Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
The Examiner acknowledges Applicants’ Response to Restriction Requirement, filed 5 May 2026. No claims were amended therein. Upon finalization and entry of the Restriction Requirement (see below), claims 8 - 13 will be available for substantive examination.
Response to Restriction/Election Requirement
The Examiner acknowledges Applicant’s election of Group II, claims 8 – 13, in the Response filed on 5 May 2026is acknowledged. Because Applicants did not distinctly and specifically point out supposed errors in the Restriction Requirement, the Examiner is treating the election as an election without traverse (MPEP § 818.03(a)).
Claims 1 – 7 and 14 – 20 are hereby withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
With respect to the Requirement for Election of Species, Applicants’ Election of Group II has rendered the Requirement moot.
Claims 8-13 are under consideration.
Information Disclosure Statements
The Examiner has considered the Information Disclosure Statements (IDS’s) filed 10 June 2024 and 21 May 2025, which are now of record in the file.
Rejections Pursuant to 35 U.S.C. § 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.
Claim 11 is rejected pursuant to 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 11 recites a limitation directed to “removing at least a portion of said carrier from said site of injury following said transplanting.” The term “portion” is a relative, or subjective, term that renders the claim indefinite. The term is not defined by the claim, and the specification does not provide a standard for ascertaining the requisite degree, with the result that one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Appropriate correction or cancelation of the claim is necessary.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 37 CFR § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 8 - 10 and 12 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2018/0361023 A1 to Dvir, T., et al., published 20 December 2018 (“Dvir ‘023”), in view of Bonner, J and O. Steward, Brain Research 1619: 115 – 123 (2015) (“Bonner (2015)”), (“Pearse (2006)”), and US 2015/0202348 A1 to Dvir, T., et al., published 23 July 2015 (“Dvir ‘348”).
The Invention As Claimed
Applicants claim a method of treating a chronic spinal cord injury in a subject, the method comprising the steps of transplanting a composition comprising a plurality of fibrous particles fabricated from decellularized omentum, the fibrous particles being between 750 µm - 3 mm in diameter, into the subject at the site of injury, at least three months following the spinal cord injury, thereby treating the spinal cord injury, wherein the transplanting is affected at least six months following the spinal cord injury, wherein the method further comprises removing scar tissue at the site of injury from the subject prior to transplanting, and wherein the transplanting is affected using a syringe.
The Teachings of the Cited Art
Dvir ‘023 discloses spherical particles comprising decellularized omentum, the particles comprising biological cells or biomolecules (see Abstract), wherein the particles may be used for cell and/or biomolecule delivery (see ¶[0001]), wherein the omentum is a double sheet of peritoneum that extends from the greater curvature of the stomach overlying most abdominal organs, is highly vascularized, and its fibrillar ECM is rich with collagens, adhesive proteins, and GAGs that bind a variety of protein ligands, allowing them to serve as growth factor depots and regulate a wide variety of biological activities, including developmental processes, angiogenesis, and cardioprotection (see ¶[0002]), wherein the particles are prepared by a process comprising
dispersing a composition comprising solubilized decellularized omentum in an oil under conditions that allow generation of emulsified, decellularized omentum (see ¶[0017]), wherein the particles can be separated from the oil by using a 3D printer (see ¶[0044]), wherein there is a method of treating a disease or medical condition which would benefit from cell transplantation in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a plurality of the particles, thereby treating the medical condition (see ¶[0019]), wherein the biological cell is a neuronal cell (see ¶[0026]), wherein the biomolecule is bone morphogenetic protein-2 (BMP-2), bone morphogenetic protein-7 (BMP-7), transforming growth factor-β (TGF-β), interleukin 10 (ILI10), vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF-1), stromal cell derived factor-1 (SDF-1), platelet derived growth factor (PDGF), neurotrophin (NT-3), dexamethasone, noradrenaline, keratinocyte growth factor (KGF), angioprotein-1 (Ang-1), fibroblast growth factor (FGF-2), or nerve growth factor (NGF) (see ¶[0029]), wherein the particles encapsulate the biological cells and/or at least one biomolecule (see ¶[0031]), such as NGF (see ¶[0033]), wherein the neuronal cells are spinal cord motor neurons (see ¶[0229]), wherein micro and nanoparticles made of autologous biomaterial originating from the omentum were prepared by harvesting the omentum from subjects via a laparoscopic procedure, decellularizing the tissue using physical, chemical or/and enzymatic processing, and converting the extracellular matrix (ECM) of the omentum into a liquid substance that was emulsified to generate omentum-ECM particles that were thermoresponsive and that gel upon incubation at 37° C (see ¶[0074]), wherein the decellularized omentum comprises extracellular matrix (ECM) components that comprise fibrous elements, such as collagen, elastin and/or reticulin (see ¶¶[0079] – [0080}), wherein the omentum is derived from a human (see ¶[0082]), wherein the cells/biomolecules can be encapsulated using 3D printing, a technique that uses electromagnetic technology to deposit tiny droplets of “ink” onto a substrate, where droplet size can be varied by adjusting pulse frequency and ink viscosity, providing high reproducibility and precise control of droplet size and dose (see ¶[0145]), wherein the generated particles are typically distinct spheres being of a homogeneous size, forming a regular shape such that they are capable of being injected without sticking to one another in a syringe (see ¶[0153]), wherein the particles can be administered as a part of a pharmaceutical composition that further comprises a pharmaceutically acceptable carrier (see ¶[0195]), such as propylene glycol, saline, emulsions, and mixtures of organic solvents with water (see ¶[0197]; see also, ¶[0204]), and wherein, in order to confirm omentum fiber existence and its support to cells, after droplet production and separation, omentum hydrogel droplets with and without encapsulated cells were imaged using SEM that indicated that cells were encapsulated within the omentum-hydrogel in a way that each cell is surrounded by the omentum-fibers, providing mechanical and biochemical support (see ¶[0241]). The reference does not explicitly disclose transplanting the particles compositions into the site of a spinal cord injury for treatment of the injury, wherein the transplantation occurs at least three months or at least six months following the injury, or decellularized omentum particles with diameters between 750 µm and 3 mm. The teachings of Bonner (2015), Pearse (2006), and Dvir ‘348 remedy those deficiencies.
Bonner (2015) discloses that cell transplantation in the injured spinal cord has the potential to lead to recovery after spinal cord injury (SCI), wherein transplanted neurons derived from fetal grafts, neural precursor cells, and neural stem cells should have the ability to reconnect long distance motor and sensory pathways of the injured spinal cord (see Abstract), wherein cell transplantation is an attractive strategy for SCI because transplanted cells have the potential to modulate the extrinsic environment, provide a growth substrate for injured axons and to replace cells lost after injury (see p. 115, 2nd col.), and wherein the grafts also contain non-cellular elements such as extracellular matrix molecules that may enhance the survival, differentiation and integration of cells in the grafts (see p. 117, 2nd col., last para.).
Pearse (2006) discloses that there are many strategies, particularly cell- and gene-based therapies, being investigated to repair the injured mammalian spinal cord, but it appears that no one strategy will be adequate, but rather that a combination strategy will be required for successful repair of spinal cord injuries, including presenting at different times after injury, interventions for neuroprotection axonal regeneration, and rehabilitation (see p. 438, 1st col.), wherein these strategies address the questions of when, how many cells, and what cell type should be transplanted into the injury site to provide a more growth supportive milieu (see p. 439, 1st col., 1st para.), wherein the time of implantation largely depends upon the ability of the cell to survive in the injury milieu, the predicted functionality of the cells, the particular pathology they are to ameliorate, or the anatomical structures they are to repair, wherein acute implantation, immediately after or within hours of injury, has been used to modify the host immune response and reduce inflammation to protect the tissue surrounding the injury epicenter from secondary damage, such as scar formation, wherein implantation of cells during the acute phase of the injury has a number of potential drawbacks, including exposure to a cytotoxic milieu due to a rapid accumulation of excitatory transmitters, degrading enzymes, reactive oxygen species, and pro-inflammatory molecules, and another disadvantage is that acute implantation is likely not clinically relevant, because time may be needed to prepare the cells, and the injured person may not be stabilized and the extent of the injury not yet known (see p. 440, 1st col., 3rd para.), wherein, to increase graft survival, transplantation can be delayed for days or weeks post-injury until the period of primary tissue destruction and the peak of the inflammatory response (7 days) has subsided (see p. 440, 2nd col., 2nd para.), and wherein at longer times post-injury, the lesion is more stabilized and a cyst into which cells may be transplanted has formed, but substantial scar tissue occurs with time, necessitating surgical debridement of the injury site before cell transplantation to remove a major barrier to axonal re-growth and re-induce the expression of regeneration-associated genes (see p. 440, 2nd col., 3rd para.).==
Dvir ‘348 discloses compositions comprising decellularized omentum (see Abstract), wherein hydrogel compositions comprising particles of decellularized omentum may be administered into the body using an injecting device (e.g., needle, catheter) so as to provide mechanical support (see ¶[0251]), wherein the hydrogel compositions undergo a process of 3D printing wherein a hydrogel precursor (together with cells or in the absence of cells), in its liquid state, is printed by extrusion through an aperture (e.g., a syringe), wherein by varying the hydrogel's temperature, velocity of printing, surface temperature or concentration, various printed hydrogel diameters may be obtained, ranging from 100 µm to several millimeters (see ¶[0254]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to treat a spinal cord injury by implanting a composition with spherical particles comprising decellularized omentum, the particles further comprising biological cells or biomolecules, wherein the composition can be used to treat a disease or medical condition which that would benefit from cell transplantation, by administering to the subject a therapeutically effective amount of a plurality of the particles, thereby treating the medical condition, wherein the particles encapsulate a biological cell such as a neuronal cell, and a biomolecule such as nerve growth factor (NGF), wherein the neuronal cells are spinal cord motor neurons, wherein the decellularized omentum comprises extracellular matrix (ECM) components that comprise fibrous elements, such as collagen, elastin and/or reticulin, wherein the omentum is derived from a human, wherein the cells/biomolecules are encapsulated using 3D printing, by which electromagnetic technology is used to deposit tiny droplets of “ink” onto a substrate, where the droplet size can be varied by adjusting pulse frequency and ink viscosity, providing high reproducibility and precise control of droplet size and dose, wherein the generated particles are typically distinct spheres being of a homogeneous size, forming a regular shape such that they are capable of being injected without sticking to one another in a syringe, wherein the particles can be administered as a part of a pharmaceutical composition that further comprises a pharmaceutically acceptable carrier, such as saline, and wherein SEM indicated that cells were encapsulated within the omentum-hydrogel in a way that each cell is surrounded by the omentum-fibers, providing mechanical and biochemical support, as taught by Dvir ‘023, wherein using the compositions for cell transplantation into an injured spinal cord can lead to recovery after spinal cord injury (SCI), wherein cell transplantation is an effective strategy for SCI because transplanted cells have the potential to modulate the extrinsic environment, provide a growth substrate for injured axons and to replace cells lost after injury, particularly when the grafts also contain non-cellular elements, such as extracellular matrix molecules that may enhance the survival, differentiation and integration of cells in the grafts, as taught by Bonner (2015), wherein debridement of scar tissue occurs before transplantation, and can occur months after acute SCI, in accord with Pearse (2006), and wherein hydrogel compositions comprising particles of decellularized omentum may be administered into the body using an injecting device (e.g., needle, catheter) so as to provide mechanical support, wherein the hydrogel compositions undergo a process of 3D printing wherein a hydrogel precursor (together with cells or in the absence of cells), in its liquid state, is printed by extrusion through an aperture (e.g., a syringe), wherein by varying the hydrogel's temperature, velocity of printing, surface temperature or concentration, various printed hydrogel diameters may be obtained, ranging from 100 µm to several millimeters, as taught by Dvir ‘348. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Bonner (2015) to the effect that implanting neuronal cells such as spinal cord motor neurons into a site of SCI is an effective strategy to treaty the injury, by the teachings of Pearse (2006) to the effect that, at longer times post-injury, the lesion is more stabilized and a cyst into which cells may be transplanted has formed, but substantial scar tissue occurs with time, necessitating surgical debridement of the injury site before cell transplantation to re-induce the expression of regeneration-associated genes, and by the teachings of Dvir ‘348 that 3D printing of the omentum compositions allows for tailoring the sizes of the particles within a range between 100 µm and several millimeters.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 8 - 10 and 12 would have been obvious within the meaning of 35 USC § 103.
Claim 13 is rejected pursuant to 35 U.S.C. § 103, as being obvious over Dvir ‘023, Bonner (2015), Pearse (2006), and Dvir ‘348, as applied in the above rejection of claims 8 10 and 12, and further in view of Chen, X., et al., Cytotherapy 19: 1522 – 1528 (2017) (“Chen (2017)”).
The Invention As Claimed
The invention with respect to claims 8 – 10 and 12 is described above. In addition, Applicants claim a method of treating a chronic spinal cord injury in a subject, the method comprising the steps of transplanting a composition comprising a plurality of fibrous particles fabricated from decellularized omentum, wherein the transplantation is affected through a syringe with an internal diameter between 1 – 5 mm.
The Teachings of the Cited Art
The teachings of Dvir ‘023, Bonner (2015), Pearse (2006), and Dvir ‘348 are replied upon as set forth in the above rejection of claims 8 – 10 and 12. The references do not disclose use of a syringe with an internal diameter if 1 – 5 mm. The teachings of Chen (2017) remedy that deficiency.
Chen (2017) discloses that the transplantation of stem cells into injured tissue can improve wound healing, tissue regeneration and functional recovery, but implanted cells rapidly lose their viability or fail to integrate into host tissue, whereas hydrogel-seeded stem cells, such as bone marrow mesenchymal stromal cells (BM-MSC’s) offer improved viability in response to mechanical forces caused by syringe needles, as well as cell density (see Abstract), wherein enriching stem cell therapy is the use of biomaterials, such as hydrogels, as vehicles for implantation of cells into local tissue for regenerative purposes that can protect encapsulated cells from inflammation and surrounding macrophages, and to provide a biocompatible environment for cell attachment, survival, migration, growth, and proliferation (see p. 1522, 1st col., 2nd para.), wherein cell viability of cryopreserved BM-MSC’s with NIH 3T3 cells (controls), in response to cell density, and as a function of delivery methods (pipette, 25G, and 27G needles, was determined (see p. 1524, 2nd col., 1st para.), wherein the viability assays indicated, at all cell densities and for both cell types, that the greatest cell viability was achieved with a pipette tip with an internal diameter of 0.830 mm, in comparison to needles with 0.260 and 0..210 mm internal diameters (see Figure 1, p. 1524, Table I, p. 1525).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to treat a spinal cord injury by implanting a composition with spherical particles comprising decellularized omentum, the particles further comprising biological cells or biomolecules, according to the teachings of Dvir ‘023, Bonner (2015), Pearse (2006), and Dvir ‘348, wherein the particle composition is delivered to a transplantation site through a device with an internal diameter of close to 1 mm, as taught by Chen (2017). One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Chen (2017) illustrating that the highest levels of viability of the implanted cells was achieved with the delivery device with the largest internal diameter.
The limitation recited in claim 13 is directed to a minimum internal diameter of 1 mm, while the cited reference discloses an internal diameter slightly smaller (0.830 mm). However, it is the Examiner’s position that, even without an objective overlap with the recited limitation, a prima facie case of obviousness can exist where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of Amer. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).” Furthermore, or in the alternative, in light of the specific disclosures of Chen (2017), where the larger internal diameters of the delivery devices produced the higher cell viabilities, adjustment or selection of delivery devices with internal diameters reading directly on the claimed range would amount to nothing more than optimization of a result-effective variable, the exercise of which is well with the expertise of one of ordinary skill in the appropriate art. Consequently, in the absence of evidence as to the criticality of such parameter, this limitation cannot support patentability. See MPEP § 2144.05 II. A.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claim 13 would have been obvious within the meaning of 35 USC § 103.
Claim 11 is rejected pursuant to 35 U.S.C. § 103, as being obvious over Dvir ‘023, Bonner (2015), Pearse (2006), and Dvir ‘348, as applied in the above rejection of claims 8 - 10 and 12, and further in view of US 2021/0346646 A1 to Kassab, G. and M. Phillips, claiming priority to 23 November 2016 (“Kassab ‘646”).
The Invention As Claimed
The invention with respect to claims 8 – 10 and 12 is described above. In addition, Applicants claim a method of treating a chronic spinal cord injury in a subject, the method comprising the steps of transplanting a composition comprising a plurality of fibrous particles fabricated from decellularized omentum, in a carrier, wherein the transplantation is affected through a syringe, and wherein the method further includes the step of removing at least a portion of the carrier from the site of injury following the transplanting.
The Teachings of the Cited Art
The teachings of Dvir ‘023, Bonner (2015), Pearse (2006), and Dvir ‘348 are replied upon as set forth in the above rejection of claims 8 – 10 and 12. The references do not disclose a method of treating a chronic spinal cord injury in a subject, the method comprising the step of transplanting through a syringe a composition comprising fibrous particles of decellularized omentum in a carrier, wherein the method further includes removing at least a portion of the carrier from the site of injury following the transplanting. The teachings of Kassab ‘646 remedy that deficiency.
Kassab ‘646 discloses devices, systems, and methods useful to engage tissue using suction, and to perform medical procedures during sectional engagement (see Abstract), wherein the methods include methods of medical treatment that comprising the introduction of a quantity of a material into a wall of a mammalian organ (see ¶[0005]), wherein the systems comprise one or more of the following: an engagement catheter, a skirt or suction cup, a delivery catheter, a needle, and/or a wire (see ¶[0008]), wherein a step of injecting is performed to inject a substance such as stem cells, a polymer, an elastomer, a drug/medicament, cells other than stem cells, or a solution (see ¶[0011]), and wherein the step of injecting a substance through a needle and out of the distal portion of the needle, and substance that is injected out of the distal portion of the needle and not into the wall of the organ would be removed from the patient via suction through the lumen of the engagement catheter (see ¶[0017]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to treat a spinal cord injury by implanting a composition with spherical particles comprising decellularized omentum, the particles further comprising biological cells or biomolecules, according to the teachings of Dvir ‘023, Bonner (2015), Pearse (2006), and Dvir ‘348, wherein the composition is delivered into a transplantation site through the needle of a delivery device, such as a catheter, and out of the distal portion of the needle, and the substance that is injected out of the distal portion of the needle and not into the wall of the organ would be removed from the patient via suction through the lumen of the engagement catheter, as taught by Kassab ‘646. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Kassab ‘646 illustrating that the delivery device can not only deliver a therapeutic composition, but also, through suction, withdraw material, either in excess, or improperly delivered to the transplantation site.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claim 11 would have been obvious within the meaning of 35 USC § 103.
Obviousness-Type 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file-/efs/guidance/eTD-info-I.jsp.
Claims 8 – 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 10, and 11 of U.S. Patent No. 12,311,075 (“the ‘075 patent”), in view of Bonner (2015), Pearse (2006), Kassab ‘646, and Chen (2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because the enumerated claims of the ‘075 patent are directed to a method of treating a disease or medical condition which would benefit from cell transplantation in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the composition of claim 1, wherein the cells are neuronal cells, or spinal cord motor neurons. The claims do not expressly disclose a method for treating spinal cord injuries by transplanting a composition comprising a plurality of fibrous particles fabricated from decellularized omentum, the fibrous particles being between 750 µm - 3 mm in diameter, into the subject at the site of injury, at least three months following the spinal cord injury, thereby treating the spinal cord injury, wherein the transplanting is affected at least six months following the spinal cord injury, wherein the method further comprises removing scar tissue at the site of injury from the subject prior to transplanting, and wherein the transplanting is affected using a syringe, wherein the transplantation is affected through a syringe, and wherein the method further includes the step of removing at least a portion of the carrier from the site of injury following the transplanting, or wherein the transplantation is affected through a syringe with an internal diameter between 1 – 5 mm. The teachings of Bonner (2015), Pearse (2006), Kassab ‘646, and Chen (2017), as set forth above remedy those deficiencies.
Thus, it would have been prima facie obvious to treat a medical condition which would benefit from cell transplantation in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the composition of claim 1, wherein the cells are neuronal cells, or spinal cord motor neurons, according to the claims of the ‘075 patent, wherein cell transplantation is an attractive strategy for SCI because transplanted cells have the potential to modulate the extrinsic environment, provide a growth substrate for injured axons and to replace cells lost after injury (see p. 115, 2nd col.), and wherein the grafts also contain non-cellular elements such as extracellular matrix molecules that may enhance the survival, differentiation and integration of cells in the grafts, as taught by Bonner (2015), wherein no one repair strategy will be adequate, but rather that a combination strategy is required for successful repair of spinal cord injuries, including presenting at different times after injury, interventions for neuroprotection axonal regeneration, and rehabilitation, wherein these strategies address the questions of when, how many cells, and what cell type should be transplanted into the injury site to provide a more growth supportive milieu (see p. 439, 1st col., 1st para.), wherein the time of implantation largely depends upon the ability of the cell to survive in the injury milieu, the predicted functionality of the cells, the particular pathology they are to ameliorate, or the anatomical structures they are to repair, wherein acute implantation, immediately after or within hours of injury, has been used to modify the host immune response and reduce inflammation to protect the tissue surrounding the injury epicenter from secondary damage, such as scar formation, wherein implantation of cells during the acute phase of the injury has a number of potential drawbacks, including exposure to a cytotoxic milieu due to a rapid accumulation of excitatory transmitters, degrading enzymes, reactive oxygen species, and pro-inflammatory molecules, and another disadvantage is that acute implantation is likely not clinically relevant, because time may be needed to prepare the cells, and the injured person may not be stabilized and the extent of the injury not yet known (see p. 440, 1st col., 3rd para.), wherein, to increase graft survival, transplantation can be delayed for days or weeks post-injury until the period of primary tissue destruction and the peak of the inflammatory response (7 days) has subsided (see p. 440, 2nd col., 2nd para.), and wherein at longer times post-injury, the lesion is more stabilized and a cyst into which cells may be transplanted has formed, but substantial scar tissue occurs with time, necessitating surgical debridement of the injury site before cell transplantation to remove a major barrier to axonal re-growth and re-induce the expression of regeneration-associated genes, as taught by Pearse (2006), wherein the composition is delivered into a transplantation site through the needle of a delivery device, such as a catheter, and out of the distal portion of the needle, and the substance that is injected out of the distal portion of the needle and not into the wall of the organ would be removed from the patient via suction through the lumen of the engagement catheter, as taught by Kassab ‘646, and wherein the particle composition is delivered to a transplantation site through a device with an internal diameter of close to 1 mm, as taught by Chen (2017). One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of the cited references to the effect that the complex issues presented by chronic spinal cord injuries must be addressed by multiple approaches based on transplantation of endogenous cellular material derived from omentum.
Claims 8-13 are directed to an invention not patentably distinct from claims 7, 10, and 11 of commonly assigned U.S. Patent No. 12,311,075. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411 ). Commonly assigned U.S. Patent No. 12,311,075, discussed above, may form the basis for a rejection of the noted claims pursuant to 35 U.S.C. §§ 102 or 103 if the commonly assigned case qualifies as prior art pursuant to 35 U.S.C. § 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention.
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In order for the Examiner to resolve this issue the Applicant or patent owner can provide a statement pursuant to 35 U.S.C. § 102(b)(2)(C) and 37 CFR § 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the Applicant or patent owner can provide a statement under 35 U.S.C. § 102(c) and 37 CFR § 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. §§ 102 or 103 based upon the commonly assigned case. Alternatively, applicant may act to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
CONCLUSION
NO CLAIM IS ALLOWED.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David J Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
Prosecution Insights