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
In view of the amendments filed on 4/30/2026, the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections, cited in the office action of 2/2/2026, are moot.
The double patenting rejections will be held in abeyance until the Applicant has submitted persuasive arguments, an acceptable terminal disclaimer, evidence, and/or amendments to overcome the rejection.
Applicant's arguments filed 4/30/2026 have been fully considered but they are not persuasive. The Applicant contends that Bursac does not disclose the cartilage layer comprising a synthetic implantable material, and the bone portion comprising any one or more of the one or more grafts comprising a monophasic material. The examiner respectfully disagrees. Bursac discloses that its cartilage layer can be made from a synthetic implantable material (paras. 0010, 0143, 0153, 0168). It further states that its bone portion comprising any one or more of the one or more grafts comprises a monophasic material (e.g., Fig. 16D; paras. 0153-0162, 0166, 0207). In view of these recitations of the prior art, the rejections over Bursac have been maintained, as described below.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 11-12, 16-17, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,779,960. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the structural elements and characteristics are disclosed by both sets of claims. Claim 1 of the present application corresponds to claim 1 of the patent. The one or more grafts with a cartilage layer and a bone portion of the application corresponds to the one or more sized grafts comprising a cartilage layer coupled with a bone portion of the patent; the sterile instrument kit comprising instruments of the application corresponds to the at least one sterile instrument kit comprising a multiplicity of instruments of the patent. Claim 2 of the application corresponds to claim 1 of the patent. Claim 3 of the application corresponds to claim 2 of the patent. Claims 4 and 5 of the application correspond to claim 3 of the patent. Claim 6 of the application corresponds to claim 1 of the patent. Claim 7 of the application corresponds to claim 13 of the patent. Claims 11 and 12 of the application correspond to claim 15 of the patent. Claim 16 of the application corresponds to claim 16 of the patent. Claim 17 of the application corresponds to claim 1 of the patent. Claim 20 of the application corresponds to claims 1 and 16 of the patent.
Claims 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,779,960 in view of Thomas et al. (Pub. No.: US 2010/0161073 A1). The patent does not explicitly recite that a central portion of the implant is disposed slightly above the surrounding cartilage; the central portion includes a shape configured to approximate an osteochondral surface to be replaced; and the central portion includes either a convex curvature or a concave curvature configured to approximate the curvature of the osteochondral surface to be replaced. Thomas teaches that it is well known in the art that implants having a cartilage layer comprise a central portion disposed slightly above the surrounding cartilage (para. 0073); the central portion includes a shape configured to approximate an osteochondral surface to be replaced (e.g., Figs. 1-14; paras. 0008-0010); and the central portion includes either a convex curvature or a concave curvature configured to approximate the curvature of the osteochondral surface to be replaced (e.g., Figs. 1-14; paras. 0008-0010). These shapes and dimensions allow the implants to properly fit and repair the patient’s defect. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of the patent to comprise the shapes and dimensions taught by Thomas, as would be needed to properly ensure that the implants properly fit and repair the patient’s defect. Such a modification would be made with a reasonable expectation of success.
Claims 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,779,960 in view of in view of Evans et al. (Pub. No. US 2003/0236573 A1). The patent does not explicitly recite that the cartilage layer comprises polyvinyl alcohol or a biostable polyurethane; and the biostable polyurethane comprises polycarbonate- urethane or thermoplastic silicone-polycarbonate-urethane. Evans teaches that it is well known in the art that implants comprise a polyvinyl alcohol (PVA) or a biostable polycarbonate-urethane (PCU) (para. 0086; Table 1), for the purpose of utilizing the materials’ structural and biocompatible properties. It would have been obvious to one having ordinary skill in the art to modify the device of the patent to comprise the materials taught by Evans, in order to utilize the materials’ structural and biocompatible properties. 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, one type of implant material for another, is generally considered to be within the level of ordinary skill in the art.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,779,960 in view of in view of Bursac et al. (Pub. No.: US 2009/0312842 A1). The patent does not explicitly recite that the implant comprises monophasic material or a xenograft. Bursac teaches that it is well known in the art that implants comprise a monophasic material or a xenograft (paras. 0130, 0153-0162, 0166), for the purpose of utilizing the materials’ structural and biocompatible properties. It would have been obvious to one having ordinary skill in the art to modify the device of the patent to comprise the materials taught by Bursac, in order to utilize the materials’ structural and biocompatible properties. 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, one type of implant material for another, is generally considered to be within the level of ordinary skill in the art.
Claims 1-7, 11-12, 16-17, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,759,335. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the structural elements and characteristics are disclosed by both sets of claims. Claim 1 of the present application corresponds to claim 1 of the patent. The one or more grafts with a cartilage layer and a bone portion of the application corresponds to one or more grafts comprising a cartilage layer coupled with a bone portion of the patent; the sterile instrument kit comprising instruments of the application corresponds to the at least one sterile instrument kit comprising a multiplicity of instruments of the patent. Claim 2 of the application corresponds to claim 1 of the patent. Claim 3 of the application corresponds to claim 2 of the patent. Claims 4-5 of the application correspond to claim 1 of the patent. Claims 6-7 of the application correspond to claim 11 of the patent. Claims 11-12 of the application correspond to claim 13 of the patent. Claim 16 of the application corresponds to claim 1 of the patent. Claim 17 of the application corresponds to claim 1 of the patent. Claim 20 of the application corresponds to claim 1 of the patent.
Claims 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,759,335 in view of Thomas et al. (Pub. No.: US 2010/0161073 A1). The patent does not explicitly recite that a central portion of the implant is disposed slightly above the surrounding cartilage; the central portion includes a shape configured to approximate an osteochondral surface to be replaced; and the central portion includes either a convex curvature or a concave curvature configured to approximate the curvature of the osteochondral surface to be replaced. Thomas teaches that it is well known in the art that implants having a cartilage layer comprise a central portion disposed slightly above the surrounding cartilage (para. 0073); the central portion includes a shape configured to approximate an osteochondral surface to be replaced (e.g., Figs. 1-14; paras. 0008-0010); and the central portion includes either a convex curvature or a concave curvature configured to approximate the curvature of the osteochondral surface to be replaced (e.g., Figs. 1-14; paras. 0008-0010). These shapes and dimensions allow the implants to properly fit and repair the patient’s defect. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of the patent to comprise the shapes and dimensions taught by Thomas, as would be needed to properly ensure that the implants properly fit and repair the patient’s defect. Such a modification would be made with a reasonable expectation of success.
Claims 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,759,335 in view of in view of Evans et al. (Pub. No. US 2003/0236573 A1). The patent does not explicitly recite that the cartilage layer comprises polyvinyl alcohol or a biostable polyurethane; and the biostable polyurethane comprises polycarbonate- urethane or thermoplastic silicone-polycarbonate-urethane. Evans teaches that it is well known in the art that implants comprise a polyvinyl alcohol (PVA) or a biostable polycarbonate-urethane (PCU) (para. 0086; Table 1), for the purpose of utilizing the materials’ structural and biocompatible properties. It would have been obvious to one having ordinary skill in the art to modify the device of the patent to comprise the materials taught by Evans, in order to utilize the materials’ structural and biocompatible properties. 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, one type of implant material for another, is generally considered to be within the level of ordinary skill in the art.
Claim 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,759,335 in view of in view of Bursac et al. (Pub. No.: US 2009/0312842 A1). The patent does not explicitly recite that the implant comprises monophasic material or a xenograft. Bursac teaches that it is well known in the art that implants comprise a monophasic material or a xenograft (paras. 0130, 0153-0162, 0166), for the purpose of utilizing the materials’ structural and biocompatible properties. It would have been obvious to one having ordinary skill in the art to modify the device of the patent to comprise the materials taught by Bursac, in order to utilize the materials’ structural and biocompatible properties. 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, one type of implant material for another, is generally considered to be within the level of ordinary skill in the art.
Claims 1-6, 11-12, 14-17, and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,036,134. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the structural elements and characteristics are disclosed by both sets of claims. Claim 1 of the present application corresponds to claim 1 of the patent. The one or more grafts with a cartilage layer and a bone portion of the application corresponds to the one or more grafts comprising a cartilage layer coupled with a bone portion of the patent; the sterile instrument kit comprising instruments of the application corresponds to the sterile instrument kit comprising a guidewire, size gauge, graft inserter, and at least one other instrument of the patent. Claim 2 of the application corresponds to claims 1 and 2 of the patent. Claims 3-5 of the application correspond to claim 1 of the patent. Claim 6 of the application corresponds to claim 15 of the patent. Claims 11-12 of the application correspond to claim 14 of the patent. Claim 14 of the application corresponds to claim 8 of the patent. Claim 15 of the application corresponds to claim 9 of the patent. Claim 16 of the application corresponds to claim 1 of the patent. Claim 17 of the application corresponds to claim 1 of the patent. Claim 19 of the application corresponds to claim 11 of the patent. Claim 20 of the application corresponds to claim 14 of the patent.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,036,134. 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 lengths and diameters needed to achieve the desired results and to properly fit the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the lengths and the diameters, would have been obvious at the time of applicant's invention. 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 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,036,134 in view of Thomas et al. (Pub. No.: US 2010/0161073 A1). The patent does not explicitly recite that a central portion of the implant is disposed slightly above the surrounding cartilage; the central portion includes a shape configured to approximate an osteochondral surface to be replaced; and the central portion includes either a convex curvature or a concave curvature configured to approximate the curvature of the osteochondral surface to be replaced. Thomas teaches that it is well known in the art that implants having a cartilage layer comprise a central portion disposed slightly above the surrounding cartilage (para. 0073); the central portion includes a shape configured to approximate an osteochondral surface to be replaced (e.g., Figs. 1-14; paras. 0008-0010); and the central portion includes either a convex curvature or a concave curvature configured to approximate the curvature of the osteochondral surface to be replaced (e.g., Figs. 1-14; paras. 0008-0010). These shapes and dimensions allow the implants to properly fit and repair the patient’s defect. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of the patent to comprise the shapes and dimensions taught by Thomas, as would be needed to properly ensure that the implants properly fit and repair the patient’s defect. Such a modification would be made with a reasonable expectation of success.
Claim Rejections - 35 USC § 102
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, 6, 11-12, 16-17, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bursac et al. (Pub. No.: US 2009/0312842 A1; hereinafter “Bursac”).
Bursac discloses the following regarding claim 1: an apparatus for treating osteochondral defects, comprising: one or more grafts (e.g., Figs. 1A-7D, 10A-10D, 16C-16E) comprising a cartilage layer (upper layer portion) and a bone portion (lower layer portion) for implantation in joint locations (paras. 0044, 0010, 0143, 0153-0162, 0166-0168), wherein the cartilage layer comprises a synthetic implantable material (paras. 0010, 0143, 0168), and wherein the bone portion comprising any one or more of the one or more grafts comprises a monophasic material (paras. 0153-0162, 0166); and a sterile instrument kit (para. 0191) comprising instruments configured for implanting the one or more grafts in the joint locations (paras. 0191, 0220, 0227-0238).
Bursac discloses the following regarding claim 6: the apparatus of claim 1, wherein the one or more grafts are configured to be specifically sized grafts to enable a surgeon to select any one or more of the one or more grafts based on the joint location to be treated (paras. 0215-0221, 0230).
Bursac discloses the following regarding claim 11: the apparatus of claim 1, wherein the cartilage layer comprises a material that is suitable for use as artificial cartilage at an implant location (Figs. 1A-7D, 10A-10D, 16C-16E; paras. 0010, 0143, 0168).
Bursac discloses the following regarding claim 12: the apparatus of claim 1, wherein the cartilage layer comprises a thickness configured to be substantially equal to the thickness of existing cartilage at an implant location (Figs. 1A-7D, 10A-10D, 16C-16E).
Bursac discloses the following regarding claim 16: the apparatus of claim 1, wherein the bone portion includes surface features configured to encourage bone tissue growth into the bone portion (e.g., 124, 304, 306; para. 0052, 0061, 0066).
Bursac discloses the following regarding claim 17: the apparatus of claim 16, wherein the surface features comprise dimples and/or circumferentially distributed longitudinal grooves having a hemispherical or rectangular cross-sectional shape (e.g., Figs. 1C, 3A; para. 0062, 0061, 0066).
Bursac discloses the following regarding claim 19: the apparatus of claim 1, wherein any one or more of the one or more grafts is of a xenograft variety that is harvested from a donor species (paras. 0130, 0153-0157).
Bursac discloses the following regarding claim 20: the apparatus of claim 1, wherein any one or more of the one or more grafts is of an allograft variety that is harvested from a cadaver (paras. 0153-0162, 0166-0168, 0205). Please note that method limitations in article claims are considered to the extent that they further defines the structure of the claimed apparatus. As presently worded, the scope of the subject matter fails to structurally distinguish the claimed invention over the prior art.
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bursac in view of Klinger et al. (Pub. No. US 2014/0316531 A1; hereinafter “Klinger”).
Bursac discloses the limitations of the claimed invention, as described above. Bursac further recites that the instrument kit comprises a graft inserter and a size gauge (paras. 0191, 0227-0238). However, it does not explicitly recite the instrument kit comprising a guidewire and a reamer. Klinger teaches that it is well known in the art that an implant insertion kit comprises a guidewire (504) and a reamer (710) (Figs. 7A-8B; paras. 0221-0223, 0313), for the purpose of assisting the user in accurately resecting bone and inserting the implant into the patient. It would have been obvious to one having ordinary skill in the art to modify the instrument kit of Bursac, to include the guidewire and the reamer taught by Klinger, in order to assist the user in accurately resecting bone and inserting the implant into the patient. Such a modification would be made with a reasonable expectation of success.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bursac in view of Klinger, further in view of Walthall et al. (Pub. No. US 2009/0054906 A1; hereinafter “Walthall”).
Bursac, as modified by Klinger, teaches the limitations of the claimed invention, as described above. However, they are silent as to the specific features of the graft inserter. Walthall teaches a graft inserter (10) comprising an elongate member (16) having a distal graft retainer (26) and a proximal applicator (24) (paras. 0030-0031), in order to allow the user to more easily insert the osteochondral implant into its desired location. It would have been obvious to one having ordinary skill in the art to modify the instrument kit of Bursac and Klinger to include the inserter taught by Walthall, for the purpose of allowing the user to more easily insert the osteochondral implant into its desired location. Such a modification would be made with a reasonable expectation of success.
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bursac in view of Klinger and Walthall (hereinafter “Combination 1”), further in view of Evans et al. (Pub. No. US 2003/0236573 A1; hereinafter “Evans”).
Combination 1 teaches the limitations of the claimed invention, as described above. Walthall further teaches that a graft inserter comprises a viewport (opening at element 34) (Fig. 1). However, Combination 1 does not explicitly recite that the graft inserter comprises graft length indicators of a series of ring lines a sequentially increasing distance from the distal graft retainer. Evans teaches that it is well known in the art that implant inserters comprise graft length indicators (11) of a series of ring lines a sequentially increasing distance from the distal graft retainer (para. 0153), for the purpose of allowing the surgeon to gauge how far the implant is advanced into the tissue. It would have been obvious to one having ordinary skill in the art to modify the instruments of Combination 1 to comprise graft length indicators as taught by Evans, in order to allow the surgeon to gauge how far the implant is advanced into the tissue. Such a modification would be made with a reasonable expectation of success.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bursac.
Bursac discloses the limitations of the claimed invention, as described above. Bursac further recites that the dimensions of the implant can be configured to fit its implantation site (paras. 0015, 0047-0048, 0155, 0161). However, it does not explicitly recite the values of the lengths and the diameters of the implant grafts. 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 lengths and diameters needed to achieve the desired results and to properly fit the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the lengths and the diameters, would have been obvious at the time of applicant's invention in view of the teachings of Bursac. 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.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bursac in view of Thomas et al. (Pub. No.: US 2010/0161073 A1; hereinafter “Thomas”).
Bursac discloses the limitations of the claimed invention, as described above. It further recites that the dimensions of the implant can be configured to fit its implantation site (paras. 0015, 0047-0048, 0155, 0161). However, it does not explicitly recite that a central portion of the implant is disposed slightly above the surrounding cartilage; the central portion includes a shape configured to approximate an osteochondral surface to be replaced; and the central portion includes either a convex curvature or a concave curvature configured to approximate the curvature of the osteochondral surface to be replaced. Thomas teaches that it is well known in the art that implants having a cartilage layer comprise a central portion disposed slightly above the surrounding cartilage (para. 0073); the central portion includes a shape configured to approximate an osteochondral surface to be replaced (e.g., Figs. 1-14; paras. 0008-0010); and the central portion includes either a convex curvature or a concave curvature configured to approximate the curvature of the osteochondral surface to be replaced (e.g., Figs. 1-14; paras. 0008-0010). These shapes and dimensions allow the implants to properly fit and repair the patient’s defect. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of Bursac to comprise the shapes and dimensions taught by Thomas, as would be needed to properly ensure that the implants properly fit and repair the patient’s defect. Such a modification would be made with a reasonable expectation of success.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bursac in view of Evans.
Bursac discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite that the synthetic implantable material comprises polyvinyl alcohol or a biostable polyurethane; and the biostable polyurethane comprises polycarbonate- urethane or thermoplastic silicone-polycarbonate-urethane. Evans teaches that it is well known in the art that implants comprise a polyvinyl alcohol (PVA) or a biostable polycarbonate-urethane (PCU) (para. 0086; Table 1), for the purpose of utilizing the materials’ structural and biocompatible properties. It would have been obvious to one having ordinary skill in the art to modify the device of Bursac to comprise the materials taught by Evans, in order to utilize the materials’ structural and biocompatible properties. 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, one type of implant material for another, is generally considered to be within the level of ordinary skill in 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.
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
Prosecution Insights