Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
The Amendments filed on March 27, 2025 has been received and entered.
Claims 211-230 are pending. Claims 211-212, 214, 217, 221, 223, 225, and 229 are examined on the merits.
Election/Restrictions
Applicant’s election without traverse of the species hemicondyle, parallel, middle in the reply filed on March 27, 2025 is acknowledged.
Claims 213, 215-216, 218-220, 222, 224, 226-228, and 230 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 27, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/28/21 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 211-212, 214, 217, 221, 223, 225, and 229 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-7 of U.S. Patent No. 9125743 in view of Webb et al. (US 4714470 A).
U.S. Patent No. 9125743 teaches:
2. A process for repairing a cartilage defect and implanting a cartilage graft into a human or animal, comprising a) crafting a cartilage matrix into individual grafts; b) cleaning and disinfecting said cartilage graft; c) applying a pretreatment solution to said cartilage graft; d) removing cellular debris using an extracting solution to produce a devitalized cartilage graft; e) recellularizing said devitalized cartilage graft according to the process of claim 1 f) implanting said cartilage graft into said cartilage defect with or without an insertion device; and g) sealing the implanted cartilage graft with the recipient tissue; and wherein said devitalized cartilage graft is optionally stored between said removing cellular debris and said recellularizing steps.
3. The process of claim 2, wherein said recellularizable cells are mixed with a carrier.
4. The process of claim 2, wherein said devitalized cartilage graft is hyaline cartilage, elastic cartilage, or fibrocartilage.
5. The process of claim 4, wherein said devitalized cartilage graft is in the form of whole condyles, whole plateaus, hemicondyles, hemiplateaus, femoral heads, phalanges, talus, tibia, fibula, rib, intervertebral discs, menisci, nose, ear, osteochondral plugs, cartilage discs, cartilage slices, cartilage curls, or cartilage flakes.
6. The process of claim 5, wherein the cartilage portion and the bone portion of said devitalized osteochondral plug are recellularized with same or different cell type(s).
7. The process of claim 5, wherein the circumferential surface and/or the superficial surface of said cartilage discs or the cartilage portion of said osteochondral plug is microperforated to facilitate the integration of graft tissue to a recipient tissue.
However, the claims do not teach cutting subcondral bone portion to obtain gaps in parallel orientations, middle zones without penetrating the superficial surface.
Webb et al. teaches implants with parallel grooves for bone ingrowth for stability of the bone (column 1, lines 31-35), about 0-15 degrees (Claim 15).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use subcondral bone portion with parallel orientations because Webb et al. teaches implants with parallel grooves for bone ingrowth for stability of the bone (column 1, lines 31-35), about 0-15 degrees (Claim 15). One would have been motivated to make implanting a cartilage graft for the expected benefit of stabilizing the implanted graft into the site with subcondral bone. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use middle zone because middle zone would have more smooth area. One would have been motivated to make cartilage implant plugs out of the middle zone for the expected benefit of more smooth surface area for extraction. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Claims 211-212, 214, 217, 221, 223, 225, and 229 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-24 of U.S. Patent No. 9744043 in view of Webb et al. (US 4714470 A).
U.S. Patent No. 9744043 teaches:
1. A cartilage graft comprising subchondral bone, and shaped, modified cartilage with a superficial surface, an opposing interface surface and a side surface therebetween, wherein the shaped, modified cartilage is cartilage allograft, xenograft or autograft modified to contain one or more gaps, bores, slots, and/or channels which penetrate the interface surface but do not penetrate the superficial surface of the shaped, modified cartilage, and the superficial surface is not in contact with the subchondral bone.
2. The cartilage graft of claim 1, wherein the shaped, modified cartilage is isolated from whole condyles, whole plateaus, hemicondyles, hemiplateaus, femoral heads, phalanges, talus, tibia, fibula, rib, intervertebral discs, menisci, nose, or ear.
3. The cartilage graft of claim 1, wherein the shaped, modified cartilage is attached to the subchondral bone at the interface surface.
6. An osteochondral plug comprising the cartilage graft of claim 1, wherein the subchondral bone comprises a cartilage/bone interface surface and a distal surface, wherein the subchondral bone is attached to the shaped, modified cartilage at the cartilage/bone interface surface; wherein the osteochondral plug is crafted into a straight cylindrical shape, a tapered cylindrical shape, a step cylindrical shape, or a dumbbell shape; wherein the subchondral bone is modified to have one or more gaps, bores, slots, and/or channels; wherein the one or more gaps, bores, slots, and/or channels of the subchondral bone are empty and hollow; and wherein the one or more empty and hollow gaps, bores, slots, and/or channels of the shaped, modified cartilage are aligned with the one or more empty and hollow gaps, bores, slots, and/or channels of the subchondral bone.
7. The osteochondral plug of claim 6, wherein the subchondral bone is crafted to have the one or more empty and hollow gaps.
8. The osteochondral plug of claim 6, wherein the osteochondral plug is drilled and/or milled from the distal surface of the subchondral bone to form the one or more empty and hollow channels of the subchondral bone.
9. The osteochondral plug of claim 6, wherein the osteochondral plug is cylindrical and is drilled and/or milled on a surface of the subchondral bone at the cartilage/bone interface surface to form the one or more through channels of the subchondral bone that are perpendicular to the superficial surface of the shaped, modified cartilage.
10. The osteochondral plug of claim 6, wherein the osteochondral plug is cylindrical and is drilled and/or milled on a surface of the subchondral bone at the cartilage/bone interface surface to form the one or more empty and hollow slots of the subchondral bone that are perpendicular to the superficial surface of the shaped, modified cartilage.
11. The osteochondral plug of claim 6, wherein the side surface of the shaped, modified cartilage is modified to facilitate the integration of the osteochondral plug into a recipient tissue.
12. The osteochondral plug of claim 11, wherein the shaped, modified cartilage has a star shape or tapered cylindrical shape.
13. The osteochondral plug of claim 11, wherein the side surface of the shaped, modified cartilage comprises microparticles or embossing with a straight or non-straight line pattern or cross-line pattern onto the side surface.
14. The osteochondral plug of claim 6, wherein the side surface and/or the superficial surface of the shaped, modified cartilage is microperforated.
15. The osteochondral plug of claim 6, wherein the one or more gaps, bores, slots, and/or channels of the subchondral bone include a bone filler.
21. A process for repairing a cartilage defect in a subject, the method comprising a. crafting the cartilage graft of claim 1 into an individual graft; b. disinfecting and cleaning the cartilage graft; c. applying a pretreatment solution to the cartilage graft; d. removing cellular debris using an extracting solution to produce a devitalized cartilage graft; e. implanting the devitalized cartilage graft into an area in the subject comprising the cartilage defect; and f. sealing the implanted devitalized cartilage graft to recipient tissue.
22. The process of claim 21, wherein the devitalized cartilage graft is stored prior to implantation.
23. The process of claim 22, further comprising recellularizing the devitalized cartilage graft prior to implanting.
24. The process of claim 22, further comprising recellularizing the devitalized cartilage graft after implanting.
However, U.S. Patent No. 9744043 does not teach parallel orientation gap, middle zone.
Webb et al. teaches implants with parallel grooves for bone ingrowth for stability of the bone (column 1, lines 31-35), about 0-15 degrees (Claim 15).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use subcondral bone portion with parallel orientations because Webb et al. teaches implants with parallel grooves for bone ingrowth for stability of the bone (column 1, lines 31-35), about 0-15 degrees (Claim 15). One would have been motivated to make implanting a cartilage graft for the expected benefit of stabilizing the implanted graft into the site with subcondral bone. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use middle zone because middle zone would have more smooth area. One would have been motivated to make cartilage implant plugs out of the middle zone for the expected benefit of more smooth surface area for extraction. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached on 571-272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655