DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Support for the claims goes back to parent application 12/080,202 filed April 1, 2008, as such the claims have an effective filing date of April 1, 2008.
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: guide and advancement structure in claim 1, 17.
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 Objections
Claims 17-24 are objected to because of the following informalities:
The last clause of Claim 17 is repetitive as this was already recited in Claim 17 lines 23-26. 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 24 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites the limitation "the retaining support surface" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner will treat this limitation as referring to the “support surface” recited in claim 17. It is suggested to stay consistent with claim terminology.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8 of U.S. Patent No. 11,737,789 (hereinafter Jackson ‘789) in view of Garamszegi US 2008/0269809 and Jackson US 2006/0149240 (‘240).
Regarding Claim 1, Jackson ‘789 discloses a pivotal bone anchor assembly intended for securing an elongate rod to a bone of a patient, the pivotal bone anchor assembly (claim 1 preamble, Col 13 lines 38-43) comprising:
a receiver (“receiver” claim 1, col 13 line 60) comprising a base (“base portion” claim 1, col 13 line 60) defining a cavity portion (claim 1, col 13 line 65- col 14 line 4 where the cavity portion is defined by the “support surface”) of a central bore (“central bore” Claim 1, col 13 lines 60-67) communicating with a bottom of the base through a bottom opening (“lower opening” claim 1, col 13 line 65), and a pair of upright arms (“upper portion.. defining a channel to configured to receive the fixation rod”, claim 1, col 13 line 60-65 where upright arms define a channel therebetween to receive the fixation rod) extending upward from the base to define a receiver channel configured to receive the elongate rod (“channel configured to receive the fixation rod” claim 1, col 13 lines 60-65), the central bore extending upward from the bottom opening through the receiver channel to tops of the upright arms (Claim 1, col 13 lines 60-67) and including a discontinuous guide and advancement structure adjacent the tops of the upright arms (“guide and advancement structure” claim 1, col 14 line 1-3) and a support surface adjacent the bottom opening (“support surface” claim 1, col 13 line 67- col 14 line 1);
a shank comprising a longitudinal axis (“shank comprising a longitudinal axis” claim 1, col 13 line 44), an upper end portion (“capture portion at upper end” claim 1, col 13 line 44-46), and an anchor portion opposite the upper end portion configured for attachment to the bone (“anchor portion ..” claim 1, col 13 line 45-46), the upper end portion having a capture structure with a partial curved upper surface (“upper outer curved surface” claim 1, col 13 line 52-53) and a partial spherical lower surface (“lower outer convex surface” claim 1, col 13 lines 54-55) extending radially outward and axially upward from the anchor portion (col 13 lines 54-55), the upper end portion configured for uploading into the cavity portion of the central bore through the bottom opening (claim 1, col 14 line 13-17);
an insert (“insert” claim 8) positionable into the central bore of the receiver (claim 8), the insert comprising an insert base (“lower surface” claim 8) defining a center aperture (“central aperture” end of claim 8, since the central aperture provides access to the drive socket of the shank, the central aperture extends through the insert base); and
a retainer structure (“retainer” claim 1 col 14 line 4-5) positionable into the cavity portion of the central bore of the receiver prior to uploading the upper end portion of the shank (claim 1 col 14 line 4-5).
Jackson ‘789 discloses the upper end portion having a capture structure with a partial curved upper surface (“upper outer curved surface” claim 1, col 13 line 52-53) but does not disclose the curved upper surface is a partial spherical upper surface.
Jackson ‘789 discloses the insert has an upper surface configured to receive the elongate rod and thus also alignable with the receiver channel and configured to receive the elongate rod (claim 8) but does not disclose the insert is positioned below the discontinuous guide and advancement structure and a pair of insert arms extending upward from the insert base to define an upward-opening insert channel alignable with the receiver channel and configured to receive the elongate rod.
Jackson ‘789 discloses the retainer structure s made out of two parts (claim 1 col 14 line 4-5) to retain the shank and allow for pivotal movement (claim 1, col 14 lines 5-17) but does not disclose wherein the retainer structure is configured to expand within the cavity portion upon the uploading of the upper end portion of the shank through the bottom opening, and thereafter to close about and capture the capture structure with an outer surface of the retainer structure in engagement with the support surface of the central bore.
Garamszegi discloses a pivotal bone anchor assembly (Fig 3, paragraph 26 “polyaxial”) intended for securing an elongate rod (#120) to a bone of a patient, the pivotal bone anchor assembly comprising:
a receiver (#110) comprising a base (see annotated Fig 8 below) defining a cavity portion of a central bore communicating with a bottom of the base through a bottom opening (see annotated Fig 8 below), and a pair of upright arms (see annotated Fig 8 below) extending upward from the base to define a receiver channel configured to receive the elongate rod (see annotated Fig 8 below, Fig 3), the central bore extending upward from the bottom opening through the receiver channel to tops of the upright arms (see annotated Fig 8 below) and including a discontinuous guide and advancement structure (threads #515, Fig 3, 8, paragraph 44-45) adjacent the tops of the upright arms (Fig 3, 8) and a support surface adjacent the bottom opening (see annotated Fig 8 below);
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a shank (#210) comprising a longitudinal axis (see annotated Fig 4b below), an upper end portion (see annotated Fig 4b below), and an anchor portion (#215) opposite the upper end portion configured for attachment to the bone (see annotated Fig 4b below, paragraph 28), the upper end portion having a capture structure with a partial spherical upper surface (#305, see annotated Fig 4b below, paragraph 30) and a partial spherical lower surface (#310, see annotated Fig 4b below, paragraph 30) extending radially outward and axially upward from the anchor portion (see annotated Fig 4b below), the upper end portion configured for uploading into the cavity portion of the central bore through the bottom opening (paragraph 58, first sentence, and as seen in Fig 7a-7b);
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an insert (#705) positionable into the central bore of the receiver below the discontinuous guide and advancement structure (as seen in Fig 8), the insert comprising an insert base (see annotated Fig 3 below) defining a center aperture (see annotated Fig 3 below, see also Fig 8) and a pair of insert arms extending upward from the insert base to define an upward-opening insert channel alignable with the receiver channel (see annotated Fig 3 below)and configured to receive the elongate rod (see annotated Fig 3 below, Fig 8, paragraph 46); and
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a retainer structure (#115) positionable into the cavity portion of the central bore of the receiver (Fig 8),
where the upward opening insert channel defines the upper surface for the insert to match the contour and receive the elongate rod (Fig 3, paragraph 46), and the partial spherical upper surface along with the retainer helps defines an overall spherical to provide pivotal/polyaxial movement of the shank against the support surface of the receiver (paragraph 61, 70).
It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify Jackson ‘789 to 1. have the curved upper surface be a partial spherical upper surface and 2. the insert is positioned below the discontinuous guide and advancement structure and a pair of insert arms extending upward from the insert base to define an upward-opening insert channel, that is also the upper surface of the insert, alignable with the receiver channel and configured to receive the elongate rod in view of Garamszegi above because 1. the partial spherical upper surface along with the retainer helps defines an overall spherical to provide pivotal/polyaxial movement of the shank against the support surface of the receiver and 2. the upward opening insert channel defines the upper surface so as to match the contour and receive the elongate rod.
Jackson ‘240 discloses a pivotal bone anchor assembly (Fig 1, paragraph 22 “polyaxial”) intended for securing an elongate rod (#21) to a bone of a patient (paragraph 64, for implanting into the vertebra), the pivotal bone anchor assembly comprising:
a receiver (#10, Fig 1, see also annotated Fig 7 below);
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a shank (#4) comprising a longitudinal axis (axis “A” as seen in Fig 1), an upper end portion (see annotated Fig 7 below), and an anchor portion (#24, Fig 1, see annotated Fig 7 below) opposite the upper end portion configured for attachment to the bone (paragraph 64), the upper end portion having a capture structure with a partial spherical upper surface (#53, paragraph 68 “domed”) and a lower surface extending radially outward and axially upward from the anchor portion (see Fig below), the upper end portion configured for uploading into the cavity portion of the central bore through the bottom opening (as seen in Fig 7-8, paragraph 89); and
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a retainer structure (#12, made up two pieces #90, #92, paragraph 75, see Fig 1, 7-8) positionable into the cavity portion of the central bore of the receiver prior to uploading the upper end portion of the shank (as seen in Fig 5-7),
wherein the retainer structure is configured to expand within the cavity portion upon the uploading of the upper end portion of the shank through the bottom opening (as seen in Fig 7-8, paragraph 89, expanded to allow receipt of the capture structure of upper end portion of the shank), and thereafter to close about and capture the capture structure with an outer surface of the retainer structure in engagement with the support surface of the central bore (as seen in Fig 9-10, paragraph 89-90), the retainer structure retaining the shank in the receiver (paragraph 75) and allow for pivotal movement (paragraph 22, 78, fig 10),
It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify the two piece retainer structure of Jackson ‘789 as modified to be the two piece retainer structure of Jackson ‘240 such that the retainer structure is configured to expand within the cavity portion upon the uploading of the upper end portion of the shank through the bottom opening, and thereafter to close about and capture the capture structure with an outer surface of the retainer structure in engagement with the support surface of the central bore, because this provides a known type of retainer structure to provide predictable results of retaining the shank in the receiver and allowing for pivotal movement.
Jackson ‘789 as modified also discloses the claimed invention as discussed above where Jackson ‘789 further discloses the limitations of Claim 2 (“upwardly opening drive socket” Claim 1, col 13 lines 48-51), Claim 3 (“axial bore”, claim 1, col 13 lines 55-59).
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, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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, 9, 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jackson US 2006/0149240 in view of Garamszegi US 2008/0269809.
Regarding Claim 1, Jackson discloses a pivotal bone anchor assembly (Fig 1, paragraph 22 “polyaxial”) intended for securing an elongate rod (#21) to a bone of a patient (paragraph 64, for implanting into the vertebra), the pivotal bone anchor assembly comprising:
a receiver (#10, Fig 1, see also annotated Fig 7 below) comprising a base defining a cavity portion of a central bore communicating with a bottom of the base through a bottom opening (see annotated Fig 7 below), and a pair of upright arms (#62, #64) extending upward from the base to define a receiver channel (see annotated Fig 7below) configured to receive the elongate rod (see Fig 12, 16), the central bore extending upward from the bottom opening through the receiver channel to tops of the upright arms (see annotated Fig 7 below) and including a discontinuous guide and advancement structure (#72, paragraph 71) adjacent the tops of the upright arms and a support surface adjacent the bottom opening (see annotated Fig 7 below);
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a shank (#4) comprising a longitudinal axis (axis “A” as seen in Fig 1), an upper end portion (see annotated Fig 7 below), and an anchor portion (#24, Fig 1, see annotated Fig 7 below) opposite the upper end portion configured for attachment to the bone (paragraph 64), the upper end portion having a capture structure with a partial spherical upper surface (#53, paragraph 68 “domed”) and a lower surface extending radially outward and axially upward from the anchor portion (see Fig below, where the lower surface includes a top surface #44 that is flat, paragraph 66, through which a retainer structure rests on, paragraph 78), the upper end portion configured for uploading into the cavity portion of the central bore through the bottom opening (as seen in Fig 7-8, paragraph 89); and
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a retainer structure (#12, made up of #90, #92, paragraph 75, see Fig 1, 7-8) positionable into the cavity portion of the central bore of the receiver prior to uploading the upper end portion of the shank (as seen in Fig 5-7),
wherein the retainer structure is configured to expand within the cavity portion upon the uploading of the upper end portion of the shank through the bottom opening (as seen in Fig 7-8, paragraph 89, expanded to allow receipt of the capture structure of upper end portion of the shank), and thereafter to close about and capture the capture structure with an outer surface of the retainer structure in engagement with the support surface of the central bore (as seen in Fig 9-10, paragraph 89-90).
Jackson discloses the claimed invention as discussed above where a closure (#18) is used to clamp the rod (#21, paragraph 63) but does not disclose the lower surface is a partial spherical lower surface extending radially outward and axially upward from the anchor portion, and an insert positionable into the central bore of the receiver below the discontinuous guide and advancement structure, the insert comprising an insert base defining a center aperture and a pair of insert arms extending upward from the insert base to define an upward-opening insert channel alignable with the receiver channel and configured to receive the elongate rod.
Garamszegi discloses a pivotal bone anchor assembly (Fig 3, paragraph 26 “polyaxial”) intended for securing an elongate rod (#120) to a bone of a patient, the pivotal bone anchor assembly comprising:
a receiver (#110) comprising a base (see annotated Fig 8 below) defining a cavity portion of a central bore communicating with a bottom of the base through a bottom opening (see annotated Fig 8 below), and a pair of upright arms (see annotated Fig 8 below) extending upward from the base to define a receiver channel configured to receive the elongate rod (see annotated Fig 8 below, Fig 3), the central bore extending upward from the bottom opening through the receiver channel to tops of the upright arms (see annotated Fig 8 below) and including a discontinuous guide and advancement structure (threads #515, Fig 3, 8, paragraph 44-45) adjacent the tops of the upright arms (Fig 3, 8) and a support surface adjacent the bottom opening (see annotated Fig 8 below);
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a shank (#210) comprising a longitudinal axis (see annotated Fig 4b below), an upper end portion (see annotated Fig 4b below), and an anchor portion (#215) opposite the upper end portion configured for attachment to the bone (see annotated Fig 4b below, paragraph 28), the upper end portion having a capture structure with a partial spherical upper surface (#305, see annotated Fig 4b below, paragraph 30) and a partial spherical lower surface (#310, see annotated Fig 4b below, paragraph 30) extending radially outward and axially upward from the anchor portion (see annotated Fig 4b below), the upper end portion configured for uploading into the cavity portion of the central bore through the bottom opening (paragraph 58, first sentence, and as seen in Fig 7a-7b);
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an insert (#705) positionable into the central bore of the receiver below the discontinuous guide and advancement structure (as seen in Fig 8), the insert comprising an insert base (see annotated Fig 3 below) defining a center aperture (see annotated Fig 3 below, see also Fig 8) and a pair of insert arms extending upward from the insert base to define an upward-opening insert channel alignable with the receiver channel (see annotated Fig 3 below)and configured to receive the elongate rod (see annotated Fig 3 below, Fig 8, paragraph 46); and
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a retainer structure (#115) positionable into the cavity portion of the central bore of the receiver (Fig 8),
wherein the partial spherical lower surface (#310) has a generally flat upper surface (see annotated Fig 4b above) that the retainer structure (#15) rests upon (Figs 7a-8, paragraph 37) and the insert allows with the upward opening insert channel allows for a maximum amount of contact of the rod (#120) when the rod is placed in the receiver and clamped down via a closure (#605) (paragraph 47, 72).
It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify Jackson and 1. have the lower surface of the shank to be a partial spherical lower surface and 2 include an insert in view of Garamszegi above because 1. having the lower surface be partially spherical provides a known alternative shape for the lower surface with the predictable results of having an upper/top surface that houses the retainer structure [examiner notes that a change of shape is generally within the skillset of one of ordinary skill in the art, MPEP 2144.04 (IV)(B)] and 2. the insert with the upward opening insert channel allows for a maximum amount of contact of the rod when the rod is placed in the receiver and clamped down via a closure.
Regarding Claim 9, Jackson as modified discloses the insert is configured for downloading into the central bore of the receiver through an upper opening defined by the tops of the upright arms (with the modification in view of Garamszegi and Fig 8, paragraph 49 in Garamszegi and see annotated Figs of Jackson above in claim 1, the insert is capable of being placed into the central bore through an upper opening between the tops of the upright arms).
Regarding Claim 14, Jackson as modified discloses the retainer structure is configured for downloading into the central bore of the receiver through an upper opening defined by the tops of the upright arms (as seen in Fig 5-6 in Jackson, paragraph 88).
Claims 1, 4-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jackson US 2006/0149240 in view of Garamszegi US 2008/0269809 and Jackson US 2006/0276789 (hereinafter ‘6789).
Regarding Claim 1, Jackson discloses a pivotal bone anchor assembly (Fig 1, paragraph 22 “polyaxial”) intended for securing an elongate rod (#21) to a bone of a patient (paragraph 64, for implanting into the vertebra), the pivotal bone anchor assembly comprising:
a receiver (#10, Fig 1, see also annotated Fig 7 below) comprising a base defining a cavity portion of a central bore communicating with a bottom of the base through a bottom opening (see annotated Fig 7 below), and a pair of upright arms (#62, #64) extending upward from the base to define a receiver channel (see annotated Fig 7below) configured to receive the elongate rod (see Fig 12, 16), the central bore extending upward from the bottom opening through the receiver channel to tops of the upright arms (see annotated Fig 7 below) and including a discontinuous guide and advancement structure (#72, paragraph 71) adjacent the tops of the upright arms and a support surface adjacent the bottom opening (see annotated Fig 7 below);
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a shank (#4) comprising a longitudinal axis (axis “A” as seen in Fig 1), an upper end portion (see annotated Fig 7 below), and an anchor portion (#24, Fig 1, see annotated Fig 7 below) opposite the upper end portion configured for attachment to the bone (paragraph 64), the upper end portion having a capture structure with a partial spherical upper surface (#53, paragraph 68 “domed”) and a lower surface extending radially outward and axially upward from the anchor portion (see Fig below, where the lower surface includes a top surface #44 that is flat, paragraph 66, through which a retainer structure rests on, paragraph 78), the upper end portion configured for uploading into the cavity portion of the central bore through the bottom opening (as seen in Fig 7-8, paragraph 89); and
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a retainer structure (#12, made up of #90, #92, paragraph 75, see Fig 1, 7-8) positionable into the cavity portion of the central bore of the receiver prior to uploading the upper end portion of the shank (as seen in Fig 5-7),
wherein the retainer structure is configured to expand within the cavity portion upon the uploading of the upper end portion of the shank through the bottom opening (as seen in Fig 7-8, paragraph 89, expanded to allow receipt of the capture structure of upper end portion of the shank), and thereafter to close about and capture the capture structure with an outer surface of the retainer structure in engagement with the support surface of the central bore (as seen in Fig 9-10, paragraph 89-90).
Jackson discloses the claimed invention as discussed above where a closure (#18) is used to clamp the rod (#21, paragraph 63) but does not disclose the lower surface is a partial spherical lower surface extending radially outward and axially upward from the anchor portion, and an insert positionable into the central bore of the receiver below the discontinuous guide and advancement structure, the insert comprising an insert base defining a center aperture and a pair of insert arms extending upward from the insert base to define an upward-opening insert channel alignable with the receiver channel and configured to receive the elongate rod. Jackson also does not disclose the limitations of Claims 4-7.
Garamszegi discloses a pivotal bone anchor assembly (Fig 3, paragraph 26 “polyaxial”) intended for securing an elongate rod (#120) to a bone of a patient, the pivotal bone anchor assembly comprising:
a receiver (#110) comprising a base (see annotated Fig 8 below) defining a cavity portion of a central bore communicating with a bottom of the base through a bottom opening (see annotated Fig 8 below), and a pair of upright arms (see annotated Fig 8 below) extending upward from the base to define a receiver channel configured to receive the elongate rod (see annotated Fig 8 below, Fig 3), the central bore extending upward from the bottom opening through the receiver channel to tops of the upright arms (see annotated Fig 8 below) and including a discontinuous guide and advancement structure (threads #515, Fig 3, 8, paragraph 44-45) adjacent the tops of the upright arms (Fig 3, 8) and a support surface adjacent the bottom opening (see annotated Fig 8 below);
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a shank (#210) comprising a longitudinal axis (see annotated Fig 4b below), an upper end portion (see annotated Fig 4b below), and an anchor portion (#215) opposite the upper end portion configured for attachment to the bone (see annotated Fig 4b below, paragraph 28), the upper end portion having a capture structure with a partial spherical upper surface (#305, see annotated Fig 4b below, paragraph 30) and a partial spherical lower surface (#310, see annotated Fig 4b below, paragraph 30) extending radially outward and axially upward from the anchor portion (see annotated Fig 4b below), the upper end portion configured for uploading into the cavity portion of the central bore through the bottom opening (paragraph 58, first sentence, and as seen in Fig 7a-7b);
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a retainer structure (#115) positionable into the cavity portion of the central bore of the receiver (Fig 8),
wherein the partial spherical lower surface (#310) has a generally flat upper surface (see annotated Fig 4b above) that the retainer structure (#15) rests upon (Figs 7a-8, paragraph 37) and the insert allows with the upward opening insert channel allows for a maximum amount of contact of the rod (#120) when the rod is placed in the receiver and clamped down via a closure (#605) (paragraph 47, 72).
It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify Jackson have the lower surface of the shank to be a partial spherical lower surface in view of Garamszegi above because having the lower surface be partially spherical provides a known alternative shape for the lower surface with the predictable results of having an upper/top surface that houses the retainer structure [examiner notes that a change of shape is generally within the skillset of one of ordinary skill in the art, MPEP 2144.04 (IV)(B)].
Jackson ‘6789 a bone anchor (Fig 1) comprising a receiver (#10),
an insert (#14), the insert (#14) positionable into the central bore of the receiver below the discontinuous guide and advancement structure (see annotated Fig 10 below), the insert comprising an insert base (see annotated Fig 10 below) defining a center aperture (#142, Fig 6-7, paragraph 87) and a pair of insert arms extending upward from the insert base to define an upward-opening insert channel alignable with the receiver channel (see annotated Fig 10 below) and configured to receive an elongate rod (rod #21, see Fig 24, paragraph 67). Regarding Claim 4-5, Jackson ‘6789 also discloses at least one engagement structure (teeth #89, paragraph 79, Fig 1) formed integral with the receiver and protruding inwardly into the central bore between the guide and advancement structure (#62, see Fig 1) and the support surface (#78)(as seen in Figs 1, 14, annotated Fig 10 below, paragraph 79), at least one groove or depression (Fig 3, 4, 8, between adjacent teeth #124, there is a groove/depression) formed into a side surface of the insert (as seen in Fig 3, 4 8) and configured to receive the at least one engagement structure to hold the insert channel in alignment with the receiver channel (paragraph 85, Fig 1); and wherein the at least one groove or depression of the insert is configured to receive the at least one at least one engagement structure protruding inwardly into the central bore of the receiver so as to hold the insert channel in angular alignment with the receiver channel (paragraph 89, 104). Regarding Claim 6, Jackson ‘6789 also discloses wherein the at least one engagement structure further comprising a pair of opposing engagement structures (Fig 1, 14, paragraph 79 where each arm #52 of the receiver has engagement structures #89) protruding inwardly into the central bore (see annotated Fig 1, 14), and wherein the at least one groove or depression further comprises a pair of opposite grooves or depressions formed into the side surface of the insert arms (paragraph 79, Figs 4, 8 where the outer side surface of each insert arm has grooves or depression, formed between adjacent teeth #124).
Jackson ‘6789 discloses the insert allows for setting of an angle of articulation between the receiver (#10) and shank (#6) prior to insertion of the rod (#21)(paragreaph 67, 104 where the engagement structure/groove or depression allows the insert to press down onto the shank to set an angle of articulation).
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It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify bone anchor assembly of Jackson as modified to include an insert having at least one groove or depression, where at least one integral engagement structure of the receiver is received into the at least one groove or depression in view of Jackson ‘6789 above because the insert with the at least one groove or depression and the at least one engagement structure allows for setting of an angle of articulation between the receiver and shank prior to insertion of the rod.
Regarding Claim 7, Jackson as modified discloses the at least one engagement structure protrudes inwardly into the central bore prior to the positioning of the insert into the central bore of the receiver (as seen in Fig 1 in Jackson ‘6789 the engagement structure is always protruding into the central bore).
Claims 1-2, 8, 10-13, 15-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sasing US 7,306,606 in view of Garamszegi US 2008/0269809.
Regarding Claim 1, Sasing discloses a pivotal bone anchor assembly (Fig 1, Col 3 lines 15-25 “multi-axial”) intended for securing an elongate rod (#60, Fig 9a) to a bone of a patient (Col 5 lines 17-20 for implanting into the pedicle), the pivotal bone anchor assembly comprising:
a receiver (#4, Fig 1, see also annotated Figs 6a-6c below) comprising a base defining a cavity portion of a central bore communicating with a bottom of the base through a bottom opening (see annotated Fig 6a-6c below), and a pair of upright arms (#56) extending upward from the base to define a receiver channel (see annotated Fig 6a-6c below) configured to receive the elongate rod (see Fig 9a), the central bore extending upward from the bottom opening through the receiver channel to tops of the upright arms (see annotated Fig 6a-6c below) and including a discontinuous guide and advancement structure (threads #27, Col 6 lines 45-48) adjacent the tops of the upright arms and a support surface adjacent the bottom opening (see annotated Fig 6a-6c below);
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a shank (#6) comprising a longitudinal axis (see annotated Figs 3a-3b), an upper end portion (see annotated Figs 3a-3b), and an anchor portion (see annotated Figs 3a-3b) opposite the upper end portion configured for attachment to the bone (Col 5 lines 17-20 for implanting into the pedicle), the upper end portion having a capture structure (as seen in Fig 3b) with a partial spherical upper surface (#10, see annotated Figs 3a-3b, Col 5 line 22) and a lower surface extending radially outward and axially upward from the anchor portion (see Fig 3a-3b below), the upper end portion configured for uploading into the cavity portion of the central bore through the bottom opening (as indicated by arrow F1 ,Fig 8a-8b, Col 8 lines 25-60);
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an insert (#3) positionable into the central bore of the receiver below the discontinuous guide and advancement structure (Fig 8a), the insert comprising an insert base defining a center aperture (see annotated Fig 5a-5b below) and a pair of insert arms extending upward from the insert base to define an upward-opening insert channel (see annotated Fig 5a-5b below) alignable with the receiver channel and configured to receive the elongate rod (Fig 9a-9b, Col 9 lines 27-30); and
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a retainer structure (#2, Fig 4) positionable into the cavity portion of the central bore of the receiver prior to uploading the upper end portion of the shank (as seen in Fig 8a, Col 8 lines 34-47),
wherein the retainer structure is configured to expand within the cavity portion upon the uploading of the upper end portion of the shank through the bottom opening (as seen in Fig 8a-8b, Col 8 lines 40-50, expanded to allow receipt of the capture structure of upper end portion of the shank), and thereafter to close about and capture the capture structure with an outer surface of the retainer structure in engagement with the support surface of the central bore (as seen in Fig 8a-8b, Col 8 line 61 to Col 9 line 2).
Sasing discloses the claimed invention as discussed above but does not disclose the lower surface is a partial spherical lower surface extending radially outward and axially upward from the anchor portion.
Garamszegi discloses a pivotal bone anchor assembly (Fig 3, paragraph 26 “polyaxial”) intended for securing an elongate rod (#120) to a bone of a patient, the pivotal bone anchor assembly comprising:
a receiver (#110) comprising a base (see annotated Fig 8 below) defining a cavity portion of a central bore communicating with a bottom of the base through a bottom opening (see annotated Fig 8 below), and a pair of upright arms (see annotated Fig 8 below) extending upward from the base to define a receiver channel configured to receive the elongate rod (see annotated Fig 8 below, Fig 3), the central bore extending upward from the bottom opening through the receiver channel to tops of the upright arms (see annotated Fig 8 below) and including a discontinuous guide and advancement structure (threads #515, Fig 3, 8, paragraph 44-45) adjacent the tops of the upright arms (Fig 3, 8) and a support surface adjacent the bottom opening (see annotated Fig 8 below);
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a shank (#210) comprising a longitudinal axis (see annotated Fig 4b below), an upper end portion (see annotated Fig 4b below), and an anchor portion (#215) opposite the upper end portion configured for attachment to the bone (see annotated Fig 4b below, paragraph 28), the upper end portion having a capture structure with a partial spherical upper surface (#305, see annotated Fig 4b below, paragraph 30) and a partial spherical lower surface (#310, see annotated Fig 4b below, paragraph 30) extending radially outward and axially upward from the anchor portion (see annotated Fig 4b below), the upper end portion configured for uploading into the cavity portion of the central bore through the bottom opening (paragraph 58, first sentence, and as seen in Fig 7a-7b);
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an insert (#705) positionable into the central bore of the receiver below the discontinuous guide and advancement structure (as seen in Fig 8), the insert comprising an insert base (see annotated Fig 3 below) defining a center aperture (see annotated Fig 3 below, see also Fig 8) and a pair of insert arms extending upward from the insert base to define an upward-opening insert channel alignable with the receiver channel (see annotated Fig 3 below)and configured to receive the elongate rod (see annotated Fig 3 below, Fig 8, paragraph 46); and
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a retainer structure (#115) positionable into the cavity portion of the central bore of the receiver (Fig 8),
wherein the partial spherical lower surface (#310) has a generally flat upper surface (see annotated Fig 4b above) that the bottom of the retainer structure (#15) rests upon (Figs 7a-8, paragraph 37).
It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify Sasing to have the lower surface of the shank to be a partial spherical lower surface with a generally flat top in view of Garamszegi above because this configuration provides a known shape for the retainer structure with a generally flat top for the retainer structure to rest on.
Regarding Claim 2, Sasing as modified discloses the upper end portion of the shank further comprises an upwardly-opening drive socket (#11 as seen in Fig 3a in Sasing) configured to receive a driving tool (Col 9 lines 22-23).
Regarding Claim 8, Sasing as modified discloses the insert (#3in Sasing) further comprises a downward-opening concave surface (#18 in Sasing) configured to engage the partial spherical upper surface of the capture portion (Col 9 lines 32-34 in Sasing).
Regarding Claim 10, Sasing as modified discloses the insert is configured for uploading into the central bore of the receiver through the bottom opening (Col 6 lines 63-67).
Regarding Claim 11, Sasing as modified discloses wherein the support surface of the central bore further comprises a partial spherical seating surface (#26 in Sasing, Col 9 lines 7-12, Fig 6c where the partial spherical seating surface and retainer #2 form a ball and socket joint) adjacent the bottom opening.
Regarding Claim 12, Sasing as modified discloses the outer surface of the retainer structure further comprises a partial spherical outer surface (#13 in Sasing, Col 5 lines 55-57) configure configured for slidable engagement with the partial spherical seating surface to provide for pivotal motion of the shank with respect to the receiver prior to locking the pivotal bone anchor assembly with a closure top (Col 9 lines 7-12 where the partial spherical seating surface and retainer #2 form a ball and socket joint prior to locking with a closure top).
Regarding Claim 13, Sasing as modified discloses wherein the partial spherical lower surface of the capture structure is configured to engage the partial spherical seating surface of the cavity portion to provide for pivotal motion of the shank with respect to the receiver prior to locking the pivotal bone anchor assembly with a closure top (with the modification in view of Garamszegi and paragraph 60-61 Garamszegi and Col 9 lines 7-12 in Sassing where with the modification, the partial spherical upper and lower surfaces and retainer form a ball and socket joint)
Regarding Claim 15, Sasing as modified discloses the retainer structure is configured for uploading into the central bore of the receiver through the bottom opening (as seen in Fig 7a-7b, Col 7 line 54 to Col 8 line 12 in Sasing).
Regarding Claim 16, Sasing as modified discloses the elongate rod (#60, Fig 9a in Sasing) and a closure top (#5, Fig 1 in Sasing), wherein the closure top is configured for positioning entirely within the central bore of the receiver above the elongate rod and in engagement with the guide and advancement structure to apply a downwardly-directed force towards a top of the elongate rod, so as to frictionally lock the shank in a fixed position relative to the receiver (as seen in Fig 9a-9b, Col 9 lines 30-36).
Claim 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sasing US 7,306,606 and Garamszegi US 2008/0269809, as applied to claim 2 abov