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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/3/2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3 and 6-19 have been considered, but are moot in view of the new grounds of rejection.
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.
Claim 1 and its dependent claims 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. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “a positive or negative curvature height to ensure compatibility with surrounding cartilage tissue,” and the claim also recites “the height of the implant is…elevating the top portion above the surrounding cartilage tissue,” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Appropriate correction is required.
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) 1-3 and 6-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKay (US Pub. No. 2010/0049322) in view of Rhodes (US Pat. No. 8,216,319).
McKay teaches the following regarding claim 1: an osteochondral implant for treating osteochondral/subchondral defects, the implant comprising: a round bottom portion (please see annotated Figure A, below) including a bottom surface (Figure A) for being pressed into an osteochondral hole drilled at a defect area (Fig. 3; para. 0019); the round bottom portion comprising a bottom diameter (Figure A; Fig. 3), wherein a first rounded periphery (Figure A) joins a cylindrical sidewall (Figure A) and the round bottom portion (Figure A; Fig. 3); the first rounded periphery comprising a first transition surface (Figure A) between the round bottom portion and the cylindrical sidewall (Figure A), wherein the round bottom portion is configured to prevent damage to an interior sidewall of the osteochondral hole (Fig. 3; para. 0019); and a second rounded periphery (Figure A) that joins a round top portion (Figure A) and the cylindrical sidewall (Figure A; Fig. 3); the round top portion comprising a top diameter (Fig. 3; para. 0063) the top portion configured to approximate an osteochondral surface to be replaced (Figs. 2B, 3); the second rounded periphery comprising a second transition surface (Figure A) between the round top portion and the cylindrical sidewall (Figure A; Fig. 3); wherein the sidewall comprises a cylindrical (Figure A) and tapered configuration (Figure A) that provides a smooth contact surface to surrounding tissue (Fig. 3; paras. 0019, 0063) wherein the height of the implant is configured to place the bottom portion in contact with a base of the osteochondral hole (Fig. 3; paras. 0019, 0063; due to its size and shape, the bottom surface is fully capable of contacting a bottom of the subchondral hole); wherein a cross-section of the round bottom portion and the round top portion is circular (Fig. 3; para. 0063) and wherein the top diameter is larger than then bottom diameter (Fig. 3).
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Figure A.
Regarding claims 1 and 8-13, McKay teaches the limitations of the claimed invention, as described above. However, it does not explicitly recite the implant comprising a positive or negative curvature height to ensure compatibility with surrounding cartilage tissue; and the implant having a height elevating the top portion above the surrounding cartilage tissue, thereby maintaining proper articulation with adjacent bones and preventing subsidence of the implant. Rhodes teaches that it is well known in the art that bone implants comprise a top surface which includes a positive or negative curvature height to ensure compatibility with surrounding cartilage tissue and a positive curvature that extends to the first rounded periphery (Figs. 7-26, 34; col. 7, lines 12-35). Rhodes further teaches that the implant has a height elevating the top portion above the surrounding cartilage tissue, thereby maintaining proper articulation with adjacent bones and preventing subsidence of the implant (Figs. 7-26, 34; col. 6, lines 50-col. 7, lines 35). This construction provides the implant with the shape, profile, and dimensions needed to best suit the implantation site. A top surface of Rhodes includes a positive curvature that imparts a convex curvature to the round top portion (Figs. 7-26, 34; col. 7, lines 12-35). The positive curvature height is configured to dispose the top surface slightly above cartilage tissue surrounding the defect area to be treated (Figs. 7-26, 34; col. 6, lines 50-col. 7, lines 35). The top surface includes a shape configured to approximate the osteochondral or subchondral surface to be replaced (Figs. 7-26, 34; col. 6, lines 50-col. 7, lines 35). An undersurface (58A-E) of Rhodes extends inward from the first rounded periphery to a cylindrical sidewall comprising the bottom portion (Figs. 7-26, 34; col. 7, lines 12-35); and the undersurface is configured to contact an exterior surface of the cartilage tissue surrounding the defect area to be treated (Figs. 7-26, 34; col. 7, lines 12-35; where the shape of the undersurface allows it to be fully capable of contacting an exterior surface of the cartilage tissue). It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the shape and height of McKay to comprise a positive curvature height above the cartilage, as taught by Rhodes, in order to provide the implant with the shape, profile, and dimensions needed to best suit the implantation site. Such a modification would be made with a reasonable expectation of success.
McKay teaches the following regarding claim 2: the implant of claim 1, wherein at least one of the bottom portion and the top portion comprises any synthetic or natural homogenous material suitable for implantation into bone, including any one or more of collagen, human allograft or human autograft, or animal xenograft, silicone, bioglass, peek, polyethylene, titanium, or cobalt chrome (paras. 0043-0047).
Regarding claim 3, McKay, as modified by Rhodes, teaches the limitations of the claimed invention, as described above. However, they do not disclose at least one of the bottom portion and the top portion comprising a material exhibiting a hardness of at least 30 durometer. The optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal hardness of the implant material needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the hardness of the implant material would have been obvious at the time of applicant's invention in view of the teachings of McKay and Rhodes. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
McKay teaches the following regarding claim 6: the implant of claim 1, wherein the round bottom portion includes a cylindrical sidewall (interpreted as a portion of the same cylindrical sidewall recited in claim 1) having a diameter that decreases from an initial diameter (near the lower, middle portion) at an undersurface (mid-lower portion of the sidewall) to the bottom diameter of the bottom surface (Figure A).
McKay teaches the following regarding claim 7: the implant of claim 6, wherein the decreasing diameter of the cylindrical sidewall is configured to prevent the implant from subsiding into the osteochondral hole (Fig. 3; paras. 0019, 0063). The size and shape of the implant’s sidewall would be fully capable of preventing the implant from subsiding into the osteochondral hole.
McKay teaches the following regarding claim 14: the implant of claim 1, wherein the round bottom portion is configured to be pressed into a subchondral hole such that the bottom surface contacts a bottom of the subchondral hole (Fig. 3; paras. 0019, 0063). Due to its size and shape, the bottom surface is fully capable of contacting a bottom of the subchondral hole.
McKay teaches the following regarding claim 15: the implant of claim 1, wherein the round top portion includes a cylindrical sidewall (Figure A) configured to contact surrounding bone within a subchondral hole (Fig. 3). Due to its size and shape, the sidewall is fully capable of contacting surrounding bone within a subchondral hole. For the present examination, the sidewall of claim 15 is being interpreted as the same sidewall element of claim 1.
McKay teaches the following regarding claim 16: the implant of claim 1, wherein the round bottom portion comprises a first implant material including any of a homogenous synthetic material, a homogenous natural material, or a combination thereof (paras. 0043-0047).
McKay teaches the following regarding claim 17: the implant of claim 16, wherein the first implant material comprises any one or more of collagen, animal xenograft, human allograft, human autograft, silicone, bioglass, peek, polyethylene, titanium, or cobalt chrome (paras. 0043-0047).
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKay, in view of Rhodes, further in view of Schwartz et al. (US Pat. No. 6,468,314; hereinafter Schwartz).
McKay, as modified by Rhodes, teaches the limitations of the claimed invention, as described above. However, they do not explicitly recite a second implant material being used to form a two-piece construct of the implant. Schwartz teaches that it is well known in the art that bone implants have a top portion comprising a second implant material configured to be placed on top of the first implant material to form a two-piece construct of the implant (col. 10, lines 43-col. 11, lines 14), for the purpose of providing different areas of the implant with the structural and physical properties needed to suit the surrounding tissue. Schwartz further teaches that the second implant material comprises any one or more of collagen, animal xenograft, human allograft, human autograft, bioglass, PGA, PLLA, calcium phosphate, silicone, peek, polyethylene, titanium, or cobalt chrome (col. 10, lines 43-col. 11, lines 14). It would have been obvious to one having ordinary skill in the art to modify the materials of McKay and Rhodes to comprise two implant materials, as taught by Schwartz, in order to provide different areas of the implant with the structural and physical properties needed to suit the surrounding tissue. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, the substitution of one known implant material for another, is generally considered to be within the level of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774