Detailed Action
This is the original office action for US application number 18/980,689. Claims are evaluated as originally filed on July 28, 2025.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
In regards to the information disclosure statements filed December 13, 2024 and September 15, 2025, due to large volume of information submitted by applicant, applicant is required to identify any specific references within the large volume which they may be aware of that may be relevant to the claimed invention. This requirement is necessary since there appear to be a number of references in the large volume that are not at all relevant to the claimed invention, including the bone cement injector of US 6,676,664, the bone introducer/manipulation tool of US 5,824,087, the bone cement injection system of US 7,544,196, the bone filler material system of US 8,147,500, 6,010,508 impaction device, the expandable member delivery system of US 7,097,648, the superconductivity of carbonaceous compounds of US 5,698,497, etc. As such, the 393 US documents, 36 foreign documents, and 4 non-patent literature documents currently cited have receive only a cursory review as the relevance of such documents to the instant application has not been established.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/526,921, 16/425,496, 14/855,919, 13/591,811, and 61/527,389, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. Application No. 17/526,921, 16/425,496, 14/855,919, 13/591,811, and 61/527,389 fail to provide adequate support for “the cannulated distal shaft is devoid of a cutting flute on a distal end of the cannulated distal shaft” of claim 23.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claim 23, the specification appears to lack proper antecedent basis for the cannulated distal shaft that is “devoid of a cutting flute on a distal end of the cannulated distal shaft” of claim 23 lines 1-2 appears to be new matter. This is a negative limitation, i.e. the claim is requiring that the cannulated distal shaft does not have a cutting flute on a distal end of the cannulated distal shaft. Negative limitations are not per se improper, but they must be supported by the originally filed disclosure. As provided by MPEP 2173.05(i), any negative limitation or exclusionary proviso must have basis in the original disclosure; if alternative elements are positively recited in the specification, they may be explicitly excluded in the claims; and the mere absence of a positive recitation is not basis for an exclusion. The specification is silent regarding the cannulated distal shaft not having a cutting flute on a distal end of the cannulated distal shaft. As noted above, the absence of a positive recitation is not a proper basis of support for a negative limitation. Additionally, since the specification is silent on the matter of the cannulated distal shaft having a cutting flute on a distal end of the cannulated distal shaft, then the “alternative elements” rationale discussed above in the MPEP is not applicable. Thus, the specification fails to provide proper antecedent basis for the cannulated distal shaft that is “devoid of a cutting flute on a distal end of the cannulated distal shaft”. Examiner suggests cancelling this claim.
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 guidewire of claim 22 line 1 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(s) 9 is/are objected to because of the following informalities:
Claim 9 line 1 should read “A bone anchor[[,]] comprising:”.
Appropriate correction is required.
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(s) 10-15 and 17-27 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 10-15 and 17-27 recites/recite the limitation " The bone anchor assembly of" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “The bone anchor
Claim(s) 11 recites/recite the limitation "the second number of thread starts" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “[[the]]a second number of thread starts” or amending to depend from claim 10.
Claim(s) 15 is/are unclear with regards to “the third minor diameter is constant over the third length” in lines 1-2 and how this is intended to differ from the same limitation in claim 9 lines 15-16. Examiner is interpreting this as referring to, and suggests amending as, “wherein the third minor diameter is
Claim(s) 21 recites/recite the limitation "the angle of the cone" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “wherein [[the]]an angle of [[the]]a cone formed by the”.
Claim(s) 22 is/are unclear with regards to a guidewire in line 1 being part of the anchor of claim 9. Examiner is interpreting this as referring to the bone anchor of claim 1 as a bone anchor assembly and suggests amending accordingly to clarify.
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 14 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. 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.
As to claim 14, “the third major diameter is less than the second major diameter over the third length” of lines 1-2 is not further limiting over the same limitation of claim 9 lines 14-15 from which claim 14 depends. Examiner suggests cancelling claim 14 and amending claim 15 to depend from claim 9.
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 of this title, 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 negatived by the manner in which the invention was made.
Claim(s) 9-15 and 19-25 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Denis et al. (US 2007/0233122, hereinafter “Denis”) in view of Michielli et al. (US 2011/0288599, hereinafter “Michielli”).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 9-15 and 19-25, Denis discloses a bone anchor (80, Figs. 2-4, ¶s 19 and 32; where ¶32 discloses that shank 52 of 80 is identical to that of Figs. 2 and 3 and ¶19 discloses an axial passage (not shown) extending entirely therethrough to define a cannulation opening and with transverse passages that communicate with the axial passage to define fenestration openings) comprising: a proximal head (lower portion of 84 as shown in Fig. 4, Fig. 4); and a cannulated distal shaft (52, ¶19 discloses an axial passage (not shown) extending entirely therethrough to define a cannulation opening and with transverse passages that communicate with the axial passage to define fenestration openings) capable of engaging bone (100, 102, Fig. 4, ¶35), the distal shaft having a first threaded section (see illustration of Fig. 2, Figs. 2 and 4) distal to the proximal head (Fig. 4), a second threaded section (see illustration of Fig. 2) distal to and adjacent the first threaded section (see illustration of Fig. 2, Figs. 2 and 4), and a third threaded section (see illustration of Fig. 2, Figs. 2 and 4) distal to and adjacent the second threaded section (Fig. 4); the first threaded section having a first major diameter (outer thread diameter of 64 and 66 in the first threaded section, Fig. 4; i.e. identified with the upper dotted vertical line in the illustration of Fig. 2), a first minor diameter (inner thread root diameter of 64 and 66 in the first threaded section, Fig. 4; i.e. identified with the upper dashed vertical line in the illustration of Fig. 2), and a first length (Fig. 2); the second threaded section having a second major diameter (outer thread diameter of 64 in the second threaded section, Fig. 4; i.e. identified with the lower dotted vertical line in the illustration of Fig. 2), a second minor diameter (inner thread root diameter of 64 in the second threaded section, Fig. 4; i.e. identified with the middle dashed vertical line in the illustration of Fig. 2), and a second length (Fig. 2), the second major diameter and the second minor diameter being less than the first major diameter and the first minor diameter, respectively, over the second length of the second threaded section (as demonstrated by the differences in the alignment with the dotted and dashed vertical lines in the illustration of Fig. 2, Figs. 2 and 4; i.e. as shown the upper dotted vertical line is contacting the first major diameter and is spaced from the second major diameter at least at the respective lower portions and the upper and middle dashed vertical lines each align with the minor diameters at lower portions of the first and second sections and yet are spaced from one another); the third threaded section having a third major diameter (outer thread diameter of 64 in the third threaded section, Fig. 4), a third minor diameter (inner thread root diameter of 64 in the second threaded section, Fig. 4; i.e. identified with the lower dashed vertical line in the illustration of Fig. 2), and a third length (Fig. 2), the third major diameter being less than the second major diameter over the third length of the third threaded section (as demonstrated by the differences in the alignment with the lower dotted vertical line in the illustration of Fig. 2, Figs. 2 and 4; i.e. as shown the lower dotted vertical line is contacting the second major diameter and is spaced from the third major diameter at least at the respective lower portions), the third minor diameter being constant over the third length of the third section (as demonstrated by the alignment with the lower dashed vertical line in the illustration of Fig. 2, Figs. 2 and 4; i.e. the lower dashed vertical line aligns with the minor diameter of the third section at all locations within the third section); wherein the second and third threaded sections have a minor diameter that is either constant or increasing in a distal to proximal direction from a distal-most end of the third threaded section to a proximal end of the second threaded section (Figs. 2-4, ¶27) and a cannulation extends therethrough (¶19 discloses an axial passage (not shown) extending entirely therethrough to define a cannulation opening and with transverse passages that communicate with the axial passage to define fenestration openings); wherein the cannulation comprises transverse passages (¶19). As to claim 10, Denis discloses that the first threaded section includes a proximal portion (upper portion of the first threaded section as shown in Figs. 2-4 comprising 66 and 54, Figs. 2-4) with a first number of thread starts (¶24 discloses that 64 and 66 cooperate to form a dual lead thread) and a distal portion (lower portion of the first threaded section as shown in Figs. 2-4 comprising 66 and 54, Figs. 2-4) with a second number of thread starts (¶24 discloses that thread 64 includes a single lead), the second number of thread starts being less than the first number of thread starts (Figs. 2-4, ¶24). As to claim 11, Denis discloses that the third threaded section includes a third number of thread starts (¶24 discloses that thread 64 includes a single lead) that is equal to the second number of thread starts (Figs. 2-4, ¶24). As to claim 12, Denis discloses that the second major diameter and the second minor diameter taper in a proximal to distal direction over the second length of the second threaded section (as shown relative to the dashed and dotted vertical lines in the illustration of Fig. 2, Figs. 2-4). As to claim 13, Denis discloses that the third major diameter tapers in a proximal to distal direction over the third length of the third threaded section (as shown relative to the dashed and dotted vertical lines in the illustration of Fig. 2, Figs. 2-4). As to claim 14, Denis discloses that the third major diameter is less than the second major diameter over the third length (as demonstrated by the differences in the alignment with the lower dotted vertical line in the illustration of Fig. 2, Figs. 2 and 4; i.e. as shown the lower dotted vertical line is contacting the second major diameter and is spaced from the third major diameter at least at the respective lower portions). As to claim 15, Denis discloses that the third minor diameter is equal to the second minor diameter at a transition from the second threaded section to the third threaded section (as demonstrated along the lower dashed line in the illustration of Fig. 2, Figs. 2-4). As to claim 19, Denis discloses an unthreaded distal tip (56, Figs. 2-4, ¶19) at a terminal end of the cannulated distal shaft adjacent to the third threaded section (Figs. 2-4, ¶19). As to claim 20, Denis discloses that the unthreaded distal tip tapers in a proximal to distal direction and is conical in shape (Figs. 2-4, ¶19). As to claim 21, Denis discloses that an angle of a cone formed by the unthreaded tip is approximately 70° (Figs. 2-4). As to claim 23, Denis discloses that the cannulated distal shaft is devoid of a cutting flute on a distal end of the cannulated distal shaft (Fig. 2-4, ¶19 discloses that in other embodiments 50a may be provided with one or more cutting flutes). As to claim 24, Denis discloses that the cannulated distal shaft includes a plurality of side wall openings (“transverse passages” of ¶19, ¶19) that communicate with the cannula (¶19).
Denis is silent to the contours of the cannulation and transverse passages, i.e. the second and third threaded sections have a wall thickness defined between a minor diameter and a cannula diameter, wherein the wall thickness is either constant or increasing in a distal to proximal direction from a distal-most end of the third threaded section to a proximal end of the second threaded section. As to claim 22, Denis is silent to a guidewire configured to be received through a central passage of the cannulated distal shaft, the guidewire exiting the cannulated distal shaft via the unthreaded distal tip. As to claim 25, Denis is silent to the side wall openings extend radially from the cannula through a side wall of the distal shaft.
Michielli teaches a similar bone anchor (10, Figs. 1-6, ¶15), comprising: a proximal head (18, 14, Fig. 3, ¶15); and a cannulated distal shaft (20, Figs. 3 and 4, ¶15) capable of engaging bone (¶15), the cannulated distal shaft having a first threaded section (see illustration of Fig. 3) distal to the proximal head (Fig. 3), a second threaded section (see illustration of Fig. 3) distal to and adjacent the first threaded section (Fig. 3), and a third threaded section (see illustration of Fig. 3) distal to and adjacent the second threaded section (Fig. 3); the first threaded section having a first major diameter (Fig. 3), a first minor diameter (Fig. 3), and a first length (Fig. 3); the second threaded section having a second major diameter (Fig. 3), a second minor diameter (Fig. 3), and a second length (Fig. 3); the third threaded section having a third major diameter (Fig. 3), a third minor diameter (Fig. 3), and a third length (Fig. 3); wherein the second and third threaded sections have a wall thickness defined between a minor diameter and a cannula diameter (Fig. 3), wherein the wall thickness is either constant or increasing in a distal to proximal direction from a distal-most end of the third threaded section to a proximal end of the second threaded section (Fig. 3) and a cannulation extends therethrough (40, Fig. 3, ¶17); wherein the cannulation comprises transverse passages (42s, Figs. 1-4, ¶17). As to claim 10, Michielli teaches that the first threaded section includes a proximal portion (upper portion of the first threaded section as shown in Fig. 3, Figs. 2-4, i.e. right portion of the first threaded section as shown in Fig. 4) with a first number of thread starts Fig. 4) and a distal portion (lower portion of the first threaded section as shown in Fig. 3, Figs. 2-4) with a second number of thread starts (Fig. 4), the second number of thread starts being less than the first number of thread starts (Fig. 4, ¶s 15 and 23, Table I). As to claim 11, Michielli teaches that the third threaded section includes a third number of thread starts (Fig. 4, ¶s 15 and 23, Table I) that is equal to the second number of thread starts (Fig. 4, ¶s 15 and 23, Table I). As to claim 22, Michielli teaches a guidewire (¶17) capable of being received through a central passage (40) of the cannulated distal shaft (Fig. 3, ¶17), the guidewire exiting the cannulated distal shaft via an unthreaded distal tip (Fig. 3). As to claim 24, Michielli teaches that the cannulated distal shaft includes a plurality of side wall openings 42s) that communicate with the cannula (Figs. 1-4, ¶17). As to claim 25, Michielli teaches that the side wall openings extend radially from the cannula through a side wall of the distal shaft (Figs. 1-4, ¶17).
One of ordinary skill in the art at the time of the invention would have been motivated to modify the cannulation and transverse passages of the distal shaft as disclosed by Denis to have the contours of the cannulation and transverse passages and a guidewire as taught by Michielli in order to provide known structural pathways (Michielli Fig. 3, ¶17; Denis ¶19) to facilitate delivery of the anchor over a guide wire (Michielli ¶17), permit bone in-growth (Michielli ¶17), and permit the dispensing of bone cement or other materials through the bone anchor (Michielli ¶17; Denis ¶19).
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Claim(s) 16-18, 26, and 27 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Denis and Michielli in view of Matthis et al. (US 2008/0132957, hereinafter “Matthis”).
As to claims 16-18, the combination of Denis and Michielli discloses the invention of claim 9 as well as a receiver member (86, upper portion of 84 as shown in Fig. 4, Fig. 4, ¶32) capable of coupling a spinal fixation element (R) to the bone anchor (Fig. 4, ¶32), the receiver member having at a proximal end thereof a pair of spaced apart arms (on either side of 86 as shown in Fig. 4, Fig. 4, ¶32) defining a recess (86) therebetween (as defined, Fig. 4, ¶32), and a distal end surface (lower surface of 84 as shown in Fig. 4) from which at least a portion of the bone anchor is capable of extending (Fig. 4). As to claim 17, the combination of Denis and Michielli discloses a closure mechanism (88) capable of being positioned between the spaced apart arms (Fig. 4, ¶32) capable of capturing the spinal fixation element within the recess of the receiver member (Fig. 4, ¶32). As to claim 18, the combination of Denis and Michielli discloses that the first length extends from the receiver head past a midpoint of the cannulated distal shaft when the receiver head is coupled to the cannulated distal shaft (as defined, see illustration of Fig. 2, Figs. 2-4).
The combination of Denis and Michielli is silent to the distal end surface defining an opening through which at least a portion of the bone anchor is configured to extend.
Matthis teaches a similar bone anchor (Figs. 1-5) comprising: a proximal head (3, 7, 23, Figs. 2-5); and a cannulated distal shaft (21, 20, Figs. 1-5) capable of engaging bone (Figs. 1-5, ¶s 22 and 23), the cannulated distal shaft having a first threaded section distal to the proximal head (Fig. 4), a second threaded section distal to and adjacent the first threaded section (Fig. 4), and a third threaded section distal to and adjacent the second threaded section (Fig. 4); the first threaded section having a first major diameter (Fig. 4), a first minor diameter (Fig. 4), and a first length (Fig. 4); the second threaded section having a second major diameter (Fig. 4), a second minor diameter (Fig. 4), and a second length (Fig. 4); the third threaded section having a third major diameter (Fig. 4), a third minor diameter (Fig. 4), and a third length (Fig. 4); further comprising a receiver member (4) capable of coupling a spinal fixation element (60, Fig. 2, ¶27) to the bone anchor (Fig. 2, ¶27), the receiver member having at a proximal end thereof a pair of spaced apart arms (45, 46) defining a recess (44) therebetween (Fig. 2, ¶s 27 and 32), and a distal end surface (surface of 40 as shown in Figs. 2, 3, and 5) defining an opening (42) through which at least a portion of the bone anchor is capable of extending (Figs. 1-5, ¶s 29-32); wherein the proximal head further comprises a cylindrically shaped proximal section (23), a separable spherically-shaped retaining member (3, Fig. 4), and a retaining ring (7). As to claim 17, Matthis teaches a closure mechanism (61) capable of being positioned between the spaced apart arms (Fig. 2, ¶27) capable of capturing the spinal fixation element within the recess of the receiver member (Fig. 2, ¶s 27 and 32). As to claim 18, Matthis teaches that the first length extends from the receiver head past a midpoint of the cannulated distal shaft when the receiver head is coupled to the cannulated distal shaft (as defined, Fig. 3).
One of ordinary skill in the art at the time of the invention would have been motivated to modify/specify that the distal end surface and head as disclosed by the combination of Denis and Michielli has an opening in the distal end surface and the head comprises a cylindrically shaped proximal section, a separable spherically-shaped retaining member, and a retaining ring as taught by Matthis in order to permit the shank to be screwed into a bone or vertebra (Matthis ¶29) and then an assembly of the receiver member, a separable spherically-shaped retaining member, and a retaining ring can be connected to the shank (Matthis ¶30) via easy and convenient insertion of the shank into the head (Matthis ¶s 8 and 31) as well as enabling an appropriate shank to selected depending on the application such as shanks of different lengths can be provided in combination with the head such that the costs for stock keeping can be reduced (Matthis ¶7).
As to claim 26, the combination of Denis and Michielli discloses the invention of claim 9 as well as the proximal head comprises a receiver member (86, upper portion of 84 as shown in Fig. 4, Fig. 4, ¶32) assembled onto the cannulated distal shaft (Fig. 4); wherein the receiver member is capable of coupling a spinal fixation element (R) to the bone anchor (Fig. 4, ¶32), the receiver member having at a proximal end thereof a pair of spaced apart arms (on either side of 86 as shown in Fig. 4, Fig. 4, ¶32) defining a recess (86) therebetween (as defined, Fig. 4, ¶32), and a distal end surface (lower surface of 84 as shown in Fig. 4) from which at least a portion of the bone anchor is capable of extending (Fig. 4).
The combination of Denis and Michielli is silent to the distal end surface defining an opening through which at least a portion of the bone anchor is configured to extend and the proximal head comprises a retaining member separate from and assembled onto the cannulated distal shaft.
Matthis teaches a similar bone anchor (Figs. 1-5) comprising: a proximal head (3, 7, 23, Figs. 2-5); and a cannulated distal shaft (21, 20, Figs. 1-5) capable of engaging bone (Figs. 1-5, ¶s 22 and 23), the cannulated distal shaft having a first threaded section distal to the proximal head (Fig. 4), a second threaded section distal to and adjacent the first threaded section (Fig. 4), and a third threaded section distal to and adjacent the second threaded section (Fig. 4); the first threaded section having a first major diameter (Fig. 4), a first minor diameter (Fig. 4), and a first length (Fig. 4); the second threaded section having a second major diameter (Fig. 4), a second minor diameter (Fig. 4), and a second length (Fig. 4); the third threaded section having a third major diameter (Fig. 4), a third minor diameter (Fig. 4), and a third length (Fig. 4); further comprising a receiver member (4) capable of coupling a spinal fixation element (60, Fig. 2, ¶27) to the bone anchor (Fig. 2, ¶27), the receiver member having at a proximal end thereof a pair of spaced apart arms (45, 46) defining a recess (44) therebetween (Fig. 2, ¶s 27 and 32), and a distal end surface (surface of 40 as shown in Figs. 2, 3, and 5) defining an opening (42) through which at least a portion of the bone anchor is capable of extending (Figs. 1-5, ¶s 29-32); wherein the proximal head further comprises a cylindrically shaped proximal section (23), a separable spherically-shaped retaining member (3, Fig. 4), and a retaining ring (7); wherein the retaining member is separate from and assembled onto the cannulated distal shaft (Figs. 3 and 4).
One of ordinary skill in the art at the time of the invention would have been motivated to modify/specify that the distal end surface and head as disclosed by the combination of Denis and Michielli has an opening in the distal end surface and the head comprises a cylindrically shaped proximal section, a separable spherically-shaped retaining member, and a retaining ring as taught by Matthis in order to permit the shank to be screwed into a bone or vertebra (Matthis ¶29) and then an assembly of the receiver member, a separable spherically-shaped retaining member, and a retaining ring can be connected to the shank (Matthis ¶30) via easy and convenient insertion of the shank into the head (Matthis ¶s 8 and 31) as well as enabling an appropriate shank to selected depending on the application such as shanks of different lengths can be provided in combination with the head such that the costs for stock keeping can be reduced (Matthis ¶7).
As to claim 27, the combination of Denis and Michielli discloses the invention of claim 9 as well as a receiver member (86, upper portion of 84 as shown in Fig. 4, Fig. 4, ¶32) capable of coupling a spinal fixation element (R) to the bone anchor (Fig. 4, ¶32), the receiver member having at a proximal end thereof a pair of spaced apart arms (on either side of 86 as shown in Fig. 4, Fig. 4, ¶32) defining a recess (86) therebetween (as defined, Fig. 4, ¶32), and a distal end surface (lower surface of 84 as shown in Fig. 4) from which at least a portion of the bone anchor is capable of extending (Fig. 4).
The combination of Denis and Michielli is silent to the distal end surface defining an opening through which at least a portion of the bone anchor is configured to extend and the proximal head further comprises a cylindrically shaped proximal section and a separable spherically-shaped retaining member that retains the proximal section within a lumen of the retaining member.
Matthis teaches a similar bone anchor (Figs. 1-5) comprising: a proximal head (3, 7, 23, Figs. 2-5); and a cannulated distal shaft (21, 20, Figs. 1-5) capable of engaging bone (Figs. 1-5, ¶s 22 and 23), the cannulated distal shaft having a first threaded section distal to the proximal head (Fig. 4), a second threaded section distal to and adjacent the first threaded section (Fig. 4), and a third threaded section distal to and adjacent the second threaded section (Fig. 4); the first threaded section having a first major diameter (Fig. 4), a first minor diameter (Fig. 4), and a first length (Fig. 4); the second threaded section having a second major diameter (Fig. 4), a second minor diameter (Fig. 4), and a second length (Fig. 4); the third threaded section having a third major diameter (Fig. 4), a third minor diameter (Fig. 4), and a third length (Fig. 4); further comprising a receiver member (4) capable of coupling a spinal fixation element (60, Fig. 2, ¶27) to the bone anchor (Fig. 2, ¶27), the receiver member having at a proximal end thereof a pair of spaced apart arms (45, 46) defining a recess (44) therebetween (Fig. 2, ¶s 27 and 32), and a distal end surface (surface of 40 as shown in Figs. 2, 3, and 5) defining an opening (42) through which at least a portion of the bone anchor is capable of extending (Figs. 1-5, ¶s 29-32); wherein the proximal head further comprises a cylindrically shaped proximal section (23), a separable spherically-shaped retaining member (3, Fig. 4), and a retaining ring (7); wherein the separable spherically-shaped retaining member retains the proximal section within a lumen of the retaining member (31, Figs. 3 and 4).
One of ordinary skill in the art at the time of the invention would have been motivated to modify/specify that the distal end surface and head as disclosed by the combination of Denis and Michielli has an opening in the distal end surface and the head comprises a cylindrically shaped proximal section, a separable spherically-shaped retaining member, and a retaining ring as taught by Matthis in order to permit the shank to be screwed into a bone or vertebra (Matthis ¶29) and then an assembly of the receiver member, a separable spherically-shaped retaining member, and a retaining ring can be connected to the shank (Matthis ¶30) via easy and convenient insertion of the shank into the head (Matthis ¶s 8 and 31) as well as enabling an appropriate shank to selected depending on the application such as shanks of different lengths can be provided in combination with the head such that the costs for stock keeping can be reduced (Matthis ¶7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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/AMY R SIPP/Primary Examiner, Art Unit 3775