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. 14G 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 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 surgically implanted in a joint”, in lines 2-3 and "not being coupled to the one or more bones" in lines 3-4. These limitations are contradictory. It is unclear how the body can be implanted 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 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, 2, 4-8, 12-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 5,702,472 to Huebner (Huebner).
Regarding at least claim 1
Huebner teaches a phalangeal joint prosthesis for replacing damaged interphalangeal finger joints (abstract).
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Huebner meets the limitations of a device, comprising: a body (34) having a top surface (36) and a bottom surface (38), the top surface having a radius of curvature and the bottom surface having another radius of curvature (the curvature of the top and bottom surface each have a radius as shown in fig. 2), the body being configured to be surgically implanted in a joint and to prevent contact between one or more bones comprising the joint, the body not being coupled to the one or more bones (col. 3, lines 42-46 discloses that the spacer/body is configured to couple the pins 12 and 14, and therefore the bones, in a spaced relationship, thereby preventing contact between them – the spacer/body is not coupled to the one or more bones as shown in fig. 3); and a peripheral protrusion (shoulders; 45) disposed substantially about a perimeter of the body (fig. 2 shows that the shoulders are disposed about a perimeter of the spacer/body), the peripheral protrusion being formed with the body and having a substantially outward facing vertical surface (sidewall; 46 is construed to be substantially outward facing vertical surfaces of the shoulders/protrusions as shown in fig. 1), the peripheral protrusion being disposed about the perimeter of the body to prevent expulsion of the body from the joint (the shoulders being a greater thickness than a central portion of the spacer/body as shown in fig. 2 would prevent expulsion of the spacer/body from the joint in the same way as applicant’s, for example as shown in fig. 3C of applicant’s figures).
Regarding at least claim 2
Huebner teaches the device of claim 1, wherein the peripheral protrusion is configured to maintain anatomical alignment of the device when inserted into the joint (the shoulders being a greater thickness than a central portion of the spacer/body as shown in fig. 2 is construed to maintain anatomical alignment of the device when inserted into the joint, in the same way as applicant’s, for example as shown in fig. 3C of applicant’s figures.
Regarding at least claim 4
Huebner teaches the device of claim 1, wherein the protrusion is disposed substantially about the perimeter at a location at which the protrusion is configured to move the device in a direction that is substantially opposite to a force transmitted by a bone surface or another bone surface (the shoulders have the same greater-in-thickness structure as applicant’s and are disposed substantially about the perimeter as shown in fig. 1 – therefore, the shoulders are at a location at which the shoulder is configured to move the device in a direction that is substantially opposite to a force transmitted by a bone surface of another bone surface at least to the same extent as applicant’s).
Regarding at least claim 5
Huebner teaches the device of claim 1, wherein the peripheral protrusion is disposed between proximally-positioned channel openings (annotated fig. 1 below shows channel openings as claimed).
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Regarding at least claim 6
Huebner teaches the device of claim 1, wherein the peripheral protrusion is disposed on the top surface at a distance from the perimeter (annotated fig. 2 below shows the shoulder disposed on the top surface at a distance from the perimeter).
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Regarding at least claim 7
Huebner teaches the device of claim 1, wherein the outward facing vertical surface has a curvature that aligns with a shape of the perimeter (the edge; 46 is shown to have a curvature that aligns with a shape of the perimeter; fig. 1).
Regarding at least claim 8
Huebner teaches the device of claim 1, wherein the top surface is substantially concave to align the body with a bone surface of the one or more bones of the joint (fig. 2 shows that the top surface is substantially concave).
Regarding at least claim 12
Huebner meets the limitations of a device, comprising: a body (34) having a top surface (36) and a bottom surface (38), the top surface having a radius of curvature and the bottom surface having another radius of curvature (the curvature of the top and bottom surface each have a radius as shown in fig. 2), the body being configured to be surgically implanted in a joint and to prevent contact between one or more bones comprising the joint, the body not being coupled to the one or more bones (col. 3, lines 42-46 discloses that the spacer/body is configured to couple the pins 12 and 14, and therefore the bones, in a spaced relationship, thereby preventing contact between them – the spacer/body is not coupled to the one or more bones as shown in fig. 3); and a plurality of peripheral protrusions (45) disposed substantially about a perimeter of the body (fig. 2 shows that the shoulders are disposed about a perimeter of the spacer/body), the plurality of peripheral protrusions being formed with the body, each of the plurality of peripheral protrusions having a substantially outward facing vertical surface (sidewall; 46 is construed to be substantially outward facing vertical surfaces of the shoulders/protrusions as shown in fig. 1), the plurality of peripheral protrusions being disposed about the perimeter of the body to retain the device in the joint (the shoulders being a greater thickness than a central portion of the spacer/body as shown in fig. 2 would retain the spacer/body in the joint in the same way as applicant’s, for example as shown in fig. 3C of applicant’s figures).
Regarding at least claim 13
Huebner teaches the device of claim 12, further comprising the body (34) being configured to be inserted into a synovial capsule substantially located within the joint (the spacer/body is disclosed as being inserted between first and second bones that are phalanges and is therefore configured to be inserted into a synovial capsule substantially located within the joint; col. 4, lines 44-48).
Regarding at least claim 14
Huebner teaches the device of claim 12, wherein the perimeter of the body substantially defines the outward facing vertical surface (the edge; 46 is defined by the perimeter of the body as shown in fig. 1).
Regarding at least claim 15
Huebner teaches the device of claim 12, wherein the top surface radius of curvature is associated with a distal or proximal end of the one or more bones comprising the joint (fig. 3 shows that the top surface 36 is associated with a distal end of one of the bones comprising the joint).
Regarding at least claim 16
Huebner 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 (fig. 3 shows that the bottom surface 38 is associated with a proximal end of one of the bones comprising the joint).
Regarding at least claim 17
Huebner teaches the device of claim 12, wherein the plurality of peripheral protrusions (45) are configured to substantially retain the device in a synovial capsule in the joint (the spacer/body is disclosed in col. 4, lines 44-48 as being inserted between first and second bones that are phalanges and is therefore configured to be inserted into a synovial capsule substantially located within the joint; the shoulders being a greater thickness than a central portion of the spacer/body as shown in fig. 2 would retain the spacer/body in the joint in the same way as applicant’s, for example as shown in fig. 3C of applicant’s figures).
Regarding at least claim 18
Huebner teaches the device of claim 12, wherein the top surface includes a channel opening disposed substantially proximate to the perimeter of the body (annotated fig. 1 below shows a channel opening as claimed).
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Regarding at least claim 19
Huebner teaches the device of claim 12, wherein the outward facing vertical surface is disposed in between opposing peripheral protrusions (at least part of the edge; 46 is disposed in between opposing shoulders 45 as shown in figs. 1 and 2).
Regarding at least claim 20
Huebner meets the limitations of a device, comprising: a body (34) having a top surface (36) and a bottom surface (38), the top surface having a radius of curvature and the bottom surface having another radius of curvature (the curvature of the top and bottom surface each have a radius as shown in fig. 2), the body being configured to be surgically implanted in a joint and to prevent contact between one or more bones comprising the joint, the body not being coupled to the one or more bones (col. 3, lines 42-46 discloses that the spacer/body is configured to couple the pins 12 and 14, and therefore the bones, in a spaced relationship, thereby preventing contact between them – the spacer/body is not coupled to the one or more bones as shown in fig. 3); and a plurality of peripheral protrusions (45) disposed substantially about a perimeter of the body (fig. 2 shows that the shoulders are disposed about a perimeter of the spacer/body), the plurality of peripheral protrusions being formed with the body, each of the plurality of peripheral protrusions having a substantially outward facing vertical surface (sidewall; 46 is construed to be substantially outward facing vertical surfaces of the shoulders/protrusions as shown in fig. 1), the plurality of peripheral protrusions being disposed about the perimeter of the body to retain the device in the joint (the shoulders being a greater thickness than a central portion of the spacer/body as shown in fig. 2 would retain the spacer/body in the joint in the same way as applicant’s, for example as shown in fig. 3C of applicant’s figures), a quantity of the plurality of peripheral protrusions being determined by a type associated with the joint (col. 3, lines 60-66 discloses that a spacer may not include shoulders/protrusions though it is preferable to include them, therefore the plurality of shoulders/protrusions is determined depending on preference which may be the type associated with the joint as claimed).
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) 3 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Huebner, as applied to claim 1 above, and further in view of US Patent No. 9,408,706 B2 to Hassler et al. (Hassler).
Regarding at least claim 3
Huebner teaches the device of claim 1, including the peripheral protrusion (shoulder; 45), which is in contact with the pins (12, 14) attached to the bones (52, 54).
The bearing surfaces (36 and 38) of the spacer (34) of Huebner are each configured to receive the bearing surfaces (18) of the pin heads (56, 58), in order to couple the pins (12, 14) in a spaced relationship to enable the prosthesis to flex and extend as the joint is articulated (col. 3, lines 42-46). Since the spacer (34) is not fixedly secured and is able to move along the bearing surfaces (18) as the joint moves, it is construed that the spacer, which includes shoulders (peripheral protrusions; 45), is in non-permanent/intermittent contact with the surfaces. However, Huebner does not explicitly teach wherein the peripheral protrusion is in intermittent contact with the one or more bones.
Hassler teaches an implant intended to be placed in a trapeziometacarpal joint when the joint is damaged by a degenerative or inflammatory pathological process (col. 1, lines 15-19). Hassler acknowledges that many trapeziometacarpal prostheses are stem prosthesis in which the components are anchored by an elongate stem in a cavity of each bone (col. 1, lines 19-24). Hassler goes on to teach an implant that is prepared to substantially match the joint surface by simulating the anatomical saddle-type joint and is interposed between the trapezium and the metacarpal such that the curvature of the surfaces stabilizes and aligns the body between the bones, thus avoiding the need to provide means of fixation to the bones (col. 2, lines 17-27) and thereby preserving bone and better corresponding to the mobility of the anatomical joint (col. 1, lines 25-29). Similar to Huebner, the body of Hassler is construed to in non-permanent/intermittent contact with the bones because it is not fixedly secured and is held movably between them (col. 5, lines 51-60).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to recognize that the peripheral protrusion of the implant of Huebner, which is in intermittent contact with the bearing surfaces of two stem prostheses, is fully capable of being in intermittent contact with the one or more bones, when the implant that is intended to preserve bone and better correspond to the mobility of the anatomical joint, as taught by Hassler.
Regarding at least claim 9
Huebner teaches the device of claim 1, including a top surface (36) that aligns the body (34) with a surface of each pin and therefore also a bone surface of the one or more bones of the joint, as shown in fig. 3. However, Huebner does not teach that the top surface is convex.
Hassler teaches an implant intended to be placed in a trapeziometacarpal joint when the joint is damaged by a degenerative or inflammatory pathological process (col. 1, lines 15-19). Hassler acknowledges that many trapeziometacarpal prostheses are stem prosthesis in which the components are anchored by an elongate stem in a cavity of each bone (col. 1, lines 19-24). Hassler goes on to teach an implant that is prepared to substantially match the joint surface by simulating the anatomical saddle-type joint and is interposed between the trapezium and the metacarpal such that the curvature of the surfaces stabilizes and aligns the body between the bones, thus avoiding the need to provide means of fixation to the bones (col. 2, lines 17-27) and thereby preserving bone and better corresponding to the mobility of the anatomical joint (col. 1, lines 25-29). Fig. 5 below shows that the saddle-shaped top surface (6) is convex.
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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 top surface of Huebner to be a saddle-shape, which includes convexity, as shown by Hassler in fig. 5, in order to simulate the anatomical saddle-type joint and align the body between the bones, thereby preserving bone and better corresponding to the mobility of the anatomical joint, as taught by Hassler.
Regarding at least claim 10
Huebner teaches the device of claim 1, including a top surface (36) that aligns the body (34) with a surface of each pin and therefore also a bone surface of the one or more bones of the joint, as shown in fig. 3. However, Huebner does not teach that the top surface is substantially saddle shaped.
Hassler teaches an implant intended to be placed in a trapeziometacarpal joint when the joint is damaged by a degenerative or inflammatory pathological process (col. 1, lines 15-19). Hassler acknowledges that many trapeziometacarpal prostheses are stem prosthesis in which the components are anchored by an elongate stem in a cavity of each bone (col. 1, lines 19-24). Hassler goes on to teach an implant that is prepared to substantially match the joint surface by simulating the anatomical saddle-type joint and is interposed between the trapezium and the metacarpal such that the curvature of the surfaces stabilizes and aligns the body between the bones, thus avoiding the need to provide means of fixation to the bones (col. 2, lines 17-27) and thereby preserving bone and better corresponding to the mobility of the anatomical joint (col. 1, lines 25-29). Fig. 5 below shows that the saddle-shaped top surface (6) is convex.
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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 top surface of Huebner to be a saddle-shape, in order to simulate the anatomical saddle-type joint and align the body between the bones, thereby preserving bone and better corresponding to the mobility of the anatomical joint, as taught by Hassler.
Regarding at least claim 11
Huebner teaches the device of claim 1, including a top surface (36) that includes a channel opening to the concave curvature, as shown in annotated fig. 1 above. However, Huebner does not teach two intersecting channels, each channel having two channel openings disposed about the perimeter of the body.
Hassler teaches an implant intended to be placed in a trapeziometacarpal joint when the joint is damaged by a degenerative or inflammatory pathological process (col. 1, lines 15-19). Hassler acknowledges that many trapeziometacarpal prostheses are stem prosthesis in which the components are anchored by an elongate stem in a cavity of each bone (col. 1, lines 19-24). Hassler goes on to teach an implant that is prepared to substantially match the joint surface by simulating the anatomical saddle-type joint and is interposed between the trapezium and the metacarpal such that the curvature of the surfaces stabilizes and aligns the body between the bones, thus avoiding the need to provide means of fixation to the bones (col. 2, lines 17-27) and thereby preserving bone and better corresponding to the mobility of the anatomical joint (col. 1, lines 25-29). Annotated fig. 2 below shows that the top surface includes two intersecting channels (convex curvature along each axis X4 and concave curvature along axis 61 shown in annotated fig. 2 below represent two intersecting channels), each channel having two channel openings disposed about the perimeter of the body (arrow shown in annotated fig. 2 below represent two channel openings of each channel that are disposed about the perimeter of the body).
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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 top surface of Huebner to be a saddle-shape that includes two intersecting channels, each channel having two channel openings disposed about the perimeter of the body, in order to simulate the anatomical saddle-type joint and align the body between the bones, thereby preserving bone and better corresponding to the mobility of the anatomical joint, as taught by Hassler.
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.
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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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