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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 25 and its dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The language “the multiplicity of instruments comprises any or more of” renders the claim indefinite as it is unclear how many of the listed tools are positively recited. Appropriate correction 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) 24-25, 28-30, and 34-43 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 24: a sterile graft plug kit for treating osteochondral defects, the kit comprising: at least one graft (e.g., Figs. 1A-1D, 10A-10D, 16C-16E) comprising a cartilage layer (upper layer portion) and a bone portion (lower layer portion); and a multiplicity of instruments for implanting the at least graft into a patient's body (paras. 0191, 0235, 0220).
Bursac discloses the following regarding claim 25: the kit of claim 24, wherein the multiplicity of instruments comprises any or more of a graft inserter, a guidewire, a reamer, and a size gauge (paras. 0191, 0235, 0220). The claim language is being interpreted to mean that multiplicity of instruments comprises any one or more of the recited tools.
Bursac discloses the following regarding claim 28: the kit of claim 25, wherein the reamer includes a distal cutting end that is configured to rotatably clear an osteochondral bore (paras. 0191, 0235, 0220). Please note that as presently worded, the claims do not require the presence of a reamer.
Bursac discloses the following regarding claim 29: the kit of claim 25, wherein the size gauge includes a distal end that is configured to indicate the depth of an osteochondral bone (para. 0220).
Bursac discloses the following regarding claim 30: the kit of claim 24, wherein the cartilage layer comprises a synthetic implantable material (paras. 0010, 0143, 0168).
Bursac discloses the following regarding claim 34: the kit of claim 24, wherein the bone portion comprises a monophasic material (paras. 0153, 0162, 0166).
Bursac discloses the following regarding claim 35: the kit of claim 24, wherein the at least one graft is a xenograft (paras. 0130, 0153-0157).
Bursac discloses the following regarding claim 36: the kit of claim 35, wherein the xenograft is harvested from a bone joint location that produces a cartilage layer having a thickness substantially similar to the thickness of existing cartilage at an implant location (paras. 0130, 0153-0157, 0172-0173). Please note that method limitations in article claims are considered to the extent that they further define the final structure of the claimed apparatus.
Bursac discloses the following regarding claim 37: the kit of claim 36, wherein the xenograft comprises any one or more of collagen, bone, and cartilage that is bovine or porcine in origin (paras. 0153-0162, 0166-0168).
Bursac discloses the following regarding claim 38: the kit of claim 37, wherein the xenograft is harvested as a one-piece component from a cartilage/bone joint location such that the cartilage layer is affixed to the bone portion (Figs. 1A-14C; paras. 0044, 0153-0162, 0166-0168).
Bursac discloses the following regarding claim 39: the kit of claim 24, wherein the at least one graft is an allograft that is harvested from a bone joint location that produces a cartilage layer having a thickness substantially similar to the thickness of existing cartilage at an implant location (paras. 0130, 0153-0157, 0172-0173). Please note that method limitations in article claims are considered to the extent that they further define the final structure of the claimed apparatus.
Bursac discloses the following regarding claim 40: the kit of claim 24, wherein the at least one graft has a diameter and a length that accommodate the particular bone joints into which the at least one graft is to be implanted (paras. 0015, 0047-0048, 0155, 0161, 0212-0230).
Bursac discloses the following regarding claim 41: the kit of claim 40, wherein the diameter and the length are configured to correlate with one another (paras. 0015, 0047-0048, 0155, 0161, 0212-0230).
Bursac discloses the following regarding claim 42: the kit of claim 41, wherein the at least one graft comprises a group of grafts ranging in size from relatively small to relatively large (paras. 0015, 0047-0048, 0155, 0161, 0212-0230).
Bursac discloses the following regarding claim 43: the kit of claim 42, wherein the group of grafts comprises specifically sized grafts that facilitate selecting a graft based on an implant location (paras. 0015, 0047-0048, 0155, 0161, 0212-0230).
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) 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bursac in view of Walthall et al. (US Pub. No. 2009/0054906; hereinafter Walthall).
Bursac discloses the limitations of the claimed invention, as described above. It further
recites a graft inserter (paras. 0191, 0235). However, it does not teach the details of the graft inserter device. Walthall teaches a kit for inserting an osteochondral implant plug that uses a graft inserter (10) having a distal graft retainer configured to hold a graft; and a proximal applicator that is configured to push the graft out of the distal graft retainer and into an osteochondral bore in the patient's body (paras. 0030-0036). This inserter will 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 graft inserter of Bursac to include the features 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) 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bursac in view of Evans et al. (Pub. No.: US 2003/0236573 A1; hereinafter “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; 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.
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 24-43 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. The at least one graft and the multiplicity of instruments of claims 24-29 of the present application correspond to the one or more grafts and the instrument kit of the claims 1-4 of the patent. The materials of claims 30-39 of the present application correspond to the materials of claims 1 and 6-15 of the patent. The dimensions of claims 39-43 of the present application correspond to the dimensions of claims 1 and 14-15 of the patent. 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 24-43 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. The at least one graft and the multiplicity of instruments of claims 24-29 of the present application correspond to the one or more grafts and the instrument kit comprising the multiplicity of instruments of the claims 1-12 of the patent. The materials of claims 30-39 of the present application correspond to the materials of claims 1 and 14-16 of the patent. The dimensions of claims 39-43 of the present application correspond to the dimensions of claim 13 of the patent. 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. 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 graft dimensions needed to achieve the desired results and fit the implantation site.
Claims 24-43 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. The at least one graft and the multiplicity of instruments of claims 24-29 of the present application correspond to the one or more grafts and the instrument kit comprising the multiplicity of instruments of the claims 1-10 of the patent. The materials of claims 30-39 of the present application correspond to the materials of claims 1 and 12-13 of the patent. The dimensions of claims 39-43 of the present application correspond to the dimensions of claim 11 of the patent. 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. 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 graft dimensions needed to achieve the desired results and fit the implantation site.
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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