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 .
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 13-15 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.
Claims 18-19 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 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 13-15 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.
Claims 18-19 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 and 11-20 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 13 of the application corresponds to claim 6 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 18 of the application corresponds to claim 10 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 § 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 11, 12, and their 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. Claim 11 states that the cartilage layer comprises a material configured to closely match existing cartilage the implant location. It is unclear in what respect the material is intended to “closely match” the cartilage. The phrase “closely match” in claims 11 and 12 is a relative phrase which renders the claim indefinite. The phrase “closely match” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate correction and/or clarification is required.
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, 11-13, and 16-20 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); 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 configured to closely match existing cartilage at an implant location (Figs. 1A-7D, 10A-10D, 16C-16E).
Bursac discloses the following regarding claim 12: the apparatus of claim 1, wherein the cartilage layer comprises a thickness configured to closely match the thickness of existing cartilage at an implant location (Figs. 1A-7D, 10A-10D, 16C-16E).
Bursac discloses the following regarding claim 13: the apparatus of claim 1, wherein the cartilage layer comprises a synthetic implantable material (paras. 0010, 0143, 0168).
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 18: the apparatus of claim 1, wherein the bone portion comprising any one or more of the one or more grafts comprises a monophasic material (paras. 0153-0162, 0166).
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 the method of forming a device is not considered germane to the patentability of the device itself. Method limitations in article claims are considered to the extent that it further defines the structure of the claimed apparatus.
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 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 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
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