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 .
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) 1-3, 5-11, and 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 5,658,338 to Tullos et al. (Tullos).
Regarding claim 1
Tullos teaches prosthetic systems, specifically acetabular implant systems, each comprising a preformed modular mantle designed to secure an acetabular implant within the acetabulum (abstract).
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Tullos meets the limitations of an acetabular spacer device adapted to be implanted in a bone cavity at a joint of a human body (col. 4, lines 3-10 discloses implantation of the prosthetic system into a mammalian bone socket, in particular a hip), the acetabular spacer device comprising: a body made from polymethylmethacrylate and having, a substantially hemispherical cup shape, an outer first surface that is convex (col. 7, lines 13-31 discloses that the modular cement mantle; 4 is preferably hemispherical and preferably formed of PMMA; fig. 2 shows that the outer surface of the body/modular cement mantle is convex) and is configured to be positioned in the bone cavity (col. 4, lines 3-10 discloses implantation of the prosthetic system into a mammalian bone socket, in particular a hip; fig. 1A), and an inner second surface that is concave and that defines an inner cavity (fig. 3A shows the inner second surface that is concave and defines an inner cavity for securing implant; 5 within); and a pharmaceutical or medical substance adapted to treat an ongoing infection in the bone cavity, the pharmaceutical or medical substance being provided within the body of the acetabular spacer device (col. 5, lines 31-40 discloses a bone growth inducing substance, which is a pharmaceutical or medical substance, that may be injected into the shell/socket interspace – when combined with antibacterial properties, the substance of Tullos is fully capable of treating an ongoing infection in the bone cavity), wherein the inner second surface is configured to be articulated with a head of a stem component that is present at the joint of the human body, or with a head of a stem of a permanent prosthesis or of a spacer device configured to be arranged at the joint of the human body (col. 9, lines 3-12 discloses articulation of the inner second surface with a spacer device/implant; 5 to find the desired orientation prior to being locked in place), wherein the outer first surface comprises a plurality of elongated recesses or projections (ribs; 8) that have perimeters that each defines a linear segment or a trapezoidal shape or a substantially rectangular shape and that extend inwardly or outwardly in relation to the outer first surface (fig. 2 shows the claimed shape and col. 7, lines 49-51 discloses that the projection/ribs are elevated from the outer surface); a base (defined by lower rim; 11), an apex of the outer first surface being opposite to the base at a top point of the outer first surface (apical port; 12 is shown to be located at the top of the outer first surface opposite to the base – any point along the area of the outer first surface that defines the port is construed to meet the limitation of an apex at a top point of the outer first surface as claimed, particularly since apex is defined by the Cambridge Dictionary as: the highest point or top of a shape or object); and an annular tab disposed at the base or at a terminal circular perimeter of the outer first surface (lower rim; 11 is shown in fig. 3A to be an annular tab disposed at the base of the outer first surface), the annular tab extending outwardly for a distance in relation to the outer first surface and/or to the elongated recesses or projections (fig. 2 shows the rim/annular tab extending outwardly for a distance in relation to the outer first surface and the projections/ribs), wherein the annular tab provides an abutment or support for a patient's articular seat or acetabular bone, so as to increase stability of positioning or implantation of the acetabular spacer device (col. 10, lines 28-34 discloses that the rim/annular tab mates with the lower lip; 20 of the implant; 5 upon assembly for the purpose of maintaining an intermediary layer of bone cement applied between the two components, which is construed to provide an abutment for a patient’s acetabular bone, at least indirectly, and to increase stability of positioning or implantation of the acetabular spacer device as claimed).
Regarding claim 2
Tullos teaches the acetabular spacer device according to claim 1, wherein the annular tab extends radially further than the outer first surface and the plurality of elongated recesses or projections (fig. 2 shows that the annular tab/rim extends radially further than the outer first surface and the projections/ribs).
Regarding claim 3
Tullos teaches the acetabular spacer device according to claim 1, wherein the elongated recesses or projections depart from the apex or from a zone surrounding the apex and extend toward or to the circular terminal perimeter of the outer first surface, or have a radial arrangement in relation to the apex (fig. 2 shows that the ribs/projections depart from the apex or from a zone surrounding the apex and have a radial arrangement in relation the apex; the examiner notes that the circular terminal perimeter is not positively recited in claim 1 and is therefore given no patentable weight).
Regarding claim 5
Tullos teaches the acetabular spacer device according to claim 1, wherein the plurality of elongated recesses or projections comprise elongated recesses that extend inwardly and that are radially arranged in relation to the apex and/or to a recessing groove defined around the apex (fig. 2 shows that portions of the body; 4 are recessed relative to the ribs; 8 and therefore meet the limitation of elongated recesses that extend inwardly and are shown to be radially arranged in relation to the apex as claimed).
Regarding claim 6
Tullos teaches the acetabular spacer device according to claim 5, wherein the recessing groove and the elongated recesses define angular sectors of the outer first surface having a triangular shape with a vertex at the recessing groove and a base at a portion of the circular terminal perimeter of the outer first surface (the limitations recited in claim 6 are moot since the recessing groove is not positively recited and, as explained above, the limitations of claim 5 are fully met because elongated recesses extend inwardly and are radially arranged in relation to the apex).
Regarding claim 7
Tullos teaches the acetabular spacer device according to claim 1, wherein the plurality of elongated recesses or projections comprise elongated recesses having a polygonal or ovoidal shape (fig. 2 shows that portions of the body; 4 are recessed relative to the ribs; 8 and therefore meet the limitation of elongated recesses and are shown to have a polygonal shape as claimed).
Regarding claim 8
Tullos meets the limitations of an acetabular spacer device (4) adapted to be implanted in a bone cavity at a joint of a human body (abstract), the acetabular spacer device comprising: a body made from polymethylmethacrylate, the body having a substantially hemispherical cup shape and defining, an outer first surface that is convex (col. 7, lines 13-31 discloses that the modular cement mantle; 4 is preferably hemispherical and preferably formed of PMMA; fig. 2 shows that the outer surface of the body/modular cement mantle is convex) and configured to be positioned in the bone cavity (col. 4, lines 3-10 discloses implantation of the prosthetic system into a mammalian bone socket, in particular a hip; fig. 1A), an inner second surface that is concave and defines an inner cavity (fig. 3A shows the inner second surface that is concave and defines an inner cavity for securing implant; 5 within), a base (defined by rim; 11), and an apex opposite to the base and positioned at a top point of the outer first surface (apical port; 12 is shown to be located at the top of the outer first surface opposite to the base – any point along the area of the outer first surface that defines the port is construed to meet the limitation of an apex at a top point of the outer first surface as claimed, particularly since apex is defined by the Cambridge Dictionary as: the highest point or top of a shape or object), wherein the outer first surface defines a plurality of elongated recesses or projections (ribs; 8) that extend inwardly or respectively outwardly in relation to the outer first surface, wherein the plurality of elongated recesses or projections have a radial arrangement in relation to the apex and depart from the apex or from a surrounding zone of the apex (fig. 2 shows the claimed radial arrangement and col. 7, lines 49-51 discloses that the projection/ribs are elevated from the outer surface), and wherein the inner second surface is configured to be articulated with a head of a stem component a stem having a head that is present at the joint of the human body, or with a head of a stem of a corresponding permanent prosthesis or spacer device of the joint of the human body (col. 9, lines 3-12 discloses articulation of the inner second surface with a spacer device/implant; 5 to find the desired orientation prior to being locked in place).
Regarding claim 9
Tullos teaches the acetabular spacer device according to claim 8, wherein the body comprises a pharmaceutical or medical substance arranged therein to be eluted in the bone cavity (col. 5, lines 31-40 discloses a bone growth inducing substance, which is a pharmaceutical or medical substance, that may be injected into the shell/socket interspace – when combined with antibacterial properties, the substance of Tullos is fully capable of treating an ongoing infection in the bone cavity).
Regarding claim 10
Tullos teaches the acetabular spacer device according to claim 8, wherein the plurality of elongated recesses or projections extend longitudinally along the outer first surface for at least a portion of a distance between the apex and the base and have longitudinal axes that meet at the apex (fig. 2 shows that the ribs extend longitudinally along the outer first surface for at least a portion of a distance between the apex/area surrounding portal; 12 and the base that is defined by the rim and have axes that meet at the apex).
Regarding claim 11
Tullos teaches the acetabular spacer device according to claim 8, wherein the plurality of elongated recesses or projections extend longitudinally along the outer first surface for at least a portion of a distance between the apex and the base and have longitudinal axes that meet at the apex (fig. 2 shows that the ribs extend longitudinally along the outer first surface for at least a portion of a distance between the apex and the base and have longitudinal axes that meet at the apex).
Regarding claim 14
Tullos teaches the acetabular spacer device according to claim 11, wherein the plurality of elongated recessed or projections are configured as longitudinal ribs extending outwardly of the outer first surface (projections/ribs; 8 are longitudinal ribs extending outwardly of the outer first surface).
Regarding claim 15
Tullos teaches the acetabular spacer device according to claim 11, wherein the elongated recesses or projections are configured as longitudinal cavities (fig. 2 shows that portions of the body; 4 are recessed relative to the ribs; 8 and therefore meet the limitation of elongated recesses configured as longitudinal cavities).
Regarding claim 16
Tullos teaches the acetabular spacer device according to claim 11, wherein the elongated recesses or projections define triangular portions of the outer first surface therebetween (fig. 2 shows that the portions of the body; 4 that are recessed relative to the ribs; 8 are defined triangular portions of the outer first surface therebetween).
Regarding claim 17
Tullos teaches the acetabular spacer device according to claim 11, wherein the elongated recesses or projections define therebetween trapezoidal portions of the outer first surface, the trapezoidal portions having a smaller upper base and a larger lower base, the smaller upper base being closer to the apex than the larger lower base (annotated fig. 2 below shows that the portions of the body; 4 that are recessed relative to the ribs; 8 are defined trapezoidal portions of the outer first surface, the trapezoidal portions having a smaller upper base and a larger lower base, the smaller upper base being closer to the apex than the larger lower base).
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Regarding claim 18
Tullos teaches the acetabular spacer device according to claim 8, wherein the base of the body is perpendicular to a longitudinal axis of the body (the base defined by the rim; 11 is perpendicular to the longitudinal axis of the body as shown in fig. 2).
Regarding claim 19
Tullos teaches the acetabular spacer device according to claim 8, wherein the acetabular spacer device consists of said body (the acetabular spacer device consists of said body; 4).
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.
In addition to the rejection above, claim(s) 1, 3, 4, 8, and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2005/0261777 A1 to Jones et al. (Jones) in view of Tullos.
Regarding claim 1
Jones teaches an orthopedic prosthesis comprising a polymeric cup member for use in a ball and socket joint (abstract).
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Jones meets the limitations of an acetabular spacer device adapted to be implanted in a bone cavity at a joint of a human body (the prosthesis is for implantation in into a socket of a ball and socket joint of a human body; paragraph 0004), the acetabular spacer device (fig. 1) comprising: a body (cup member; 10) made from a polymeric material (paragraph 0034) and having, a substantially hemispherical cup shape, an outer first surface that is convex (paragraph 0039 discloses that the outer convex surface; 20 is dimensioned in a substantially partially-spherical shape) and is configured to be positioned in the bone cavity (paragraph 0036 discloses that the cup member may adequately fit within the spherical recess of the bone), and an inner second surface that is concave and that defines an inner cavity (inner surface; 30 is configured and arranged as a bearing surface for receiving a head of a femoral prosthesis therein; paragraph 0041); and a pharmaceutical or medical substance adapted to treat an ongoing infection in the bone cavity, the pharmaceutical or medical substance being provided within the body of the acetabular spacer device (paragraphs 0033 and 0040 disclose use of a fixation material that may include bone cements, adhesives, epoxies, bone that may grow into the implant, or proteins, or other tissues that may grow into the implant to secure the implant to the socket of the patient’s bone, as well as any other suitable material, that flows and enters into the surface of the cup member thereby creating a mechanical lock between the cup member and the fixation material), wherein the inner second surface is configured to be articulated with a head of a stem component that is present at the joint of the human body, or with a head of a stem of a permanent prosthesis or of a spacer device configured to be arranged at the joint of the human body (inner surface; 30 is configured and arranged as a bearing surface for receiving a head of a femoral prosthesis therein; paragraph 0041), wherein the outer first surface comprises a plurality of elongated recesses or projections (recesses: medial, lateral, anterior, and posterior portions of recessed channel; 50 or projections: medial, lateral, anterior, or posterior portions of raised portions; 80 – see annotated fig. 1 above) that have perimeters that each defines a linear segment or a trapezoidal shape or a substantially rectangular shape and that extend inwardly or outwardly in relation to the outer first surface (annotated fig. 1 above shows that each of the medial, lateral, anterior, and posterior portions of channel; 50, and/or medial, lateral, anterior, and posterior portions of raised portion; 80 define at least a linear segment that extends inwardly or outwardly in relation to the outer first surface); a base (defined by rim; 40), an apex of the outer first surface being opposite to the base at a top point of the outer first surface (pole; 12 is an extremity of a central axis running through the center of the cup member as shown in fig. 1); and an annular tab disposed at the base or at a terminal circular perimeter of the outer first surface (lower rim; 40 is shown in fig. 3A to be an annular tab disposed at the base or at a terminal circular perimeter of the outer first surface), the annular tab extending outwardly for a distance in relation to the outer first surface and/or to the elongated recesses or projections (fig. 2 shows the rim/annular tab extending outwardly for a distance in relation to the outer first surface and the recesses or projections), wherein the annular tab provides an abutment or support for a patient's articular seat or acetabular bone, so as to increase stability of positioning or implantation of the acetabular spacer device (the annular tab/rim comprises a radially-projecting annular lip and defines the terminal edge of the cup member, as disclosed in paragraph 0038, such that when the cup member is securely implanted within the acetabulum, the annular tab/rim provides abutment or support for a patient’s acetabular bone, thereby increasing stability of positioning or implantation of the device, as claimed by applicant).
However, Jones does not teach that the polymeric material from which the acetabular spacer device body is made from polymethylmethacrylate.
Tullos teaches a similar spacer device body that is made from PMMA, which is a polymeric adhesive material (col. 6, lines 44-51).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the polymeric material from which the acetabular spacer device is made is polymethylmethacrylate, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding claim 3
Jones in view of Tullos teaches the acetabular spacer device according to claim 1. Jones further teaches wherein the elongated recesses or projections depart from the apex or from a zone surrounding the apex and extend toward or to the circular terminal perimeter of the outer first surface, or have a radial arrangement in relation to the apex (annotated fig. 1 above shows that the recesses and/or projections, at least portions of channel; 50 and portions of raised portion; 80, depart from the apex or from a zone surrounding the apex and extend toward or to the circular terminal perimeter and have a radial arrangement in relation the apex).
Regarding claim 4
Jones in view of Tullos teaches the acetabular spacer device according to claim 3. Jones further teaches wherein the plurality of elongated recesses or projections (channel; 50, raised medial, lateral, anterior, and posterior portions of raised portion; 80, and/or groove; 86) comprise a first elongated projection (raised medial portion; 80) and second elongated projections (lateral, anterior, and posterior portions of raised portions; 80) that extends outwardly (the raised portions extend outwardly relative to the recessed channel; 50), wherein the second elongated projections are radially disposed with respect to the apex and are spaced therefrom by a distance (each of lateral, anterior, and posterior raised portions are radially disposed and spaced from the apex at a distance defined by groove 86). Jones also teaches wherein the first elongated projection (medial portion of raised portion 80) further extends along a portion of an outer circumference of the outer first surface or along an arc of circumference of the outer first surface (fig. 1 shows the raised portion extends long a portion of the outer circumference or along an arc of circumference of the outer first surface).
Further still, Jones teaches that the groove (86) may be modified such that it does not extend through the pole (apex; 12) of the cup member (10), but may circumvent the pole completely, or may pass through only a portion of said pole (paragraph 0048). When the groove is designed to circumvent the pole completely, the raised medial portion would cross the pole (apex).
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 groove such that it circumvents the pole, thereby allowing the raised medial portion to cross the pole, since there is no evidence of record that establishes that changing the extension of the groove would result in a difference in function of the Jones device. Further, a person having ordinary skill in the art, being faced with modifying the groove of Jones, 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 circumvention of the pole such that at least a portion of the raised portion would cross the pole. Lastly, applicant has not disclosed that the claimed crossing of the apex solves any stated problem, indicating that the first projection “for example” passes through the apex, and offering other acceptable versions (e.g., the projections are arranged radially with respect to the apex; specification at para. [0130] and fig. 3) and therefore there appears to be no criticality placed on the configuration 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 groove of Jones to circumvent the apex such that at least a portion of the raised portion crosses the apex as an obvious matter of design choice within the skill of the art.
Regarding claim 8
An acetabular spacer device adapted to be implanted in a bone cavity at a joint of a human body (the prosthesis is for implantation in into a socket of a ball and socket joint of a human body; paragraph 0004), the acetabular spacer device comprising: a body (10) made from polymeric material (paragraph 0034), the body having a substantially hemispherical cup shape and defining, an outer first surface that is convex (paragraph 0039 discloses that the outer convex surface; 20 is dimensioned in a substantially partially-spherical shape) and is configured to be positioned in the bone cavity (paragraph 0036 discloses that the cup member may adequately fit within the spherical recess of the bone), and an inner second surface that is concave and that defines an inner cavity (inner surface; 30 is configured and arranged as a bearing surface for receiving a head of a femoral prosthesis therein; paragraph 0041), a base (defined by rim: 40), and an apex (pole; 12) opposite to the base (defined by rim; 40) and positioned at a top point of the outer first surface (pole; 12 is an extremity of a central axis running through the center of the cup member as shown in fig. 1), wherein the outer first surface defines a plurality of elongated recesses or projections that extend inwardly or respectively outwardly in relation to the outer first surface (recesses: portions of recessed channel; 50, or projections: portions of raised portions; 80 – see annotated fig. 1 above), wherein the plurality of elongated recesses or projections have a radial arrangement in relation to the apex and depart from the apex or from a surrounding zone of the apex (each of the portions of recessed channel; 50, and/or portions of raised portions; 80 have a radial arrangement in relation to the apex and depart from the apex or form a surrounding zone of the apex), and wherein the inner second surface is configured to be articulated with a head of a stem component that is present at the joint of the human body, or with a head of a stem of a corresponding permanent prosthesis or spacer device of the joint of the human body (inner surface; 30 is configured and arranged as a bearing surface for receiving a head of a femoral prosthesis therein; paragraph 0041).
However, Jones does not teach that the polymeric material from which the acetabular spacer device body is made from polymethylmethacrylate.
Tullos teaches a similar spacer device body that is made from PMMA, which is a polymeric adhesive material (col. 6, lines 44-51).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the polymeric material from which the acetabular spacer device is made is polymethylmethacrylate, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding claim 11
Jones in view of Tullos teaches the acetabular spacer device according to claim 8. Jones also teaches wherein the plurality of elongated recesses or projections extend longitudinally along the outer first surface for at least a portion of a distance between the apex and the base and have longitudinal axes that meet at the apex (annotated fig. 1 above shows that the portions of the channel; 50 or the portions of the raised portion; 80 extend longitudinally along the outer first surface for at least a portion of a distance between the apex and the base and have longitudinal axes that meet at the apex; 12).
Regarding claim 12
Jones in view of Tullos teaches the acetabular spacer device according to claim 11. Jones also teaches wherein the plurality of elongated recesses or projections extend longitudinally along the outer first surface for only a portion of a distance between the apex and the base and have longitudinal axes that meet at the apex (each of the portions of the recessed channel; 50 or portions of the raised portions; 80 extend longitudinally along the outer first surface for only a portion of a distance between the apex and base as shown in fig. 1).
Regarding claim 13
Jones in view of Tullos teaches the acetabular spacer device according to claim 12. Jones also teaches wherein the plurality of elongated recesses or projections extend longitudinally along the outer first surface and are spaced both from the apex and the base (fig. 1 shows that at least each of the portions of the recessed channel; 50 and the portions of the raised portions; 80 extend longitudinally along the outer first surface and are spaced from both the apex/pole and the base defined by rim).
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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