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 .
Drawings
The drawings are objected to because Fig. 10 includes two reference characters “7”, one of which points to the patellar bone, and the other appears to redundantly point to the patellar articular surface, which is already designated as reference character “26”. 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
Claims 24 and 31 is objected to because of the following informalities: Claim 24 recites “of second dimple” in line 2, which appears to be missing the word – the –. Claim 31, line 20, recites “an anchor comprising configured”, which appears to include a grammatical error in which the word – comprising – should be removed. 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 21-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21, lines 13-14 recites “a second bone facing surface of the trochlear groove implant”. It is unclear whether this limitation is referring to the “femur facing surface” recited previously in the claim or a separate, additional surface of the trochlear groove implant. For the purpose of further examination, the examiner interprets the “second bone facing surface” to be the same as the “femur facing surface”.
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) 21, 28, and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 6,616,696 B1 to Merchant (Merchant).
Regarding claim 21
Merchant discloses a trochlear implant (130) for a prosthetic knee that cooperates with a patellar implant (112) (abstract).
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Merchant meets the limitations of an implant system for a knee (fig. 9) comprising:
(a) a patella implant (112) comprising a patella implant body (body of implant; 112) extending between a patella bone facing surface (fig. 3 shows a patella bone facing surface that is opposite to the bearing surface; 124) and an articular facing surface (bearing surface; 124) configured to face towards a patient's trochlear groove when the patella implant is implanted at an implant site (col. 3, lines 57-65 discloses that the patellar implant has an apex 134 that aligns with a longitudinal axis 136 forming a trochlear groove), wherein the patella bone facing surface comprises a mounting component configured to secure the patella implant to a patella bone (fig. 3 shows a mounting component configured to install the patellar implant in a patella in a knee as disclosed in col. 2, lines 45-47), and wherein the articular surface (124) has a
truncated spherical curvature (col. 4, lines 42-44 discloses a substantially spherical, dome-shaped patellar implant which is construed to have a truncated spherical curvature as claimed);
(b) a trochlear groove implant (130) comprising a trochlear groove implant body (body of implant 130) extending between a femur facing surface (back surface; 154) and a load bearing surface (articulation surface; 132), wherein the load bearing surface is configured to articulate with the articular facing surface of the patella
Implant (col. 3, lines 57-65 discloses that the articulation surface 132 is shaped to slidably receive a portion of the bearing surface 124 of the patellar implant 112); and
(c) an anchor (col. 5, lines 6-9 disclose that the trochlear implant is fixed to the femur using screws; at least one of the screws used to fix the trochlear implant; 130 to the femur is construed to be an anchor) comprising
(i) a coupling region configured to removably couple to a second bone facing
surface of the trochlear groove implant (the head of the screw is construed to be a coupling region that is fully capable of removably coupling to a second bone facing surface of the trochlear groove implant; 130 – it is noted that the second bone facing surface is interpreted to be the femur facing surface in view of the 112 rejection above), and
(ii) a securing region having one or more securing elements extending outwardly
from an external surface of the securing region and configured to be disposed
into a femur so as to secure the anchor and the trochlear groove implant to the
femur (screw threads of the screw are construed to be one or more securing elements extending outwardly from an external surface of a shaft/securing region and configured to be disposed into a femur to secure the anchor and the trochlear implant to the femur as claimed).
Regarding claim 28
Merchant teaches the implant system of claim 21, wherein a perimeter of the patella implant body is configured to abut against a portion of the patella bone surrounding the perimeter of the patella implant body (fig. 9 shows that a perimeter of the patella implant body is configured to abut against a portion of the patella bone; 106 as claimed).
Regarding claim 29
Merchant teaches the implant system of claim 21, wherein the mounting component is selected from a group consisting of bone cement, one or more pegs, hooks, protrusions, ribs, cut-outs, screws, and anchors (the mounting component shown in fig. 3 is a protrusion).
[AltContent: arrow][AltContent: textbox (Mounting portion that is a protrusion)]
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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) 22-26 and 31-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merchant in view of US Patent Application Publication No. 2007/0265708 A1 to Brown (Brown).
Regarding claim 22
Merchant teaches the implant system of claim 21, including a patella implant (112). However, Merchant does not teach wherein the patella implant comprises a first dimple and a second dimple.
Brown teaches a patellar implant that includes a posterior portion, which defines an articulating surface and a first retaining feature, and an anterior portion, which defines a tissue engaging portion and a second retaining feature (abstract).
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More specifically, a collection of passages (dimples; 48) are formed substantially, but not entirely, through the posterior portion (12), for the purpose of providing, in combination with bridge (50), an engagement surface when securing the modular patella system to an implant site with sutures (paragraph 0043 and fig. 5).
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 patella implant of Merchant to include a first dimple and a second dimple, in order to provide an engagement surface when securing the modular patella system to an implant site with sutures, as taught by Brown.
Regarding claim 23
Merchant in view of Brown teaches the implant system of claim 22. Brown also teaches wherein at least one of a load bearing surface of the first and second dimple has a circular or an elongated oval shape (fig. 5 shows a circular shape on the edges of each dimple; 48 which form a portion of the load bearing posterior surface as disclosed in paragraph 0043).
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 dimples of Brown to specify that at least one of a load bearing surface of the first and second dimple has a circular or an elongated oval shape, in order to provide an engagement surface, in combination with bridge (50), when securing the modular patella system to an implant site with sutures, as taught by Brown.
Regarding claim 24
Merchant in view of Brown teaches the implant system of claim 22. Brown also teaches an area of a load bearing surface of the first and second dimple, as shown in fig. 3. However, Brown does not teach wherein an area of a load bearing surface of the first dimple is at least 50% greater than an area of a load bearing surface of second dimple.
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 first dimple of Brown to have an area of a load bearing surface that is 50% greater than an area of a load bearing surface of the second dimple since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Brown would not operate differently with the claimed load bearing surface area proportions of each dimple and since the load bearing surface area of each dimple is intended to cooperate with surface of a trochlear groove, the device would function appropriately having the claimed load bearing surface area proportions of each dimple. Further, it appears that applicant places no criticality on the proportions claimed, indicating simply that the area of the load bearing surface of the lateral dimple “may” be larger than the area of the load bearing surface of the medial dimple (specification pages 12-13).
Regarding claim 25
Merchant in view of Brown teaches the implant system of claim 22. Brown also teaches an area of a load bearing surface of the first and second dimple, as shown in fig. 3. However, Brown does not teach wherein an area of a load bearing surface of the first dimple is larger than an area of a load bearing surface of the second dimple.
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 first dimple of Brown to have an area of a load bearing surface that is larger than an area of a load bearing surface of the second dimple since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Brown would not operate differently with the claimed load bearing surface area proportions of each dimple and since the load bearing surface area of each dimple is intended to cooperate with surface of a trochlear groove, the device would function appropriately having the claimed load bearing surface area proportions of each dimple. Further, it appears that applicant places no criticality on the proportions claimed, indicating simply that the area of the load bearing surface of the lateral dimple “may” be larger than the area of the load bearing surface of the medial dimple (specification pages 12-13).
Regarding claim 26
Merchant in view of Brown teaches the implant system of claim 22. Brown also teaches wherein the first dimple and the second dimple are aligned along a common plane, wherein the common plane extends through a central region of the patella implant, wherein the common plane extends perpendicular to a direction of movement of the patella implant relative to the articulating surface of the trochlear groove implant (fig. 15 shows that the dimples; 48 are aligned along a common plane that extends through a central region of the patella implant as claimed).
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 first dimple and the second dimple are aligned along a common plane, wherein the common plane extends through a central region of the patella implant, wherein the common plane extends perpendicular to a direction of movement of the patella implant relative to the articulating surface of the trochlear groove implant, in order to provide an engagement surface, in combination with bridge (50), when securing the modular patella system to an implant site with sutures, as taught by Brown.
Regarding claim 30
Merchant teaches the implant system of claim 21. Merchant also teaches a porous coating on the back surface of the trochlear implant (col. 5, lines 2-3). However, Merchant does not explicitly teach wherein the patella implant body comprises a coating configured to promote bone regrowth and/or regrowth of a patient's native articular cartilage.
Brown teaches a patellar implant that includes a posterior portion, which defines an articulating surface and a first retaining feature, and an anterior portion, which defines a tissue engaging portion and a second retaining feature (abstract). Brown also teaches that the implant comprises a porous coating, for the purpose of encouraging bone and tissue ingrowth (paragraphs 0061 and 0069).
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 patella implant body to include a coating configured to promote bone regrowth and/or regrowth of a patient’s native articular cartilage, in order to encourage bone and tissue ingrowth, as taught by Brown.
Regarding claim 31
Merchant also meets the limitations of an implant system for a knee (fig. 2) comprising:
(a) a patella implant (112) comprising
(i) a patella implant body (body of implant; 112) extending between a patella bone facing surface (surface opposite bearing surface; 124 as shown in fig. 3) and an articular facing surface (124) configured to face towards a patient's trochlear
groove when the patella implant is implanted at an implant site (fig. 3), wherein the
patella bone facing surface comprises a mounting component configured to
secure the patella implant to a patella bone (fig. 3 shows a mounting component extending from the bone facing surface of the patella implant), wherein the articular surface has a truncated spherical curvature (col. 4, lines 42-44 discloses a substantially spherical, dome-shaped patellar implant which is construed to have a truncated spherical curvature as claimed);
(b) a trochlear groove implant (130) comprising a trochlear groove implant body (body of implant; 130) extending between a femur facing surface (back surface; 154) and a load bearing surface (articulation surface; 132), wherein the load bearing
surface is configured to articulate with the articular facing surface of the patella
implant (col. 3, lines 57-65 discloses that the articulation surface 132 is shaped to slidably receive a portion of the bearing surface 124 of the patellar implant 112); and
(c) an anchor comprising configured to be disposed in a femur so as to secure the anchor and the trochlear groove implant to the femur (col. 5, lines 6-9 disclose that the trochlear implant is fixed to the femur using screws; at least one of the screws used to fix the trochlear implant; 130 to the femur is construed to be an anchor).
However, Merchant does not teach (ii) a first and second dimple each being formed in the articular facing surface, the first and second dimple each having a load bearing surface configured to engage against the articulating surface of said femur, so as to increase a contact area between the articulating facing surface and the articulating surface of said femur; wherein the first dimple comprises a medial dimple and the second dimple comprises a lateral dimple configured to articulate against a medial facet
and a lateral facet, respectively, of a trochlear groove of said femur.
Brown teaches a patellar implant that includes a posterior portion, which defines an articulating surface and a first retaining feature, and an anterior portion, which defines a tissue engaging portion and a second retaining feature (abstract).
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More specifically, a collection of passages (dimples; 48) are formed substantially, but not entirely, through the posterior portion (articular facing surface; 12), for the purpose of providing, in combination with bridge (50), an engagement surface when securing the modular patella system to an implant site with sutures (paragraph 0043 and fig. 5). Because they are located on the posterior portion (articular facing surface; 12), the passages (dimples; 48) each have a load bearing surface configured to engage against the articulating surface of said femur, and are construed to increase a contact area between the articulating facing surface and the articulating surface of said femur, in the same way as applicant’s. It can also be seen from fig. 5 that the passages (dimples; 48) include a medial dimple and a lateral dimple configured to articulate against a medial facet and a lateral facet, respectively, of a trochlear groove of said femur, in the same way as applicant’s.
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 patella implant of Merchant to include (ii) a first and second dimple each being formed in the articular facing surface,
the first and second dimple each having a load bearing surface configured to
engage against the articulating surface of said femur, so as to increase a contact
area between the articulating facing surface and the articulating surface of said
femur; wherein the first dimple comprises a medial dimple and the second
dimple comprises a lateral dimple configured to articulate against a medial facet
and a lateral facet, respectively, of a trochlear groove of said femur, in order to provide an engagement surface, in combination with bridges (50), when securing the modular patella system to an implant site with sutures, as taught by Brown.
Regarding claim 32
Merchant in view of Brown teaches the implant system of claim 31. Merchant also teaches the use of cobalt-chrome-molybdenium as suitable material for manufacturing an implant (col. 4, lines 45-48). However, Merchant does not explicitly teach wherein at least a portion of the patella implant comprises a material selected from the group consisting of chromium alloys, titanium alloys, stainless steel alloys, polyethylene based plastics, ceramics, and a combination of two or more thereof.
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 at least a portion of the patella implant comprises a material selected from the group consisting of chromium alloys, titanium alloys, stainless steel alloys, polyethylene based plastics, ceramics, and a combination of two or more thereof, 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 33
Merchant in view of Brown teaches the implant system of claim 31. Merchant also teaches wherein a perimeter of the patella implant body is configured to abut against a portion of the patella bone surrounding the perimeter of the patella implant body (fig. 9 shows that a perimeter of the patella implant body is configured to abut against a portion of the patella bone; 106 as claimed).
Regarding claim 34
Merchant in view of Brown teaches the implant system of claim 31. Merchant also teaches wherein the mounting component is selected from a group consisting of bone cement, one or more pegs, hooks, protrusions, ribs, cut-outs, screws, and anchors (the mounting component shown in fig. 3 is a protrusion).
Regarding claim 35
Merchant in view of Brown teaches the implant system of claim 31. Merchant also teaches a porous coating on the back surface of the trochlear implant (col. 5, lines 2-3). However, Merchant does not explicitly teach wherein the patella implant body comprises a coating configured to promote bone regrowth and/or regrowth of a patient's native articular cartilage.
Brown teaches a patellar implant that includes a posterior portion, which defines an articulating surface and a first retaining feature, and an anterior portion, which defines a tissue engaging portion and a second retaining feature (abstract). Brown also teaches that the implant comprises a porous coating, for the purpose of encouraging bone and tissue ingrowth (paragraphs 0061 and 0069).
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 patella implant body to include a coating configured to promote bone regrowth and/or regrowth of a patient’s native articular cartilage, in order to encourage bone and tissue ingrowth, as taught by Brown.
Regarding claim 36
Merchant in view of Brown teaches the implant system of claim 31. Brown also teaches wherein at least one of a load bearing surface of the first and second dimple has a circular or an elongated oval shape (fig. 5 shows a circular shape on the edges of each dimple; 48 which form a portion of the load bearing posterior surface as disclosed in paragraph 0043).
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 dimples of Brown to specify that at least one of a load bearing surface of the first and second dimple has a circular or an elongated oval shape, in order to provide an engagement surface, in combination with bridge (50), when securing the modular patella system to an implant site with sutures, as taught by Brown.
Regarding claim 37
Merchant in view of Brown teaches the implant system of claim 31. Brown also teaches an area of a load bearing surface of the first and second dimple, as shown in fig. 3. However, Brown does not teach wherein an area of a load bearing surface of the first dimple is larger than an area of a load bearing surface of the second dimple.
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 first dimple of Brown to have an area of a load bearing surface that is larger than an area of a load bearing surface of the second dimple since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Brown would not operate differently with the claimed load bearing surface area proportions of each dimple and since the load bearing surface area of each dimple is intended to cooperate with surface of a trochlear groove, the device would function appropriately having the claimed load bearing surface area proportions of each dimple. Further, it appears that applicant places no criticality on the proportions claimed, indicating simply that the area of the load bearing surface of the lateral dimple “may” be larger than the area of the load bearing surface of the medial dimple (specification pages 12-13).
Regarding claim 38
Merchant in view of Brown teaches the implant system of claim 31. Brown also teaches wherein the first dimple and the second dimple are aligned along a common plane, wherein the common plane extends through a central region of the patella implant, wherein the common plane extends perpendicular to a direction of movement of the patella implant relative to the articulating surface of the trochlear groove implant (fig. 15 shows that the dimples; 48 are aligned along a common plane that extends through a central region of the patella implant as claimed).
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 first dimple and the second dimple are aligned along a common plane, wherein the common plane extends through a central region of the patella implant, wherein the common plane extends perpendicular to a direction of movement of the patella implant relative to the articulating surface of the trochlear groove implant, in order to provide an engagement surface, in combination with bridge (50), when securing the modular patella system to an implant site with sutures, as taught by Brown.
Regarding claim 39
Merchant in view of Brown teaches the implant system of claim 31. Brown also teaches an area of a load bearing surface of the first and second dimple, as shown in fig. 3. However, Brown does not teach wherein an area of a load bearing surface of the first dimple is at least 50% greater than an area of a load bearing surface of second dimple.
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 first dimple of Brown to have an area of a load bearing surface that is 50% greater than an area of a load bearing surface of the second dimple since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Brown would not operate differently with the claimed load bearing surface area proportions of each dimple and since the load bearing surface area of each dimple is intended to cooperate with surface of a trochlear groove, the device would function appropriately having the claimed load bearing surface area proportions of each dimple. Further, it appears that applicant places no criticality on the proportions claimed, indicating simply that the area of the load bearing surface of the lateral dimple “may” be larger than the area of the load bearing surface of the medial dimple (specification pages 12-13).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merchant.
Merchant teaches the implant system of claim 21. Merchant also teaches the use of cobalt-chrome-molybdenium as suitable material for manufacturing an implant (col. 4, lines 45-48). However, Merchant does not explicitly teach wherein at least a portion of the patella implant comprises a material selected from the group consisting of chromium alloys, titanium alloys, stainless steel alloys, polyethylene based plastics, ceramics, and a combination of two or more thereof.
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 at least a portion of the patella implant comprises a material selected from the group consisting of chromium alloys, titanium alloys, stainless steel alloys, polyethylene based plastics, ceramics, and a combination of two or more thereof, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
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
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
