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 .
Priority
The examiner notes that support for the current claims go back to US Provisional 62,194,955 filed July 21, 2015. As such, the claims have an effective filing date of July 21, 2015.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/17/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) below 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: “closing mating structure” in claim 24.
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 1-6, 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Biederman US 2015/0032162 (1st interpretation) in view of Harris US 2015/0230829 (which claims priority to US Provisional 61/940,687, hereinafter ‘687).
Regarding Claim 1, Biedermann discloses a pivotal bone anchor assembly (Fig 1, see Fig below, see paragraph 78) intended for securing an elongate rod (#100) to a bone of a patient with tooling (paragraph 75, 79), the pivotal bone anchor assembly comprising:
a receiver (#6, see annotated Fig 8 below) comprising a vertical centerline axis (axis “C”), a lower portion (see annotated Fig 8 below) defining a bottom opening (see annotated Fig 8 below) communicating with a bottom surface of the lower portion (see annotated Fig 8 below), an upper portion (see annotated Fig 8 below), a central opening extending upwards from the bottom opening through the lower portion and the upper portion to a top surface thereof (see annotated Fig 8 below), internal surfaces (see annotated Fig 8 below where the multiple internal surfaces help define the central opening) of the central opening including a support surface (see annotated Fig 8 below) adjacent to the bottom opening, a closure mating structure (threads #63, paragraph 53) adjacent to a top of the receiver (see annotated Fig 8 below) configured to mate with a closure top (#10, as seen in Fig 3-4), opposed integrally-formed first abutment structure (#67 see annotated Fig 8 below, where each leg #62a, #62b of the receiver has a first abutment structure in the form of groove #67) beneath the closure mating structure (see annotated Fig 8 below, paragraph 54) (it is noted that the opposed arcuate attachment grooves #67 engage with a complimentary with arcuate projecting structures #86, paragraph 69, discussed further below), and opposed integrally-formed second abutment structures (see annotated Figs 5, 7-8 where the opposed arcuate recessed surface are recessed from the top surface and supports the rod #100) between the first abutment structures and the support surface (see annotated Fig 8 below);
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a bone attachment structure (#1, Fig 1) comprising a longitudinal axis, a capture head having a partial spherical surface (see annotated Fig 1 below, paragraph 50) defining a hemisphere plane at a greatest width perpendicular to the longitudinal axis (Fig 1 where taken at its greatest width, would define a hemisphere shape, see 112 rejection above) , and an anchor portion (see Fig below) opposite the capture head configured for attachment to the bone (paragraph 50), the capture head being pivotally positionable in the lower portion of the receiver in an unlocked configuration (paragraph 7 “polyaxial”, see also paragraph 57),
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an insert disposable into the central opening of the receiver (#8, see Fig below), the insert comprising an upper surface configured to receive the elongate rod (see Fig below), a central through-bore (see Fig below), a lower surface configured to engage the partial spherical surface of the capture head (see Fig below, Fig 1 where prior to assembly, the lower surface is able to engage the partially spherical surface of the capture head; or one can place the insert #8 in the receiver and without placing component #7 in the receiver, the bone attachment structure can be inserted into the receiver such that the capture head is engaged by the lower surface of the insert #8)(alternatively,see Fig 3 where the lower surface is indirectly engaged to partial spherical surface via component #7)(it is noted that applicant is not claiming how they are engaged or a direct engagement, see Response to Arguments above), and opposite outwardly-facing arcuate side engagement surfaces (#86, see Fig below) extending circumferentially around curvate side surfaces of the insert (see Fig below), the arcuate side engagement surfaces being engageable with the first abutment structures in a first overlapping surface arrangement configured to inhibit substantial axial movement in either direction within the central opening until forcibly engaged by the tooling (paragraph 79 where arcuate side engagement surface #86 is held in the first abutment structures #67 and substantial axial movement is inhibited until an “instrument” is used),
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wherein after the capture head of the bone anchor is positioned within the lower portion of the receiver, the insert is configured for forced downward displacement via direct engagement with the tooling to a second overlapping surface arrangement (as seen in Fig 24, paragraph 79 where arcuate projecting structures #86 is moved into grooves #66) to inhibit upward displacement of the insert back to the first overlapping surface arrangement (paragraph 72 via surface #86a of projecting structures #86 engaged with an upper surface of grooves #66), and
wherein prior to locking the assembly with the closure top, the bone attachment structure is configured to remain pivotal with respect to the receiver in the unlocked configuration after the insert is forcibly downwardly displaced into the second overlapping surface arrangement (paragraph 12, end of paragraph 79, “pre-locking condition” and see Fig 25, paragraph 80 where only when closure top #10 is applied that the angular position of the head #3 is locked and thus prior to the use of the closure top #10, the bone attachment structure is pivotable).
Regarding Claim 2, Biedermann discloses the receiver and the bone attachment structure have a non-floppy friction fit with respect to each other in the unlocked configuration after the insert is forcibly downwardly displaced into the second overlapping surface arrangement (paragraph 12, end of paragraph 79).
Regarding Claim 3, Biedermann discloses the upper portion of the receiver includes a channel communicating with the central opening and configured to receive the elongate rod (see Fig below, Fig 25-26 where the channel receives the rod and leads to the arcuate recessed surfaces).
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Regarding Claim 4, Biedermann discloses a retainer (#71, Figs 9-12) positionable in the lower portion of the receiver in engagement with the support surface and with the capture head of the bone attachment structure (as seen in Fig 3-4), the retainer being spaced apart from the insert after the insert is forcibly downwardly displaced into the second overlapping surface arrangement (Fig 25, where collar #79 separates the retainer #71 from the insert #8)(it is noted that collar #70 and retainer #71 help make up pressure member #7).
Regarding Claim 5, Biedermann discloses the capture head of the bone attachment structure is uploaded through the bottom opening of the receiver and retained in the lower portion by the retainer (paragraph 75, as seen in Fig 21, 23).
Regarding Claim 6, Biedermann discloses the retainer is uploaded into the receiver through the bottom opening (paragraph 72).
Regarding Claim 11, Biedermann discloses further comprising the elongate rod (#100), wherein the closure top rotatably engageable with the closure mating structure to secure the elongate rod in the receiver with the pivotal bone anchor assembly in a locked configuration (as seen in Fig 26, paragraph 81).
Regarding Claim 12, Biedermann discloses a release of the closure top with respect to the closure mating structure allows for further adjustment of the assembly in the unlocked configuration without utilization of tooling to engage the insert (paragraph 83 adjustment of the rod #100 of the assembly can occur without engaging the insert).
Regarding Claim 13, Biedermann discloses wherein the first abutment structures further comprise upper opposed arcuate grooves (#67) recessed into the internal surfaces of the central opening (see annotated Fig 8 above), and wherein the second abutment structures further comprise lower opposed arcuate grooves (#66) recessed into the internal surfaces of the central opening below the upper opposed arcuate grooves (see annotated Fig 8 above).
Regarding Claim 14, Biedermann discloses the arcuate side engagement surfaces further comprise outer surfaces of opposed arcuate projections (see fig below, where there are four arcuate projections, for convenience only two are identified, the other two are on the other side of the insert, where the projections extend completely across their respective cylindrical side surface) extending uninterrupted at least between ends of each arcuate side engagement surface and circumferentially around upper cylindrical side surfaces of the insert (see fig below, examiner notes that only one side is shown but the other side has the same configuration)(examiner notes that applicant is not claiming where the ends are taken from).
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Regarding Claim 15, Biedermann discloses the opposed arcuate projections are spaced below insert top surfaces (see fig in claim 14 above).
Biedermann does not disclose at least one guide and alignment surface is integrally formed in the internal surface of the central opening, the insert having an outer mating surface for engaging the at least one insert guide and alignment surface of the receiver, wherein, when the outer mating surface of the insert engages the at least one insert guide and alignment surface of the receiver, rotation between the insert and the receiver is inhibited.
Harris discloses a receiver and an insert (see Fig below), at least one guide and alignment surface is integrally formed in the internal surface of a central opening (see Fig below, see Fig 7, see also Fig 5 in ‘687) of the receiver, the insert having an outer mating surface for engaging the at least one insert guide and alignment surface of the receiver (see Fig below), wherein, when the outer mating surface of the insert engages the at least one insert guide and alignment surface of the receiver so rotation between the insert and the receiver is inhibited (paragraph 7,29, see also bottom of page 1 in the specification in ‘687).
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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 outer profile of the insert of Biedermann to have a keyed profile such that the receiver has at least one guide and alignment surface that engages with an outer mating surface of the insert in view of Harris above because rotation between the insert and the receiver is inhibited.
Claims 1, 7, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Biederman US 2015/0032162 (2nd interpretation) in view of Harris US 2015/0230829 (which claims priority to US Provisional 61/940,687, hereinafter ‘687).
Regarding Claim 1, Biedermann discloses a pivotal bone anchor assembly (Fig 1, see Fig below, see paragraph 78) intended for securing an elongate rod (#100) to a bone of a patient with tooling (paragraph 75, 79), the pivotal bone anchor assembly comprising:
a receiver (#6, see annotated Fig 8 below) comprising a vertical centerline axis (axis “C”), a lower portion (see annotated Fig 8 below) defining a bottom opening (see annotated Fig 8 below) communicating with a bottom surface of the lower portion (see annotated Fig 8 below), an upper portion (see annotated Fig 8 below), a central opening extending upwards from the bottom opening through the lower portion and the upper portion to a top surface thereof (see annotated Fig 8 below), internal surfaces (see annotated Fig 8 below where the multiple internal surfaces help define the central opening) of the central opening including a support surface (see annotated Fig 8 below) adjacent to the bottom opening, a closure mating structure (threads #63, paragraph 53) adjacent to a top of the receiver (see annotated Fig 8 below) configured to mate with a closure top (#10, as seen in Fig 3-4), opposed integrally-formed first abutment structure (#67 see annotated Fig 8 below, where each leg #62a, #62b of the receiver has a first abutment structure in the form of groove #67) beneath the closure mating structure (see annotated Fig 8 below, paragraph 54) (it is noted that the opposed arcuate attachment grooves #67 engage with a complimentary with arcuate projecting structures #86, paragraph 69, discussed further below), and opposed integrally-formed second abutment structures (see annotated Figs 5, 7-8 where the opposed arcuate recessed surface are recessed from the top surface and supports the rod #100) between the first abutment structures and the support surface (see annotated Fig 8 below);
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a bone attachment structure (#1, Fig 1) comprising a longitudinal axis, a capture head having a partial spherical surface (see annotated Fig 1 below, paragraph 50) defining a hemisphere plane at a greatest width perpendicular to the longitudinal axis (Fig 1 where taken at its greatest width, would define a hemisphere shape, see 112 rejection above) , and an anchor portion (see Fig below) opposite the capture head configured for attachment to the bone (paragraph 50), the capture head being pivotally positionable in the lower portion of the receiver in an unlocked configuration (paragraph 7 “polyaxial”, see also paragraph 57),
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an insert disposable into the central opening of the receiver (#7 and #8, see Fig 1, see Response to Arguments above), the insert comprising an upper surface configured to receive the elongate rod (see Fig below), a central through-bore (see Fig below), a lower surface configured to engage the partial spherical surface of the capture head (see Fig below, see Response to Arguments above), and opposite outwardly-facing arcuate side engagement surfaces (#86, see Fig below) extending circumferentially around curvate side surfaces of the insert (see Fig below), the arcuate side engagement surfaces being engageable with the first abutment structures in a first overlapping surface arrangement configured to inhibit substantial axial movement in either direction within the central opening until forcibly engaged by the tooling (paragraph 79 where arcuate side engagement surface #86 is held in the first abutment structures #67 and substantial axial movement is inhibited until an “instrument” is used),
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wherein after the capture head of the bone anchor is positioned within the lower portion of the receiver, the insert is configured for forced downward displacement via direct engagement with the tooling to a second overlapping surface arrangement (as seen in Fig 24, paragraph 79 where arcuate projecting structures #86 is moved into grooves #66) to inhibit upward displacement of the insert back to the first overlapping surface arrangement (paragraph 72 via surface #86a of projecting structures #86 engaged with an upper surface of grooves #66), and
wherein prior to locking the assembly with the closure top, the bone attachment structure is configured to remain pivotal with respect to the receiver in the unlocked configuration after the insert is forcibly downwardly displaced into the second overlapping surface arrangement (paragraph 12, end of paragraph 79, “pre-locking condition” and see Fig 25, paragraph 80 where only when closure top #10 is applied that the angular position of the head #3 is locked and thus prior to the use of the closure top #10, the bone attachment structure is pivotable).
Regarding Claim 7, Biedermann discloses the insert is uploaded into the receiver through the bottom opening (paragraph 72 where the lower portion #7 of the inserted is uploaded through the bottom opening, it is noted that applicant is not claiming that the entirety of the insert is uploaded).
Regarding Claim 10, Biedermann disclose the insert includes a downward-facing concave surface (#72, Fig 10, 12, paragraph 56 “substantially spherical”) on a lower portion (#7) thereof configured for direct engagement with the capture head (paragraph 56, see also Fig 3) after the forced downward displacement of the insert within the central through-bore (as seen in Figs 3, 24-25).
Biedermann does not disclose at least one guide and alignment surface is integrally formed in the internal surface of the central opening, the insert having an outer mating surface for engaging the at least one insert guide and alignment surface of the receiver, wherein, when the outer mating surface of the insert engages the at least one insert guide and alignment surface of the receiver, rotation between the insert and the receiver is inhibited.
Harris discloses a receiver and an insert (see Fig below), at least one guide and alignment surface is integrally formed in the internal surface of a central opening (see Fig below, see Fig 7, see also Fig 5 in ‘687) of the receiver, the insert having an outer mating surface for engaging the at least one insert guide and alignment surface of the receiver (see Fig below), wherein, when the outer mating surface of the insert engages the at least one insert guide and alignment surface of the receiver so rotation between the insert and the receiver is inhibited (paragraph 7,29, see also bottom of page 1 in the specification in ‘687).
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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 outer profile of the insert of Biedermann to have a keyed profile such that the receiver has at least one guide and alignment surface that engages with an outer mating surface of the insert in view of Harris above because rotation between the insert and the receiver is inhibited.
Claims 16-17, 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Biederman US 2015/003216 in view of Harris US 2015/0230829 (which claims priority to US Provisional 61/940,687, hereinafter ‘687).
Regarding Claim 16, Biedermann discloses a pivotal bone anchor assembly (Fig 1, see Fig below, see paragraph 78) intended for securing an elongate rod (#100) to a bone of a patient with tooling (paragraph 75, 79), the pivotal bone anchor assembly comprising:
a receiver (#6, see Fig below) comprising a vertical centerline axis (axis “C”), a lower portion defining a bottom opening communicating with a bottom surface of the lower portion (see Fig below), an upper portion (see Fig below), a central opening extending upwards from the bottom opening through the lower portion and the upper portion to a top surface thereof (see Fig below), internal surfaces of the central opening including a support surface adjacent to the bottom opening (see Fig below), a closure mating structure (threads #63, paragraph 53) adjacent to a top of the receiver configured to mate with a closure top (#10, Fig 3-4), opposed integrally-formed first abutment structures (#67 see annotated Fig 8 below, where each leg #62a, #62b of the receiver has a first abutment structure in the form of groove #67) beneath the closure mating structure (see annotated Fig 8 below, paragraph 54) (it is noted that the opposed arcuate attachment grooves #67 engage with a complimentary with arcuate projecting structures #86, paragraph 69, discussed further below), and opposed integrally-formed second abutment structures (see annotated Figs 5, 7-8 where the opposed arcuate recessed surface are recessed from the top surface and supports the rod #100) between the first abutment structures and the support surface (see annotated Fig 8 below);
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a bone attachment structure (#1, Fig 1) comprising a longitudinal axis, a capture head having a partial spherical surface (see annotated Fig 1 below, paragraph 50) defining a hemisphere plane at a greatest width perpendicular to the longitudinal axis (Fig 1 where taken at its greatest width, would define a hemisphere shape, see 112 rejection above) , and an anchor portion (see Fig below) opposite the capture head configured for attachment to the bone (paragraph 50), the capture head being pivotally positionable in the lower portion of the receiver in an unlocked configuration (paragraph 7 “polyaxial”, see also paragraph 57); and
an insert (#8, see Fig below) disposable into the central opening of the receiver (Fig 3-4), the insert comprising an upper rod-receiving surface between insert top surfaces (see Fig below), a central through-bore (see Fig below), a lower surface configured to engage the partial spherical surface of the capture head (see Fig below, Fig 1 where prior to assembly, the lower surface is able to engage the partially spherical surface of the capture head; or one can place the insert #8 in the receiver and without placing component #7 in the receiver, the bone attachment structure can be inserted into the receiver such that the capture head is engaged by the lower surface of the insert #8)(alternatively,see Fig 3 where the lower surface is indirectly engaged to partial spherical surface via component #7)(it is noted that applicant is not claiming how they are engaged or a direct engagement, see Response to Arguments above), and opposite outwardly-facing arcuate side engagement surfaces extending circumferentially around upper cylindrical side surfaces of the insert (see Fig below), the arcuate side engagement surfaces being engageable with the first abutment structures in a first overlapping surface arrangement configured to inhibit substantial axial movement in either direction within the central opening until the insert is forcibly engaged by the tooling (paragraph 79 where arcuate side engagement surface #86 is held in the first abutment structures #67 and substantial axial movement is inhibited until an “instrument” is used),
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wherein after the capture head of the bone anchor is positioned within the lower portion of the receiver, the insert is configured for forced downward displacement via direct engagement with the tooling to a second overlapping surface arrangement (as seen in Fig 24, paragraph 79 where arcuate projecting structures #86 is moved into grooves #66) to inhibit upward displacement of the insert back to the first overlapping surface arrangement (paragraph 72 via surface #86a of projecting structures #86 engaged with an upper surface of grooves #66), and
wherein prior to locking the assembly with the closure top, the bone attachment structure is configured to remain pivotal with respect to the receiver in the unlocked configuration after the insert is forcibly downwardly displaced into the second overlapping surface arrangement (paragraph 12, end of paragraph 79, “pre-locking condition” and see Fig 25, paragraph 80 where only when closure top #10 is applied that the angular position of the head #3 is locked and thus prior to the use of the closure top #10, the bone attachment structure is pivotable).
Regarding Claim 17, Biedermann discloses the receiver and the bone attachment structure have a non-floppy friction fit with respect to each other in the unlocked configuration after the insert is forcibly downwardly displaced into the second overlapping surface arrangement (paragraph 12, end of paragraph 79).
Regarding Claim 20, Biedermann discloses the elongate rod (#100), wherein the closure top (#10) rotatably engageable with the closure mating structure to secure the elongate rod in the receiver with the pivotal bone anchor assembly in a locked configuration (Fig 2, 26a-b paragraph 81).
Regarding Claim 21, Biedermann discloses wherein the first abutment structures further comprise upper opposed arcuate grooves (#67) recessed into the internal surfaces of the central opening (see annotated Fig 8 above), and wherein the second abutment structures further comprise lower opposed arcuate grooves (#66) recessed into the internal surfaces of the central opening below the upper opposed arcuate grooves (see annotated Fig 8 above).
Regarding Claim 22, Biedermann discloses the arcuate side engagement surfaces further comprise outer surfaces of opposed arcuate projections (#86 as seen in Fig 16).
Regarding Claim 23, Biedermann discloses the opposed arcuate projections (#86) are spaced below the insert top surfaces (as seen in Fig 16, annotated Fig 16 above).
Biedermann does not disclose at least one guide and alignment surface is integrally formed in the internal surface of the central opening, the insert having an outer mating surface for engaging the at least one insert guide and alignment surface of the receiver, wherein, when the outer mating surface of the insert engages the at least one insert guide and alignment surface of the receiver, rotation between the insert and the receiver is inhibited.
Harris discloses a receiver and an insert (see Fig below), at least one guide and alignment surface is integrally formed in the internal surface of a central opening (see Fig below, see Fig 7, see also Fig 5 in ‘687) of the receiver, the insert having an outer mating surface for engaging the at least one insert guide and alignment surface of the receiver (see Fig below), wherein, when the outer mating surface of the insert engages the at least one insert guide and alignment surface of the receiver so rotation between the insert and the receiver is inhibited (paragraph 7,29, see also bottom of page 1 in the specification in ‘687).
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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 outer profile of the insert of Biedermann to have a keyed profile such that the receiver has at least one guide and alignment surface that engages with an outer mating surface of the insert in view of Harris above because rotation between the insert and the receiver is inhibited.
Claims 16-17, 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Biederman US 2015/003216 in view of Harris US 2015/0230829 (which claims priority to US Provisional 61/940,687, hereinafter ‘687).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Biedermann US 2015/0032162 (1st or 2nd interpretation) and Harris US 2015/0230829, as applied to claim 1 above, and in further view of Biedermann US 2010/0234902 (hereinafter ‘902).
Biedermann as modified discloses the claimed invention as discussed above where the insert further comprises an upper portion above a lower portion, the upper portion of the insert defining the upper rod- receiving surface (see annotated Fig 16 of Biedermann below) where there are through-slots (#85) to receive a pin (#9)(paragraph 68, Fig 1,3 in Biedermann) but does not disclose being devoid of a through-slot extending from one surface to an opposite surface of the insert on the upper portion.
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Biedermann ‘902 discloses a similar bone anchor assembly (Fig 1) comprising a receiver (#5) having a central opening (as seen in Fig 8-10), an insert (#8) disposable in the central opening (Fig 8-10), wherein the insert further comprises an upper portion above a lower portion (see Fig 6 below), the upper portion of the insert defining the upper rod- receiving surface (see Fig 6 below) and being devoid of a through-slot extending from one surface to an opposite surface of the insert on the upper portion (see Fig below), where slots (#84) are not through-slots (Fig 6 below) and able to receive pins (#9a-9b, paragraph 47, Fig 1, 8-10).
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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 through-slots of Biedermann to be the non-through slots in view of Biedermann ‘902 above because this provides a known alternative type of slots to obtain predictable results of receiving a pin to retain the insert. The examiner notes that with the modification, the upper portion would be devoid of a through-slot extending from one surface to an opposite surface of the insert on the upper portion.
Allowable Subject Matter
Claims 8, 18, 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 24-27 are allowed.
The following is an examiner’s statement of reasons for allowance:
Claim 24 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, a receiver, bone attachment structure, insert, a retainer and a ring structure, the retainer disposable into the lower locking chamber and configured to expandably capture the capture head of the bone attachment structure by being pushed up into upper expansion chamber and returning to the lower locking chamber when the capture head is uploaded into the receiver; the ring structure positionable within the upper expansion chamber, wherein the ring structure occupies the upper expansion chamber so as to inhibit the retainer from returning up into the upper expansion chamber, as claimed. Biedmerann US 2015/0032162 discloses a similar device (as discussed above) but lacks the retainer and ring structure as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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
