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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 6/9/2026 is acknowledged. Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/9/2026. The requirement is deemed proper and is therefore made FINAL.
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 1-11 and 16 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 12-13 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, further 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 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 Thomas, further in view of Bursac et al. (Pub. No.: US 2009/0312842 A1). The patent does not explicitly recite that the implant comprises monophasic material. Bursac teaches that it is well known in the art that implants comprises the claimed monophasic material (paras. 0130, 0153-0162, 0166-0168), 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 1-11 and 16 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 12-13 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, further 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 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 Thomas, further in view of Bursac et al. (Pub. No.: US 2009/0312842 A1). The patent does not explicitly recite that the implant comprises monophasic material. Bursac teaches that it is well known in the art that implants comprises the claimed monophasic material (paras. 0130, 0153-0162, 0166-0168), 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.
Claim 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 14-17, and 19-20 of copending Application No. 18/089,902 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the present application corresponds to claims 1 and 8 of the ‘902 application. In particular the graft, the bone portion, the cartilage portion, and the central portion of claim 1 correspond to the one or more grafts, the bone portion, the cartilage layer, and the central portion of claims 1 and 8. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1, 8, 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 1 states that the cartilage portion closely matches existing cartilage the implant location. It is unclear in what respect the material is intended to closely match the cartilage. The phrase “closely matches” is a relative phrase which renders the claim indefinite. The phrase “closely matches” 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 8 recites the limitation "the 1st proximal phalangeal bone" in line 2. There is insufficient antecedent basis for this limitation in the claim. 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) 1-11 and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bursac et al. (Pub. No.: US 2009/0312842 A1; hereinafter “Bursac”) in view of Thomas et al. (Pub. No.: US 2010/0161073 A1; hereinafter “Thomas”).
Bursac teaches the following regarding claim 1: a graft for treating osteochondral defects, comprising: a bone portion (lower portion) for implantation in a joint location (e.g., Figs. 1A-7D, 10A-10D, 16C-16E); a cartilage portion (upper portion) that closely matches existing cartilage at the joint location (e.g., Figs. 1A-7D, 10A-10D, 16C-16E); and a central portion (e.g., Figs. 1A-7D, 10A-10D, 16C-16E).
Bursac teaches the limitations of the claimed invention, as described above. It further recites that the dimensions of the implant are 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. 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), for the purpose of providing the implant with the shapes and dimensions needed 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 have a central portion slightly above the surrounding cartilage, as taught by Thomas, as would be needed to ensure that the implants properly fit and repair the patient’s defect. Such a modification would be made with a reasonable expectation of success.
Bursac teaches the following regarding claim 2: the graft of claim 1, wherein the graft includes a size based on the joint location to be treated (paras. 0215-0221, 0230).
Regarding claim 3, Bursac, as modified by Thomas, teaches 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, they do 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 and Thomas. 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.
Bursac teaches the following regarding claim 4: the graft of claim 1, wherein the central portion is shaped to approximate an osteochondral surface to be treated (e.g., Figs. 1A-7D, 10A-10D, 16C-16E).
Bursac teaches the following regarding claim 5: the graft of claim 4, wherein the central portion includes a convex curvature that approximates the curvature of the osteochondral surface (e.g., Figs. 1A-7D, 10A-10D, 16C-16E; paras. 0046-0047).
Bursac teaches the following regarding claim 6: the graft of claim 5, wherein the central portion includes a positive curvature height (paras. 0046-0047).
Bursac teaches the following regarding claim 7: the graft of claim 4, wherein the central portion includes a concave curvature that approximates the curvature of the osteochondral surface (0015, 0047-0048, 0155, 0161).
Bursac teaches the following regarding claim 8: the graft of claim 7, wherein the central portion includes a negative curvature height for treating cartilage defects in the 1st proximal phalangeal bone (0015, 0047-0048, 0155, 0161). The variable dimensions of the implant allow it to be fully capable of treating a phalangeal bone.
Bursac teaches the following regarding claim 9: the graft of claim 1, wherein the cartilage portion comprises a cartilage layer having a thickness that matches the thickness of the existing cartilage (Fig. 2).
Bursac teaches the following regarding claim 10: the graft of claim 9, wherein the cartilage layer comprises a synthetic implantable material (paras. 0143, 0168).
Bursac teaches the following regarding claim 11: the graft of claim 10, wherein the synthetic implantable material has a modulus of elasticity that is similar to the modulus of elasticity of articular cartilage (para. 0197). Please also note that 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 modulus of elasticity 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 modulus of elasticity, would have been obvious at the time of applicant's invention in view of the teachings of Bursac and Thomas. 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.
Bursac teaches the following regarding claim 14: the graft of claim 1, wherein the bone portion comprises a monophasic material (Fig. 16D; paras. 0153-0162, 0166, 0207).
Bursac teaches the following regarding claim 15: the graft of claim 14, wherein the monophasic material comprises any one of polycarbonate-urethane, thermoplastic silicone-polycarbonate-urethane, polyvinyl alcohol, bioglass, collagen, and silicone (paras. 0166-0168).
Bursac teaches the following regarding claim 16: the graft of claim 14, wherein the monophasic material includes surface features (e.g., 124, 304, 306) configured to encourage bone tissue growth into the bone portion (paras. 0052, 0061, 0066).
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bursac in view of Thomas, further in view of Evans et al. (Pub. No. US 2003/0236573 A1; hereinafter “Evans”).
Bursac, as modified by Thomas, teaches the limitations of the claimed invention, as described above. However, they do not explicitly recite that the cartilage layer comprising 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 and Thomas, 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
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