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 .
The Amendment filed 3/2/2026 has been entered. The previous objection to the claims is withdrawn in light of applicant’s amendments.
Terminal Disclaimer
The terminal disclaimer filed on 3/20/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,000,378 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments, see page 6, filed 3/2/2026, with respect to the 35 USC 102 rejection in view of Lewis have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the newly added limitations.
Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive. With regard to applicant’s argument that the nail of Tronzo is not anteverted in orientation with respect to a hemisphere, the examiner disagrees. As explained in the previous office action, annotated fig. 5 above shows that the stress-diffusion element/nail extends anteriorly to the axis of the cup, particularly an anterior angulation relative to the plane defined by the rim, in a similar way to applicant’s as disclosed in applicant’s specification at paragraph 0054 – the examiner suggests that applicant further clarify the anteverted orientation, for example by specifying a polar axis, a plane defined by the rim, a tangent line to the convex exterior surface of the cup, etc.
Claim Objections
Claims 7 and 17 are objected to because of the following informalities: Claim 7 recites “wherein the stem includes a plurality of longitudinal flutes” which appears to be redundant since claim 1, from which claim 7 depends, already requires a plurality of longitudinal flutes. The examiner suggests that applicant amend this limitation to recite – wherein each of the plurality of longitudinal flutes extends – . Claim 17 recites “wherein the stress-diffusion element includes a plurality of longitudinal flutes” which appears to be redundant since claim 15, from which claim 17 depends, already requires a plurality of longitudinal flutes. The examiner suggests that applicant amend this limitation to recite – wherein each of the plurality of longitudinal flutes extends – . Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-12 and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 4 and 18 fail to further limit the subject matter of the claims upon which they depend because claims 1 and 15 already require that the stress-diffusion element comprises a stem extending directly from the bone-abutment exterior surface of the hemispherical cup. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-5, 7, 8, 11, 12, 14, and 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tronzo.
Regarding at least claim 1
Tronzo teaches a hip prosthesis that includes a socket supported on a nail protruding from the back of the socket and adapted to enter the acetabulum (abstract).
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Tronzo meets the limitations of a surgical implant comprising: a hemispherical cup (socket; 20) having (i) a bone-abutment exterior surface defining a convex side of the cup (fig. 2 shows that the exterior surface which abuts the bone defines a convex side of the cup) and (ii) an interior surface defining a concave side of the cup with a cavity (fig. 5 shows that the interior surface defines a concave side of the cup with a cavity); and a stress-diffusion element comprising a stem (nail; 21 is construed to be a stem because it resembles the long, thin part of a plant, as shown in fig. 2) extending directly from the bone-abutment exterior surface of the hemispherical cup at an anteverted orientation to the hemispherical cup (annotated fig. 5 above shows that the stress-diffusion element/nail extends anteriorly to the axis of the cup, particularly an anterior angulation relative to the plane defined by the rim, in a similar way to applicant’s as disclosed in applicant’s specification at paragraph 0054 – the examiner suggests that applicant further clarify the anteverted orientation, for example by specifying a polar axis, a plane defined by the rim, a tangent line to the convex exterior surface of the cup, etc.), the stem having a plurality of longitudinal flutes extending to a tip of the stem and configured for forming grooves in bone (col. 3, lines 1-4 discloses that nail (stem; 21) has extended over its full length (i.e., to a tip) three tapering (24) flutes (22) which are equally and circumferentially placed and configured for forming grooves in the bone at least to the same extent as applicant’s because they have the same structure; fig. 2).
Regarding at least claim 2
Tronzo teaches the surgical implant of claim 1, wherein the hemispherical cup and the stress-diffusion element are monolithic (col. 2, line 67 through col. 3, lines 1-3 discloses that the nail/stress-diffusion element extends from the back of the socket and is suitably integral).
Regarding at least claim 3
Tronzo teaches the surgical implant of claim 1, further comprising at least one aperture defined by a circumferential surface extending between the bone-abutment exterior surface and the interior surface, the at least one aperture configured to receive a screw therethrough (fig. 6 shows an aperture/threaded bore 29 extending between the exterior surface and the interior surface that receives a screw/threaded projection 30 of a driver 31 therethrough).
Regarding at least claim 4
Tronzo teaches the surgical implant of claim 3, wherein the stress-diffusion element is a stem extending from the hemispherical cup (the nail is construed to be a stem extending from the cup because it supports the socket and is adapted to enter the acetabulum as shown in fig. 1).
Regarding at least claim 5
Tronzo teaches the surgical implant of claim 4, wherein the stem includes a base formed on the bone-abutment exterior surface of the hemispherical cup (annotated fig. 2 below shows a base formed on the exterior surface as claimed).
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Regarding at least claim 7
Tronzo teaches the surgical implant of claim 4, wherein the stem (21) includes a plurality of longitudinal flutes (22), each of the plurality of longitudinal flutes extending along an entirety of the stem (col. 3, lines 1-4 discloses that the flutes extend over the full length; fig. 2) with (i) distal ends of the plurality of longitudinal flutes adjoining at a common point (tip of the stem; fig. 2), and (ii) proximal ends of the plurality of longitudinal flutes tapering (24) at separate points (col. 2, lines 64-67 through col. 3, lines 1-6 and fig. 2).
Regarding at least claim 8
Tronzo teaches the surgical implant of claim 7, wherein adjacent ones of the plurality of longitudinal flutes are spaced from each other by one of a plurality of troughs, and each of the plurality of troughs includes sidewalls and a bottom wall (col. 2, lines 64-67 through col. 3, lines 1-6 discloses three flutes; 22 of Tronzo equally circumferentially placed such that the flutes are spaced from each other by one of a plurality of troughs/sidewalls and a bottom wall, as shown in annotated fig. 2 below).
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Regarding at least claim 11
Tronzo teaches the surgical implant of claim 8. Tronzo also teaches the plurality of longitudinal flutes, wherein each of the plurality of longitudinal flutes surrounds a portion of the adjacent ones of the plurality of troughs (col. 2, lines 64-67 through col. 3, lines 1-6 discloses that the flutes; 22 are equally circumferentially placed such that the flutes are spaced from each other by one of a plurality of troughs/sidewalls such that a portion of the adjacent ones of the troughs are surrounded by each of the flutes, as claimed).
Regarding at least claim 12
Tronzo in view of Ries teaches the surgical implant of claim 8. Tronzo also teaches the sidewalls of each of the plurality of troughs, wherein the sidewalls of each of the plurality of troughs converge (see annotated fig. 2 below).
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Regarding at least claim 14
Tronzo in view of Ries teaches the surgical implant of claim 3, including wherein the at least one aperture is a plurality of apertures, the plurality of apertures are equidistant relative to each other along the cup. Tronzo also teaches wherein, the stress-diffusion element extends from a point on the bone-abutment exterior surface (fig. 2 shows that the stress-diffusion element extends from a point on the exterior surface of the cup).
Regarding at least claim 15
Tronzo meets the limitations of a surgical implant comprising: a hemispherical cup (socket; 20) having (i) a bone-abutment exterior surface defining a convex side of the cup (fig. 2 shows that the exterior surface which abuts the bone defines a convex side of the cup) and (ii) an interior surface defining a concave side of the cup with a cavity (fig. 5 shows that the interior surface defines a concave side of the cup with a cavity); and a stress-diffusion element comprising a stem (nail; 21 is construed to be a stem because it resembles the long, thin part of a plant, as shown in fig. 2) extending directly from the bone-abutment exterior surface of the hemispherical cup at an anteverted orientation to the hemispherical cup (annotated fig. 5 above shows that the stress-diffusion element/nail extends anteriorly to the axis of the cup – the examiner suggests that applicant further clarify the anteverted orientation, for example by specifying a polar axis, a plane defined by the rim, a tangent line to the convex exterior surface of the cup, etc.), wherein the hemispherical cup and the stem are monolithic (col. 2, line 67 through col. 3, lines 1-3 discloses that the nail/stress-diffusion element extends from the back of the socket and is suitably integral), the stem having a plurality of longitudinal flutes extending to a tip of the stem and configured for forming grooves in bone (col. 3, lines 1-4 discloses that nail (stem; 21) has extended over its full length (i.e., to a tip) three tapering (24) flutes (22) which are equally and circumferentially placed and configured for forming grooves in the bone at least to the same extent as applicant’s because they have the same structure; fig. 2).
Regarding at least claim 16
Tronzo teaches the surgical implant of claim 15, further comprising at least one aperture defined by a circumferential surface extending between the bone-abutment exterior surface and the interior surface, the at least one aperture configured to receive a screw therethrough (fig. 6 shows an aperture/threaded bore 29 extending between the exterior surface and the interior surface that receives a screw/threaded projection 30 of a driver 31 therethrough).
Regarding at least claim 17
Tronzo teaches the surgical implant of claim 15, wherein the stress-diffusion element (21) includes a plurality of longitudinal flutes (22), each of the plurality of longitudinal flutes extending along an entirety of the stress-diffusion element (col. 3, lines 1-4 discloses that the flutes extend over the full length; fig. 2) with (i) distal ends of the plurality of longitudinal flutes adjoining at a common point (tip of the stem; fig. 2), and (ii) proximal ends of the plurality of longitudinal flutes tapering (24) at separate points (col. 2, lines 64-67 through col. 3, lines 1-6 and fig. 2).
Regarding at least claim 18
Tronzo teaches the surgical implant of claim 15, wherein the stress-diffusion element is a stem extending from the hemispherical cup (the nail is construed to be a stem extending from the cup because it supports the socket and is adapted to enter the acetabulum as shown in fig. 1).
Regarding at least claim 19
Tronzo meets the limitations of a surgical implant comprising: a hemispherical cup (socket; 20) having (i) a bone-abutment exterior surface defining a convex side of the cup (fig. 2 shows that the exterior surface which abuts the bone defines a convex side of the cup) and (ii) an interior surface defining a concave side of the cup with a cavity (fig. 5 shows that the interior surface defines a concave side of the cup with a cavity); at least one aperture defined by a circumferential surface extending between the bone-abutment exterior surface and the interior surface, the at least one aperture operable to receive a screw therethrough (fig. 6 shows an aperture/threaded bore 29 extending between the exterior surface and the interior surface that receives a screw/threaded projection 30 of a driver 31 therethrough); and a stress-diffusion element (nail; 21) extending directly from the bone-abutment exterior surface of the hemispherical cup at an anteverted orientation to the hemispherical cup (annotated fig. 5 above shows that the stress-diffusion element/nail extends anteriorly to the axis of the cup – the examiner suggests that applicant further clarify the anteverted orientation, for example by specifying a polar axis, a plane defined by the rim, a tangent line to the convex exterior surface of the cup, etc.), wherein the hemispherical cup and the stress-diffusion element are monolithic (col. 2, line 67 through col. 3, lines 1-3 discloses that the nail/stress-diffusion element extends from the back of the socket and is suitably integral).
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) 1 and 3-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2007/0142921 A1 to Lewis et al. (Lewis) in view of US Patent No. 3,685,058 to Tronzo (Tronzo).
Regarding at least claim 1
Lewis teaches an orthopaedic joint assembly that includes a hip cup having a fastener that may be positioned in a multitude of angular positions within the bone, for the purpose of aligning the fastener where the bone of that particular patient is best (paragraph 0120).
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Lewis meets the limitations of a surgical implant (400) comprising: a hemispherical cup (402) having (i) a bone-abutment exterior surface (426) defining a convex side of the cup (fig. 4) and (ii) an interior surface (430) defining a concave side of the cup with a cavity (fig. 4); and a stress-diffusion element comprising a stem (fastener; 410 is construed to be a stem because it resembles the long, thin part of a plant, as shown in fig. 4) extending directly from the bone-abutment exterior surface of the hemispherical cup at an anteverted orientation to the hemispherical cup (fig. 15 shows that the stress-diffusion element extends directly from the bone-abutment exterior surface of the cup and paragraphs 0147-0148 disclose that each of the fasteners may be positioned in a multitude of positions/orientations to accomplish locations that are compatible with portions of the acetabulum more suitable for securement of the hip cup assembly to the acetabulum; therefore, the stress-diffusion element/fastener of Lewis is at least fully capable of extending at an anteverted orientation to the hemispherical cup as claimed).
Lewis also teaches that the fastener/stem (410) may include not include threads or may be smooth, for example in the form of a peg that includes a bone growth-enhancing feature (paragraphs 0109-0110). However, Lewis does not teach wherein the stem (410) includes a plurality of longitudinal flutes extending to a tip of the stem and configured for forming grooves in the bone.
Tronzo teaches treatment of hip joints including a socket (20) having a hemispherical hollow body which is adapted to be mounted in the acetabulum (col. 2, lines 64-66) and includes a nail (stem; 21) which has extended over its full length (i.e., to a tip) three tapering (24) flutes (22) which are equally and circumferentially placed (col. 3, lines 1-4 and fig. 2), for the purpose of aiding in the seating of the nail within the bone. The longitudinal flutes of Tronzo are configured for forming grooves in bone in the same way as applicant’s since they have the same structure.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the stem of Lewis, which is intended to attach the orthopaedic implant to bone, to include a plurality of longitudinal flutes extending to a tip of the stem and configured for forming grooves in the bone, in order to aid in the seating of the nail/stem within the bone, as implicitly taught by Tronzo.
Regarding at least claim 3
Lewis in view of Tronzo teaches the surgical implant of claim 1. Lewis further teaches at least one aperture defined by a circumferential surface extending between the bone-abutment exterior surface and the interior surface (fig. 15 shows apertures through which screws 484 and 486 extend that is defined by a circumferential surface extending between the exterior surface and the interior surface), the at least one aperture configured to receive a screw (484, 486) therethrough (fig. 15).
Regarding at least claim 4
Lewis in view of Tronzo teaches the surgical implant of claim 3. Lewis further teaches wherein the stress-diffusion element is a stem extending from the hemispherical cup (fastener; 410 is construed to be a stem extending from the cup as claimed because it resembles the long, thin part of a plant).
Regarding at least claim 5
Lewis in view of Tronzo teaches the surgical implant of claim 4. Lewis also teaches wherein the stem includes a base formed on the bone- abutment exterior surface of the hemispherical cup (bushing; 466 is construed to be a base formed on the exterior surface of the cup as shown in fig. 15).
Regarding at least claim 6
Lewis in view of Tronzo teaches the surgical implant of claim 5. Lewis also teaches wherein the base is centrally formed between the at least one aperture and another aperture extending between the bone-abutment exterior surface and the interior surface (fig. 15 shows that bushing/base; 466 is centrally formed between two apertures that each extend between the exterior and interior surface as claimed).
Regarding at least claim 7
Lewis in view of Tronzo teaches the surgical implant of claim 4, including the stem having a plurality of longitudinal flutes extending to a tip of the stem. Tronzo further teaches that the longitudinal flutes extend along an entirety of the stem with distal ends of the plurality of longitudinal flutes adjoining at a common point (tip of the stem) and proximal ends tapering (24) at separate points (col. 2, lines 64-67 through col. 3, lines 1-6 and fig. 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the stem of Lewis, which is intended to attach the orthopaedic implant to bone, to specify that each of the plurality of longitudinal flutes extending along an entirety of the stem with (i) distal ends of the plurality of longitudinal flutes adjoining at a common point, and (ii) proximal ends of the plurality of longitudinal flutes tapering at separate points, in order to aid in the seating of the nail/stem within the bone, as implicitly taught by Tronzo.
Regarding at least claim 8
Lewis in view of Tronzo teaches the surgical implant of claim 7. Tronzo also teaches wherein adjacent ones of the plurality of longitudinal flutes are spaced from each other by one of a plurality of troughs, and each of the plurality of troughs includes sidewalls and a bottom wall (col. 2, lines 64-67 through col. 3, lines 1-6 discloses three flutes; 22 of Tronzo equally circumferentially placed such that the flutes are spaced from each other by one of a plurality of troughs/sidewalls and a bottom wall, as shown in annotated fig. 2 below).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the stem of Lewis in view of Tronzo to further specify wherein adjacent ones of the plurality of longitudinal flutes are spaced from each other by one of a plurality of troughs, and each of the plurality of troughs includes sidewalls and a bottom wall, in order to aid in the seating of the nail/stem within the bone, as implicitly taught by Tronzo.
Regarding at least claim 9
Lewis in view of Tronzo teaches the surgical implant of claim 8. Tronzo also teaches the plurality of longitudinal flutes that are spaced from each other by one of a plurality of troughs. However, Tronzo does not teach wherein each of the plurality of troughs includes an increasing depth along the stem.
There is no evidence of record that establishes that increasing the depth of the plurality of troughs along the stem would result in a difference in function of the Tronzo device. Further, a person having ordinary skill in the art, being faced with modifying the stem of Tronzo, 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 troughs that include an increasing depth along the stem. Lastly, applicant has not disclosed that the claimed depth increase solves any stated problem, indicating that the stem may not even require flutes, and therefore the troughs which separate the flutes from one another (para. [0049]), and therefore there appears to be no criticality placed on the trough depth 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 plurality of troughs to include an increasing depth along the stem as an obvious matter of design choice within the skill of the art.
Regarding at least claim 10
Lewis in view of Tronzo teaches the surgical implant of claim 8. Tronzo also teaches the plurality of longitudinal flutes. However, Tronzo does not teach wherein each of the plurality of longitudinal flutes includes a plateau along a portion thereof with an increasing width along the stem.
There is no evidence of record that establishes that including a plateau along a portion of each of the plurality of longitudinal flutes with an increasing width along the stem would result in a difference in function of the Tronzo device. Further, a person having ordinary skill in the art, being faced with modifying the stem of Tronzo, 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 plateau along a portion of each of the plurality of longitudinal flutes with an increasing width along the stem. Lastly, applicant has not disclosed that the claimed plateau with an increasing width along the stem solves any stated problem, indicating that the stem may not even require flutes, and therefore the claimed plateau with an increasing width (para. [0049]), and therefore there appears to be no criticality placed on the plateau with increasing width 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 each of the plurality of longitudinal flutes to include a plateau along a portion thereof with an increasing width along the stem, as an obvious matter of design choice within the skill of the art.
Regarding at least claim 11
Lewis in view of Tronzo teaches the surgical implant of claim 8. Tronzo also teaches the plurality of longitudinal flutes, wherein each of the plurality of longitudinal flutes surrounds a portion of the adjacent ones of the plurality of troughs (col. 2, lines 64-67 through col. 3, lines 1-6 discloses that the flutes; 22 are equally circumferentially placed such that the flutes are spaced from each other by one of a plurality of troughs/sidewalls such that a portion of the adjacent ones of the troughs are surrounded by each of the flutes, as claimed).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the stem of Lewis in view of Tronzo to further specify wherein each of the plurality of longitudinal flutes surrounds a portion of the adjacent ones of the plurality of troughs, in order to aid in the seating of the nail/stem within the bone, as implicitly taught by Tronzo.
Regarding at least claim 12
Lewis in view of Tronzo teaches the surgical implant of claim 8. Tronzo also teaches the sidewalls of each of the plurality of troughs, wherein the sidewalls of each of the plurality of troughs converge (see annotated fig. 2 below).
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Regarding at least claim 13
Lewis in view of Tronzo teaches the surgical implant of claim 3. Lewis also teaches wherein the at least one aperture includes four apertures arranged equidistant relative to each other along the hemispherical cup (fig. 16 and 16A show four apertures arranged equidistant relative to each other, depending on the anatomical requirements of the individual patient’s bone, for the purpose of securing the cup to the acetabulum).
Regarding at least claim 14
Lewis in view of Tronzo teaches the surgical implant of claim 3. Lewis also teaches wherein, the at least one aperture is a plurality of apertures, the plurality of apertures are equidistant relative to each other along the cup, and the stress-diffusion element extends from a point on the bone-abutment exterior surface (figs. 15 and 15A show a plurality/two apertures equidistant relative to each other and the stress diffusion element/fastener that extends from a point on the exterior surface).
Claim(s) 6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tronzo in view of US Patent No. 9,248,023 B2 to Ries et al. (Ries).
Regarding at least claim 6
Tronzo teaches the surgical implant of claim 5. Tronzo also teaches wherein the base is centrally formed between at least one protruding spike and another protruding spike as shown in fig. 2. In addition to the at least one aperture that receives the screw/threaded end of the tool, Tronzo further teaches three evenly circumferentially spaced protruding spikes (26), for the purpose of engaging the acetabulum and preventing rotation of the socket (col. 3, lines 6-10). However, Tronzo does not teach at least one aperture and another aperture extending between the bone-abutment exterior surface and the interior surface.
Ries teaches an acetabular prosthetic device for implantation in an iliac canal and acetabulum of an ilium comprising a stem and an acetabular component (abstract). In addition to the stem, Ries also teaches one or more secondary fixation means, which are bone screws inserted through apertures, that may be used to secure the device to the acetabular bone (col. 11, lines 15-21 and figs. 22-23).
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 acetabular component of Tronzo by substituting the evenly circumferentially spaced protruding spikes with apertures that receive bone screws, and particularly including at least one aperture and another aperture extending between the bone-abutment exterior surface and the interior surface, as taught by Ries, since both elements perform the function of fixing the device to the acetabular bone and also since the substitution of one known element for another yields predictable results to one of ordinary skill in the art (see MPEP 2143).
Regarding at least claim 13
Tronzo in view of Ries teaches the surgical implant of claim 3. Tronzo in view of Ries also teaches wherein the at least one aperture includes a plurality of apertures arranged equidistant relative to each other along the hemispherical cup. However, Tronzo in view of Ries does not explicitly teach four apertures.
Ries also teaches one or more secondary fixation means, which are bone screws inserted through apertures, that may be used to secure the device to the acetabular bone (col. 11, lines 15-21 and figs. 22-23). As seen in Fig. 23, the fixation means include a plurality of bone screws received in apertures depending on the individual anatomical requirements of the patient and, as such, the number of apertures, and therefore bone screws, is disclosed to be a result effective variable in that changing the amount of fixation means changes the fixation to the bone which affects the stability of the device when implanted. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Ries device to have a number of apertures that is four, as it involves only adjusting the amount of a component disclosed to be dependent on the anatomical requirements of the individual patient. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Ries by making the plurality of apertures of the fixation means be four as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Lastly, applicant has not disclosed that the claimed number of apertures solves any stated problem, indicating that the at least one aperture “may” include two sets of apertures, i.e., four apertures, and offering other acceptable ranges (e.g., one set of apertures, specification at para. [0017]) and therefore there appears to be no criticality placed on the four apertures as claimed such that it produces an unexpected result.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tronzo.
Regarding at least claim 9
Tronzo teaches the surgical implant of claim 8. Tronzo also teaches the plurality of longitudinal flutes that are spaced from each other by one of a plurality of troughs. However, Tronzo does not teach wherein each of the plurality of troughs includes an increasing depth along the stem.
There is no evidence of record that establishes that increasing the depth of the plurality of troughs along the stem would result in a difference in function of the Tronzo device. Further, a person having ordinary skill in the art, being faced with modifying the stem of Tronzo, 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 troughs that include an increasing depth along the stem. Lastly, applicant has not disclosed that the claimed depth increase solves any stated problem, indicating that the stem may not even require flutes, and therefore the troughs which separate the flutes from one another (para. [0049]), and therefore there appears to be no criticality placed on the trough depth 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 plurality of troughs to include an increasing depth along the stem as an obvious matter of design choice within the skill of the art.
Regarding at least claim 10
Tronzo teaches the surgical implant of claim 8. Tronzo also teaches the plurality of longitudinal flutes. However, Tronzo does not teach wherein each of the plurality of longitudinal flutes includes a plateau along a portion thereof with an increasing width along the stem.
There is no evidence of record that establishes that including a plateau along a portion of each of the plurality of longitudinal flutes with an increasing width along the stem would result in a difference in function of the Tronzo device. Further, a person having ordinary skill in the art, being faced with modifying the stem of Tronzo, 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 plateau along a portion of each of the plurality of longitudinal flutes with an increasing width along the stem. Lastly, applicant has not disclosed that the claimed plateau with an increasing width along the stem solves any stated problem, indicating that the stem may not even require flutes, and therefore the claimed plateau with an increasing width (para. [0049]), and therefore there appears to be no criticality placed on the plateau with increasing width 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 each of the plurality of longitudinal flutes to include a plateau along a portion thereof with an increasing width along the stem, as an obvious matter of design choice within the skill of the art.
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.
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/M.A.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774