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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/30/2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
This application repeats a substantial portion of prior Application No. 16420732, filed 05/23/2019, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
The disclosure directed towards the crest height being less than the thread depth (claim 29) is considered new and not found in the prior applications. Applicant points to figure 18 of PRO 61851300 and figure 3 of PRO 91796859, however these figures lack specificity. The crest height is not indicated in the figures and these figures are a cross section of a perspective drawings and cannot be relied upon for the disclosure of the crest height being less than a thread depth. In addition, the application makes no mention of the drawings being to scale or the like. Because the crest height being less than the thread depth was not explicitly disclosed, it is considered new. Therefore, the effective filing date for the claim 29 is 06/26/2023.
Response to Arguments
Applicant's arguments filed 02/02/2026 have been fully considered but they are not persuasive. Applicant argues that Jackson ‘244, along with other cited references, do not teach or suggest “providing a shank having a distal end, a head that is integral with the distal end and partially spherically shaped with an outer continuous surface extending above and below a hemisphere thereof, the including a central internal drive socket formed in an upper portion thereof”. More specifically that Jackson ‘244 does not teach or suggest a head that is integral with the distal end and partially spherically shaped. The Office respectfully disagrees. Jackson discloses a shank (ref. 16) having a distal end (ref. 124) and a head (refs. 22, 18) that is integral with the distal end. Although ref. 22 is physically separate from the shank ref. 16, they are assembled to form a unit. Because ref. 22 is required to complete the unit it is considered “integral”. In addition, paragraph [0083] discloses that ref. 22 may be integral with the bone screw shank. However, it is noted that Jackson fails to disclose a shank having a monolithic head.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the protrusions and notches of claims 27 and 34 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 29 is objected to because of the following informalities: Claim 29 should read as claim 36 because is follows claim 35. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 27, 32, and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 27 and 34 recite “the receiver comprises opposed integral protrusions extending toward the longitudinal axis positionable within opposite sides notches formed in the insert. No such language was found in the written description and the drawings do not show either structure. It is noted that figure 7 appears to show a surface of both the receiver and insert being deformed inwardly. However, no other figures show this, including next in sequence fig. 8 once the set screw is fully inserted. In addition, these deformed surfaces are not projections and notches and it is unclear if they are meant to be present given their absence in any other figures.
Claim 32 recites “the thread pitch is substantially twice the second height”. No such language was found in the written description and the figures, which are not disclosed as being drawn to scale, show no values to make such a determination. Therefore this is considered new matter.
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.
Claims 27 and 34 are 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.
Claims 27 and 34 require integral protrusions on the receiver and opposite side notches on the insert. No such claim language was found in the written description or drawings showing notches in the insert and protrusions on the receiver. It is unclear if the deformed surfaces of the receiver and insert in Fig. 7 (see below) are meant to be the claimed structures. For purposes of examination, they are assumed to be the notches and protrusions.
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The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 28 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 28 repeats claims already cited in independent claim 23. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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) 1, 2, 4, 23, 24, 26 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 2007/0055244 A1) in view of Colleran et al. (US 2005/0216000 A1) and in view of Jackson (US 2006/0058794 A1).
Regarding claim 1, Jackson (244) discloses a method for securing an elongate rod to a bone of a patient with a pivotal bone anchor assembly (Abstract, paragraph [0014]), the method comprising:
providing a receiver (ref. 20, Fig. 8) having a longitudinal axis (see remarked Fig. 8 below), a base portion (see remarked Fig. 6 below) having a bottom surface (see remarked Fig. 6), and an upper portion having a pair of opposed upright arms (see remarked Fig. 6 below) extending upwardly from the base portion to define an open channel (ref. 156) therebetween configured to receive the elongate rod (Fig. 6), the open channel extending between a front surface and a back surface of the receiver (Fig. 5 shows a front surface located at ref. 150, the opposite back surface is hidden) and opening onto top surfaces of the upright arms to define a top of the receiver (ref. 154), the upright arms having interior surfaces with a discontinuous helically wound thread form formed therein (ref. 162) and outer side surfaces opposite the interior surfaces (Fig. 7 shows an outer surface opposite the inner surface), the outer side surfaces having first and second horizontal curvature extending instrument engaging grooves (HCEIEG) formed therein (ref. 164) and being proximate the top surface of the receiver (Fig. 7), each of the front surface and the back surface including a planar surface extending parallel with respect to each other (Fig. 5), each of the first and second HCEIEG including a first outer end opening onto the planar surface of the front surface of the receiver and a second outer end opening onto the planar surface of the back surface of the receiver (Fig. 5 shows the HCEIEG opening onto the front surface, the b ack surface being hidden), each of the first and second HCEIEG including a downward- facing groove surface, an opposed upwardly-facing groove surface (paragraph [0079] and Figs. 7 – 9, see remarked Fig. 9 below);
providing an elongate rod-engaging insert configured to be positioned within the receiver (paragraph [0062], ref. 24, Fig. 5);
providing a shank having a distal end (Fig. 5, ref. 124), a head that is integral with the distal end and partially spherically shaped with an outer continuous surface extending above and below a hemisphere thereof (paragraphs [0082-83], Fig. 5, refs. 22, 18 shows a partially spherical head, the head is considered to be integral because it is essential to the completeness of the bone anchor/shank and because the description uses the term “integral with the bone screw shank” in paragraph [0083]), the head including a central internal drive socket formed in an upper portion thereof (Fig. 5, ref. 144), the head of the shank configured to be positioned within the receiver and spaced apart from the elongate rod positioned within the open channel by the insert (Fig. 9);
providing a closure (ref. 30) configured to be positioned within the open channel to secure the elongate rod to the receiver in a locked configuration (Fig. 9), the closure comprising a cylindrical body (Fig. 5) having a central axis and an outer surface with a mating helically wound thread form formed thereon (Figs. 5, 9), the thread form of the closure being configured to limit splaying between the pair of upright arms upon rotatably advancing the closure within the open channel of the receiver (paragraph [0078] discloses that splaying is resisted, not prevented entirely), the thread form of the closure having a thread pitch (paragraph [0105]), an axially extending cylindrical root surface, an outer cylindrical crest surface having a crest height, an upper portion with a linear radially extending thrust surface (see remarked Figure 9 below, “upper thrust surface”) and a lower portion with a linear radially extending clearance surface (see remarked Fig. 9 below, “lower clearance surface), the linear radially extending clearance surface and the linear radially extending thrust surface sloping upwardly and outwardly with respect to the central axis of the cylindrical body of the closure (Fig. 9),
wherein when the pivotal bone anchor assembly is in the locked configuration, the closure does not extend over any part of the top surface of the upright arms (Fig. 9);
and with the distal end of the shank in the bone of the patient and the head positioned within the receiver, and with the elongate rod-engaging insert positioned in the receiver, and with the elongate rod in the open channel of the receiver, rotatably advancing the closure within the open channel of the receiver so as to secure the elongate rod to the receiver in the locked configuration (paragraphs [0096, 115]).
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Jackson (244) is silent regarding the limitations that the HCEIEG has an outwardly facing vertically extending groove surface and that the entire lower clearance surface and the entire outer cylindrical crest surface of the thread form of the closure are spaced apart from the thread form of the receiver.
Colleran teaches an analogous method (Abstract) comprising a receiver (ref. 20) having an HCEIEG (Fig. 1 at “Fig. 5”) having a substantially square shape (Fig. 1), thus having a downward facing surface (top surface), outwardly-facing vertically extending surface (middle) and upwardly facing surface (bottom). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jackson (244) such that the HCEIEG has an outwardly facing vertically extending groove or substantially square profile, as taught by Colleran, for the purpose of better mating with an insertion instrument and since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a forming edge in the heating portion or clamp. In re Dailey and Eilers, 149 USPQ 47 (1966).
Jackson (794) teaches an analogous method (Abstract) wherein the entire lower clearance surface of a closure (ref. 43) and the entire outer cylindrical crest surface of the thread form of the closure are spaced apart from the thread form of the receiver (Fig. 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jackson (244) such that the entire lower clearance surface and the entire outer cylindrical crest surface of the thread form of the closure are spaced apart from the thread form of the receiver, as taught by Jackson (794) for the purpose of allowing considerably higher, more positive clamping force to be applied to the closure while also limiting splaying of the arms of the receiver (paragraph [0037]).
Regarding claim 2, Jackson (244) in view of Colleran and in view of Jackson (794) discloses the method of claim 1, wherein a distance between the outer cylindrical crest surface and the axially extending cylindrical root surface defines a thread depth (Jackson (244), Fig. 9).
Regarding claim 4, Jackson (244) in view of Colleran and in view of Jackson (794) discloses the method of claim 1, wherein the cylindrical body of the closure further comprises a top end surface, a bottom end surface, and a plurality of vertical tool engagement surfaces aligned parallel with the central axis (Jackson (244), Fig. 6 best shows a plurality of vertical tool engagement surfaces in the form of a star pattern in a top surface of the closure).
Regarding claim 23, Jackson (244) discloses a method for securing an elongate rod to a bone of a patient with a pivotal bone anchor assembly (Abstract, paragraph [0014]), the method comprising:
providing a receiver (ref. 20, Fig. 8) having a longitudinal axis (see remarked Fig. 8 below), a base portion (see remarked Fig. 6 below) having a bottom surface (see remarked Fig. 6), and an upper portion having a pair of opposed upright arms (see remarked Fig. 6 below) extending upwardly from the base portion to define an open channel (ref. 156) therebetween configured to receive the elongate rod (Fig. 6), the open channel extending between a front surface and a back surface of the receiver (Fig. 5 shows a front surface located at ref. 150, the opposite back surface is hidden) and opening onto top surfaces of the upright arms to define a top of the receiver (ref. 154), the upright arms having interior surfaces with a discontinuous helically wound thread form formed therein (ref. 162) and outer side surfaces opposite the interior surfaces (Fig. 7 shows an outer surface opposite the inner surface), the outer side surfaces having first and second horizontal extending instrument engaging grooves (HCEIEG) formed therein (ref. 164) and being proximate the top surface of the receiver (Fig. 7), each of the front surface and the back surface including a planar surface extending parallel with respect to each other (Fig. 5), each of the first and second HEIEG including a first outer end opening onto the planar surface of the front surface of the receiver and a second outer end opening onto the planar surface of the back surface of the receiver (Fig. 5 shows the HEIEG opening onto the front surface, the b ack surface being hidden), each of the first and second HEIEG including a downward- facing groove surface, an opposed upwardly-facing groove surface (paragraph [0079] and Figs. 7 – 9, see remarked Fig. 9 below);
providing an elongate rod-engaging insert configured to be positioned within the receiver (paragraph [0062], ref. 24, Fig. 5);
providing a shank having a distal end (Fig. 5, ref. 124), a head that is integral with the distal end and partially spherically shaped with an outer continuous surface extending above and below a hemisphere thereof (paragraphs [0082-83], Fig. 5, refs. 22, 18 shows a partially spherical head, the head is considered to be integral because it is essential to the completeness of the bone anchor/shank and because the description uses the term “integral with the bone screw shank” in paragraph [0083]), the head including a central internal drive socket formed in an upper portion thereof (Fig. 5, ref. 144), the head of the shank configured to be positioned within the receiver and spaced apart from the elongate rod positioned within the open channel by the insert (Fig. 9);
providing a closure (ref. 30) configured to be positioned within the open channel to secure the elongate rod to the receiver in a locked configuration (Fig. 9), the closure comprising a cylindrical body (Fig. 5) having a central axis and an outer surface with a mating helically wound thread form formed thereon (Figs. 5, 9), the thread form of the closure being configured to limit splaying between the pair of upright arms upon rotatably advancing the closure within the open channel of the receiver (paragraph [0078] discloses that splaying is resisted, not prevented entirely), the thread form of the closure having a thread pitch (paragraph [0105]), an axially extending cylindrical root surface, an outer cylindrical crest surface having a crest height, an upper portion with a linear radially extending thrust surface (see remarked Figure 9 below, “upper thrust surface”) and a lower portion with a linear radially extending clearance surface (see remarked Fig. 9 below, “lower clearance surface), the linear radially extending clearance surface and the linear radially extending thrust surface sloping upwardly and outwardly with respect to the central axis of the cylindrical body of the closure (Fig. 9),
wherein when the pivotal bone anchor assembly is in the locked configuration, the closure does not extend over any part of the top surface of the upright arms (Fig. 9);
and with the distal end of the shank in the bone of the patient and the head positioned within the receiver, and with the elongate rod-engaging insert positioned in the receiver, and with the elongate rod in the open channel of the receiver, rotatably advancing the closure within the open channel of the receiver so as to secure the elongate rod to the receiver in the locked configuration (paragraphs [0096, 115]).
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Jackson (244) is silent regarding the limitations that the HEIEG has an outwardly facing vertically extending groove surface and that the entire lower clearance surface and the entire outer cylindrical crest surface of the thread form of the closure are spaced apart from the thread form of the receiver.
Colleran teaches an analogous method (Abstract) comprising a receiver (ref. 20) having an HCEIEG (Fig. 1 at “Fig. 5”) having a substantially square shape (Fig. 1), thus having a downward facing surface (top surface), outwardly-facing vertically extending surface (middle) and upwardly facing surface (bottom). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jackson (244) such that the HEIEG has an outwardly facing vertically extending groove or substantially square profile, as taught by Colleran, for the purpose of better mating with an insertion instrument and since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a forming edge in the heating portion or clamp. In re Dailey and Eilers, 149 USPQ 47 (1966).
Jackson (794) teaches an analogous method (Abstract) wherein the entire lower clearance surface of a closure (ref. 43) and the entire outer cylindrical crest surface of the thread form of the closure are spaced apart from the thread form of the receiver (Fig. 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jackson (244) such that the entire lower clearance surface and the entire outer cylindrical crest surface of the thread form of the closure are spaced apart from the thread form of the receiver, as taught by Jackson (794) for the purpose of allowing considerably higher, more positive clamping force to be applied to the closure while also limiting splaying of the arms of the receiver (paragraph [0037]).
Regarding claim 24, Jackson (244) in view of Colleran and in view of Jackson (794) discloses the method of claim 23, wherein a distance between the outer cylindrical crest surface and the axially extending cylindrical root surface defines a thread depth (this definition may apply to both Jackson references).
Regarding claim 26, Jackson (244) in view of Colleran and in view of Jackson (794) discloses the method of claim 23, wherein the cylindrical body of the closure further comprises a top end surface, a bottom end surface, and a plurality of vertical tool engagement surfaces aligned parallel with the central axis (Jackson (244), Fig. 6 best shows a plurality of vertical tool engagement surfaces in the form of a star pattern in a top surface of the closure).
Regarding claim 28, Jackson (244) in view of Colleran and in view of Jackson (794) discloses the method of claim 23, wherein the linear radially extending clearance surface slopes outwardly and upwardly with respect to the central axis of the cylindrical body of the closure (Fig. 9).
Claim(s) 30, 31, 33 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 2007/0055244 A1) in view of in view of Colleran et al. (US 2005/021600 A1) and in view of Jackson (US 2005/0182410 A1).
Regarding claim 30, Jackson (244) discloses a method for securing an elongate rod to a bone of a patient with a pivotal bone anchor assembly (Abstract, paragraph [0014]), the method comprising:
providing a receiver (ref. 20, Fig. 8) having a longitudinal axis (see remarked Fig. 8 below), a base portion (see remarked Fig. 6 below) having a bottom surface (see remarked Fig. 6), and an upper portion having a pair of opposed upright arms (see remarked Fig. 6 below) extending upwardly from the base portion to define an open channel (ref. 156) therebetween configured to receive the elongate rod (Fig. 6), the open channel extending between a front surface and a back surface of the receiver (Fig. 5 shows a front surface located at ref. 150, the opposite back surface is hidden) and opening onto top surfaces of the upright arms to define a top of the receiver (ref. 154), the upright arms having interior surfaces with a discontinuous helically wound thread form formed therein (ref. 162); and outer side surfaces opposite the interior surfaces (Fig. 7 shows an outer surface opposite the inner surface), the outer side surfaces having first and second horizontal extending instrument engaging grooves (HEIEG) formed therein (ref. 164) and being proximate the top surface of the receiver (Fig. 7), each of the front surface and the back surface including a planar surface extending parallel with respect to each other (Fig. 5), each of the first and second HEIEG including a first outer end opening onto the planar surface of the front surface of the receiver and a second outer end opening onto the planar surface of the back surface of the receiver (Fig. 5 shows the HEIEG opening onto the front surface, the b ack surface being hidden), each of the first and second HEIEG including a downward- facing groove surface, an opposed upwardly-facing groove surface (paragraph [0079] and Figs. 7 – 9, see remarked Fig. 9 below);
providing an elongate rod-engaging insert configured to be positioned within the receiver (paragraph [0062], ref. 24, Fig. 5);
providing a shank having a distal end (Fig. 5, ref. 124), a head that is integral with the distal end and partially spherically shaped with an outer continuous surface extending above and below a hemisphere thereof (paragraphs [0082-83], Fig. 5, refs. 22, 18 shows a partially spherical head, the head is considered to be integral because it is essential to the completeness of the bone anchor/shank and because the description uses the term “integral with the bone screw shank” in paragraph [0083]), the head including a central internal drive socket formed in an upper portion thereof (Fig. 5, ref. 144), the head of the shank configured to be positioned within the receiver and spaced apart from the elongate rod positioned within the open channel by the insert (Fig. 9);
providing a closure (ref. 30) configured to be positioned within the open channel to secure the elongate rod to the receiver in a locked configuration (Fig. 9), the closure comprising a cylindrical body (Fig. 5) having a central axis and an outer surface with a mating helically wound thread form formed thereon (Figs. 5, 9), the thread of the closure being configured to limit splaying between the pair of upright arms upon rotatably advancing the closure within the open channel of the receiver (paragraph [0078] discloses that splaying is resisted, not prevented entirely), the thread of the closure having a thread pitch (paragraph [0105]), an axially extending cylindrical root surface, an outer thread portion having a first height (the height of the crest surface measured axially), an axially extending base opposite the outer thread portion having a second height (the height of the thread at the root measured axially), an upper portion with a linear radially extending thrust surface (see remarked Figure 9 below, “upper thrust surface”) and a lower portion with a linear radially extending clearance surface (see remarked Fig. 9 below, “lower clearance surface), the linear radially extending thrust surface extending outwardly and perpendicular with respect to the central axis of the cylindrical body of the closure (Fig. 9 shows a portion of the thrust surface, radially closer to the root before the sloped “toe”, extending perpendicularly),
wherein when the pivotal bone anchor assembly is in the locked configuration, the closure does not extend over any part of the top surface of the upright arms (Fig. 9); and
with the distal end of the shank in the bone of the patient and the head positioned within the receiver, and with the elongate rod-engaging insert positioned in the receiver, and with the elongate rod in the open channel of the receiver, rotatably advancing the closure within the open channel of the receiver so as to secure the elongate rod to the receiver in the locked configuration (paragraphs [0096, 115]).
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Jackson (244) is silent regarding the limitations that the HEIEG has an outwardly facing vertically extending groove surface and wherein the first height is less than or equal to the second height and that the entire lower clearance surface and the entire outer cylindrical crest surface of the thread form of the closure are spaced apart from the thread form of the receiver.
Colleran teaches an analogous method (Abstract) comprising a receiver (ref. 20) having an HCEIEG (Fig. 1 at “Fig. 5”) having a substantially square shape (Fig. 1), thus having a downward facing surface (top surface), outwardly-facing vertically extending surface (middle) and upwardly facing surface (bottom). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jackson (244) such that the HEIEG has an outwardly facing vertically extending groove or substantially square profile, as taught by Colleran, for the purpose of better mating with an insertion instrument and since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a forming edge in the heating portion or clamp. In re Dailey and Eilers, 149 USPQ 47 (1966).
Jackson (410) teaches an analogous method (Abstract) wherein a first height is less than or equal to a second height (Figs. 16 – 17 show the height of the thread being substantially equal and, in some portions, at ref. 125, being less than a root height) and that an entire lower clearance surface and an entire outer cylindrical crest surface of the thread form of the closure are spaced apart from the thread form of the receiver (Figs. 16 – 17). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the thread profile and the method of Jackson (244) such that the first height is less than or equal to the second height and the entire lower clearance surface and the entire outer cylindrical crest surface of the thread form of the closure are spaced apart from the thread form of the receiver, as taught by Jackson (410) for the purpose of allowing considerably higher, more positive clamping force to be applied to the closure while also limiting splaying of the arms of the receiver (paragraph [0051]).
Regarding claim 31, Jackson (244) in view of Colleran and in view of Jackson (7410) discloses the method of claim 30, wherein a distance between a cylindrical crest surface on the outer thread portion and the axially extending cylindrical root surface defines a thread depth (this definition may be applied to any of the applied art).
Regarding claim 33, Jackson (244) in view of Colleran and in view of Jackson (7410) discloses the method of claim 30, wherein the cylindrical body of the closure further comprises a top end surface, a bottom end surface, and a plurality of vertical tool engagement surfaces aligned parallel with the central axis (Jackson (244), Figs. 5 – 6, paragraph [0089], ref. 262).
Regarding claim 35, Jackson (244) in view of Colleran and in view of Jackson (7410) discloses the method of claim 30, except wherein pitch is between 0.039 inches and 0.060 inches. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the thread form such that the pitch is between 0.039 inches and 0.060 inches for purpose of providing a relatively fine pitch for increased resistance to loosening under vibration and, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 3 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 2007/0055244 A1) in view of in view of Colleran et al. (US 2005/021600 A1) and in view of Jackson (US 2006/0058794 A1) and in view of DeLange et al. (US 5,092,635) and further in view of Corradi et al. (US 2005/0267478 A1).
Regarding claim 3, Jackson (244) in view of Colleran and in view of Jackson (794) discloses the method of claim 2, except wherein the thread pitch is greater than twice the thread depth.
Regarding claim 25, Jackson (244) in view of Colleran and in view of Jackson (794) discloses the method of claim 24, except wherein the thread pitch is greater than twice the thread depth.
DeLange discloses a thread form (Abstract) in the related field of helical wound thread forms in which a thread depth (L8, Fig. 2) is within a range of 0.02 inches and 0.100 inches. (Col. 4, table). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the closure of Jackson (244) in view of Colleran and in view of Jackson (794) such that the thread depth is in a range of 0.05 to 0.9 mm (the range as taught by DeLange is inclusive), as taught by DeLange, for the purpose of better preventing the occurrence of cross-threading while also maintaining structural integrity.
Corradi teaches a surgical fastener (Abstract) having a pitch which can be 0.050 inches (paragraph [0101]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the closure of Jackson (244) in view of Colleran and in view of Jackson (794) and in view of DeLange, such that the pitch is 0.050 inches, for the purpose of better load distribution (the forces between the closure and receiver will be more evenly distributed across the threads). Note that the pitch would be greater than twice the thread depth given the taught ranges.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 2007/0055244 A1) in view of in view of Colleran et al. (US 2005/021600 A1) and in view of Jackson (US 2006/0058794 A1) and in view of Mueller (US 2006/0200128 A1).
Regarding claim 5, Jackson (244) in view of Jackson (794) discloses the method of claim 4, except wherein the mating helically wound thread form on the closure is configured as a dual lead thread form with diametrically opposite start structure adjacent the bottom end surface.
Mueller teaches an analogous method and device (Abstract, Fig. 1) comprising a closure having a helically wound thread form configured as a dual lead thread form with diametrically opposite start structures (paragraph [0020]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jackson (244) in view of Jackson (794) such that the mating helically wound thread form on the closure is configured as a dual lead thread form with diametrically opposite start structure adjacent the bottom end surface, as taught by Mueller for the purpose of preventing cross threading (Mueller, paragraph [0020]).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 2007/0055244 A1) in view of Colleran et al. (US 2005/0216000 A1) and in view of Jackson (US 2006/0058794 A1) and in view of Garamszegi (US 2012/0150239 A1).
Regarding claim 27, Jackson (244) in view of Colleran and in view of Jackson (794) discloses the method of claim 23, except wherein the receiver comprises opposed integral protrusions extending toward the longitudinal axis positionable within opposite side notches formed in the insert.
Garamszegi teaches an analogous device and method (Abstract) comprising a receiver (Fig. 15a, ref. 615) comprising opposed integral protrusions extending towards a longitudinal axis of the receiver (see remarked Fig. 15a below) and are positionable within opposite side notches formed in an insert (see remarked Fig. 15a below). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the receiver and insert of Jackson (244) in view of Colleran and in view of Jackson (794) to include the opposed integral protrusions extending toward the longitudinal axis positionable within opposite side notches formed in the insert, as taught by Garamszegi, for the purpose of better stabilizing the system and preventing unwanted loosening.
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Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 2007/0055244 A1) in view of in view of Colleran et al. (US 2005/021600 A1) and in view of Jackson (US 2006/0058794 A1) and in view of Jackson (US 2006/0083603 A1).
Regarding claim 29, Jackson (244) in view of Colleran and in view of Jackson (794) discloses method of claim 24, except wherein the crest height is less than the thread depth.
Jackson (603) teaches an analogous method and device (Abstract) comprising a closure with a thread form (Figs. 1 – 2, ref. 1) wherein the thread form has a crest height less than a thread depth (Figs. 3 – 14 all show form having a crest height less than a thread depth). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jackson (244) in view of Colleran and in view of Jackson (794) such that the crest height is less than the thread depth, as taught by Jackson (603) for the purpose of increased root strength which would increase resistance to shearing or bending forces.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 2007/0055244 A1) in view of Colleran et al. (US 2005/0216000 A1) and in view of Jackson (US 2005/0182410 A1) and in view of Garamszegi (US 2012/0150239 A1).
Regarding claim 34, Jackson (244) in view of Colleran and in view of Jackson (7410) discloses the method of claim 30, except wherein the receiver comprises opposed integral protrusions extending toward the longitudinal axis positionable within opposite side notches formed in the insert.
Garamszegi teaches an analogous device and method (Abstract) comprising a receiver (Fig. 15a, ref. 615) comprising opposed integral protrusions extending towards a longitudinal axis of the receiver (see remarked Fig. 15a below) and are positionable within opposite side notches formed in an insert (see remarked Fig. 15a below). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the receiver and insert of Jackson (244) in view of Colleran and in view of Jackson (410) to include the opposed integral protrusions extending toward the longitudinal axis positionable within opposite side notches formed in the insert, as taught by Garamszegi, for the purpose of better stabilizing the system and preventing unwanted loosening.
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Claim(s) 36 (29 as written) is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 2007/0055244 A1) in view of in view of Colleran et al. (US 2005/021600 A1) and in view of Jackson (US 2005/0182410 A1) and in view of Jackson (US 2006/0083603 A1).
Regarding claim 36 (29 as written), Jackson (244) in view of Colleran and in view of Jackson (410) discloses method of claim 24, except wherein the crest height is less than the thread depth.
Jackson (603) teaches an analogous method and device (Abstract) comprising a closure with a thread form (Figs. 1 – 2, ref. 1) wherein the thread form has a crest height less than a thread depth (Figs. 3 – 14 all show form having a crest height less than a thread depth). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jackson (244) in view of Colleran and in view of Jackson (410) such that the crest height is less than the thread depth, as taught by Jackson (603) for the purpose of increased root strength which would increase resistance to shearing or bending forces.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/TESSA M MATTHEWS/Examiner, Art Unit 3773