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.
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: “closure mating structure” in claim 1, 11-12, “first/second abutment structure” in claim 1, “retainer” in claim 4.
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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 in view of Biederman US 2015/0032162 (1st interpretation) 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. Applicant reinterpreted Biederman (1st interpretation) in view of applicant’s amendment and as discussed in the rejection below, the lower surface of the insert is able to engage the capture head either directly (for example prior to inserting into the receiver)(alternatively, 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) or indirectly engaged (as seen in Fig 3 where the lower surface is engaged to the capture head via component #7). Applicant is not claiming how they are engaged.
Applicant's arguments filed May 19, 2026 have been fully considered but they are not persuasive. Regarding Biederman US 2015/0032162 (2nd interpretation), the applicant argues that #7 and #8 are separate components. While the examiner does not disagree with that point, the claim does not require the insert piece to be made out of a single component. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). If applicant were to claim that the insert is made up of a single or one component then the examiner would agree with applicant. The rejection of Biederman US 2015/0032162 (2nd interpretation) is modified in accordance with applicant’s amendments.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “opposed arcuate projections extending uninterrupted and circumferentially around the upper cylindrical side surface..” (in claim 14)(see 112 rejection below) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “opposed arcuate projections extending uninterrupted and circumferentially around the upper cylindrical side surface..” (in claim 14) was not disclosed in the original specification, see 112 rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 14 recites “opposed arcuate projections extending uninterrupted and circumferentially around the upper cylindrical side surface..” which was not shown and disclosed in the original specification. See Fig 18 where for convenience, only one projection #184 is discussed, where the ends #186 are interrupted and do not extend completely circumferentially around the side surface #185. As such Claims 14-15 recite new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites “opposed arcuate projections extending uninterrupted and circumferentially around the upper cylindrical side surface..” which was not shown and disclosed in the original specification. See Fig 18 where for convenience, only one projection #184 is discussed, where the ends #186 are interrupted and do not extend completely circumferentially around the side surface #185, see also new matter rejection above. As such it is not clear how the opposed arcuate projections extend uninterrupted. The examiner will interpret with art as best understood.
Claim 23 recites the limitation "opposed arcuate projections" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The examiner will treat with art as best understood.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biederman US 2015/0032162 (1st interpretation).
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 position (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 and circumferentially around upper cylindrical side surfaces of the insert (see fig below, where only two side surfaces are identified, the other two are on the other side of the insert) (see also 112 rejection above).
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Regarding Claim 15, Biedermann discloses the opposed arcuate project
tions are spaced below insert top surfaces (see fig in claim 14 above).
Claims 1, 7, 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biederman US 2015/0032162 (2nd interpretation).
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 position (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).
Claims 16-17, 20-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biederman US 2015/0032162.
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 position (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).
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Biedermann US 2015/0032162 (1st or 2nd interpretation) in view of Biedermann US 2010/0234902 (hereinafter ‘902).
Biedermann 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 below) where there are through-slots (#85) to receive a pin (#9)(paragraph 68, Fig 1,3) 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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