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 .
Response to Arguments
Applicant's arguments filed 2/12/2026 have been fully considered, but they are not persuasive. The Applicant contends that Fisher does not recite a first and a second rounded periphery that matches the Applicant’s rounded peripheries which are intentionally rounded along a vertical direction. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., peripheries that are intentionally rounded along a vertical direction) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Absent an explicit definition in the specification, the phrase “rounded periphery” is being given its broadest, reasonable interpretation. The phrase is being interpreted as the external boundary of any surface or area that is round or curved; not angular (“periphery.” “rounded.” “round.” Collins English Dictionary-Complete and Unabridged Digital Edition). In view of this interpretation of the claim language, it maintained that Fisher reads on the present claim language as it discloses implants with shapes that have rounded, cylindrical shapes with upper and lower rounded/curved peripheries (Figure A; Figs. 3-7C, 9A-13A).
The Applicant also contends that Fisher, Truncale, and Bursac do not recite a multiplicity of surface features configured to promote bone growth into the cylindrical sidewall. The examiner respectfully disagrees. The primary reference, Fisher, teaches a multiplicity of surface features (e.g., pores) that are configured to promote bone growth into the cylindrical sidewall (Figs. 11A-13A; abstract; paras. 0141-0143). In view of these disclosures by the prior art, the rejections over Fisher and Truncale have been maintained, as described below.
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.
Claims 1-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fisher et al. (WO 2010/114578 A1; hereinafter “Fisher”) in view of Truncale et al. (Pub. No. US 2009/0291112 A1; hereinafter “Truncale”).
Fisher teaches the following regarding claim 1: a tapered monophasic implant treatment system for treating osteochondral/subchondral defects, comprising: one or more grafts (e.g., Figs. 11A-13A); a top portion (e.g., 94, 101) configured to approximate an osteochondral surface to be replaced (Figs. 11A-13A) and including a positive or negative curvature height to ensure compatibility with surrounding cartilage tissue (Figs. 11A-13A); a bottom portion (Figure A, below) configured to fit into an osteochondral hole (para. 0032); a cylindrical sidewall (Figure A) extending between the top portion and the bottom portion (Figure A; Figs. 11a-13A), the cylindrical sidewall including: a taper characterized by a taper half-angle (Figs. 11A-13A; paras. 0032, 00153, where the device is stabilized within its implantation site upon the device’s full assembly), wherein the taper prevents subsidence of the implant into the osteochondral hole (Figs. 11A-13A; paras. 0032, 153); a multiplicity of surface features (e.g., pores) configured to promote bone growth into the cylindrical sidewall (Figs. 11A-13A; paras. 0141-0143); a first rounded periphery (Figure A) joining the top portion and the cylindrical sidewall (Figs. 11A-13A), providing a smooth transition surface to minimize damage to surrounding tissues (Figs. 11A-13A); a second rounded periphery (Figure A) joining the cylindrical sidewall and the bottom portion (Figure A; Figs. 11A-13A), configured to prevent damage to an interior wall of the osteochondral hole during insertion (Figure A; Figs. 11A-13A).
Fisher teaches the limitations of the claimed invention, as described above. However, it does not explicitly recite that the height of the implant is configured to place the bottom portion in contact with a base of the osteochondral hole while elevating the top portion above the surrounding cartilage tissue. Truncale teaches that it is well known in the art that osteochondral implants are provided with a variety of sizes, such that it has a height configured to place the bottom portion in contact with a base of the osteochondral hole while elevating the top portion above the surrounding cartilage tissue (paras. 0040-0049, 0052), in order to provide the implant with the dimensions needed to best suit the implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the height of the implant of Fisher according to the teachings of Truncale, for the purpose of providing the implant with the appropriate dimensions needed to best suit the implantation site. Such a modification would be made with a reasonable expectation of success.
PNG
media_image1.png
383
514
media_image1.png
Greyscale
Figure A.
Please note that claim recitations defining how and where the applicant’s invention is used are considered to be intended use limitations. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Fisher teaches the following regarding claim 2: the system of claim 1, wherein the one or more grafts each comprises a cartilage layer (upper layer) coupled with a bone portion (lower layer) suitable for treating the osteochondral/subchondral defect (Figs. 11A-13A; paras. 0030-0032).
Fisher teaches the following regarding claim 3: the system of claim 2, wherein the cartilage layer is comprised of a material that closely matches existing cartilage at an implant location (Figs. 11A-13A; paras. 0030-0032).
Fisher teaches the following regarding claim 4: the system of claim 2, wherein the cartilage layer is comprised of a synthetic implantable material (para. 00103).
Regarding claim 5, Fisher teaches the limitations of the claimed invention, as described above. However, it does not explicitly recite that the one or more grafts is a xenograft. Truncale teaches that it is well known in the art that osteochondral implants comprise a xenograft (paras. 0081-0088), in order to utilize the biocompatibility of the material and promote healing. It would have been obvious to one having ordinary skill in the art to modify the implant of Fisher to comprise a xenograft, as taught by Truncale, for the purpose of utilizing the biocompatibility of the material and promoting healing. 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, replacing one type of implant material for another, is generally considered to be within the level of ordinary skill in the art.
Regarding claim 6, Fisher teaches the limitations of the claimed invention, as described above. However, it does not explicitly recite that the one or more grafts is an allograft; and that the cartilage layer has a thickness that substantially matches the thickness of existing cartilage at an implant location. Truncale teaches that it is well known in the art that osteochondral implants comprise an allograft (paras. 0050-0052, 0081-0088); and that the upper cartilage layer is provided with a desired thickness that can substantially match the implantation site (paras. 0040-0052). These features allow the implant to utilize the biocompatibility and durability of the material, and provide the implant with the dimensions needed to best suit the implantation site. It would have been obvious to one having ordinary skill in the art to modify the implant of Fisher to comprise an allograft and the desired thickness dimensions, as taught by Truncale, for the purpose of utilizing the biocompatibility and durability of the material, and providing the implant with the dimensions needed to best suit the implantation site. 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, replacing one type of implant material for another, is generally considered to be within the level of ordinary skill in the art.
Regarding claim 7, Fisher teaches the limitations of the claimed invention, as described above. However, it does not explicitly recite that the one or more grafts include diameters and lengths that depend upon the particular bone joints into which the one or more grafts are to be implanted, the diameters and lengths being configured to correlate with one another and ranging from relatively small to relatively large. Truncale teaches that it is well known in the art that osteochondral implants are provided with a variety of sizes, such that the diameters and lengths that depend upon the particular bone joints into which the one or more grafts are to be implanted, and they are being configured to correlate with one another and ranging from relatively small to relatively large (paras. 0040-0052), in order to provide the implant with the dimensions needed to best suit the implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the dimensions of the implant of Fisher according to the teachings of Truncale, for the purpose of providing the implant with the appropriate dimensions needed to best suit the implantation site. Such a modification would be made with a reasonable expectation of success.
Fisher teaches the following regarding claim 8: the system of claim 1, wherein the one or more grafts are comprised of a homogenous synthetic material, a homogenous natural material, or a combination thereof (para. 00103).
Fisher teaches the following regarding claim 9: the system of claim 8, wherein the one or more grafts are comprised of any one or more of collagen, animal allograft, human allograft, silicone, bioglass, peek, polyethylene, titanium, and cobalt chrome (paras. 00100-00101).
Regarding claim 11, Fisher, a modified by Truncale, teaches the limitations of the claimed invention, as described above. However, they do not explicitly recite the one or more grafts having a hardness of at least 30 durometer. The optimization of parameters and values 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 implant material hardness needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the implant material hardness, would have been obvious at the time of applicant's invention in view of the teachings of Fisher and Truncale. 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.
Claims 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fisher in view of Truncale, further in view of Bursac et al. (Pub. No. US 2009/0312842; hereinafter “Bursac”).
Fisher as modified by Truncale, teaches the claimed invention, as described above. However, they do not explicitly recite the one or more grafts and a multiplicity of instruments being packaged together in an exterior container suitable for delivery to a practitioner. Bursac teaches that it is well known in the art that a plurality of graft implants and their associated instruments, including a size gauge to indicate depth, an insertion tamp, etc., are packaged together in an exterior container suitable for delivery to a practitioner (paras. 0191, 0212-0221), for the purpose of providing the implantation devices to the user in more convenient manner. It would have been obvious to one having ordinary skill in the art to modify the invention of Fisher and Truncale, to comprise a container for the grafts and the medical instruments, as taught by Bursac, in order to of provide the devices to the user in more convenient manner. Such a modification would be made with a reasonable expectation of success.
Further regarding claim 16, Truncale teaches that it is well known in the art that osteochondral implants are stored in a first sterile container (paras. 0035), in order preserve the implant. It would have been obvious to one having ordinary skill in the art to modify the implant of Fisher, to be stored in a sterile container, as taught by Truncale, for the purpose of preserving the implant. Such a modification would be made with a reasonable expectation of success. Please note that this is product-by-process language which does not alter the structure of the prosthesis.
Please also note that one having ordinary skill in the art would recognize that an instrument kit, storage containers, and the implants would inherently be sterilized, as it is understood to be proper medical practice. Under the doctrine of an inherent disclosure, when a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties (citing Kennecott Corp. v. Kyocera Int’l, Inc., 835 F.2d 1419, 1423 (Fed. Cir. 1987)).
Further regarding claims 17 and 18, it would have been an obvious matter of design choice to one having ordinary skill in the art to modify the invention of Bursac to comprise multiple containers to hold the various surgical instruments, as would be needed to properly package the instruments, and since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Such a modification would be made with a reasonable expectation of success.
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.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANN HU/Primary Examiner, Art Unit 3774