DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Objections
Claim 7 is objected to because of the following informalities: line 1 should be amended to -The implantable cell containing device of claim 1, wherein-. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: line 2 should be amended to - wherein the hydrophilic external surface of the scaffold comprises a hydrophilic-. Appropriate correction is required.
Claim 36 is objected to because of the following informalities: line 1 should be amended to -The implantable cell containing device of claim 1, wherein-. Appropriate correction is required.
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.
Claims 1-36 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.
Regarding claim 1:
The claim is unclear because of the limitation “tracheal-like internal system” in line 4. It’s unclear what “tracheal-like internal system” requires structurally beyond simply micro-channels in the scaffold. Further, the specification and figures fail to elaborate on what this limitation requires. For the sake of examination, the office has assumed that the scaffold including micro-channels will read on this limitation. However, the applicant should amend the claim to clarify.
Claims 2-36 are rejected due to their dependence on claim 1.
Regarding claim 22:
The claim is unclear because of the limitation “the modified alginate is a zwitterionically modified alginate” in line 2. This further modifies the “modified alginate” in claim 21 (on which this claim depends) without further indicating if the hydrogel material comprises this material. For the sake of examination, the office has assumed that the hydrogel material should include modified alginate however the applicant should amend the claim to further clarify.
Regarding claim 28:
The claim is unclear because of the limitation “the cells of the hydrogel comprise human cells” in line 2. The line is unclear because claim 27 (on which this claim depends) indicates the cells of hydrogel comprise mammalian cells including primate cells, rodent cells, canine cells, feline cells, equine cells, bovine cells, and porcine cells none of which include human cells which conflicts with what is required in claim 28. For the sake of examination, the office has assumed the human cells reads on the mammalian cells described in claim 27.
Regarding claim 35:
The claim recites the limitation " the preparation of islets" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 1-3, 7, 10, 12, 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2006082270 A1 to Santos (see English language machine translation attached to this or a previous office action).
Santos discloses:
Regarding claim 1:
An implantable cell containing device (figure 1) comprising:
a scaffold (translation, page 4, ¶4) and
a cell-containing hydrogel (see hydrogel mentioned on translation page 3, ¶1) encapsulating the scaffold (the scaffold can be made from hydrogel and therefore it is encapsulated by it),
wherein the scaffold comprises a tracheal-like internal system of continuous air-filled (see channels mentioned of page 4, ¶4 of the translation; page 5, ¶5 indicates it is air dried), hydrophobic micro-channels that traverse the scaffold's dimensions (the scaffold can be made from a combination of hydrophobic, hydrophilic and hydrogel as indicated on translation page 3, ¶1), and a hydrophilic external surface (the scaffold can be made from a combination of hydrophobic, hydrophilic and hydrogel as indicated on translation page 3, ¶1 which indicates the internal surfaces and external surfaces can be hydrophilic and hydrophobic).
Regarding claim 2:
The implantable cell containing device of claim 1, wherein the scaffold comprises a polymeric material (the scaffold can be made from hydrophobic, hydrophilic and hydrogel polymers as indicated on translation page 3, ¶1).
Regarding claim 3:
The implantable cell containing device of claim 1 or claim 2, wherein the scaffold comprises a hydrophobic material (the scaffold can be made from hydrophobic, hydrophilic and hydrogel as indicated on translation page 3, ¶1).
Regarding claim 7:
The implantable cell device of claim 1, wherein the scaffold comprises a material selected from the group consisting of silicone, PDMS, rubber, nylon (see nylon fibers on page 4 of the translation, ¶4), polyurethane, polysulfone, polyacrylonitrile, polyester such as polyethylene terephthalate and polybutester, polyvinylidene difluoride, polyacrylamide, poly (ethyl methacrylate), poly(methyl methacrylate), polyvinyl chloride, polyoxymethylene, polycarbonate, polypropylene, polyethylene, polybenzimidazole, polyaniline, polystyrene, polyvinylcarbazole, polyamide, poly vinyl phenol, cellulose acetate, polyacrylamide, poly(2-hydroxyethyl methacrylate), polyether imide, poly(ferrocenyldimethylsilane), poly(ethylene-co-vinylacetate), polyethylene-co-vinyl acetate, polyacrylic acid-polypyrene methanol, poly(ethylene-co-vinyl alcohol), polymetha- phenylene isophthalamide, poly(lactic acid), poly(s-caprolactone), poly(lactic-co-glycolic acid), poly(1-lactide-co-s-caprolactone), and combinations thereof.
Regarding claim 10:
The implantable cell containing device of claim 1, wherein the air-filled micro-channels of the scaffold comprise a hydrophobic surface (the scaffold can be made from hydrophobic, hydrophilic and hydrogel as indicated on translation page 3, ¶1).
Regarding claim 12:
The implantable cell containing device of claim 1, wherein hydrophilic external surface of the scaffold comprises a hydrophilic polymer coating (the scaffold (and by extension its outer surface) can be made from hydrophobic, hydrophilic and hydrogel as indicated on translation page 3, ¶1).
Regarding claim 17:
The implantable cell containing device of claim 1, wherein the hydrophilic external surface of the scaffold and the cell-containing hydrogel are cross-linked (see cross linked material mentioned on page 6, ¶4).
Regarding claim 18:
The implantable cell containing device of claim 1, wherein the scaffold comprises a ladder-like geometry (see ladder like geometry as shown in figure 1), a spiral geometry, a toroidal geometry, planar geometry, rod-shaped geometry, tubular geometry.
Regarding claim 19:
The implantable cell containing device of claim 1, wherein the hydrogel comprises a natural polymeric material, a synthetic polymeric material (see translation, page 4, ¶4, “synthetic polyamide”), or a combination thereof.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7, 10, 11, 19-21, 23 and 36 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20200390933 A1 to Williams et al. (Williams).
Williams discloses:
Regarding claim 1:
An implantable cell containing device (figure 1) comprising:
a scaffold (¶0065, “In certain embodiments, the implants comprise micropores and/or are in the form of scaffolds”) and
a cell-containing hydrogel (¶0522, “For example, the mesh may be coated on one side using a hydrogel barrier, such as the Sepra® coating, or using another hyaluronic acid coating”) encapsulating the scaffold,
wherein the scaffold comprises a tracheal-like internal system of continuous air-filled (¶0928, “ the matrix including a series of channels communicating between the upper and lower surface of the device”), hydrophobic micro-channels (¶0065, “In certain embodiments, the implants comprise micropores”; ¶0460, “In embodiments, a hydrophobic core material is dissolved in an effective amount of a first solvent that is free of polymer”) that traverse the scaffold's dimensions, and a hydrophilic external surface (¶0478, “The microparticle compositions may comprise other excipients including any number of other medically or pharmaceutically acceptable agents such as preservatives, lipids, fatty acids, waxes, surfactants, plasticizers, porosigens, antioxidants, bulking agents, buffering agents, chelating agents, co-solvents, water-soluble agents, insoluble agents, metal cations, anions, salts, osmotic agents, synthetic polymers, biological polymers, hydrophilic polymers, polysaccharides, sugars, hydrophobic polymers, hydrophilic block copolymers, hydrophobic block copolymers, block copolymers containing hydrophilic and hydrophobic blocks”).
Regarding claim 2:
The implantable cell containing device of claim 1, wherein the scaffold comprises a polymeric material (¶0142).
Regarding claim 3:
The implantable cell containing device of claim 1 or claim 2, wherein the scaffold comprises a hydrophobic material (¶0460, “In embodiments, a hydrophobic core material is dissolved in an effective amount of a first solvent that is free of polymer”).
Regarding claim 4:
The implantable cell containing device of claim 1, wherein the scaffold comprises a fluorinated polymer material (¶0465, “ fluorinated liquid vehicles such as polyfluoroalkylmethylsiloxanes, Miglyol or other pharmaceutically acceptable oils and oil-based vehicles”).
Regarding claim 7:
The implantable cell device of claim 1, wherein the scaffold comprises a material selected from the group consisting of silicone, PDMS, rubber, nylon, polyurethane, polysulfone, polyacrylonitrile, polyester such as polyethylene terephthalate and polybutester, polyvinylidene difluoride, polyacrylamide, poly (ethyl methacrylate), poly(methyl methacrylate), polyvinyl chloride, polyoxymethylene, polycarbonate (see polycarbonate in ¶0173), polypropylene, polyethylene (see polyethylene in ¶0173), polybenzimidazole, polyaniline, polystyrene, polyvinylcarbazole, polyamide (see polyamide in ¶0173), poly vinyl phenol, cellulose acetate, polyacrylamide, poly(2-hydroxyethyl methacrylate), polyether imide, poly(ferrocenyldimethylsilane), poly(ethylene-co-vinylacetate), polyethylene-co-vinyl acetate, polyacrylic acid-polypyrene methanol, poly(ethylene-co-vinyl alcohol), polymetha- phenylene isophthalamide, poly(lactic acid), poly(s-caprolactone), poly(lactic-co-glycolic acid), poly(1-lactide-co-s-caprolactone), and combinations thereof.
Regarding claim 10:
The implantable cell containing device of claim 1, wherein the air-filled micro-channels of the scaffold comprise a hydrophobic surface (¶0460, “In embodiments, a hydrophobic core material is dissolved in an effective amount of a first solvent that is free of polymer”).
Regarding claim 11:
The implantable cell containing device of claim 1, wherein the microchannel surfaces of the scaffold are modified to comprise SiO2 nanoparticles (¶0838, “bioactive glasses composed of SiO.sub.2”), hydrophobic attapulgite, ZnO nanorods, and combinations thereof.
Regarding claim 19:
The implantable cell containing device of claim 1, wherein the hydrogel comprises a natural polymeric material, a synthetic polymeric material (¶0466, “Examples of viscosity-modifying agents include, but are not limited to, synthetic polymers, such as poloxamers, Pluronics, or polyvinyl pyrrolidone”), or a combination thereof.
Regarding claim 20:
The implantable cell containing device of claim 19, wherein the hydrogel comprises a natural polymeric material selected from the group consisting of collagen, hyaluronate, fibrin, alginate, agarose, chitosan, bacterial cellulose, elastin, keratin, derivatives thereof, and combinations thereof.
Regarding claim 21:
The implantable cell containing device of claim 20, wherein the hydrogel material comprises a pure alginate (¶0161, “alginate”), a modified alginate, or a mixture of pure and modified alginate.
Regarding claim 23:
The implantable cell containing device of claim 19, wherein the hydrogel comprises a synthetic polymeric material selected from polyethylene glycol (PEG) (¶0479, “PEG”), poly(acrylic acid), poly(ethylene oxide), poly(vinyl alcohol), polyphosphazene, poly(hydroxyethyl methacrylate), triazole-zwitterion hydrogels (TR-qCB, TR-CB, TR-SB), poly(sulfobetaine methacrylate), carboxybetaine methacrylate, poly[2-methacryloyloxyethyl phosphorylcholine, N-hydroxyethyl acrylamide, a copolymer thereof, a derivatives thereof, and a combination thereof.
Regarding claim 36:
The implantable cell delivery device of claim 1, wherein the cell-containing hydrogel further comprises one or more biologically active agents selected from the group consisting of a protein (¶0149), peptide (¶0149), antibody or antibody fragment thereof, antibody mimetic, a nucleic acid, a small molecule, a hormone, a growth factor, an angiogenic factor, a cytokine, an anti-inflammatory agent, and combinations thereof.
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200390933 A1 to Williams et al. (Williams) as applied to claim 4 above, and further in view of US 20110027181 A1 to Amodei et al. (Amodei).
Regarding claim 5:
Williams fails to disclose:
The implantable cell containing device of claim 4, wherein the fluorinated polymer material is selected from poly(vinylidene fluoride-co-hexafluoropropylene) (PVDF-HFP), poly(vinylidene fluoride) (PVDF), polyvinylidene difluoride, polytetrafluoroethylene (PTFE), poly(vinylidene fluoride-co-trifluoroethylene) (P(VDF-TrFE)), poly(vinylidene fluoride-co-tetrafluoroethylene) (P(VDF-TFE)), poly(vinylidene fluoride-co- chlorotrifluoroethylene) (P(VDF-CTFE)), Teflon AF® family: copolymers made from 2,2- bistrifluoromethyl-4,5-difluoro-1,3-dioxole and tetrafluoroethylene, and polychlorotrifluoroethylene (PCTFE).
Amodei teaches:
An implantable device (figure 1a) that can be made from biocompatible material such as polytetrafluoroethylene (¶0212) for a semi-permeable barrier. The reference further teaches that scaffolds can be made from this material (¶0427).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to replace the fluorinated polymer material with polytetrafluoroethylene as taught by Amodei. This is a simple substitution of one known element (fluorinated polymer material of Williams) for another (polytetrafluoroethylene of Amodei) to obtain predictable results (to form a scaffold).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200390933 A1 to Williams et al. (Williams) as applied to claim 2 above, and further in view of US 20170198100 A1 to Qiu et al. (Qiu).
Regarding claim 6:
Williams fails to disclose:
The implantable cell containing device of claim 2, wherein the scaffold comprises a non-fluorinated polymer material chemically modified with fluoroalkysilanes.
Qiu teaches:
Using non-fluorinated polymer material that has been formatted with (chemically modified) with fluoroalkyl silicone (¶0093) or with fluoroalkysilanes (¶0123 or ¶0063) in order to make the material hydrophobic (¶0005).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to include a non-fluorinated polymer material chemically modified with fluoroalkysilanes as taught by Qiu in order to add hydrophobic properties to the scaffold.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200390933 A1 to Williams et al. (Williams) as applied to claim 1 above, and further in view of US 20110027181 A1 to Amodei et al. (Amodei).
Regarding claim 8:
Williams fails to disclose:
The implantable cell containing device of claim 1, wherein the scaffold is a carbon material.
Amodei teaches:
A microchannel implant device (column 9, lines 5-20) that includes a tissue interface including carbon nanotubes (column 22, lines 1-15).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to make the scaffold of carbon nano-tubes as taught by Amodei. This is a simple substitution of one known element (scaffold material of Williams) for another (carbon nanotubes as taught by Amodei) to obtain predictable results (to build/form the structure of the scaffold).
Regarding claim 9:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 8 by Williams and Amodei:
The implantable cell containing device of claim 8, wherein the carbon material is selected from the group consisting of activated carbon, carbon microbelts, graphite, carbon nanoparticles, carbon soot, carbon nanofibers, graphene and carbon nanotubes (see the carbon nanotube material of Amodei incorporated into Williams).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200390933 A1 to Williams et al. (Williams) as applied to claim 12 above, and further in view of KR 20120092443 A to Kim et al. (Kim)(see English language machine translation attached to this or a previous office action).
Regarding claim 13:
Williams fails to disclose:
The implantable cell containing device of claim 12, wherein the hydrophilic polymer coating comprises a polydopamine coating.
Kim teaches:
A scaffold (translation, page 3, ¶4) that includes a polydopamine coating that helps with biocompatibility and cell compatibility (translation, page 3, ¶5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to apply a polydopamine coating as taught by Kim to enhance biocompatibility and cell compatibility (Kim, translation, page 3, ¶5).
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200390933 A1 to Williams et al. (Williams) as applied to claim 12 above, and further in view of US 20200140858 A1 to Saha et al. (Saha).
Regarding claim 14:
Williams fails to disclose:
The implantable cell containing device of claim 12, wherein the hydrophilic polymer coating comprises a silane coating.
Saha teaches:
Implantable nanoparticles that can be coated with PEGylated silanes (¶0104). Further, the reference teaches that the PEG coating is hydrophilic (¶0182).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to replace the hydrophilic material with a hydrophilic coating (PEGylated silanes coating) as taught by Saha. This is a simple substitution of one known element (hydrophilic material of Williams) for another (hydrophilic coating as taught by Saha) to obtain predictable results (to make the scaffolding hydrophilic).
Regarding claim 15:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 14 by Williams and Saha:
The implantable cell containing device of claim 14, wherein the silane coating comprises PEGylated silanes (see the PEGylated silanes coating taught by Saha and incorporated into Williams).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200390933 A1 to Williams et al. (Williams) as applied to claim 21 above, and further in view of KR 20180105496 A to Nam (see English language machine translation attached to this or a previous office action).
Regarding claim 16:
Williams fails to disclose:
The implantable cell containing device of claim 1, wherein the hydrophilic external surface of the scaffold is a plasma-treated hydrophilic surface.
Nam teaches:
An anti-adhesion material/film which includes hydrophobic or hydrophilic properties (see abstract). Further, this film/coating can be applied to biocompatible polymer compounds (abstracts).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to replace the external hydrophilic material for the scaffold with a plasma-treated hydrophilic surface as taught by Nam. This is a simple substitution of one known element (hydrophilic material of Williams) for another (plasma-treated hydrophilic surface as taught by Nam) to obtain predictable results (to make the scaffolding hydrophilic).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200390933 A1 to Williams et al. (Williams) as applied to claim 21 above, and further in view of WO 2020223525 A1 to Ma et al. (Ma).
Regarding claim 22:
Williams fails to disclose:
The implantable cell containing device of claim 21, wherein the modified alginate is a zwitterionically modified alginate.
Ma teaches:
The reference teaches using zwitterionically modified alginate (¶0006) on biomaterial/biocompatible polymers (¶0008) to prevent fibrotic deposition (¶0006).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to replace the alginate with zwitterionically modified alginate as taught by Ma. This is a simple substitution of one known element (alginate of Williams) for another (zwitterionically modified alginate as taught by Ma) to obtain predictable results (to form a coating on the scaffold).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200390933 A1 to Williams et al. (Williams) as applied to claim 1 above, and further in view of US 20050069572 A1 to Williams et al. (Williams ‘572).
Regarding claim 24:
Williams fails to disclose:
The implantable cell containing device of claim 1, wherein the cells of the hydrogel comprise a preparation of single cells or a preparation of cell aggregates.
Williams ‘572 teaches:
A scaffold including single cell types embedded in hydrogel (¶0021). Layer the cells in this manner allows for the scaffolds to more closely mimic the tissue they are within (¶0016).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to further include single cells in the hydrogel as taught by Williams ‘572 in order for the scaffold to more closely mimic the tissue they are implanted in (Williams ‘572, ¶0016).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200390933 A1 to Williams et al. (Williams) as applied to claim 1 above, and further in view of US 20030144373 A1 to Bowman et al. (Bowman).
Regarding claim 25:
Williams fails to disclose:
The implantable cell containing device of claim 1, wherein the cells of the hydrogel comprise a preparation of primary cells or a preparation of immortalized cells.
Bowman teaches:
A biocompatible material does not promote an immune, allergenic or inflammatory response in the body. The biocompatible material includes biocompatible hydrogel matrix that includes immortalized cell lines (¶0033).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to further include immortalized cells for the hydrogel as taught by Bowman to prevent immune, allergenic or inflammatory response in the body (Bowman, ¶0033).
Claim(s) 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200390933 A1 to Williams et al. (Williams) as applied to claim 1 above, and further in view of US 20100215731 A1 to Emans et al. (Emans).
Regarding claim 26:
Williams fails to disclose:
The implantable cell containing device of claim 1, wherein the cells of the hydrogel comprise a preparation of mammalian cells.
Emans teaches:
Hydrogels used in scaffolds comprise a preparation of mammalian cells/human cells in order to repair tissue (¶0062).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to further include human cells/mammalian cells as taught by Emans in order to repair tissue (Emans, ¶0062).
Regarding claim 27 (as best understood by the examiner, see the 35 USC 112(b) rejection above for the claim interpretation):
All limitations of the claim are taught by the 35 USC 103 rejection of claim 26 by Williams and Emans:
The implantable cell containing device of claim 26, wherein cells of the hydrogel comprise a preparation of mammalian cells selected from the group consisting of primate cells (see the human cells in the hydrogel as taught by Emans incorporated into Emans), rodent cells, canine cells, feline cells, equine cells, bovine cells, and porcine cells.
Regarding claim 28:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 26 by Williams and Emans:
The implantable cell containing device of claim 27, wherein the cells of the hydrogel comprise human cells (see the human cells in the hydrogel as taught by Emans incorporated into Emans).
Claim(s) 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200390933 A1 to Williams et al. (Williams) as applied to claim 1 above, and further in view of US 20080193536 A1 to Khademhosseini et al. (Khademhosseini).
Regarding claim 29:
Williams fails to disclose:
The implantable cell containing device of claim 1, wherein the cells of the hydrogel comprise a preparation of stem cells or stem cell derived cells.
Khademhosseini teaches:
A scaffold including cell laden hydrogels (¶0024). The cells can include stem cells including pluripotent stem cells or embryonic stem cells (¶0100) in order to provide support for cell adhesion, migration and proliferation (¶0024).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams for the hydrogels to further include steam cells including pluripotent stem cells or embryonic stem cells as taught by Khademhosseini to aid in cell adhesion, migration and proliferation (Khademhosseini, ¶0024).
Regarding claim 30:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 29 by Williams and Khademhosseini:
The implantable cell containing device of claim 29, wherein the stem cells are pluripotent (see the pluripotent stem cells of Khademhosseini incorporated into Williams), multipotent, oligopotent, or unipotent stem cells.
Regarding claim 31:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 29 by Williams and Khademhosseini:
The implantable cell containing device of claim 29, wherein the preparation of stem cells is selected from the group consisting of embryonic stem cells (see the embryonic stem cells of Khademhosseini incorporated into Williams), epiblast cells, primitive ectoderm cells, primordial germ cells, and induced pluripotent stem cells.
Claim(s) 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200390933 A1 to Williams et al. (Williams) as applied to claim 1 above, and further in view of US 20170226232 A1 to Vegas et al. (Vegas).
Regarding claim 32:
Williams fails to disclose:
The implantable cell containing device of claim 1, wherein the cells of the hydrogel are selected from the group consisting of smooth muscle cells, cardiac myocytes, platelets, epithelial cells, endothelial cells, urothelial cells, fibroblasts, embryonic fibroblasts, myoblasts, chondrocytes, chondroblasts, osteoblasts, osteoclasts, keratinocytes, hepatocytes, bile duct cells, islet cells, thyroid, parathyroid, adrenal, hypothalamic, pituitary, ovarian, testicular, salivary gland cells, adipocytes, embryonic stem cells, mesenchymal stem cells, neural cells, endothelial progenitor cells, hematopoietic cells, precursor cells, mesenchymal stromal cells, Baby Hamster Kidney (BHK) cells, Chinese Hamster Ovary cells, Human Amniotic Epithelial (HAE) cells, choroid plexus cells, chromaffin cells, adrenal chromaffin cells, pheochomocytoma cell line PC12, human retinal pigment epithelium cells, recombinant human retinal pigment epithelium cells, NGF-secreting Baby Hamster Kidney (BHK) cells, human bone marrow-derived stem cells transfected with GLP-1, BDNF-producing fibroblasts, NGF-producing cells, CNTF-producing cells, BDNF-secreting Schwann cells, IL-2-secreting myoblasts, endostatin-secreting cells, and cytochrome P450 enzyme overexpressed feline kidney epithelial cells, myogenic cells, embryonic stem cell- derived neural progenitor cells, irradiated tumor cells, proximal tubule cells, neural precursor cells, astrocytes, genetically engineered cells.
Vegas teaches:
A scaffold (¶1805) that can include hydrogels with pancreatic islet cells further including insulin and glucagon (¶1535) for treating diabetes (¶0004).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Williams to further include islet cells that release insulin and glucagon as taught by Vegas to treat diabetes (Vegas, ¶0004).
Regarding claim 33:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 32 by Williams and Vegas:
The implantable cell containing device of claim 32, wherein the cells of the hydrogel comprise a preparation of islet cells that release insulin and glucagon (see the insulin and glucagon of the islet cells as taught by Vegas and incorporated into Williams).
Regarding claim 34:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 32 by Williams and Vegas:
The implantable cell containing device of claim 32, wherein the preparation of islet cells is a preparation of human cells (Vegas teaches human cells in ¶2051 in order to treat diabetes and would be incorporated into Williams accordingly), porcine cells, or rodent islets.
Regarding claim 35:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 32 by Williams and Vegas:
The implantable cell containing device of claim 33, wherein the preparation of islets comprise a density between 1x103 to 6x105 islet equivalents (IEQs)/mL (Vegas teaches the islet cells can be concentrated at 100-10000 IE/ml in ¶1539 and would be incorporated into Williams accordingly).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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