (‘772) and in view of Jackson (2005) discloses the bone anchor assembly of claim 10, wherein the root surface is parallel with respect to the central axis of the closure and helically wound around the cylindrical body of the closure (Jackson 2005, Fig. 3).
Regarding claim 14, Jackson (2011) in view of DeLange and in view of Jackson (‘772) and in view of Jackson (2005) discloses the bone anchor assembly of claim 10, wherein the outer mating continuous helically wound thread further comprises a toe defined between the upwardly facing linear surface of the closure load flank and the cylindrical surface on the thread crest, the toe angling upward from the upwardly facing linear surface of the closure load flank (Jackson 2011, Fig. 29 and Jackson 2005, Fig. 3).
Regarding claim 15, Jackson (2011) in view of DeLange and in view of Jackson (‘772) and in view of Jackson (2005) discloses the bone anchor assembly of claim 10, wherein the bottom surface of the bottom end of the closure end includes a central nub protruding downward therefrom (Jackson 2011, Fig. 29, ref. 164).
Allowable Subject Matter
Claims 16 and 18 – 28 are allowed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5 – 8 and 10 - 15 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/TESSA M MATTHEWS/ Examiner, Art Unit 3773
