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 .
Response to Amendment
In response to the amendment filed on 4/13/2026, Claims 4-10 and 12-15 are pending.
Amendments to claim 15 to remedy USC 112(b) issues have been acknowledged and the rejection has been withdrawn.
Response to Arguments
Applicant's arguments filed 4/13/2026 have been fully considered but they are not persuasive. Applicant argues that “when McGrath discloses using MSCs (see, e.g., page 22), the product is a "relatively soft fibrin clot" (see the first full paragraph on page 22), indicating that MSCs are not extracellular matrix-producing cells.” (pg. 5 of applicant remarks). However, examiner respectfully disagrees and notes that just because McGrath states a “relatively soft fibrin clot”, this does not mean that MSCs are not extracellular matrix producing cells. MSCs are indeed known in the art as extracellular matrix producing cells and as further reinforced by Novoseletskaya et al. (https://www.frontiersin.org/journals/cell-and-developmental-biology/articles/10.3389/fcell.2020.555378/full). Therefore, McGrath does disclose the use of extracellular matrix producing cells and hence the rejections for claims 4-10 and 12-15 are maintained.
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.
Claims 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGrath, “Development of Biosynthetic Conduits for Peripheral Nerve Repair”, Umea University Medical Dissertations, 2012 (disclosed in Applicant’s IDS filed 3/3/2025; hereinafter McGrath).
Regarding claim 14, McGrath discloses a tissue communication product wherein one end of a damaged tissue is in communication with a second end, wherein the product comprises a tube, tubular shape, or wrap (pg. 21, last paragraph, Tubular fibrin conduit was molded from two compound fibrin glue; pg. 22, paragraph 1, conduits with a 1 mm-thick wall at the proximal end, which became 2mm-thick at the distal end, with a uniform 2mm lumen; pg. 27, paragraph 2, The neo nerve connecting the proximal and distal stump contained a network of small blood vessels. Numerous axons connecting the proximal and distal nerve stumps associated with Schwann cells were arranged in a structure resembling a peripheral nerve...Repair of the nerve gap with the fibrin conduit resulted in regeneration of 3096 ± 187 (mean ± SEM) sensory DRG neurons...implantation of tubular fibrin conduit supported regeneration of approximately 40% of all motoneurons projecting into the tibial nerve) comprised of extracellular matrix-producing cells (pg. 6, paragraph 2, 5-6, combined with human mesenchymal stem cells (MSC); pg. 14, paragraph 2, addition of ECM molecules such as laminin or fibronectin; pg. 21, last paragraph, Fibrin glue contains...2-9mg/ml of plasma fibronection) mixed with a fibrinogen monomer (pg. 21, last paragraph, Fibrin glue contains; 70-110mg/ml fibrinogen) and a polymerization catalyst (pg. 14, paragraph 3, Fibrin is a natural ECM protein and has an inherent role in blood clotting and wound healing. It is formed from fibrinogen by the protease thrombin and then polymerised to form a "mesh"; pg. 21, last paragraph, Fibrin glue contains...5 IU/ml of thrombin), and wherein said product includes a lumen or space that communicates between one end of a damaged tissue and another end (pg. 22, paragraph 1, conduits with a 1 mm-thick wall at the proximal end, which became 2mm-thick at the distal end, with a uniform 2mm lumen; pg. 27, paragraph 2, The neo nerve connecting the proximal and distal stump contained a network of small blood vessels. Numerous axons connecting the proximal and distal nerve stumps associated with Schwann cells were arranged in a structure resembling a peripheral nerve).
Regarding claim 15, McGrath discloses the limitations of claim 14, and further discloses wherein the tissue is a nerve or one or more nerve ends (pg. 27, paragraph 2, The neo nerve connecting the proximal and distal stump contained a network of small blood vessels. Numerous axons connecting the proximal and distal nerve stumps associated with Schwann cells were arranged in a structure resembling a peripheral nerve...Repair of the nerve gap with the fibrin conduit resulted in regeneration of 3096 ± 187 (mean ± SEM) sensory DRG neurons...implantation of tubular fibrin conduit supported regeneration of approximately 40% of all motoneurons projecting into the tibial nerve).
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.
Claims 4-10 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over McGrath in view of US 20210315587 A1 Bright et al. (hereinafter Bright).
Regarding claim 4, McGrath discloses a nerve wrap (pg. 21, last paragraph, Tubular fibrin conduit was molded from two compound fibrin glue; pg. 27, paragraph 2, Repair of the nerve gap with the fibrin conduit resulted in regeneration of 3096 ± 187 (mean ± SEM) sensory DRG neurons...implantation of tubular fibrin conduit supported regeneration of approximately 40% of all motoneurons projecting into the tibial nerve) comprising constructed tissue formed from extracellular matrix-producing cells (pg. 6, paragraph 2, 5-6, combined with human mesenchymal stem cells (MSC); pg. 13, last paragraph, tissue-engineered scaffold should offer the most effective strategy to enhance the progression of the neural tissue towards the distal nerve stump ensuring bridging of the nerve defect; pg. 14, paragraph 2, addition of ECM molecules such as laminin or fibronectin; pg. 21, last paragraph, Fibrin glue contains...2-9mg/ml of plasma fibronection) combined with fibrinogen monomer (pg. 21, last paragraph, Fibrin glue contains; 70-110mg/ml fibrinogen) and a polymerization catalyst (pg. 14, paragraph 3, Fibrin is a natural ECM protein and has an inherent role in blood clotting and wound healing. It is formed from fibrinogen by the protease thrombin and then polymerised to form a "mesh"; pg. 21, last paragraph, Fibrin glue contains...5 IU/ml of thrombin), for nerve treatment (pg. 27, paragraph 2, Repair of the nerve gap with the fibrin conduit resulted in regeneration of 3096 ± 187 (mean ± SEM) sensory DRG neurons...implantation of tubular fibrin conduit supported regeneration of approximately 40% of all motoneurons projecting into the tibial nerve).
McGrath is silent on decellularized constructed tissue.
However, Bright, in the same field of nerve tissue regeneration (abstract, paragraph 13), teaches using decellularized tissue (paragraph 402, decellularized peripheral nerve specific scaffold...growth permissive media including a hydrogel comprising a decellularized peripheral nerve scaffold that has been enzymatically degraded, so that it bridges a gap in the nerve).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McGrath with the teachings of Bright to achieve wherein the nerve wrap is comprised of decellularized constructed tissue in order to incorporate a material that substantially lacks immunogenic cellular components and thereby provide a product that is non-cytotoxic as disclosed by Bright (paragraph 402).
Regarding claim 5, the combination of McGrath and Bright teaches the limitations of claim 4, and McGrath further discloses wherein the constructed tissue is also regenerative tissue (pg. 13, last paragraph, tissue-engineered scaffold should offer the most effective strategy to enhance the progression of the neural tissue towards the distal nerve stump ensuring bridging of the nerve defect; pg. 27, paragraph 2, Repair of the nerve gap with the fibrin conduit resulted in regeneration of 3096 ± 187 (mean ± SEM) sensory DRG neurons...implantation of tubular fibrin conduit supported regeneration of approximately 40% of all motoneurons projecting into the tibial nerve).
Regarding claim 6, the combination of McGrath and Bright teaches the limitations of claim 4, and McGrath further discloses wherein the nerve wrap comprises a diameter and/or length that approximates the anatomy of one or more nerves selected from the group consisting of a CNS nerve, brachial plexus; radial nerve; ulnar nerve; median nerve (pg. 13, paragraph 1, diameter, rigidity, permeability and biodegradability can be adjusted to suit the injury; pg. 22, paragraph 1, conduits with a 1 mm-thick wall at the proximal end, which became 2mm-thick at the distal end, with a uniform 2mm lumen; pg. 27, paragraph 2, Repair of the nerve gap with the fibrin conduit resulted in regeneration of 3096 ± 187 (mean ± SEM) sensory DRG neurons (p< 0.05; 60% of control, Table 1; Fig. 2B) and 520 ± 85 (mean± SEM) spinal motor neurons).
Regarding claim 7, McGrath discloses a method of treating a nerve injury (pg. 21, last paragraph, Tubular fibrin conduit was molded from two compound fibrin glue; pg. 27, paragraph 2, At 16 weeks after implantation, the fibrin conduits were completely reabsorbed...Repair of the nerve gap with the fibrin conduit resulted in regeneration of 3096 ± 187 (mean ± SEM) sensory DRG neurons...implantation of tubular fibrin conduit supported regeneration of approximately 40% of all motoneurons projecting into the tibial nerve) comprising treating the nerve with regenerative tissue formed from extracellular matrix-producing cells (pg. 6, paragraph 2, 5-6, combined with human mesenchymal stem cells (MSC); pg. 13, last paragraph, tissue-engineered scaffold should offer the most effective strategy to enhance the progression of the neural tissue towards the distal nerve stump ensuring bridging of the nerve defect; pg. 14, paragraph 2, addition of ECM molecules such as laminin or fibronectin; pg. 21, last paragraph, Fibrin glue contains...2-9mg/ml of plasma fibronection; pg. 27, paragraph 2, At 16 weeks after implantation, the fibrin conduits were completely reabsorbed...Repair of the nerve gap with the fibrin conduit resulted in regeneration of 3096 ± 187 (mean± SEM) sensory DRG neurons...implantation of tubular fibrin conduit supported regeneration of approximately 40% of all motoneurons projecting into the tibial nerve) combined with fibrinogen monomer (pg. 21, last paragraph, Fibrin glue contains; 70-110mg/ml fibrinogen) and a polymerization catalyst (pg. 14, paragraph 3, Fibrin is a natural ECM protein and has an inherent role in blood clotting and wound healing. It is formed from fibrinogen by the protease thrombin and then polymerised to form a "mesh"; pg. 21, last paragraph, Fibrin glue contains...5 IU/ml of thrombin).
McGrath is silent on decellularized regenerative tissue.
However, Bright, in the same field of nerve tissue regeneration (abstract, paragraph 13), teaches using decellularized tissue (paragraph 402, decellularized peripheral nerve specific scaffold...growth permissive media including a hydrogel comprising a decellularized peripheral nerve scaffold that has been enzymatically degraded, so that it bridges a gap in the nerve).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McGrath with the teachings of Bright to achieve treating the nerve with decellularized regenerative tissue in order to incorporate a material that substantially lacks immunogenic cellular components and thereby provide a product that is non-cytotoxic as disclosed by Bright (paragraph 402).
Regarding claim 8, the combination of McGrath and Bright teaches the limitations of claim 7, and McGrath further discloses wherein treating comprises contacting or wrapping (pg. 22, paragraph 3, the 14 mm or 24 mm long conduit was inserted into the gap, allowing for intubation of the nerve end 2 mm into the conduit, resulting again in 10 mm and 20 mm gap respectively between proximal and distal sciatic stump).
Regarding claim 9, the combination of McGrath and Bright teaches the limitations of claim 7, and Bright further teaches wherein the nerve injury includes carpel tunnel syndrome, nerve neuroma, and a transected nerve (paragraph 232, 370, 376, The hydrogel can be delivered circumferentially around the nerve using a syringe or applicator tip, in this manner, the nerve has protection over the length of the damage. Ideally, the hydrogel would be applied between e.g. 5 and 15 mm on each site of the damaged or transected nerve).
Regarding claim 10, the combination of McGrath and Bright teaches the limitations of claim 7, and McGrath further discloses wherein the tissue is a nerve or one or more nerve ends (pg. 22, paragraph 3, the 14 mm or 24 mm long conduit was inserted into the gap, allowing for intubation of the nerve end 2 mm into the conduit, resulting again in 10 mm and 20 mm gap respectively between proximal and distal sciatic stump).
Regarding claim 12, the combination of McGrath and Bright teaches the limitations of claim 4, and McGrath further discloses wherein the nerve wrap is tubular (pg. 21, last paragraph, Tubular fibrin conduit was molded from two compound fibrin glue).
Regarding claim 13, the combination of McGrath and Bright teaches the limitations of claim 12, and Bright further teaches wherein the tubular wrap comprises a slit (paragraph 429, nerve wraps (e.g. conduits with a top slit in them that allow the nerve to be pushed into the semi-rigid wrap)).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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