DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
Regarding claim 51, the term “substantially” is being interpreted as a broad term, per MPEP § 2173.05(b)(III)(D).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
(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 20-21, 50-54, and 65 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Berry (US 20130034898) (previously cited).
Regarding claim 20, Berry discloses a bioreactor (abstract), comprising,
a plurality of three-dimensional structures (paragraph [0050]; a layer of a matrix of cylindrical structures; Fig. 1), wherein each three-dimensional structure comprises a scaffold (paragraph [0050]; scaffold; Fig. 1) in the form of a lattice (paragraph [0050]; interconnection of a matrix of cylindrical structures; Fig. 1) having a plurality of units (paragraph [0050]; a matrix of cylindrical structures; Fig. 1), each unit being defined by struts of the lattice (paragraph [0016]; open spaces formed by the interconnection of the structures; Fig. 1), wherein walls of the scaffold are defined by the units (Fig. 1); and
polymer-immobilized whole cells present in at least some of the units (paragraphs [0038] and [0056]; Figs. 7 and 8).
The limitation “printed” is a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP § 2113.
Alternatively, while Berry does not teach that their invention is “a bioreactor” as stated in the claimed preamble, a preamble merely indicates the intended use of the apparatus and does not add structural limitations to the claims. MPEP § 2111.02(II). Because the apparatus taught by Berry teaches all the structural limitations claimed, it would be capable of being used as “a bioreactor”. Applicant is also reminded that the intended use of or manner of operating a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II).
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Berry, Fig. 1
Regarding claim 21, Berry discloses wherein the scaffold comprises at least one sidewall (Fig. 1, outermost sides of the scaffold) having a thickness defined by a length of one unit (Fig. 1, the outermost sides of the scaffold are defined by a length of one unit of the lattice: paragraph [0016]; open spaces formed by the interconnection of the structures; Fig. 1).
Regarding claim 50, Berry discloses wherein a geometry of at least some of the plurality of printed three-dimensional structures (paragraph [0050]; a layer of a matrix of cylindrical structures; Fig. 1) is selected from the group consisting of: a cylinder (paragraph [0018]) and a cubic structure (paragraph [0018]).
Regarding claim 51, Berry discloses wherein the plurality of units have at least one substantially uniform dimension (paragraph [0019]).
Regarding claim 52, Berry discloses wherein the bioreactor (abstract) includes a flow (paragraph [0030]) channel (paragraph [0012]).
Regarding claim 53, Berry discloses wherein the bioreactor (abstract) is configured to operate at a temperature that correlates to a viable temperature of the polymer-immobilized whole cells (inherent to body temperature 37℃, paragraph [0029] “implanted into the patient”).
Additionally, regarding the limitation, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Berry would be fully capable of operating in this manner given the structure of the bioreactor.
Regarding claim 54, Berry discloses wherein the bioreactor is configured to operate at a temperature in a range of greater than 20 degrees Celsius to less than about 45 degrees Celsius (inherent to body temperature 37℃, paragraph [0029] “implanted into the patient”).
Additionally, regarding the limitation, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Berry would be fully capable of operating in this manner given the structure of the bioreactor.
Regarding claim 65, Berry discloses wherein an arrangement of at least some of the plurality of units (paragraph [0050]; a matrix of cylindrical structures; Fig. 1) defines a flow (paragraph [0030]) channel (paragraph [0012]).
Claim Rejections - 35 USC §§ 102 | 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
(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.
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.
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.
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.
Claim 63 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by Berry (US 20130034898) (previously cited) or, in the alternative, under 35 U.S.C. 103 as obvious over Berry (US 20130034898) (previously cited) in view of West (US 20120058174) (newly disclosed).
Regarding claim 63, Berry discloses a bioreactor (abstract), comprising,
a plurality of printed three-dimensional structures (paragraph [0050]; a layer of a matrix of cylindrical structures; Fig. 1), wherein each printed three-dimensional structure comprises a scaffold (paragraph [0050]; scaffold; Fig. 1) in the form of a lattice (paragraph [0050]; interconnection of a matrix of cylindrical structures; Fig. 1) having a plurality of units (paragraph [0050]; a matrix of cylindrical structures; Fig. 1), each unit being defined by struts of the lattice (paragraph [0016]; open spaces formed by the interconnection of the structures; Fig. 1),
wherein walls of the scaffold are defined by the units (Fig. 1), wherein each unit defines a void volume that for at least some of the units is infilled with a hydrogel (paragraphs [0021]-[0022]) having polymer-immobilized whole cells (paragraphs [0038] and [0056]; Figs. 7 and 8) therein.
If it is deemed that Berry does not disclose wherein each unit defines a void volume that for at least some of the units is infilled with a hydrogel, West discloses wherein each unit defines a void volume (Fig. 2B; paragraphs [0038]-[0039], backfilling the void space) that for at least some of the units is infilled with a hydrogel (paragraphs [0042] and [0050]).
In the analogous art of interconnected model vasculature gels, it would have been obvious to one skilled in the art before the effective filing date to modify Berry’s bioreactor with the hydrogel infill of West in order to provide a biomaterial that can sustain a suspension of viable cells for use in biological applications (West, paragraph [0050]), and additionally, the infill can contain pharmaceuticals, proteins, DNA, or other moieties for drug delivery applications (West, paragraph [0051]).
Regarding the limitation “printed three-dimensional structures”, is a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP § 2113.
Alternatively, while Berry does not teach that their invention is “a bioreactor” as stated in the claimed preamble, a preamble merely indicates the intended use of the apparatus and does not add structural limitations to the claims. MPEP § 2111.02(II). Because the apparatus taught by Berry teaches all the structural limitations claimed, it would be capable of being used as “a bioreactor”. Applicant is also reminded that the intended use of or manner of operating a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Berry (US 20130034898) (previously cited) as applied to claim 20.
Regarding claim 22, Berry discloses wherein each unit has a dimension measured between the opposite struts of the unit, wherein the dimension has a length of at least 700 microns (paragraph [0016]).
Berry does not disclose wherein each unit has a dimension measured between the opposite struts of the unit, wherein the dimension has a length of at least 250 microns.
However, this is obvious under routine optimization of the struts of Berry. The limitation is obvious as a matter of routine optimization, because the length of the struts is a result-effective variable. The motivation for optimizing this result-effective variable is to be able to hold cells while optimizing the flow of medium throughout the scaffold (Berry, paragraph [0017]). MPEP § 2144.05(II).
Claims 45, 47-49, and 55-58 are rejected under 35 U.S.C. 103 as being unpatentable over Berry (US 20130034898) (previously cited) as applied to claim 20, in view of Silverman (US 20150232888) (previously cited).
Regarding claim 45, Berry discloses the polymer-immobilized whole cells (paragraphs [0038] and [0056]; Figs. 7 and 8).
Berry does not disclose wherein the polymer-immobilized whole cells are selected from the group consisting of: yeasts, methanotrophic organisms, and methylotrophic organisms.
Silverman discloses wherein the polymer-immobilized whole cells (paragraph [0100] “calcium alginate gel bead”) are selected from the group consisting of: yeasts (paragraph [0053]), methanotrophic organisms (paragraph [0054]), and methylotrophic organisms (paragraph [0055]).
In the analogous art of genetically engineered microbes, it would have been obvious to one skilled in the art before the effective filing date to modify Berry with the polymer-immobilized whole cells of Silverman in order to biologically oxidize hydrocarbons (Silverman, paragraph [0019]) so that there is a way to produce methanol and other alcohol products (Silverman, paragraph [0007]).
Regarding claim 47, Berry does not disclose wherein the methanotrophic organisms include a strain that is genetically-engineered strain.
Silverman discloses wherein the methanotrophic organisms (paragraph [0054]) include a strain that is genetically-engineered strain ([0052]-[0054]).
In the analogous art of genetically engineered microbes, it would have been obvious to one skilled in the art before the effective filing date to modify modified Berry with the genetically-engineered strain of methanotrophic organisms of Silverman in order to biologically oxidize hydrocarbons (Silverman, paragraph [0019]) so that there is a way to produce methanol and other alcohol products (Silverman, paragraph [0007]).
Regarding claim 48, Berry does not disclose wherein the methanotrophic organisms include a strain that utilizes a gas as a substrate, wherein the substrate is configured to provide a carbon source and an energy source.
Silverman discloses wherein the methanotrophic organisms include a strain (paragraph [0054] for example strains) that utilizes a gas as a substrate, wherein the substrate is configured to provide a carbon source and an energy source (paragraphs [0008]-[0009], [0023], and [0054] “converting methane into methanol” and “methane as its primary carbon and energy source”).
In the analogous art of genetically engineered microbes, it would have been obvious to one skilled in the art before the effective filing date to modify Berry with the strain of methanotrophic organism that utilizes a gas for a carbon and energy source of Silverman in order to biologically oxidize hydrocarbons (Silverman, paragraph [0019]) so that there is a way to produce methanol and other alcohol products (Silverman, paragraph [0007]).
Regarding claim 49, Berry discloses wherein the polymer-immobilized whole cells are present (paragraphs [0038] and [0056]; Figs. 7 and 8).
Berry does not disclose wherein the polymer-immobilized whole cells are present in a concentration that provides an optical density in a range of approximately 1 to about 200.
Silverman discloses wherein the polymer-immobilized whole cells (paragraph [0132]) are present in a concentration that provides an optical density in a range of approximately 1 to about 200 (paragraph [0156] “OD 15”).
In the analogous art of genetically engineered microbes, it would have been obvious to one skilled in the art before the effective filing date to modify modified Berry with the polymer-immobilized whole cells of Silverman at an optical density of 1 to 200, in order to biologically oxidize hydrocarbons (Silverman, paragraph [0019]) so that there is a way to produce methanol and other alcohol products (Silverman, paragraph [0007]).
Regarding claim 55, Berry discloses wherein the bioreactor is configured to permit a flow of gas through the bioreactor such that the gas contacts the polymer-immobilized whole cells (paragraph [0012]).
Berry does not disclose wherein the bioreactor is configured to permit [that] … a product is formed as a result of an uptake of the gas by the polymer-immobilized whole cells
Silverman discloses: wherein the bioreactor is configured to permit a flow of gas through the bioreactor (paragraphs [0050] and [0098]) such that the gas contacts the polymer-immobilized whole cells (paragraph [0132] “gas phase bioreactor is a fluidized bed reactor … a solid matrix is a … calcium alginate gel bead”) and a product is formed as a result of an uptake of the gas by the polymer-immobilized whole cells (paragraph [0126] “one light alkane or alkene from a gas source into the bioreactor … such that the microorganism or cell-free fractions oxidize the light alkane into a corresponding alcohol product or the alkene into a corresponding epoxide product”).
In the analogous art of genetically engineered microbes, it would have been obvious to one skilled in the art before the effective filing date to modify modified Berry with the polymer-immobilized whole cells of Silverman in order to biologically oxidize hydrocarbons (Silverman, paragraph [0019]) so that there is a safe, efficient, specific, environmentally clean, and cost-effective way to produce methanol and other alcohol products of higher value for fuels and chemicals (Silverman, paragraph [0007]).
Additionally, regarding the limitation “the bioreactor is configured to permit [that] … a product is formed as a result of an uptake of the gas by the polymer-immobilized whole cells” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Berry would be fully capable of operating in this manner given the structure of the bioreactor.
Regarding claim 56, Berry does not disclose wherein a rate of the gas uptake is controlled based at least in part on an optical density of the polymer-immobilized whole cells and an extent of immobilization of the polymer-immobilized whole cells in a geometry of each of the printed three-dimensional structures.
Regarding the phrase “wherein a rate of the gas uptake is controlled based at least in part on an optical density of the polymer-immobilized whole cells and an extent of immobilization of the polymer-immobilized whole cells in a geometry of each of the printed three-dimensional structures”, this is an inherent property of a perfusion fluid carrying a gas diffusing to cells. The cells act as a gas “sink” that uptake the gas, while the fluid acts as a gas “source” to give to the cells. It would naturally flow from this idea that a differing number of gas sinks (the cells) would influence the rate of uptake. Similarly, the location of these gas sinks within a geometry of each printed three-dimensional structure (close or far away from the gas source) would influence at least the transient rate of uptake.
Regarding the limitation “printed three-dimensional structures”, is a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP § 2113.
Additionally, regarding the phrase “wherein a rate of the gas uptake is controlled based at least in part on an optical density of the polymer-immobilized whole cells and an extent of immobilization of the whole cells in a geometry of each of the printed three-dimensional structures” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Berry would be fully capable of operating in this manner given the polymer-immobilized whole cells and the three-dimensional structures.
Regarding claim 57, Berry does not disclose wherein the product is selected from the group consisting of: a chemical intermediate, a fuel, and carbon dioxide.
Silverman discloses wherein the product is selected from the group consisting of: a chemical intermediate (paragraph [0019] “wherein the alkane(s) is subsequently converted to its corresponding alcohol(s) and/or the alkene(s) is subsequently converted to its corresponding epoxide(s)”) and a fuel (paragraph [0008], “methanol”).
In the analogous art of genetically engineered microbes, it would have been obvious to one skilled in the art before the effective filing date to modify modified Berry with the microbes of Silverman to obtain the products as in Silverman for the production of higher value fuels and chemicals in a manner that is environmentally clean and cost-effective (Silverman, paragraph [0007]).
Regarding the limitations “a chemical intermediate, a fuel, and carbon dioxide”, the other limitations need not be rejected at this time, as they are claimed in the alternative.
Regarding claim 58, Berry discloses oxygen (paragraph [0007]) and gases (paragraphs [0007] and [0012]).
Berry does not disclose wherein the gas is a mixture comprising at least two gases selected from the group consisting of: methane, air, and carbon dioxide.
Silverman discloses wherein the gas is a mixture comprising at least two gases selected from the group consisting of: methane and air (paragraph [0097]).
In the analogous art of genetically engineered microbes, it would have been obvious to one skilled in the art before the effective filing date to modify modified Berry with the polymer-immobilized whole cells of Silverman in order to biologically oxidize hydrocarbons (Silverman, paragraph [0019]) so that there is a safe, efficient, specific, environmentally clean, and cost-effective way to produce methanol and other alcohol products of higher value for fuels and chemicals (Silverman, paragraph [0007]).
Claims 59-62 are rejected under 35 U.S.C. 103 as being unpatentable over Berry (US 20130034898) (previously cited) in view of Silverman (US 20150232888) (previously cited) as applied to claim 55, further in view of Ozbolat (US 20160288414) (previously cited).
Regarding claim 59, Berry discloses the bioreactor is configured to permit the flow of the gas (paragraph [0012]).
Berry does not disclose wherein the bioreactor is configured to permit addition of humidity to the flow of the gas.
Ozbolat discloses wherein the bioreactor is configured to permit addition of humidity (paragraphs [0428]-[0430]) to the flow of the gas (paragraphs [0028] and [0322]).
In the analogous art of bioprinting, it would have been obvious to one skilled in the art before the effective filing date to modify modified Berry with the humidity of Ozbolat in order to retain moisture in the scaffold so that cells can continue to grow without drying the culture media from evaporation.
Regarding the phrase “wherein the bioreactor is configured to permit addition of humidity to the flow of the gas”, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Berry would be fully capable of operating in this manner given the structure of the modified bioreactor.
Regarding claim 60, Berry discloses the flow of the gas (paragraph [0053]).
Berry does not disclose wherein a duration of the flow of the gas is in a range of about 8 hours to about 72 hours.
Ozbolat discloses wherein a duration of the flow of the gas is in a range of about 8 hours to about 72 hours (paragraphs [0052], [0309], [0321]-[0322] “12 hours of media perfusion”).
In the analogous art of bioprinting, it would have been obvious to one skilled in the art before the effective filing date to modify modified Berry with the duration of the flow of the gas of Ozbolat in order to continue to perfuse the cells with gaseous reagents for continued cell viability and manufacture of products.
Regarding the phrase “wherein a duration of the flow of the gas is in a range of about 8 hours to about 72 hours”, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Berry would be fully capable of operating in this manner given the modified bioreactor.
Regarding claim 61, Berry discloses wherein the bioreactor (abstract) is configured to permit a flow of liquid (paragraph [0017] “flow of medium”) through the bioreactor (abstract) concurrently with the flow of the gas (paragraph [0012]).
Berry does not disclose “to permit a flow … in order to collect the product”.
Ozbolat discloses wherein the bioreactor is configured to permit a flow of liquid through the bioreactor concurrently with the flow of gas (Fig. 38a-e and paragraph [0322] “The bubble was moving along the media flow.”)
In the analogous art of bioprinting, it would have been obvious to one skilled in the art before the effective filing date to modify modified Berry’s bioreactor with a flow of liquid such as that of Ozbolat in order to supply liquid and gaseous nutrients to cells simultaneously so that the cells can grow continuously.
Regarding the phrase “wherein the bioreactor is configured to permit a flow of liquid through the bioreactor concurrently with the flow of the gas in order to collect the product”, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Berry would be fully capable of operating in this manner given the structure of the modified bioreactor.
Regarding claim 62, Berry discloses wherein the liquid includes a buffer solution (paragraphs [0017] and [0030]) having nutrients (paragraph [0012]) for the polymer-immobilized (paragraphs [0021]-[0022]) whole cells (paragraph [0013]).
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Berry (US 20130034898) (previously cited) in view of Silverman (US 20150232888) (previously cited) as applied to claim 45, as evidenced by Nguyen (“Metabolic role of pyrophosphate-linked phosphofructokinase pfk for C1 assimilation in Methylotuvimicrobium alcaliphilum 20Z”) (previously cited).
Regarding claim 46, Berry does not disclose wherein the methanotrophic organisms include strains selected from the group of genera consisting of: Methylococcus, Methylosinus, and Methylotuvimicrobium.
Silverman discloses wherein the methanotrophic organisms include strains selected from the group of genera consisting of: Methylococcus (paragraph [0054]), Methylosinus (paragraph [0054]), and Methylotuvimicrobium (paragraph [0054] “Methylomicrobium alcaliphilum 20Z”)
In the analogous art of genetically engineered microbes, it would have been obvious to one skilled in the art before the effective filing date to modify modified Berry with the polymer-immobilized whole cells of Silverman in order to biologically oxidize hydrocarbons (Silverman, paragraph [0019]) so that there is a way to produce methanol and other alcohol products (Silverman, paragraph [0007]).
Regarding the term “Methylotuvimicrobium alcaliphilum 20Z”, the term is found to be the same as Methylomicrobium alcaliphilum 20Z, as it is only a different name for the same species (evidentiary reference Nguyen, pg. 2 of 14, col 1., middle column).
Claim 64 is rejected under 35 U.S.C. 103 as obvious over Berry (US 20130034898) (previously cited) as applied to claim 20, in view of Espinosa-Hoyos (US 20230107666) (newly disclosed).
Regarding claim 64, Berry discloses the scaffolds (paragraph [0050]; scaffold; Fig. 1) and polymer-immobilized whole cells therein (paragraphs [0038] and [0056]; Figs. 7 and 8).
Berry does not disclose wherein the scaffolds comprise a cured ink.
Espinosa-Hoyos discloses wherein the scaffolds comprise a cured ink (paragraph [0099]).
In the analogous art of bioprinting, it would have been obvious to one skilled in the art before the effective filing date to modify modified Berry in view of Espinosa-Hoyos in order to deposit 3D constructs onto a platform or substrate and cure the construct with UV or thermal curing so that complex architectures can be created with local composition, geometry, and mechanical stiffness can be programmably defined (Espinosa-Hoyos, paragraph [0099]).
Claim 66 is rejected under 35 U.S.C. 103 as obvious over Berry (US 20130034898) (previously cited) as applied to claim 63, in view of Espinosa-Hoyos (US 20230107666) (newly disclosed) or, in the alternative, under 35 U.S.C. 103 as obvious over Berry (US 20130034898) (previously cited) in view of West (US 20120058174) (newly disclosed) as applied to claim 63, further in view of Espinosa-Hoyos (US 20230107666) (newly disclosed).
Regarding claim 66, Berry discloses the scaffolds (paragraph [0050]; scaffold; Fig. 1) and polymer-immobilized whole cells therein (paragraphs [0038] and [0056]; Figs. 7 and 8).
Berry does not disclose wherein the scaffolds comprise a cured ink.
Espinosa-Hoyos discloses wherein the scaffolds comprise a cured ink (paragraph [0099]).
In the analogous art of bioprinting, it would have been obvious to one skilled in the art before the effective filing date to modify modified Berry in view of Espinosa-Hoyos in order to deposit 3D constructs onto a platform or substrate and cure the construct with UV or thermal curing so that complex architectures can be created with local composition, geometry, and mechanical stiffness can be programmably defined (Espinosa-Hoyos, paragraph [0099]).
Additional Prior Art References
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Ling (US 20170321178) (newly cited) – This invention discloses a three-dimensional bioreactor for cell expansion with interconnected spherical voids in a lattice.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the independent claims 20 and 63, new reference Berry discloses a lattice.
Regarding the dependent claims, these claims are rejected as the independent claim is still rejected and no further arguments were made regarding the dependent claims.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN G ESPERON whose telephone number is 571-272-9807, and whose fax number is 571-273-8464. The examiner can normally be reached 9 am - 6 pm Monday through Thursday, and 9 am - 6 pm every other Friday.
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, Michael Marcheschi can be reached at 571-272-1374. 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.
/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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