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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the soft tissue implant that is coupled via lock and key connection to a bone implant, which is a spinal bone implant or an orthopedic joint bone implant, and that includes a functional component that comprises at least one catheter embedded within an interior spaced of its body (see claims 1 and 2) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 6, 7, and 8 are objected to because of the following informalities: Claims 6 and 7 each recite “wherein the soft tissue”, in line 1, which appears to be referring to – the soft tissue implant –. Claim 8 recites “lock-and key”, which appears to include a typographical error that should read – lock-and-key –. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-8, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2006/0089646 A1 to Bonutti (Bonutti) in view of US Patent Application Publication No. 2007/0179609 A1 to Goble et al. (Goble).
Regarding claim 1
Bonutti teaches a method for intervertebral disc surgery (abstract). The intervertebral disc implant meets the limitations of an anatomy-specific implant (the implant is made for the spine), comprising: a bone implant (110) adapted to replace missing bone or healthy bone in need of removal (paragraph 0093 discloses replacement of the intervertebral disc); and a soft tissue implant (paragraph 0103 discloses stabilization of the surrounding tissue of the spine following intervertebral disc replacement and paragraphs 0132-0133 discloses ligament or tendon augmentation; the augment is the soft tissue implant) adapted to replace missing soft tissue and occupy a soft tissue space around the bone replaced by the bone implant (the augmentation of the ligaments of the spine include replacement of at least a portion of a ligament that was torn or ruptured, as disclosed in paragraphs 0125 and 0132-0133), the soft tissue implant being coupled to the bone implant (the vertebral implant and surrounding augmented soft tissue are coupled to one another); and wherein the bone implant and soft tissue implant are anatomy-specific and not patient-specific (the implant is intended for the spine, and is therefore anatomy-specific, and is not disclosed as being patient-specific).
Bonutti also teaches that time-released therapeutic substances and drugs may also be incorporated into or coated on the surface of the implant (paragraph 0075). However, Bonutti does not explicitly teach wherein a functional component is embedded within an interior space of a body of the soft tissue implant, and the functional component comprises at least one catheter for delivery of medicine.
Goble teaches a therapeutic agent eluting implant that includes channels for delivering medication to treat proximate tissues (abstract). More specifically, Goble teaches a therapeutic agent source (20) that is connected to a conduit (catheter; 22) which connects to a therapeutic agent interface (40) and therapeutic agent delivery structure (60) that may be fully or partially embedded within the body of an implant (50) which has been implanted in a patient’s body (paragraphs 0057 and 0072). Goble also teaches that the implant can be applied to many other implants, including joint prostheses, intrabone implants, cosmetic implants, and artificial organs (paragraph 0095), for the purpose of releasing medication to soft tissues (28) proximate the implantation site (paragraph 0060).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the soft tissue implant of Bonutti to include a functional component that is embedded within an interior space of a body of the soft tissue implant, and the functional component comprises at least one catheter for delivery of medicine, in order to release medication to soft tissues proximate the implantation site, as taught by Goble.
Regarding claim 2
Bonutti in view of Goble teaches the implant of claim 1. Bonutti also teaches wherein the bone implant is a spinal bone implant or an orthopedic joint bone implant (the implant of Bonutti is a vertebral implant).
Regarding claim 3
Bonutti in view of Goble teaches the implant of claim 2. Goble also teaches wherein the functional component is configured for medicine infusion in spine or orthopedic joint areas (paragraph 0060 discloses that the medication is released/infused into an intra-articular space and those of an adjacent bone or prosthesis, or to soft tissues proximate the implantation site via the conduit/catheter/functional component 22; therefore the functional component is configured for medicine infusion in spine or orthopedic joint areas).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the soft tissue implant of Bonutti in view of Goble to specify that the functional component is configured for medicine infusion in spine or orthopedic joint areas, in order to release medication to intra-articular and soft tissues proximate the implantation site, as taught by Goble, which is in spine or orthopedic joint areas, as taught by both Bonutti and Goble.
Regarding claim 4
Bonutti in view of Goble teaches the implant of claim 3. Bonutti also teaches wherein the orthopedic joint areas comprise a hip, knee, shoulder and ankle (paragraph 0002 discloses that the present invention provides devices and methods for repairing, reconstructing, augmenting, and stabilizing joints of the body, and more particularly, the knee and joints of the spine).
Regarding claim 5
Bonutti in view of Goble teaches the implant of claim 3. Bonutti also teaches wherein the medicine comprises chronic pain medicine and/or cancer treatment medicine (paragraph 0075 discloses therapeutic substances that may include anti-inflammatory agents, steroids, chemotherapeutic agents, etc.).
Regarding claim 6
Bonutti in view of Goble teaches the implant of claim 1. Bonutti also teaches wherein the soft tissue comprises one of small-sized, medium-sized, and large-sized dimensions to accommodate different degrees of expected soft tissue resorption (the augment disclosed by Bonutti is at least one of small-sized, medium-sized, and large-sized dimensions to accommodate the anatomical requirements and individual needs of the patient).
Regarding claim 7
Bonutti in view of Goble teaches the implant of claim 1. Bonutti also teaches wherein the soft tissue is configured to replace at least one of missing muscle, fat, or subcutaneous tissue around the bone (the ligament augment is configured to replace at least a portion of missing subcutaneous tissue around the bone as shown in fig. 10).
Regarding claim 8
Bonutti in view of Goble teaches the implant of claim 1. Bonutti also teaches wherein the soft tissue implant is coupled to the bone implant by a lock- and key connection (paragraphs 0126-0129 and 0154 discloses an interspinous ligament graft 170, as shown in fig. 10, that may be used to stabilize an implant).
Regarding claim 12
Bonutti in view of Goble teaches the implant of claim 1. Bonutti also teaches wherein the soft tissue implant is interchangeable with another soft tissue implant in a plug-and-play fashion (the augment of Bonutti is capable of being interchangeable with another soft tissue implant in a plug-and-play fashion, for example, when the original augment does not fit properly).
Regarding claim 13
Bonutti in view of Goble teaches the implant of claim 1. Goble also teaches wherein the functional component is further configured to remove or cure dysfunction, restore traumatized spinal cord, or to improve or superficially augment the aging central nervous system with external, wireless connections (paragraph 0089 teaches therapeutic substances, like antibiotics, hydroxypatite, anti-inflammatory agents, steroids, antibiotics, analgesic agents, chemotherapeutic agents, bone morphogenetic protein, demineralized bone matrix, collagen, growth factors, autogenetic bone marrow, progenitor cells, calcium sulfate, immo suppressants, fibrin, osteoinductive materials, apatite compositions, fetal cells, stem cells, enzymes, proteins, hormones, and germicides, at least one of which would remove or cure dysfunction and/or restore traumatized spinal cord).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the soft tissue implant of Bonutti in view of Goble to specify that the functional component is configured to remove or cure dysfunction, restore traumatized spinal cord, or to improve or superficially augment the aging central nervous system with external, wireless connections, in order to release medication to intra-articular and soft tissues proximate the implantation site, as taught by Goble, which is in spine or orthopedic joint areas, as taught by both Bonutti and Goble.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti in view of Goble, as applied to claim 1, and further in view of US Patent Application Publication No. 2002/0151876 A1 to Chan (Chan).
Regarding claim 9
Bonutti in view of Goble teaches the implant of claim 1. Goble also teaches wherein the functional component comprises a housing (channels; 62 are construed to be a housing for the conduit), a refillable reservoir (paragraph 0060 discloses a therapeutic agent reservoir), and at least one pump (paragraph 0060 discloses a “pain pump”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the soft tissue implant of Bonutti in view of Goble to specify that the functional comprises a housing, a refillable reservoir, and at least one pump, in order to release medication to intra-articular and soft tissues proximate the implantation site, as taught by Goble, which is in spine or orthopedic joint areas, as taught by both Bonutti and Goble.
However, Goble does not explicitly teach that the pump is an electro-osmotic pump.
Chan teaches methods for the delivery of a formulation to an individual using a drug delivery device that is implanted into a site in the body and a includes a conduit/catheter (abstract). Chan also teaches that the drug delivery device can be based on, for example, diffusive, erodible, or convective systems, e.g., osmotic pumps, electroosmosis systems, etc. (paragraph 0023), for the purpose of delivering the appropriate drug to the implantation site (paragraph 0023).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the pump of Goble is an electro-osmotic pump, since this type of drug delivery device is well known in the art, in order to deliver the appropriate drug to the implantation site, as taught by Chan.
Regarding claim 10
Bonutti in view of Goble and Chan teaches the implant of claim 9. Goble also teaches wherein a diaphragm of the reservoir protrudes above a surface of the housing (paragraph 0062 discloses that the dermis is sutured around the conduit to form a cutaneous interface that is formed by a polymer structure congruent with patient dermis on its exterior, which protrudes above a surface of the channels/housing as shown in fig. 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the soft tissue implant of Bonutti in view of Goble and Chan to specify that the wherein a diaphragm of the reservoir protrudes above a surface of the housing, in order to release medication to intra-articular and soft tissues proximate the implantation site, as taught by Goble.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti in view of Goble and Chan, as applied to claim 9, and further in view of US Patent Application Publication No. 2009/0163965 A1 to Boyden et al. (Boyden).
Bonutti in view of Goble and Chan teaches the implant of claim 9. Goble also teaches delivering medicine to a joint using an implantable pump system. However, Goble does not teach further comprising a processor, a wirelessly rechargeable battery, and a wireless communications device.
Boyden teaches implantable devices that may be joint replacement implants, subcutaneous drug delivery devices, etc. (paragraph 0074). Boyden also teaches the use of a control means (microprocessor, for example; paragraph 0111), configured to wirelessly couple to the implantable device (102) (paragraph 0111) and a rechargeable power source (battery; 702), for the purpose of providing an actively-controllable disinfecting implantable device to treat or prevent infection (paragraph 0064).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Goble to include a processor, a wirelessly rechargeable battery, and a wireless communications device, in order to provide an actively-controllable disinfecting implantable device to treat or prevent infection, as taught by Boyden.
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 and 7-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,471,267 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, the patent claims also recite an anatomy-specific implant, comprising: a bone implant adapted to replace missing bone or healthy bone in need of removal; and a soft tissue implant adapted to replace missing soft tissue and occupy a soft tissue space around the bone replaced by the bone implant, the soft tissue implant being coupled to the bone implant; wherein a functional component is embedded within an interior space of a body of the soft tissue implant, and the functional component comprises at least one catheter for delivery of medicine, and wherein the bone implant and soft tissue implant are anatomy-specific and not patient- specific (see patent claims 1, 2, and 9).
Regarding claim 7, the patent claims also recite implant of claim 1, wherein the soft tissue is configured to replace at least one of missing muscle, fat, or subcutaneous tissue around the bone (see patent claims 3 and 10).
Regarding claim 8, the patent claims also recite implant of claim 1, wherein the soft tissue implant is coupled to the bone implant by a lock- and key connection (see patent claims 7 and 14).
Regarding claim 9, the patent claims also recite implant of claim 1, wherein the functional component comprises a housing, a refillable reservoir, and at least one electro-osmotic pump (see patent claims 4 and 11).
Regarding claim 10, the patent claims also recite implant of claim 9, wherein a diaphragm of the reservoir protrudes above a surface of the housing (see patent claims 5 and 12).
Regarding claim 11, the patent claims also recite implant of claim 9, further comprising a processor, a wirelessly rechargeable battery, and a wireless communications device (see patent claims 6 and 13).
Regarding claim 12, the patent claims also recite implant of claim 1, wherein the soft tissue implant is interchangeable with another soft tissue implant in a plug-and-play fashion (see patent claims 8 and 15).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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/M.A.H/Examiner, Art Unit 3774
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
