CTNF 18/288,096 CTNF 89643 DETAILED ACTION Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries 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. 07-20-02-aia AIA 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(s) absent any evidence to the contrary. Applicant is advised of the obligation under 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. 07-21-aia AIA Claim (s) 16-19, 21-24, 26-29, and 31-33, are rejected under 35 U.S.C. 103 as being unpatentable over Aebischer et al. US Patent Number 5,418,154 hereinafter AEBISCHER in view of Simon et al. US PGPub 2017/0296706 hereinafter SIMON and Patel et al. US PGPub 2010/0233115 hereinafter PATEL . As for claim 16 , AEBISCHER teaches “Elongated seamless capsules containing biological material are prepared” (abstract, lines 1-2) and “Therapeutic agents, including living cells which produce biologically active factors, can be encapsulated within a semipermeable, polymeric membrane” (column 3, lines 3-5), i.e. a method of manufacturing a therapeutic device. AEBISCHER teaches “The polymeric membrane provides a network of pores” (column 4, lines 54-56) and “The membrane is a porous structure capable of protecting transplanted cells from autoimmune or viral assault, as well as from other detrimental agents in the external environment, while allowing essential nutrients, cellular waste procures and cell secretions to diffuse therethrough” (column 4, lines 30-37), i.e. providing a member that defines first pores having a first average size that (i) allows passage of a therapeutic agent through the first pores and (ii) prevents passage of immune cells through the first pores . AEBISCHER does teach “Moreover, two or more layers of different morphology (e.g. tight-pored inner skin or outer skin or both) can be formed” (column 5, lines 2-5), i.e. wherein the interior layer has a pore first average size and the exterior layer as a second average size that is larger than the first average size . AEBISCHER is silent on spinning the member about an axis of the member; and applying a fibrous material to the member while the member spins to form a coating that surrounds the member, the coating defining second pores… the second pores being sized to promote vascularization along the coating . SIMON teaches “Two-dimensional materials, particularly graphene-based materials, having a plurality of apertures thereon can be formed into enclosures for various substances and introduced to an environment, particularly a biological environment (in vivo or in vitro). One or more selected substances can be released into the environment” (abstract, lines 1-7), i.e. a method of manufacturing a therapeutic device . SIMON further teaches “The substrate layer can be porous and/or nonporous… In some embodiments, the substrate layer comprises a plurality of polymer filaments” (paragraph 63, lines 1-12) and “Suitable techniques for depositing or forming a porous or permeable polymer on the graphene-based material layer include casting or depositing a polymer solution onto the graphene-based material layer or intermediate layer using a method such as… electrospinning” (paragraph 65, lines 1-7). SIMON further teaches “In some embodiments, the substrate layer can provide a scaffold for tissue growth, cell growth, support, and/or vascularization” (paragraph 75, lines 1-3) and “In some embodiments, the substrate layer can increase vascularization near the enclosure, thus prompting the formation of blood vessels and/or tissue ingrowth in close proximity to the enclosure” (paragraph 61, lines 9-12). It would have been obvious to one of ordinary skill in the art before the effective filing date to apply the fibrous material of SIMON to the capsule of AEBISCHER such that it includes applying a fibrous material to the member… to form a coating that surrounds the member, the coating defining second pores… the second pores being sized to promote vascularization along the coating because SIMON teaches that doing so such a layer can increase vascularization near the enclosure, thus prompting the formation of blood vessels and/or tissue ingrowth in close proximity. SIMON is silent on spinning the member about an axis of the member… applying a fibrous material… while the member spins . However, as noted above, SIMON does teach electrospinning. PATEL teaches “Fibrous polymer scaffolds and methods of manufacture are provided” (abstract, line 1-2) and “The disclosure relates to fibrous scaffolds finding application as medical devices” (paragraph 2, lines 1-2). PATEL shows in Fig. 1, the electrospinning of a fiber onto a spinning substrate that is being spun around an axis and “In various aspects, the conductive arms can be used during electrospinning to control and/or improve polymer fiber alignment in a scaffold. In some embodiments, conductive arms can be used in an electrospinning apparatus having a steel drum collector to improve fiber alignment by orienting the conductive arms parallel to the longitudinal axis of the collector” (paragraph 338, lines 1-7), i.e. spinning the member about an axis of the member… applying a fibrous material… while the member spins. It would have been obvious to include the steps of spinning the member about an axis of the member… applying a fibrous material… while the member spins in the combined process of AEBISCHER and SIMON because PATEL teaches that such an electrospinning process has improved fiber alignment. As for claims 17, AEBISCHER does teach “Moreover, two or more layers of different morphology (e.g. tight-pored inner skin or outer skin or both) can be formed” (column 5, lines 2-5), i.e. wherein comprising adhering the coating to the member as both skins are applied on top of each other. As for claim 18 , AEBISCHER teaches “Elongated seamless capsules containing biological material are prepared by a method in which a coagulant, which includes a cell suspension or other biologically active factor, and a polymeric casting solution are extruded through a common extrusion port having at least two concentric bores” (abstract, lines 1-6) and “In addition to the formation of capsular vehicles of various shapes (e.g., round or tubular)” (column 5, lines 61-62), i.e. further comprising forming the member as a tubular wall using an extrusion apparatus. As for claim 19 , AEBISCHER is silent on fibrous material. SIMON teaches “The substrate layer can be porous and/or nonporous… In some embodiments, the substrate layer comprises a plurality of polymer filaments” (paragraph 63, lines 1-12) and “Suitable techniques for depositing or forming a porous or permeable polymer on the graphene-based material layer include casting or depositing a polymer solution onto the graphene-based material layer or intermediate layer using a method such as… electrospinning” (paragraph 65, lines 1-7). SIMON further teaches “In some embodiments, the substrate layer can provide a scaffold for tissue growth, cell growth, support, and/or vascularization” (paragraph 75, lines 1-3) and “In some embodiments, the substrate layer can increase vascularization near the enclosure, thus prompting the formation of blood vessels and/or tissue ingrowth in close proximity to the enclosure” (paragraph 61, lines 9-12). It would have been obvious to one of ordinary skill in the art before the effective filing date to apply the fibrous material of SIMON to the capsule of AEBISCHER such that it includes further comprising performing an electrospinning process to apply the fibrous material to the member because SIMON teaches that doing so such a layer can increase vascularization near the enclosure, thus prompting the formation of blood vessels and/or tissue ingrowth in close proximity. As for claim 21 , AEBISCHER is silent on fibrous material. SIMON teaches “The substrate layer can be porous and/or nonporous… In some embodiments, the substrate layer comprises a plurality of polymer filaments” (paragraph 63, lines 1-12) and “Suitable techniques for depositing or forming a porous or permeable polymer on the graphene-based material layer include casting or depositing a polymer solution onto the graphene-based material layer or intermediate layer using a method such as… electrospinning” (paragraph 65, lines 1-7). SIMON further teaches “In some embodiments, the substrate layer can provide a scaffold for tissue growth, cell growth, support, and/or vascularization” (paragraph 75, lines 1-3) and “In some embodiments, the substrate layer can increase vascularization near the enclosure, thus prompting the formation of blood vessels and/or tissue ingrowth in close proximity to the enclosure” (paragraph 61, lines 9-12). SIMON further teaches “In some embodiments, the substrate layer comprises a polymer selected from the group consisting of… polypropylene” (paragraph 63, lines 17-20), i.e. wherein the fibrous material comprises one or more second materials including… polypropylene . It would have been obvious to one of ordinary skill in the art before the effective filing date to apply the fibrous material of SIMON to the capsule of AEBISCHER such that it includes wherein the fibrous material comprises one or more second materials including… polypropylene because SIMON teaches that doing so such a layer can increase vascularization near the enclosure, thus prompting the formation of blood vessels and/or tissue ingrowth in close proximity. As for claim 22 , AEBISCHER is silent on pore size, but does state “Moreover, two or more layers of different morphology (e.g. tight-pored inner skin or outer skin or both) can be formed” (column 5, lines 2-5), i.e. wherein the interior layer has a pore first average size and the exterior layer as a second average size that is larger than the first average size . SIMON teaches “The cells within the enclosure are immune-isolated. In some embodiments, hole sizes in perforated two-dimensional materials useful for immunoisolation range in size from about 1-20 nm, about 1-10 nm, about 3-10 nm, or about 3-5 nm” (paragraph 98, lines 11-15), i.e. wherein the first layer has a range the overlaps with wherein the first pores have first widths in the range of about 10 nm to about 400 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim , 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff , 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler , 116 F.3d 1465, 1469-71, 43 USPQ2d, 1362, 1365-66 (Fed. Cir. 1997). See MPEP 2144.05. It would have been obvious to one of ordinary skill in the art before the effective filing date to apply the fibrous material of SIMON to the capsule of AEBISCHER such that it includes a range the overlaps with wherein the first pores have first widths in the range of about 10 nm to about 400 nm because SIMON teaches that such a range process immunoisolation for the interior of the capsule. As for claim 23 , AEBISCHER is silent on pore size, but does state “Moreover, two or more layers of different morphology (e.g. tight-pored inner skin or outer skin or both) can be formed” (column 5, lines 2-5), i.e. wherein the interior layer has a pore first average size and the exterior layer as a second average size that is larger than the first average size . SIMON teaches “the substrate layer can have pores with an effective pore size of from about 1 nm to about 100 μm, or about 10 nm to about 1 μm, or about 10 nm to about 500 nm, or about 100 nm to about 200 nm, or about 50 nm to about 120 nm, or about 1 μm to about 5 μm, or about 1 μm to about 6 μm, or about 5 μm to about 10 μm” (paragraph 68, lines 1-6), i.e. a range that overlaps with wherein the second pores have second widths in a range of about 2 μm to about 60 μm . In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim , 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff , 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler , 116 F.3d 1465, 1469-71, 43 USPQ2d, 1362, 1365-66 (Fed. Cir. 1997). See MPEP 2144.05. SIMON further teaches “In some embodiments, the substrate layer can provide a scaffold for tissue growth, cell growth, support, and/or vascularization” (paragraph 75, lines 1-3) and “In some embodiments, the substrate layer can increase vascularization near the enclosure, thus prompting the formation of blood vessels and/or tissue ingrowth in close proximity to the enclosure” (paragraph 61, lines 9-12). It would have been obvious to one of ordinary skill in the art before the effective filing date to apply the fibrous material of SIMON to the capsule of AEBISCHER such that it includes a range that overlaps with wherein the second pores have second widths in a range of about 2 μm to about 60 μm because SIMON teaches that doing so such a layer can increase vascularization near the enclosure, thus prompting the formation of blood vessels and/or tissue ingrowth in close proximity. As for claim 24 , AEBISCHER teaches “The skins are generally on the order of 5-10 µm in thickness” (column 12, lines 50-51), i.e. a range that overlaps with wherein the container has a wall thickness in a range of about 1 μm to about 100 μm . In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim , 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff , 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler , 116 F.3d 1465, 1469-71, 43 USPQ2d, 1362, 1365-66 (Fed. Cir. 1997). See MPEP 2144.05. As for claim 26 , AEBISCHER and SIMON are silent on the apparatus or specific process for electrospinning. PATEL shows in Fig. 1, the electrospinning of a fiber onto a spinning substrate that is being spun around an axis, wherein the substrate being coated is mounted on to the mandrels for rotation, i.e. further comprising loading the member onto a support member prior to spinning the member about the axis . PATEL further teaches “In various aspects, the conductive arms can be used during electrospinning to control and/or improve polymer fiber alignment in a scaffold. In some embodiments, conductive arms can be used in an electrospinning apparatus having a steel drum collector to improve fiber alignment by orienting the conductive arms parallel to the longitudinal axis of the collector” (paragraph 338, lines 1-7). It would have been obvious to include the steps of further comprising loading the member onto a support member prior to spinning the member about the axis in the combined process of AEBISCHER and SIMON because PATEL teaches that such an electrospinning process has improved fiber alignment. As for claim 27 , AEBISCHER and SIMON are silent on the apparatus or specific process for electrospinning. PATEL shows in Fig. 1, the electrospinning of a fiber onto a spinning substrate that is being spun around an axis and further teaches “Once the aligned fibers reach a critical density and length through the electrospinning process, electrospinning may be stopped or it may continue. If electrospinning is stopped, a single-layer scaffold membrane comprising aligned polymer fibers is generated. If continued, the subsequent deposition of fibers through the same rotation rate and electrical potential applied to the conveyor belt and spinnerets results in the formation of a second layer of fibers, on top of the first layer, having a different orientation from the first aligned fibers deposited on the inner conducting region 506” (paragraph 346, lines 1-10), a process which inherently includes further comprising: terminating spinning of the member; and removing the container from the support member as those steps are necessary to recover the produced spun fiber coating. PATEL further teaches “In various aspects, the conductive arms can be used during electrospinning to control and/or improve polymer fiber alignment in a scaffold. In some embodiments, conductive arms can be used in an electrospinning apparatus having a steel drum collector to improve fiber alignment by orienting the conductive arms parallel to the longitudinal axis of the collector” (paragraph 338, lines 1-7). It would have been obvious to include the steps of further comprising: terminating spinning of the member; and removing the container from the support member in the combined process of AEBISCHER and SIMON because PATEL teaches that such an electrospinning process has improved fiber alignment. As for claim 28 , AEBISCHER further teaches a process of producing its invention in claims 1 and 9 further shows in Fig. 6B which includes sealing a first end of the container; inserting the plurality of cells into the interior region of the container; and sealing a second end of the container to form the therapeutic device, the second end being opposite from the first end . As for claim 29, AEBISCHER is silent on wherein the interior region has a width that is limited to accommodating a single cell of the plurality of cells . However, Examiner notes that AEBISCHER teaches “The maximum outer diameter of the vehicle will typically range from about 0.1 to about 1.0 millimeters. The membrane wall thickness will typically range from about 50 to about 200 micrometers” (column 126, lines 29-33). Examiner notes that it is within the skill of the ordinary artisan to calculate the interior width of the capsule from the outer diameter and wall thickness, and it appears to overlap with the claimed range of wherein the width of the interior region is in a range of about 100 μm to about 2 mm which is a limitation that is paired with wherein the interior region has a width that is limited to accommodating a single cell of the plurality of cells . In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim , 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff , 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler , 116 F.3d 1465, 1469-71, 43 USPQ2d, 1362, 1365-66 (Fed. Cir. 1997). See MPEP 2144.05. As for claim 31 , AEBISCHER teaches “Elongated seamless capsules containing biological material are prepared by a method in which a coagulant, which includes a cell suspension or other biologically active factor, and a polymeric casting solution are extruded through a common extrusion port having at least two concentric bores” (abstract, lines 1-6) and “In addition to the formation of capsular vehicles of various shapes (e.g., round or tubular)” (column 5, lines 61-62), i.e. wherein the support member comprises a tubular mandrel such that the container forms a tube and wherein the method further comprises: maintaining the tube in a linear configuration . As for claim 32 , AEBISCHER is silent on further comprising applying a growth factor to the coating, the growth factor promoting vascularization . SIMON teaches “In some embodiments, the substrate layer or wall comprises additives, such as pharmaceuticals, cells, growth factors ( e.g., VEGF)” (paragraph 75, lines 3-8) and “In some embodiments, additives beneficially promote cell or tissue viability or growth, reduce or prevent infection, improve vascularization to or near the enclosure” (paragraph 76, lines 1-5). SIMON further teaches “In some embodiments, the substrate layer can provide a scaffold for tissue growth, cell growth, support, and/or vascularization” (paragraph 75, lines 1-3) and “In some embodiments, the substrate layer can increase vascularization near the enclosure, thus prompting the formation of blood vessels and/or tissue ingrowth in close proximity to the enclosure” (paragraph 61, lines 9-12). It would have been obvious to one of ordinary skill in the art before the effective filing date to apply the fibrous material of SIMON to the capsule of AEBISCHER such that it includes further comprising applying a growth factor to the coating, the growth factor promoting vascularization because SIMON teaches that doing so such a layer can increase vascularization near the enclosure, thus prompting the formation of blood vessels and/or tissue ingrowth in close proximity. As for claim 33 , AEBISCHER teaches “The shape of the multi-compartment vehicles can be tubular, resembling sausages or nearly spherical, resembling a string of pearls” (column 16, lines 27-29), i.e. forming one or more additional containers; and associating the container with the one or more additional containers in a spaced configuration with a flexible structure that maintains the spaced configuration or coupling the container to the one or more additional containers in a matrix configuration . 07-22-aia AIA Claim (s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Aebischer et al. US Patent Number 5,418,154 hereinafter AEBISCHER, Simon et al. US PGPub 2017/0296706 hereinafter SIMON and Patel et al. US PGPub 2010/0233115 hereinafter PATEL as applied to claim 16 above, and further in view of Martinson et al. US Patent Number 8,425,928 hereinafter MARTINSON . As for claim 20 , AEBISCHER is silent on what polymer the member is made of. MARTINSON teaches “The present invention relates to methods for encapsulating pancreatic progenitors in a biocompatible semi-permeable encapsulating device” (abstract, lines 1-3), i.e. a method of manufacturing a therapeutic device . MARTINSON teaches “In one embodiment, the encapsulating devices are comprised of a biocompatible material including, but are not limited to… ePTFE (expanded polytetrafluoroethylene)” (column 18, line 64 – column 19, line 2). It would have been obvious to one of ordinary skill in the art before the effective filing date to include wherein the member comprises one or more first materials including expanded polytetrafluoroethylene (ePTFE) in the process of AEBISCHER because MARTINSON teaches that such a polymer was known to be used in the formation of microencapsulated therapeutic devices . 07-22-aia AIA Claim (s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Aebischer et al. US Patent Number 5,418,154 hereinafter AEBISCHER, Simon et al. US PGPub 2017/0296706 hereinafter SIMON and Patel et al. US PGPub 2010/0233115 hereinafter PATEL as applied to claim 16 above, and further in view of Lim et al. US Patent Number 4,409,331 hereinafter LIM . As for claim 25 , AEBISCHER teaches “Furthermore, due to the limited diffusional surface area per unit volume of larger size spheres, only a limited amount of tissue can be loaded into a single microcapsule” (column 2, lines 42-45), but is otherwise silent on an external surface area to volume ratio. LIM teaches “Disclosed is a system and process for producing substances produced in cells such as antibodies and biological response modifiers. Cells which produce the substance of interest are encapsulated within semipermeable membranes having an upper limit of permeability sufficient to allow traverse of ions, amino acids and other cell nutrients and then suspended in a culture medium” (abstract, lines 1-8). LIM teaches “The ongoing viability of such cell clusters is aided by the fact that the surface area to volume ratios of the capsules can be quite large, and thus all the cells have access to required nutrients, oxygen, etc.” (column 8, line 66 – column 9, line 2), i.e. wherein the external surface area to volume ratio is a result effective variable. It would have been obvious to one of ordinary skill in the art before the effective filing date to design the external surface area to volume ratio such that the desired nutrients and oxygen exposure to the cells is achieved. Discovery of optimum value of result effective variable in known process is ordinarily within the skill of the art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215 . 07-22-aia AIA Claim (s) 30 is rejected under 35 U.S.C. 103 as being unpatentable over Aebischer et al. US Patent Number 5,418,154 hereinafter AEBISCHER, Simon et al. US PGPub 2017/0296706 hereinafter SIMON and Patel et al. US PGPub 2010/0233115 hereinafter PATEL as applied to claim 16, and 26-28 above, and further in view of Shao et al. US Patent Number 5,620,883 hereinafter SHAO . As for claim 30, AEBISCHER teaches “Alternatively, artificial organs capable of secreting other biological factors, such as hormones (e.g., insulin…) can also be constructed using the capsules, and/or multi-compartment cell capsule strings of the present invention” (column 4, lines 25-29), i.e. the therapeutic agent comprises insulin . AEBISHCER is silent on wherein the plurality of cells are beta cells . SHAO teaches “A biocompatible microcapsule containing living cells encapsulated in a membrane is disclosed” (abstract, lines 1-2). SHAO teaches ““Encapsulated cells which secrete hormones also may be suspended in a culture medium and will excrete hormone over an extended period. Encapsulated insulin-producing cells, for example, mammalian pancreatic alpha cells, beta cells, or intact islets of Langerhans, may also be used as an artificial pancreas. Such encapsulated cells can be implanted into a diabetic mammal and will function in vivo to excrete insulin and other hormones in response to host blood glucose concentration” (column 10, lines 37-46), i.e. wherein the plurality of cells are beta cells. It would have been obvious to one of ordinary skill in the art before the effective filing date to include wherein the plurality of cells are beta cells in the process of AEBISCHER because SHAO teaches such cells can produce the insulin desired by AEBISCHER to control glucose levels . 07-22-aia AIA Claim (s) 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over over Aebischer et al. US Patent Number 5,418,154 hereinafter AEBISCHER, Simon et al. US PGPub 2017/0296706 hereinafter SIMON and Patel et al. US PGPub 2010/0233115 hereinafter PATEL as applied to claim 16 above, and further in view of Ward et al. US PGPub 2009/0169630 hereinafter WARD . As for claim 34 , AEBISCHER is silent on further comprising loading the container with a substance capable of reacting to generate oxygen within the interior region for the plurality of cells . AEBISCHER does teach “Normally cells in the center of large cross sectional area capsules are deprived of nutrients and oxygen” (column 17, lines 44-46). WARD teaches “Methods and compositions for the controlled and sustained release of peroxides or oxygen to aqueous environments ( e.g. a patient's body or circulatory system, or for other applications) or non-aqueous environments, include a material coating or encapsulating hydrogen peroxide, inorganic peroxides or peroxide adducts” (abstract, lines 1-6). WARD further teaches “the complex 50 can consist of a single granule or particle of membrane or coated peroxide or oxygen producing composition 10. However, FIG. 1 shows that a number of particles of the peroxide or oxygen producing composition 10 might be included in a complex. The diameter of the peroxide or oxygen producing composition 10, as well as the complex 50, can vary widely depending on the application” (paragraph 39, lines 1-8). WARD further teaches “However, the rate can also be controlled by using a encapsulating or coating material 20. The membrane or coating material 20 preferably will selectively allow water ( e.g., from the environment in which the composition is to be used) to pass through (from the environment into encapsulated or coated composition), and will allow hydrogen peroxide or oxygen (which are similarly sized to water and have other similar characteristics) that is generated upon contact of the peroxide or oxygen producing composition with water to pass through ( e.g., the oxygen or hydrogen peroxide (or inorganic peroxide) will be directed out through the membrane or coating material 20 into the environment 40)” (paragraph 45, lines 1-17), i.e. loading a membrane with a substrate capable of reacting to generate oxygen . It would have been obvious to one of ordinary skill in the art before the effective filing date to apply the substrate of WARD to the membranes of AEBISCHER such that it includes further comprising loading the container with a substance capable of reacting to generate oxygen within the interior region for the plurality of cells because WARD teaches that such a material can produce a controlled and sustained release of oxygen to feed the cells of AEBISCHER. As for claim 35 , AEBISCHER is silent on the substance. WARD teaches “Methods and compositions for the controlled and sustained release of peroxides or oxygen to aqueous environments ( e.g. a patient's body or circulatory system, or for other applications) or non-aqueous environments, include a material coating or encapsulating hydrogen peroxide, inorganic peroxides or peroxide adducts” (abstract, lines 1-6). WARD further teaches “However, the rate can also be controlled by using a encapsulating or coating material 20. The membrane or coating material 20 preferably will selectively allow water ( e.g., from the environment in which the composition is to be used) to pass through (from the environment into encapsulated or coated composition), and will allow hydrogen peroxide or oxygen (which are similarly sized to water and have other similar characteristics) that is generated upon contact of the peroxide or oxygen producing composition with water to pass through ( e.g., the oxygen or hydrogen peroxide (or inorganic peroxide) will be directed out through the membrane or coating material 20 into the environment 40)” (paragraph 45, lines 1-17), i.e. loading a membrane with a substrate capable of reacting to generate oxygen. It would have been obvious to one of ordinary skill in the art before the effective filing date to apply the substrate of WARD to the membranes of AEBISCHER such that it includes applying a first plurality of particles comprising the substance to an inner surface of the member, because WARD teaches that such a material can produce a controlled and sustained release of oxygen to feed the cells of AEBISCHER. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN A DAGENAIS whose telephone number is (571)270-1114. The examiner can normally be reached 8-12 and 1-5. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dah Wei Yuan can be reached at 571-272-1295. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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. /KRISTEN A DAGENAIS/ Examiner, Art Unit 1717 Application/Control Number: 18/288,096 Page 2 Art Unit: 1717 Application/Control Number: 18/288,096 Page 3 Art Unit: 1717 Application/Control Number: 18/288,096 Page 4 Art Unit: 1717 Application/Control Number: 18/288,096 Page 5 Art Unit: 1717 Application/Control Number: 18/288,096 Page 6 Art Unit: 1717 Application/Control Number: 18/288,096 Page 7 Art Unit: 1717 Application/Control Number: 18/288,096 Page 8 Art Unit: 1717 Application/Control Number: 18/288,096 Page 9 Art Unit: 1717 Application/Control Number: 18/288,096 Page 10 Art Unit: 1717 Application/Control Number: 18/288,096 Page 11 Art Unit: 1717 Application/Control Number: 18/288,096 Page 12 Art Unit: 1717 Application/Control Number: 18/288,096 Page 13 Art Unit: 1717 Application/Control Number: 18/288,096 Page 14 Art Unit: 1717 Application/Control Number: 18/288,096 Page 15 Art Unit: 1717