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 .
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: Claim 1 recites “a peripheral protrusion”. An embodiment having a single peripheral protrusion is not disclosed in the specification and therefore lacks proper antecedent basis for the claimed subject matter. It is noted that Fig. 14G shows a single protrusion, however, this protrusion is located in the center of the body and is not peripheral.
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 “a peripheral protrusion” recited in claim 1 must be shown or the feature(s) canceled from the claim(s). It is noted that fig. 13G shows a single protrusion, however, this protrusion is located in the center of the body, and is therefore not peripheral. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 19 is objected to because of the following informalities: Claim 19 recites “the outward facing vertical surface” in line 1, which appears to be referring to –the substantially outward facing vertical surface of each of the notches –. 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.
Claims 1-20 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.
Claims 1, 12, and 20 each recite the limitations “configured to be disposed in a joint”, in lines 4-5 and "not being coupled to the one or more bones" in lines 6-7. These limitations are contradictory. It is unclear how the body can be disposed in a joint without being coupled to the bones of the joint. For the purpose of further examination, the examiner interprets the limitation “not being coupled to the one or more bones” as: indirect or “floating” contact, as described in paragraph 0066 of applicant’s specification.
Claim 19 recites “the outward facing vertical surface is disposed in between opposing notches”. It is unclear how each of the plurality of notches can have an outward facing vertical surface and also that the outward facing vertical surface is disposed in between opposing notches. Further clarification of this limitation is requested, particularly in view of the figures.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-4 and 6-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 4,759,766 to Buettner-Janz et al. (Buettner-Janz).
Regarding claim 1
Buettner-Janz teaches an intervertebral disc endoprosthesis comprising two symmetrical, concave end plates with an intermediate convex spacing piece (abstract).
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Buettner-Janz meets the limitations of a device, comprising: a body (fig. 2) having a top surface and a bottom surface, the top surface having a plurality of regions (the top surface is shown to have a plurality of regions; 4 and 6), each region having a radius of curvature (the convex center part 4 and the toroid guard 6 each have a radius of curvature), and the bottom surface having another radius of curvature (the bottom surface is shown to have another radius of curvature, at least at the convex center part 4), the body being configured to be disposed in a joint and to prevent contact between one or more bones comprising the joint (col.1, lines 9-12 discloses insertion of the endoprosthesis between two adjacent vertebrae bodies and therefore, the body is configured to be disposed in a joint; col. 1, lines 53-58 discloses that the endoprosthesis insures spacing maintenance or restoration and a physiological mobility in the affected section of the spinal column and therefore the body is configured to prevent contact between the adjacent vertebrae bodies/bone comprising the joint), the radii of curvature being configured to anatomically align the body within the joint (col. 5, lines 5-13 discloses that the convex center part 4 radius of curvature corresponds exactly to the concave center portion 1 of the end plates and is also provided with an annular, plane guide rim 5 and has a toroid as a guard 6 against slip-out; therefore the radii of curvature of the convex center part and the toroidal guard are configured to anatomically align the body within the joint), the body not being coupled to the one or more bones (there is no direct coupling of the body to the one or more bones, at least to the same extent as disclosed by applicant – see 112 rejection above); a peripheral protrusion disposed substantially about a perimeter of the body (the toroidal guard; 6 is formed with the top surface region and defines a peripheral protrusion disposed substantially about a perimeter of the body as shown in fig. 2), the peripheral protrusion being formed with the body (the toroidal guard 6 is formed with the body as shown in fig. 2), the peripheral protrusion being disposed about the perimeter of the body to prevent expulsion of the body from the joint (col. 5, lines 5-13 discloses that the toroidal guard 6 prevents slip-out, thereby preventing expulsion of the body from the joint); and a notch disposed substantially about the perimeter of the body and formed with a region of the top surface (the convex center part 4 is formed with the top surface region and defines a notch; the outer part of the convex center part is also construed to be disposed substantially about the perimeter of the body because it is near the perimeter as disclosed in applicant’s specification at paragraph 00277, and particularly since the term substantially is broad), the notch having a substantially outward facing vertical surface and configured to retain the device in position within the joint (the outer rim of the notch/convex center part 4 is construed to be a substantially facing outward vertical surface because it extends in a substantially vertical direction from the plane guide 5 and because it faces substantially outward from the center of the body, particularly since the term substantially is broad, and is configured to retain the device in position within the joint as disclosed in col. 5, lines 5-13).
Regarding claim 2
Buettner-Janz teaches the device of claim 1, wherein the peripheral protrusion is configured to maintain anatomical alignment of the device when inserted into the joint (col. 5, lines 5-13 discloses that the toroidal guard 6 prevents slip-out and is therefore configured to maintain anatomical alignment of the device when inserted into the joint).
Regarding claim 3
Buettner-Janz teaches the device of claim 1, wherein the peripheral protrusion is in intermittent contact with the one or more bones (col. 5, lines 5-13 discloses that the toroidal guard 6 prevents slip-out and is therefore construed to be in intermittent contact with the one or more bones, at least indirectly, in the same way as applicant’s).
Regarding claim 4
Buettner-Janz teaches the device of claim 1, wherein a region of the top surface is substantially convex to align the body with a bone surface of the one or more bones of the joint (convex center part 4 is substantially convex to align the body with a bone surface of the one or more bones of the joint as disclosed in col. 5, lines 5-13).
Regarding claim 6
Buettner-Janz teaches the device of claim 1, wherein the outward facing vertical surface has a curvature that substantially aligns with a shape of the perimeter (the outer rim of the convex center part 4 is circular and therefore has a curvature that substantially aligns with the circular shape of the perimeter).
Regarding claim 7
Buettner-Janz teaches the device of claim 1, wherein the peripheral protrusion is substantially spherical in shape (the toroidal guard 6 is construed to be substantially spherical in shape because a toroid and a sphere can share some visual or geometric properties in certain views and both have smooth, closed surfaces, and particularly since the term substantially is broad and the term spherical is defined as: like a sphere).
Regarding claim 8
Buettner-Janz teaches the device of claim 1, wherein the peripheral protrusion is formed with an outward facing vertical surface (the toroidal guard 6 forms the outer surface of the spacing device body and extends vertically as shown in fig. 2).
Regarding claim 9
Buettner-Janz teaches the device of claim 1, wherein a region is configured to be disposed in between two other regions (plane guide 5 is a region configured to be disposed between two other regions 4 and 6 as shown in fig. 2).
Regarding claim 10
Buettner-Janz teaches the device of claim 1, wherein the top surface includes two substantially parallel channels, each channel having two channel openings disposed about a perimeter of the body (the cross-sectional view of fig. 2 shows two channels formed by the plane guide 5 which can be accessed from an opening positioned in front of and behind each channel – the channels are construed to be substantially parallel because the term substantially is broad and the limitation is met at least when viewed cross-sectionally).
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Regarding claim 11
Buettner-Janz teaches the device of claim 1, wherein the top surface includes a channel opening disposed substantially between the notch and the peripheral protrusion (guide 5 is construed to be a channel opening disposed substantially between the notch 4 and the peripheral protrusion 6).
Regarding claim 12
Buettner-Janz meets the limitations of a device, comprising: a body (fig. 2) having a top surface and a bottom surface, the top surface having a plurality of regions (the top surface is shown to have a plurality of regions; 4 and 6), each region having a radius of curvature (the convex center part 4 and the toroid guard 6 each have a radius of curvature), and the bottom surface having another radius of curvature (the bottom surface is shown to have another radius of curvature, at least at the convex center part 4), the body being configured to be disposed in a joint and to prevent contact between one or more bones comprising the joint (col.1, lines 9-12 discloses insertion of the endoprosthesis between two adjacent vertebrae bodies and therefore, the body is configured to be disposed in a joint; col. 1, lines 53-58 discloses that the endoprosthesis insures spacing maintenance or restoration and a physiological mobility in the affected section of the spinal column and therefore the body is configured to prevent contact between the adjacent vertebrae bodies/bone comprising the joint), the radii of curvature being configured to anatomically align the body within the joint (col. 5, lines 5-13 discloses that the convex center part 4 radius of curvature corresponds exactly to the concave center portion 1 of the end plates and is also provided with an annular, plane guide rim 5 and has a toroid as a guard 6 against slip-out; therefore the radii of curvature of the convex center part and the toroidal guard are configured to anatomically align the body within the joint), the body not being coupled to the one or more bones (there is no direct coupling of the body to the one or more bones, at least to the same extent as disclosed by applicant – see 112 rejection above); a plurality of peripheral protrusions disposed substantially about a perimeter of the body (the toroidal guard; 6 defines a peripheral protrusion disposed substantially about a perimeter of the body on each of the upper and lower surface portions, thereby meeting the limitation of a plurality of peripheral protrusions, as shown in fig. 2), the plurality of peripheral protrusions being formed with the body (the toroidal guard 6 is formed with the body as shown in fig. 2), the plurality of peripheral protrusions being disposed about the perimeter of the body to prevent expulsion of the body from the joint (col. 5, lines 5-13 discloses that the toroidal guard 6 prevents slip-out, thereby preventing expulsion of the body from the joint); and a plurality of notches disposed substantially about the perimeter of the body and formed with a region of the top surface (at least one notch/convex center part 4 is formed with the top surface region and defines a notch while the notch/convex center part 4 formed with the bottom surface region is another notch thereby meeting the limitation of a plurality of notches; the outer part of the convex center part is also construed to be disposed substantially about the perimeter of the body because it is near the perimeter as disclosed in applicant’s specification at paragraph 00277, and particularly since the term substantially is broad), each of the notches having a substantially outward facing vertical surface and configured to retain the device in position within the joint (the outer rim of each notch/convex center part 4 is construed to be a substantially facing outward vertical surface because it extends in a substantially vertical direction from the plane guide 5 and because it faces substantially outward from the center of the body, particularly since the term substantially is broad, and is configured to retain the device in position within the joint as disclosed in col. 5, lines 5-13).
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Regarding claim 13
Buettner-Janz teaches the device of claim 12, further comprising the body being configured to be inserted into a synovial capsule substantially located within the joint (col.1, lines 9-12 discloses insertion of the endoprosthesis between two adjacent vertebrae bodies and therefore, the body is configured to be inserted into a synovial capsule substantially located within the joint).
Regarding claim 14
Buettner-Janz teaches the device of claim 12, wherein the perimeter of the body substantially defines the outward facing vertical surface (the outer rim of the convex center part 4 is circular which is the same shape as the perimeter and is therefore construed to be substantially defined by the perimeter of the body).
Regarding claim 15
Buettner-Janz teaches the device of claim 12, wherein the radii of curvature of the regions are associated with a distal or proximal end of the one or more bones comprising the joint (col. 5, lines 5-13 discloses that the convex center part 4 radius of curvature corresponds exactly to the concave center portion 1 of the end plates and is also provided with an annular, plane guide rim 5 and has a toroid as a guard 6 against slip-out; therefore the radii of curvature of the convex center part and the toroidal guard are associated with a distal or proximal end of the one or more bones comprising the joint).
Regarding claim 16
Buettner-Janz teaches the device of claim 12, wherein the bottom surface radius of curvature is associated with a distal or proximal end of the one or more bones comprising the joint (col. 5, lines 5-13 discloses that the convex center part 4 radius of curvature corresponds exactly to the concave center portion 1 of the end plates; therefore the bottom surface radius of curvature of the convex center part is associated with a distal or proximal end of the one or more bones comprising the joint).
Regarding claim 17
Buettner-Janz teaches the device of claim 12, wherein the plurality of peripheral protrusions are configured to substantially retain the device in a synovial capsule in the joint (col. 5, lines 5-13 discloses that the toroidal guard 6 prevents slip-out from between adjacent vertebrae and is therefore configured to substantially retain the device in a synovial capsule in the joint).
Regarding claim 18
Buettner-Janz teaches the device of claim 12, wherein the top surface includes a channel opening disposed substantially proximate to the perimeter of the body (guide 5 on the top surface is a channel opening disposed substantially proximate to the perimeter as shown in fig. 2).
Regarding claim 19
Buettner-Janz teaches the device of claim 12, wherein the outward facing vertical surface is disposed in between opposing notches (the outward facing vertical surface is disposed in between upper surface notch and lower surface notch, which are construed to be opposing notches, as shown in fig. 2).
Regarding claim 20
comprising: a body (fig. 2) having a top surface and a bottom surface, the top surface having a plurality of regions (the top surface is shown to have a plurality of regions; 4 and 6), each region having a radius of curvature (the convex center part 4 and the toroid guard 6 each have a radius of curvature), and the bottom surface having another radius of curvature (the bottom surface is shown to have another radius of curvature, at least at the convex center part 4), the body being configured to be disposed in a joint and to prevent contact between one or more bones comprising the joint (col.1, lines 9-12 discloses insertion of the endoprosthesis between two adjacent vertebrae bodies and therefore, the body is configured to be disposed in a joint; col. 1, lines 53-58 discloses that the endoprosthesis insures spacing maintenance or restoration and a physiological mobility in the affected section of the spinal column and therefore the body is configured to prevent contact between the adjacent vertebrae bodies/bone comprising the joint), the radii of curvature being configured to anatomically align the body within the joint (col. 5, lines 5-13 discloses that the convex center part 4 radius of curvature corresponds exactly to the concave center portion 1 of the end plates and is also provided with an annular, plane guide rim 5 and has a toroid as a guard 6 against slip-out; therefore the radii of curvature of the convex center part and the toroidal guard are configured to anatomically align the body within the joint), the body not being coupled to the one or more bones (there is no direct coupling of the body to the one or more bones, at least to the same extent as disclosed by applicant – see 112 rejection above); a plurality of peripheral protrusions disposed substantially about a perimeter of the body (the toroidal guard; 6 defines a peripheral protrusion disposed substantially about a perimeter of the body on each of the upper and lower surface portions, thereby meeting the limitation of a plurality of peripheral protrusions, as shown in fig. 2), the plurality of peripheral protrusions being formed with the body (the toroidal guard 6 is formed with the body as shown in fig. 2), the plurality of peripheral protrusions being disposed about the perimeter of the body to prevent expulsion of the body from the joint (col. 5, lines 5-13 discloses that the toroidal guard 6 prevents slip-out, thereby preventing expulsion of the body from the joint), a quantity of the plurality of peripheral protrusions being determined by a type associated with the joint (the peripheral protrusions are intended to prevent sliding off or slipping out of the end plates of the adjacent vertebrae and are therefore construed to be determined by a type associated with the joint as claimed); and a plurality of notches disposed substantially about the perimeter of the body and formed with a region of the top surface (at least one notch/convex center part 4 is formed with the top surface region and defines a notch while the notch/convex center part 4 formed with the bottom surface region is another notch thereby meeting the limitation of a plurality of notches; the outer part of the convex center part is also construed to be disposed substantially about the perimeter of the body because it is near the perimeter as disclosed in applicant’s specification at paragraph 00277, and particularly since the term substantially is broad), each of the notches having a substantially outward facing vertical surface and configured to retain the device in position within the joint (the outer rim of each notch/convex center part 4 is construed to be a substantially facing outward vertical surface because it extends in a substantially vertical direction from the plane guide 5 and because it faces substantially outward from the center of the body, particularly since the term substantially is broad, and is configured to retain the device in position within the joint as disclosed in col. 5, lines 5-13).
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buettner-Janz.
Buettner-Janz teaches the device of claim 1, including a region (guide; 5) of the top surface that is indented to align the body with a surface of the end plates which are coupled to a bone surface of the one or more bones of the joint and therefore configured to align the body with a bone surface of the one or more bones of the joint. However, Buettner-Janz does not teach that the region is substantially concave.
There is no evidence of record that establishes that changing the shape of the guide would result in a difference in function of the Buettner-Janz device. Further, a person having ordinary skill in the art, being faced with modifying the shape of the guide of Buettner-Janz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed substantially concave shape. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the region “may” be substantially concave, and offering other acceptable shapes (e.g., substantially convex, specification at para. [00277]) and therefore there appears to be no criticality placed on the shape as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the guide region of Buettner-Janz to be substantially concave as an obvious matter of design choice within the skill of the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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