DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/12/2026 has been entered.
Election/Restrictions
Claims 6-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/20/2023.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 15, 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “attachment feature” in claim 2, 22.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 27 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor US 2006/0074419 in view of Baynham US 2006/0036252 and Reed US 2014/0053696.
Regarding Claim 1, Taylor discloses a pedicle bone fastener (Fig 2) comprising:
a shaft (Fig 2) comprising:
a proximal end (see Fig below);
a distal end (see Fig below);
a longitudinal axis (see Fig below); and
a minor diameter (root diameter of the shaft, Fig 2);
a threaded portion disposed about the distal end of the shaft (distal portion of threads #76, see Fig below);
a head (see Fig below) disposed at the proximal end of the shaft (see Fig below); and
a neck portion positioned intermediate the head portion and the threaded portion (see Fig below);
a helical thread (#76) disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft (paragraph 47, see Fig below),
a tip (see Fig below), and
a main portion of the shaft encompasses a majority of a length of the pedicle bone fastener (see Fig below).
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Taylor does not disclose wherein the neck portion proximate the threaded portion comprises a distally facing shoulder;
the helical thread comprising:
a first undercut surface;
a second undercut surface; and
a third undercut surface, wherein:
the first undercut surface and the second undercut surface are located on one of a proximal facing side and a distal facing side of the helical thread;
the third undercut surface is located on the other one of the proximal facing side and the distal facing side of the helical thread, opposite the first undercut surface;
the first undercut surface and the third undercut surface are angled toward one of the proximal end and the distal end of the shaft;
the second undercut surface is angled toward the other one of the proximal end and the distal end of the shaft;
the minor diameter of the shaft is constant along a main portion of the shaft intermediate a pointed tip portion and a proximal portion of the pedicle bone fastener; and
the main portion of the shaft encompasses a majority of a length of the pedicle bone fastener.
Baynham discloses a pedicle bone fastener (Fig 1-3, paragraph 20) comprising:
a shaft (Fig 1-3) comprising:
a proximal end (see Fig below);
a distal end (see Fig below);
a longitudinal axis (see Fig below); and
a threaded portion disposed about the distal end of the shaft (distal portion of threads #19, see Fig below);
a head (see Fig below) disposed at the proximal end of the shaft (see Fig below); and
a neck portion (see Fig below) positioned intermediate the head portion and the threaded portion (see Fig below), wherein the neck portion proximate the threaded portion comprises a distally facing shoulder (#36, see Fig below);
a helical thread (#19) disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft (paragraph 21, see Fig below),
the distally facing shoulder will contact bone and rotationally groom the bone to accept seating of the screw and provide a space between the bone and head, which serves to stabilize the head of the screw against the hard outer shell of the vertebrae and prevent the bone from interfering with completion of the assembly (paragraph 21).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the neck portion of Taylor to include a distally facing shoulder in view of Baynham above because the distally facing shoulder will contact bone and rotationally groom the bone to accept seating of the screw and provide a space between the bone and head, which serves to stabilize the head of the screw against the hard outer shell of the vertebrae and prevent the bone from interfering with completion of the assembly.
Reed discloses a pedicle bone fastener (Fig 1-2, 11) comprising:
a shaft (Fig 1) comprising:
a proximal end (see Fig below);
a distal end (see Fig below);
a longitudinal axis (#16, Fig 2); and
a minor diameter (see Fig below);
a helical thread (#12) comprising a uniform geometry disposed about a majority of the shaft (Fig 1-2, 11, paragraph 52 where the majority of the thread is uniform), the helical thread comprising:
a first undercut surface (#21, Fig 11);
a second undercut surface (#22, Fig 11); and
a third undercut surface (#20, Fig 11), wherein:
the first undercut surface and the second undercut surface are located on one of a proximal facing side (as seen in Fig 11) and a distal facing side of the helical thread;
the third undercut surface is located on the other one of the proximal facing side and the distal facing side (as seen in Fig 11) of the helical thread, opposite the first undercut surface (Fig 11);
the first undercut surface and the third undercut surface are angled toward one of the proximal end and the distal end of the shaft (Fig 11, starting from the root #46, the first and second undercut surfaces #21, #20 are angled towards the distal end);
the second undercut surface is angled toward the other one of the proximal end and the distal end of the shaft (Fig 11, taken from an end closest to root #46 towards the opposite end, the second undercut surface is angled towards the proximal end);
the minor diameter of the shaft is constant along a main portion of the shaft intermediate a pointed tip portion and a proximal portion of the pedicle bone fastener (see Fig below, paragraph 54, 62 where the minor diameter is a cylindrical, only interrupted by the threads); and
the main portion of the shaft encompasses a majority of a length of the pedicle bone fastener (see Fig below),
where the threads (#12) prevent cracking bone or compress living bone excessively and provide maximum bone engagement and optimize compression pressure for the entrained bone located between the threads (paragraph 65-66).
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It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the shape of the helical thread, including the proximal most portion and a middle portion of the helical thread, of Taylor with that Reed (with the first, second and third undercut surfaces), where the minor diameter is constant as discussed above because this configuration prevents cracking bone or compress living bone excessively and provide maximum bone engagement and optimize compression pressure for the entrained bone located between the threads.
Regarding Claim 2, Taylor discloses as modified an attachment feature (#72 in Taylor) coupled to the proximal end of the shaft (Fig 1-2 in Taylor) and configured to be secured to an implement (examiner notes that the implement is only functionally recited and that the head #72 is capable of engaging an implement, such as #30 and #50, Fig 3-4 in Taylor).
Regarding Claim 3, Taylor as modified discloses the attachment feature comprises a polyaxial head (#72 in Taylor) having a first semi-spherical surface (paragraph 43, as seen in Fig 1-2 in Taylor).
Regarding Claim 4, Taylor as modified discloses the implement comprises a discrete tulip having a second semi-spherical surface configured to engage the first semi- spherical surface of the polyaxial head to secure the discrete tulip to the polyaxial head at any of a variety of relative orientations (paragraph 36, 43, abstract in Taylor, “multi-axial”, examiner notes that the implement is only functionally recited and that the head #72 is capable of engaging an implement with a semi-spherical surface to position the polyaxially head in a variety of orientations, an example of which would be implement #30, #50 of Taylor having a discrete tulip with a second semi-spherical surface #58).
Regarding Claim 5, Taylor as modified disclose the discrete tulip further comprises: at least one opening; and a locking member configured to secure a rod received through the at least one opening to the discrete tulip (examiner notes that the implement is only functionally recited and that the head #72 is capable of engaging an implement that has an opening and a locking member as claimed)[this is evidenced by Matthis US 2004/0186474, Matthis discloses a spinal system (Fig 4) comprising: a pedicle bone fastener (Fig 4), attachment feature (#2) coupled to the proximal end of a threaded shaft (#1) and configured to be secured to an implement (#3), wherein the attachment feature comprises a polyaxial head (#2, paragraph 31) having a first semi-spherical surface (#2, paragraph 31, Fig 4), wherein the implement comprises a discrete tulip (#3, Fig 4) having a second semi-spherical surface (#6, paragraph 31, Fig 1-2) configured to engage the first semi- spherical surface of the polyaxial head to secure the discrete tulip to the polyaxial head at any of a variety of relative orientations (Fig 1-2, paragraph 31, 38), wherein the discrete tulip further comprises: at least one opening (opening to receive locking member #20, Fig 1-4); and a locking member (#20) configured to secure a rod (#100) received through the at least one opening to the discrete tulip (paragraph 38), where the polyaxial head allows the angle between the pedicle fastener and discrete tulip to be adjusted (paragraph 38)]. In short, the polyaxial head of Taylor is capable of engaging with an implement like that taught by Matthis.
Regarding Claim 27, Taylor as modified disclose the neck portion of the pedicle bone fastener comprises an hourglass shape (see annotated Fig 2 of Taylor above where the upper portion of the neck curves outwardly towards the head and a lower portion towards the threads, where with the modification in view of Baynham, the lower portion would instead extend towards the distally facing shoulder and thus would provide an hourglass shape).
Regarding Claim 27, Taylor as modified discloses the claimed invention as discussed above where the head extends outwardly from an upper portion of the neck portion (see Fig 2 of Taylor above) and the shoulder extends outwardly from a lower portion of the neck portion (Fig 3 in Baynham) but does not the neck portion of the pedicle bone fastener comprises an hourglass shape.
However, It would have been an obvious matter of design choice to one skilled in the art at a time before the effective filing date of the claimed invention to have the neck portion have an hour glass shape, 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 neck portion between a head and neck portion of a bone fastener. In re Dailey and Eilers, 149 USPQ 47 (1966). See MPEP 2144.04 (IV)(B).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor US 2006/0074419, Baynham US 2006/0036252 and Reed US 2014/0053696, as applied to claim 1 above, and in further view of Crook US 2011/0152948.
Taylor as modified discloses the claimed invention as discussed above but does not disclose the pointed tip portion of the pedicle bone fastener comprises a rounded shape.
Crook discloses a pedicle bone fastener (Figs 1-8, abstract) with a pointed tip portion (#38, Fig 5, 8) of the pedicle bone fastener comprises a rounded shape (paragraph 23, 25, can be rounded or pointed).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Taylor as modified and have the pointed tip comprise a rounded shape in view of Crook above because this provides a known alternate shape for pointed tips of pedicle bone fasteners.
Claims 15-18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor US 2006/0074419 in view of Baynham US 2006/0036252, Reed US 2014/0053696, and Moumene US 2013/0041412.
Regarding Claim 15, Taylor discloses a bone fastener (Fig 2) comprising:
a shaft (Fig 2) comprising:
a proximal end (see Fig below);
a distal end (see Fig below);
a longitudinal axis (#16, Fig 2); and
a minor diameter (see Fig below where between adjacent threads defines a minor or root diameter for the shaft);
a threaded portion disposed about the distal end of the shaft (distal portion of threads #76, see Fig below);
a head (see Fig below) disposed at the proximal end of the shaft (see Fig below); and
a neck portion positioned intermediate the head portion and the threaded portion (see Fig below);
a helical thread (#76) disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft and defining a major diameter of the bone fastener (see Fig below, outer ends of the threads defines the major diameter).
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Taylor does not disclose the neck portion proximate the threaded portion comprises a distally facing shoulder, at least one self-tapping feature formed in the distal end of the shaft; the helical thread comprising:
a first undercut surface;
a second undercut surface;
a third undercut surface; and
a fourth open surface, wherein:
the first undercut surface and the third undercut surface are angled toward one of the proximal end and the distal end of the shaft;
the second undercut surface and the fourth open surface are angled toward the other one of the proximal end and the distal end of the shaft;
the first undercut surface and the second undercut surface form a concave undercut surface facing toward one of the proximal end and the distal end of the shaft;
the third undercut surface and the fourth open surface form a convex undercut surface facing toward the other one of the proximal end and the distal end of the shaft;
at least a portion of the helical thread comprising the first undercut surface and the second undercut surface is disposed about the distal end of the shaft.
Regarding Claims 15-18, Taylor discloses the claimed invention as discussed above where the major diameter is not much greater than the minor diameter (see Fig above) but does not explitly disclose a ratio of the major diameter to the minor diameter is less than 1.50/1.25/1.10/1.05.
Baynham discloses a pedicle bone fastener (Fig 1-3, paragraph 20) comprising:
a shaft (Fig 1-3) comprising:
a proximal end (see Fig below);
a distal end (see Fig below);
a longitudinal axis (see Fig below); and
a threaded portion disposed about the distal end of the shaft (distal portion of threads #19, see Fig below);
a head (see Fig below) disposed at the proximal end of the shaft (see Fig below); and
a neck portion (see Fig below) positioned intermediate the head portion and the threaded portion (see Fig below), wherein the neck portion proximate the threaded portion comprises a distally facing shoulder (#36, see Fig below);
a helical thread (#19) disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft (paragraph 21, see Fig below),
the distally facing shoulder will contact bone and rotationally groom the bone to accept seating of the screw and provide a space between the bone and head, which serves to stabilize the head of the screw against the hard outer shell of the vertebrae and prevent the bone from interfering with completion of the assembly (paragraph 21).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the neck portion of Taylor to include a distally facing shoulder in view of Baynham above because the distally facing shoulder will contact bone and rotationally groom the bone to accept seating of the screw and provide a space between the bone and head, which serves to stabilize the head of the screw against the hard outer shell of the vertebrae and prevent the bone from interfering with completion of the assembly.
Reed discloses a bone fastener (Fig 1-2, 11) comprising:
a shaft (see Fig below, Fig 1, 2, 11) comprising:
a proximal end (see Fig below);
a distal end (see Fig below);
at least one self-tapping feature (#55, paragraph 10, 68) formed in the distal end of the shaft (Fig 8);
a longitudinal axis (#16); and
a minor diameter (see Fig below);
a helical thread (#12) disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft and defining a major diameter of the bone fastener (see Fig below), the helical thread (#12) comprising a uniform geometry disposed about a majority of the shaft (Fig 1-2, 11, paragraph 52 where the majority of the thread is uniform), the helical thread comprising
a first undercut surface (#21, Fig 11);
a second undercut surface (#22, Fig 11);
a third undercut surface (#20, Fig 11); and
a fourth open surface (#19, Fig 11), wherein:
the first undercut surface and the third undercut surface are angled toward one of the proximal end and the distal end of the shaft (as seen in Fig 11, from adjacent the second undercut surface #22 towards the root of the thread, first undercut surface #21 is angled proximally to the proximal end, likewise, taken from point #39 towards the root of the thread, the third undercut surface is also angled proximally to the proximal end);
the second undercut surface and the fourth open surface are angled toward the other one of the proximal end and the distal end of the shaft (as seen in Fig 11, when taken from the crest of the thread towards the first undercut surface #21, the second undercut surface #22 is angled distally towards the distal end and likewise, taken from the crest of the thread towards point #39, the fourth open surface #19 is angled distally towards the distal end);
the first undercut surface and the second undercut surface form a concave undercut surface facing toward one of the proximal end and the distal end of the shaft (Fig 11, as well as Figs 1-3 where the first and undercut surfaces collectively form a concave surface as it spirals about the shaft and faces the proximal end);
the third undercut surface and the fourth open surface form a convex undercut surface facing toward the other one of the proximal end and the distal end of the shaft (Fig 11, as well as Figs 1-3 where the third undercut surface and fourth open surface collectively form a convex surface as it spirals about the shaft and faces the distal end);
at least a portion of the helical thread comprising the first undercut surface and the second undercut surface is disposed about the distal end of the shaft (see Fig below, Fig 1 where the threads including the first and third undercut surfaces extends and disposed about the distal end),
where the self-tapping feature provides cutting of the bone and bone chip dispersal as the screw is threaded into bone (paragraph 68, 71),
where the threads (#12) prevent cracking bone or compress living bone excessively and provide maximum bone engagement and optimize compression pressure for the entrained bone located between the threads (paragraph 65-66).
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It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the distal end of the shaft to include at least on self-tapping feature in view of Reed because the self-tapping feature provides cutting of the bone and bone chip dispersal as the screw is threaded into bone and to modify the helical thread, including the first and second geometries of Taylor with that Reed (with the first, second, and third undercut surfaces and the fourth open surface), where the minor diameter is constant as discussed above because this configuration prevents cracking bone or compress living bone excessively and provide maximum bone engagement and optimize compression pressure for the entrained bone located between the threads.
It would have also been an obvious matter of design choice to one of ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the diameters of have the major and minor diameters have a ration of less than 1.50/1.25/1.10/1.05, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). See MPEP 2144.04 (IV)(A)
Furthermore, Moumene teaches a bone fastener whose size can vary depending on use and can have a major diameter of 3-12 mm and a minor diameter of 2.5-10mm (paragraph 28), such that the ratio of the major diameter and minor diameter is less than 1.50/1.25/1.10/1.05 (paragraph 29 where various combinations can be made, for example, taken the minimum and maximum of the ranges for the major and minor diameters would yield 1.2, and taken values just above and below the ranges would provide for less than 1.05).
It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Taylor as modified such that the major diameter is 3-12 mm and a minor diameter is 2.5-10mm such that the ratio of the major diameter and minor diameter is less than 1.50/1.25/1.10/1.05 in view of Mouene above because these provides known dimensions for bone screws depending on their intended use.
Regarding Claim 20, Taylor as modified discloses an attachment feature (#72 in Taylor) at the proximal end of the shaft (see annotated Figs above, Figs 1-2) configured to be adjustably secured to an implement (examiner notes that the implement is only functionally recited and not part of the claimed invention and that the attachment feature can be secured to an implement, an example of which is #30, #50 as seen in Figs 3-4 in Taylor).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor US 2006/007441, Baynham US 2006/0036252, Reed US 2014/0053696 and Moumene US 20130041412, as applied to claim 15 above, and in further view of Bosacco US 3,670,724.
Taylor as modified discloses the claimed invention as discussed above where the bone fastener can be coupled to a plate (Fig 13, paragraph 46 in Taylor) but does not disclose at least a portion of the bone fastener is configured to be received within an intramedullary canal of a bone.
Bosacco discloses the use of a plate (#22, Fig 6-7), the plate secured to bone via bone fasteners (#23), where at least a portion of the bone fastener is configured to be received within an intramedullary canal of a bone (as seen in Fig 7-8) to help treat a fracture (#19a) on a femur (Col 2 lines 55- Col 3 line 12).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the Taylor as modified to be sized appropriately such that a portion can be received in an intramedullary canal of bone in view of Bosacco above in situations where a plate is used to treat a femoral fracture.
Claims 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor US 2006/0074419 in view of Baynham US 2006/0036252 and Reed US 2014/0053696.
Regarding Claim 21, Taylor discloses a pedicle bone fastener (Fig 2) comprising:
a shaft (Fig 2) comprising:
a proximal end (see Fig below);
a distal end (see Fig below);
a longitudinal axis (#21, Fig 2); and
a minor diameter (see Fig below);
a threaded portion disposed about the distal end of the shaft (distal portion of threads #76, see Fig below);
a head (see Fig below) disposed at the proximal end of the shaft (see Fig below); and
a neck portion positioned intermediate the head portion and the threaded portion (see Fig below);
a helical thread (#76) disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft (see Fig below, paragraph 47).
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Taylor does not disclose the neck portion proximate the threaded portion comprises a distally facing shoulder, the helical thread comprising:
a first undercut surface;
a second undercut surface;
a third undercut surface; and
a fourth open surface, wherein:
the first undercut surface and the third undercut surface are angled toward one of the proximal end and the distal end of the shaft;
the second undercut surface and the fourth open surface are angled toward the other one of the proximal end and the distal end of the shaft;
the third undercut surface and the fourth open surface form a convex undercut surface with an intermediate portion that forms a point at a location along the convex undercut surface where the third undercut surface and the fourth open surface meet;
the minor diameter of the shaft proximate the distal end of the shaft is constant;
the minor diameter of the shaft proximate the proximal end of the shaft is constant; and
the minor diameter of the shaft proximate the distal end of the shaft is equal to the minor diameter of the shaft proximate the proximal end of the shaft.
Baynham discloses a pedicle bone fastener (Fig 1-3, paragraph 20) comprising:
a shaft (Fig 1-3) comprising:
a proximal end (see Fig below);
a distal end (see Fig below);
a longitudinal axis (see Fig below); and
a threaded portion disposed about the distal end of the shaft (distal portion of threads #19, see Fig below);
a head (see Fig below) disposed at the proximal end of the shaft (see Fig below); and
a neck portion (see Fig below) positioned intermediate the head portion and the threaded portion (see Fig below), wherein the neck portion proximate the threaded portion comprises a distally facing shoulder (#36, see Fig below);
a helical thread (#19) disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft (paragraph 21, see Fig below),
the distally facing shoulder will contact bone and rotationally groom the bone to accept seating of the screw and provide a space between the bone and head, which serves to stabilize the head of the screw against the hard outer shell of the vertebrae and prevent the bone from interfering with completion of the assembly (paragraph 21).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the neck portion of Taylor to include a distally facing shoulder in view of Baynham above because the distally facing shoulder will contact bone and rotationally groom the bone to accept seating of the screw and provide a space between the bone and head, which serves to stabilize the head of the screw against the hard outer shell of the vertebrae and prevent the bone from interfering with completion of the assembly.
Regarding Claim 21, Reed discloses a pedicle bone fastener (Fig 1-2, 11, paragraph 1, capable of being used on a pedicle) comprising:
a shaft (Fig 1, see Fig below) comprising:
a proximal end (see Fig below);
a distal end (see Fig below, where the distal end contains self tapping feature #55);
a longitudinal axis (#16); and
a minor diameter (see Fig below);
a helical thread disposed about the shaft along the longitudinal axis between the proximal and distal ends of the shaft (see Fig below), wherein
the helical thread (#12) comprising a uniform geometry disposed about a majority of the shaft (Fig 1-2, 11, paragraph 52 where the majority of the thread is uniform), the helical thread comprising
the helical thread comprising:
a first undercut surface (#21, Fig 11);
a second undercut surface (#22, Fig 11);
a third undercut surface (#20, Fig 11); and
a fourth open surface (#19, Fig 11), wherein:
the first undercut surface and the third undercut surface are angled toward one of the proximal end and the distal end of the shaft (as seen in Fig 11, from adjacent the second undercut surface #22 towards the root of the thread, first undercut surface #21 is angled proximally to the proximal end, likewise, taken from point #39 towards the root of the thread, the third undercut surface is also angled proximally to the proximal end)(examiner notes that how the surfaces are angled is not being claimed)
the second undercut surface and the fourth open surface are angled toward the other one of the proximal end and the distal end of the shaft (as seen in Fig 11, when taken from the crest of the thread towards the first undercut surface #21, the second undercut surface #22 is angled distally towards the distal end and likewise, taken from the crest of the thread towards point #39, the fourth open surface #19 is angled distally towards the distal end) (examiner notes that how the surfaces are angled is not being claimed),
the third undercut surface and the fourth open surface form a convex undercut surface (Fig 11, as well as Figs 1-3 where the third undercut surface and fourth open surface collectively form a convex surface as it spirals about the shaft) with an intermediate portion that forms a point (#39) at a location along the convex undercut surface where the third undercut surface and the fourth open surface meet (Fig 11);
the minor diameter of the shaft proximate the distal end of the shaft is constant (see Fig 1-2, Fig below, paragraph 54 where proximate the distal end, above the self-tapping feature #55, the minor diameter proximate the distal end is constant)(examiner notes that the minor diameter of the main portion of the shaft, see Fig below, resembles that of a cylinder only interrupted by the threads and has a constant diameter, paragraph 54, 62);
the minor diameter of the shaft proximate the proximal end of the shaft is constant (see Fig 1-2, Fig below, paragraph 54, where proximate the proximal end, the minor diameter is constant); and
the minor diameter of the shaft proximate the distal end of the shaft is equal to the minor diameter of the shaft proximate the proximal end of the shaft (see Fig below, Figs 1-2, paragraph 54 where the minor diameters proximate the distal and proximal ends are the same/constant and form a cylinder),
where the threads (#12) prevent cracking bone or compress living bone excessively and provide maximum bone engagement and optimize compression pressure for the entrained bone located between the threads (paragraph 65-66).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the shape of the helical thread of Taylor with that Reed (with the first, second and third undercut surfaces and the fourth open surface), where the minor diameter is constant from the proximal end to proximate the distal end, as discussed above because this configuration prevents cracking bone or compress living bone excessively and provide maximum bone engagement and optimize compression pressure for the entrained bone located between the threads.
Regarding Claim 22, Taylor discloses as modified an attachment feature (#72 in Taylor) coupled to the proximal end of the shaft (Fig 1-2 in Taylor) and configured to be secured to an implement (examiner notes that the implement is only functionally recited and that the head #72 is capable of engaging an implement, such as #30 and #50, Fig 3-4 in Taylor).
Regarding Claim 23, Taylor as modified discloses the attachment feature comprises a polyaxial head (#72 in Taylor) having a first semi-spherical surface (paragraph 43, as seen in Fig 1-2 in Taylor).
Regarding Claim 24, Taylor as modified discloses the implement comprises a discrete tulip having a second semi-spherical surface configured to engage the first semi- spherical surface of the polyaxial head to secure the discrete tulip to the polyaxial head at any of a variety of relative orientations (paragraph 36, 43, abstract in Taylor, “multi-axial”, examiner notes that the implement is only functionally recited and that the head #72 is capable of engaging an implement with a semi-spherical surface to position the polyaxially head in a variety of orientations, an example of which would be implement #30, #50 of Taylor having a discrete tulip with a second semi-spherical surface #58).
Regarding Claim 25, Taylor as modified disclose the discrete tulip further comprises: at least one opening; and a locking member configured to secure a rod received through the at least one opening to the discrete tulip (examiner notes that the implement is only functionally recited and that the head #72 is capable of engaging an implement that has an opening and a locking member as claimed)[this is evidenced by Matthis US 2004/0186474, Matthis discloses a spinal system (Fig 4) comprising: a pedicle bone fastener (Fig 4), attachment feature (#2) coupled to the proximal end of a threaded shaft (#1) and configured to be secured to an implement (#3), wherein the attachment feature comprises a polyaxial head (#2, paragraph 31) having a first semi-spherical surface (#2, paragraph 31, Fig 4), wherein the implement comprises a discrete tulip (#3, Fig 4) having a second semi-spherical surface (#6, paragraph 31, Fig 1-2) configured to engage the first semi- spherical surface of the polyaxial head to secure the discrete tulip to the polyaxial head at any of a variety of relative orientations (Fig 1-2, paragraph 31, 38), wherein the discrete tulip further comprises: at least one opening (opening to receive locking member #20, Fig 1-4); and a locking member (#20) configured to secure a rod (#100) received through the at least one opening to the discrete tulip (paragraph 38), where the polyaxial head allows the angle between the pedicle fastener and discrete tulip to be adjusted (paragraph 38)]. In short, the polyaxial head of Taylor is capable of engaging with an implement like that taught by Matthis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for art of cited interest, in particular other fasteners with shoulders.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773