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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/26/2025 has been entered.
Claim Objections
The claims are objected to because of the following informalities:
Portions of the claims are in grayscale text rather than black text.
Appropriate correction is required.
Claim Interpretation
The following claims have recitations of intended use or a manner of operating the claimed invention:
Regarding claim 1, the preamble states an intended use limitation “An apparatus configured to grow a meat product”.
Regarding claim 1, the claim states the limitation “wherein: … the three-dimensional lattice is … configured to support growth of the meat product”.
Regarding claim 10, the claim states the limitation “one or more fluid nozzles that introduce fluid to the cavity”.
Regarding claim 21, the preamble states an intended use limitation “A bioreactor configured to grow a cell-based meat product”.
Regarding claim 21, the claim states the limitation “wherein the plurality of planar substrates is arranged … to support growth of the cell-based meat product”.
Regarding claim 22, the claim states the limitation “wherein the bioreactor is configured to rotate after seeding of cells on the plurality of planar substrates to grow the cell-based meat product”.
Regarding claim 23, the claim states the limitation “a plurality of fluid nozzles that direct fluid at the plurality of planar substrates to separate the cell-based meat product from the plurality of planar substrates”.
Regarding claim 24, the claim states the limitation “wherein the fluid nozzles … are configured to rotate about a predetermined axis”.
Regarding claim 26, the claim states the limitation “the bioreactor is configured to cause fluid to flow one or more of across or through the plurality of planar substrates arranged into the three-dimensional lattice as the fluid flows downwards from the inlet to the outlet”.
Claim Rejections - 35 USC § 112
Regarding the previous rejections under 35 U.S.C. § 112(b), they have been withdrawn in light of the amendments.
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 13-14 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.
The term “fan-like” in claim 13 is a relative term which renders the claim indefinite. The term “fan-like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding the dependent claim 14, this claim is rejected for the same reason as the base claim upon which it depends.
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.
Claims 1-4, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Castillo (US 20180282678) (previously cited) in view of Spielmann (US 5650325) (newly cited).
Regarding claim 1, Castillo discloses an apparatus, comprising:
a substantially cylindrical enclosure having a cavity (paragraph [0065] “cylindrical bioreactor”); a horizontal longitudinal axis (Fig. 6; paragraph [0080]), wherein the substantially cylindrical enclosure is composed of stainless steel (paragraph [0065]); and
a three-dimensional lattice comprising a plurality of substrates (paragraphs [0053]-[0054]), wherein:
substrates of the plurality of substrates comprise different widths (paragraphs [0054] and [0059] “concentrically wound along an axis or core”; claims 7 and 8; the different diameters of each substrate wound along an axis or core would constitute different widths, similarly to the way that a “Russian doll” is formed, which each consecutive layer being slightly larger than the previous one) so the plurality of substrates conform to a shape of the substantially cylindrical enclosure (paragraph [0065] “cylindrical bioreactor”); and
the three-dimensional lattice is arranged within the cavity (paragraph [0053]-[0054]).
Castillo does not disclose:
an inlet at a first end of the horizontal longitudinal axis
an outlet at an opposing second end of the horizontal longitudinal axis
a plurality of planar substrates
substrates of the plurality of planar substrates are substantially horizontally-oriented and comprise different widths so the plurality of planar substrates conform to a shape of the substantially cylindrical enclosure
Regarding features 1-2, Spielmann discloses an inlet at a first end of the horizontal longitudinal axis (Fig. 6B, elements 67 or 68; col 7., line 65 to col. 8, line 15 “inlet/outlet ports”), and an outlet at an opposing second end of the horizontal longitudinal axis (Fig. 6B, elements 67 or 68; col 7., line 65 to col. 8, line 15 “inlet/outlet ports”).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Castillo with the inlets and outlets of an embodiment of Spielmann in order to fill or empty the bioreactor without having to open it, reducing the risk of contamination (Spielmann, col. 8, lines 5-15).
Regarding the location of the inlet and outlet ports, if it is deemed that the inlet and outlet ports of modified Castillo as above are not located directly along the horizontal longitudinal axis, rearrangement of parts would have been obvious to one of ordinary skill in the art as an obvious matter of design choice and would not have modified the operation of the device. MPEP § 2144.04(VI)(C). Additionally, it would have been obvious to one skilled in the art before the effective filing date to modify the ports to be directly along the axis of rotation in order to fully rotate the bioreactor, even without detaching associated inlet or outlet tubing.
Regarding features 3-4, Spielmann discloses a plurality of planar substrates (col. 4, lines 44-64 “trays 12 are constituted by a planar base sheet 12a which has a substantially rectangular shape, and are normally rigid”); substrates of the plurality of planar substrates are substantially horizontally-oriented (Fig. 1A, elements 12 “trays”) and comprise different widths (Fig. 1A, elements 12 “trays”) so the plurality of planar substrates conform to a shape of the substantially cylindrical enclosure (col. 4, lines 44-64 “external cylindrical housing 11”).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Castillo with the planar substrates in a cylindrical housing of an embodiment of Spielmann in order to rotate the bioreactor while causing fluid to move over both sides of the planar substrates for an increased surface area for the cultivation of cells (Spielmann, col. 4, lines 30-43).
PNG
media_image1.png
361
381
media_image1.png
Greyscale
Spielmann, Fig. 1A
Regarding the phrases “configured to grow a meat product” and “configured to support growth of the meat product”, this is an example of intended use of the apparatus. While Castillo does not teach that their invention is for the growth of a meat product 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 Castillo teaches all the structural limitations claimed, it would be capable of being used for the growth of a meat product. Additionally, 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).
Regarding claim 2, Castillo discloses wherein the three-dimensional lattice is porous (paragraph [0034]).
Regarding claim 3, Castillo discloses wherein the apparatus enables perfusion of fluid between the plurality of substrates (paragraph [0065] “perfusion bioreactor”).
Castillo does not disclose planar substrates.
Modified Castillo teaches planar substrates (see rejection to claim 1).
Regarding claim 4, Castillo discloses wherein the plurality of substrates are parallel (Figs. 1A-1B and 3C, paragraph [0054]).
Castillo does not disclose planar substrates.
Modified Castillo teaches planar substrates (see rejection to claim 1).
If it is deemed that Castillo does not disclose parallel substrates, Spielmann also discloses parallelism (abstract).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Castillo with the parallel planar substrates in a cylindrical housing of an embodiment of Spielmann in order to rotate the bioreactor while causing fluid to move over both sides of the parallel planar substrates for an increased surface area for the cultivation of cells (Spielmann, col. 4, lines 30-43) per unit space of the bioreactor for optimal packing of substrates.
Regarding claim 6, Castillo does not disclose wherein the outlet has a diameter sized to allow cell sheets to pass therethrough.
Spielmann teaches the outlet has a diameter sized to allow cells to pass therethrough (col. 8, lines 15-20, “cell or microorganism harvesting”).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify modified Castillo with the outlet of Spielmann in order to harvest cells for the production of biological substances (Spielmann, col. 1, lines 14-20).
Regarding the limitation “wherein the outlet has a diameter sized to allow cell sheets to pass therethrough”, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. Additionally, it would have been obvious to one skilled in the art before the effective filing date to modify the outlet of modified Castillo to have a larger-sized diameter in order to have harvest an intact cell sheet as a product.
Regarding claim 8, Castillo discloses the plurality of substrates (paragraphs [0053]-[0054]).
Castillo does not disclose wherein the plurality of planar substrates comprise grooves.
Spielmann discloses wherein the plurality of planar substrates comprise grooves (col. 5, lines 25-30 “corrugated surface contour”).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify modified Castillo with the corrugations of Spielmann in order to increase the exchange surface area and to make cell or microorganism culture very efficient (Spielmann, col. 5, lines 25-30).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Castillo (US 20180282678) (previously cited) in view of Spielmann (US 5650325) (newly cited) as applied to claim 1, further in view of Krabbe (US 3193460) (newly cited).
Regarding claim 5, Castillo discloses the substantially cylindrical enclosure (paragraph [0065] “cylindrical bioreactor”).
Castillo does not disclose a volume between 25 liters and 20,000 liters.
Krabbe discloses a volume between 25 liters and 20,000 liters (col. 3, lines 27-34 “a stainless steel drum 10 of standard 55-gallon capacity and of conventional construction”).
In the analogous art of apparatuses for culturing micro-organisms, it would have been obvious to one skilled in the art before the effective filing date to modify the size of modified Castillo to be able to hold between 25 liters and 20,000 liters in order to reduce the number of containers required to be handled in production, facilitate sterilization of the containers, and reduce the danger of contamination (Krabbe, col. 1, lines 33-45).
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Castillo (US 20180282678) (previously cited) in view of Spielmann (US 5650325) (newly cited), as applied to claim 1, further in view of Birch (US 4343904) (newly cited).
Regarding claim 7, Castillo discloses the plurality of substrates (paragraphs [0053]-[0054]) and the horizontal longitudinal axis of the apparatus (Fig. 6; paragraph [0080]).
Castillo does not disclose wherein the plurality of planar substrates are angled relative to the horizontal longitudinal axis of the apparatus.
Birch discloses wherein the plurality of planar substrates are angled relative to a longitudinal axis of the apparatus (Fig. 3; col. 5, lines 9-11).
In the analogous art of apparatuses for growing animal cells, it would have been obvious to one skilled in the art before the effective filing date to modify modified Castillo with the inclined angle of the planar substrates of Birch in order to mount the plates at an angle so that more effective mixing occurs (Birch, col. 2, lines 61-68).
Regarding claim 9, Castillo does not disclose wherein the plurality of planar substrates are oriented at a non-parallel and a non-perpendicular angle relative to the inlet.
Birch discloses wherein the plurality of planar substrates are oriented at a non-parallel and a non-perpendicular angle (Fig. 3; col. 5, lines 9-11) relative to the inlet (Fig. 3, elements 7, 7`, 8, 8`, and 9 are all inlets in the top plate 2; col. 4, lines 64-68).
In the analogous art of apparatuses for growing animal cells, it would have been obvious to one skilled in the art before the effective filing date to modify modified Castillo with the inclined angle of the planar substrates of Birch in order to mount the plates at an angle so that more effective mixing occurs (Birch, col. 2, lines 61-68).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Castillo (US 20180282678) (previously cited) in view of Spielmann (US 5650325) (newly cited) as applied to claim 1, further in view of Banks (US 20110195462) (previously cited).
Regarding claim 10, Castillo does not disclose further comprising one or more fluid nozzles that introduce fluid to the cavity.
Banks discloses further comprising one or more fluid nozzles that introduce fluid to the cavity (paragraphs [0030], [0033], and [0035] “spray nozzles 18 assists in removing both the biomass and substrate 42 from the support structure”).
In the analogous art of using spray nozzles in a bioreactor for harvesting biomass, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Castillo with the nozzles of Banks in order to remove the biomass from the support structure (Banks, paragraph [0035]).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Castillo (US 20180282678) (previously cited) in view of Spielmann (US 5650325) (newly cited) and Banks (US 20110195462) (previously cited), as applied to claim 10, further in view of Edwards (US 20090311777) (previously cited).
Regarding claim 11, Castillo does not disclose further comprising a fluid separator.
Edwards discloses further comprising a fluid separator (Fig. 3, elements 38 “fluid distribution plate”; paragraphs [0053]-[0054]).
In the analogous art of fluid distribution plates in bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of modified Castillo with the fluid separator of Edwards in order to enable equal entry velocities from a fluid source into the bioreactor at different membrane conduits (Edwards, paragraph [0054]).
Regarding claim 12, Castillo does not disclose wherein the fluid separator is configured to distribute fluid across the plurality of planar substrates in accordance with a fluid flow pattern.
Modified Castillo teaches planar substrates (see rejection to claim 1).
Edwards discloses wherein the fluid separator (Fig. 3, elements 38 “fluid distribution plate”; paragraphs [0053]-[0054]) is configured to distribute fluid across the plurality of substrates (paragraph [0054], Fig. 2, element 37 “membrane conduits”) in accordance with a fluid flow pattern (Fig. 3, elements 38 “fluid distribution plate”; paragraphs [0053]-[0054], perforations in the fluid distribution plate).
In the analogous art of fluid distribution plates in bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of modified Castillo in order to enable equal entry velocities from a fluid source into the bioreactor at different membrane conduits (Edwards, paragraph [0054]).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Castillo (US 20180282678) (previously cited) in view of Spielmann (US 5650325) (newly cited), Banks (US 20110195462) (previously cited), and Edwards (US 20090311777) (previously cited) as applied to claim 12, further in view of Swanda (US 20130168296) (previously cited).
Regarding claim 13, Castillo does not disclose wherein the fluid flow pattern comprises a fan-like fluid flow pattern.
Banks discloses wherein the fluid flow pattern comprises a fan-like fluid flow pattern (Fig. 2, element 18 “sprayer nozzles”; paragraph [0033]-[0034]).
In the analogous art of using spray nozzles in a bioreactor for harvesting biomass, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Castillo with the nozzles of Banks in order to remove the biomass from the support structure (Banks, paragraph [0035]).
If it is deemed that the phrase “a fan-like fluid flow pattern” is not disclosed by modified Castillo, Edwards discloses wherein the fluid flow pattern comprises a fan-like fluid flow pattern (Figs. 2-3, elements 38 “fluid distribution plate”; paragraphs [0053]-[0054], the perforations are fanned out throughout the plate).
In the analogous art of fluid distribution plates in bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of modified Castillo in order to enable equal entry velocities from a fluid source into the bioreactor at different membrane conduits (Edwards, paragraph [0054]).
If it is deemed that the phrase “a fan-like fluid flow pattern” is not disclosed by modified Castillo, Swanda discloses this limitation (paragraph [0032]).
In the analogous art of spray apparatuses, it would have been obvious to one skilled in the art before the effective filing date to modify modified Castillo with the rotating spray apparatus of Swanda in order to facilitate the washing off of culture from different media such as water or a nutrient solution (Swanda, paragraph [0024]).
In addition, if it is deemed that the phrase “a fan-like fluid flow pattern” is not disclosed by modified Castillo, the claim limitation is obvious, as the configuration of the claimed shape is a matter of choice, absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the nozzle to emit a fan-shape in order to wash off planar substrates, such as the discs of Banks or the planar substrates of modified Castillo.
Regarding claim 14, Castillo discloses the plurality of substrates (paragraphs [0053]-[0054]).
Castillo does not disclose wherein the fluid separator is positioned perpendicularly to the plurality of planar substrates.
Modified Castillo teaches the planar substrates (see rejection to claim 1).
Edwards discloses wherein the fluid separator (Fig. 3, elements 38 “fluid distribution plate”; paragraphs [0053]-[0054]) is positioned perpendicularly (Figs. 2-3) to the plurality of substrates (Fig. 2, element 37 “membrane conduits”; paragraphs [0053]-[0054]).
In the analogous art of fluid distribution plates in bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of modified Castillo in order to enable equal entry velocities from a fluid source into the bioreactor at different membrane conduits (Edwards, paragraph [0054]).
Claims 21-22 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Castillo (US 20180282678) (previously cited) in view of Spielmann (US 5650325) (newly cited).
Regarding claim 21, Castillo discloses a bioreactor (abstract), comprising:
an interior cavity (paragraph [0065] “cylindrical bioreactor”), a horizontal longitudinal axis (Fig. 6; paragraph [0080]), and a plurality of substrates arranged in a three-dimensional lattice (paragraphs [0053]-[0054]), wherein:
the plurality of substrates is arranged within the interior cavity in the three-dimensional lattice (paragraphs [0053]-[0054]).
Castillo does not specifically disclose though it is arguably inherent to the axial fluid flow (see Castillo, Fig. 5 and paragraph [0018]):
an inlet at a first end of the horizontal longitudinal axis
an outlet at an opposing second end of the horizontal longitudinal axis
Castillo also does not disclose:
the planar substrates
the planar substrates of the plurality of planar substrates each have a substantially rectangular shape and substantially horizontally-oriented; and
the plurality of planar substrates forms a substantially cylindrical shape.
Regarding features 1-2, Spielmann discloses an inlet at a first end of the horizontal longitudinal axis (Fig. 6B, elements 67 or 68; col 7., line 65 to col. 8, line 15 “inlet/outlet ports”), and an outlet at an opposing second end of the horizontal longitudinal axis (Fig. 6B, elements 67 or 68; col 7., line 65 to col. 8, line 15 “inlet/outlet ports”).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Castillo with the inlets and outlets of an embodiment of Spielmann in order to fill or empty the bioreactor without having to open it, reducing the risk of contamination (Spielmann, col. 8, lines 5-15).
Regarding the location of the inlet and outlet ports, if it is deemed that the inlet and outlet ports of modified Castillo as above are not located directly along the horizontal longitudinal axis, rearrangement of parts would have been obvious to one of ordinary skill in the art as an obvious matter of design choice and would not have modified the operation of the device. MPEP § 2144.04(VI)(C). Additionally, it would have been obvious to one skilled in the art before the effective filing date to modify the ports to be directly along the axis of rotation in order to fully rotate the bioreactor, even without detaching associated inlet or outlet tubing.
Regarding features 3-5, Spielmann discloses the planar substrates (col. 4, lines 44-64 “trays 12 are constituted by a planar base sheet 12a which has a substantially rectangular shape, and are normally rigid”); planar substrates of a plurality of planar substrates each have a substantially rectangular shape (col. 4, lines 44-64 “trays 12 are constituted by a planar base sheet 12a which has a substantially rectangular shape, and are normally rigid”) and [are] substantially horizontally-oriented (Fig. 1A, elements 12 “trays”); and the plurality of planar substrates forms a substantially cylindrical shape (col. 4, lines 44-64 “external cylindrical housing 11”; and Fig. 1A, elements 12 “trays”).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Castillo with the planar substrates in a cylindrical housing of an embodiment of Spielmann in order to rotate the bioreactor while causing fluid to move over both sides of the planar substrates for an increased surface area for the cultivation of cells (Spielmann, col. 4, lines 30-43).
Regarding the phrases “configured to grow a cell-based meat product” and “to support growth of the cell-based meat product”, although Castillo does not teach that their invention is 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 Castillo teaches all the structural limitations claimed, it would be capable of being used for growing a cell-based meat product. 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).
Regarding claim 22, Castillo discloses wherein the bioreactor is configured to rotate (paragraph [0019] and Fig. 6).
Regarding the phrase “after seeding of cells on the plurality of planar substrates to grow the cell-based meat 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 Castillo would be fully capable of operating in this manner given the structures of modified Castillo.
Regarding claim 26, Castillo discloses wherein the bioreactor (abstract) is configured to cause fluid to flow one or more of across or through the plurality of planar substrates arranged into the three-dimensional lattice as the fluid flows (paragraph [0018]).
Castillo does not specifically disclose the inlet and the outlet.
Regarding features 1-2, Spielmann discloses an inlet (Fig. 6B, elements 67 or 68; col 7., line 65 to col. 8, line 15 “inlet/outlet ports”) and an outlet (Fig. 6B, elements 67 or 68; col 7., line 65 to col. 8, line 15 “inlet/outlet ports”).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Castillo with the inlets and outlets of an embodiment of Spielmann in order to fill or empty the bioreactor without having to open it, reducing the risk of contamination (Spielmann, col. 8, lines 5-15).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Castillo (US 20180282678) (previously cited) in view of Spielmann (US 5650325) (newly cited) as applied to claim 21, further in view of Banks (US 20110195462) (previously cited).
Regarding claim 23, Castillo does not disclose further comprising a plurality of fluid nozzles that direct fluid at the plurality of planar substrates to separate the cell-based meat product from the plurality of planar substrates.
Banks discloses a plurality of fluid nozzles that direct fluid at a plurality of planar substrates (paragraphs [0030], [0033], and [0035] “spray nozzles 18 assists in removing both the biomass and substrate 42 from the support structure”).
In the analogous art of using spray nozzles in a bioreactor for harvesting biomass, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Castillo with the nozzles of Banks in order to remove the biomass from the support structure (Banks, paragraph [0035]).
Regarding the limitation “to separate the cell-based meat product from the plurality of planar substrates”, this is an intended use or manner of operating the claimed invention. 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 Castillo would be fully capable of operating in this manner given the bioreactor of Castillo and the fluid nozzles of modified Castillo.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Castillo (US 20180282678) (previously cited) in view of Spielmann (US 5650325) (newly cited) and Banks (US 20110195462) (previously cited), as applied to claim 23, further in view of Swanda (US 20130168296) (previously cited).
Regarding claim 24, Castillo does not disclose wherein fluid nozzles of the plurality of fluid nozzles are configured to rotate about a predetermined axis.
Swanda discloses wherein fluid nozzles of the plurality of fluid nozzles (paragraph [0008]) are configured to rotate about a predetermined axis (paragraphs [0016] and [0047] and Fig. 6).
In the analogous art of spray apparatuses, it would have been obvious to one skilled in the art before the effective filing date to modify modified Castillo with the rotating spray apparatus of Swanda in order to facilitate the washing off of culture from different media such as water or a nutrient solution (Swanda, paragraph [0024]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Castillo (US 20180282678) (previously cited) in view of Spielmann (US 5650325) (newly cited), as applied to claim 21, further in view of Birch (US 4343904) (newly cited).
Regarding claim 25, Castillo discloses the plurality of substrates (paragraphs [0053]-[0054]) and the horizontal longitudinal axis of the bioreactor (Fig. 6; paragraph [0080]).
Castillo does not disclose wherein the plurality of planar substrates are angled relative to the horizontal longitudinal axis of the bioreactor.
Birch discloses wherein the plurality of planar substrates are angled relative to a longitudinal axis of the bioreactor (Fig. 3; col. 5, lines 9-11).
In the analogous art of apparatuses for growing animal cells, it would have been obvious to one skilled in the art before the effective filing date to modify modified Castillo with the inclined angle of the planar substrates of Birch in order to mount the plates at an angle so that more effective mixing occurs (Birch, col. 2, lines 61-68).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 19-20 of U.S. Patent No. 12256761 (Leung) in view of Castillo (US 20180282678) (previously cited) and Spielmann (US 5650325) (newly cited).
Regarding claim 1, Leung discloses an apparatus configured to grow a meat product (claim 14), comprising:
an enclosure having a cavity (claim 14), a longitudinal axis (claim 20), an inlet at a first end of the longitudinal axis (claim 20), and an outlet at an opposing second end of the longitudinal axis (claim 20); and
a three-dimensional lattice comprising a plurality of planar substrates (claims 14 and 19), wherein:
the three-dimensional lattice (claims 14 and 19) is arranged within the cavity and configured to support growth of the meat product (claim 14).
Leung does not disclose:
a substantially cylindrical enclosure
a horizontal longitudinal axis
wherein the substantially cylindrical enclosure is composed of stainless steel;
substrates of the plurality of planar substrates are substantially horizontally-oriented
substrates of the plurality of planar substrates comprise different widths so the plurality of planar substrates conform to a shape of the substantially cylindrical enclosure.
Regarding features 1-3, Castillo discloses a substantially cylindrical enclosure having a cavity (paragraph [0065] “cylindrical bioreactor”); a horizontal longitudinal axis (Fig. 6; paragraph [0080]), wherein the substantially cylindrical enclosure is composed of stainless steel (paragraph [0065]).
In the analogous art of cell growth matrices and their bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify Leung with the substantially cylindrical enclosure, horizontal longitudinal axis, and stainless steel of Castillo in order to create a bioreactor enclosure that is easily rotatable and does not have corners in the bioreactor to have to sterilize during decontamination or to clean out during harvesting of the cells and their products.
Regarding features 4-5, Spielmann discloses a plurality of planar substrates (col. 4, lines 44-64 “trays 12 are constituted by a planar base sheet 12a which has a substantially rectangular shape, and are normally rigid”); substrates of the plurality of planar substrates are substantially horizontally-oriented (Fig. 1A, elements 12 “trays”) and comprise different widths (Fig. 1A, elements 12 “trays”) so the plurality of planar substrates conform to a shape of the substantially cylindrical enclosure (col. 4, lines 44-64 “external cylindrical housing 11”).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Leung with the planar substrates in a cylindrical housing of an embodiment of Spielmann in order to rotate the bioreactor while causing fluid to move over both sides of the planar substrates for an increased surface area for the cultivation of cells (Spielmann, col. 4, lines 30-43).
If it is deemed that claims 14 and 19 and claims 14 and 20 of Leung need an obviousness statement to be combined, it would have been obvious to one skilled in the art before the effective filing date to modify Leung’s 14 and 19 with Leung’s 14 and 20 in order to create a three-dimensional lattice for the growth of meat-product cells so as to increase the surface area of the cells so that more meat-product can be produced.
Regarding claim 4, Leung does not disclose wherein the plurality of planar substrates are parallel.
Castillo discloses wherein the plurality of substrates are parallel (Figs. 1A-1B and 3C, paragraph [0054]).
In the analogous art of cell growth matrices and their bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify Leung with the parallelism of Castillo in order to have, per unit space of the bioreactor, optimal packing of substrates.
If it is deemed that Castillo does not disclose parallel substrates, Spielmann also discloses parallelism (see 103 rejection to claim 4).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Leung with the parallel planar substrates in a cylindrical housing of an embodiment of Spielmann in order to rotate the bioreactor while causing fluid to move over both sides of the parallel planar substrates for an increased surface area for the cultivation of cells (Spielmann, col. 4, lines 30-43) per unit space of the bioreactor for optimal packing of substrates.
Modified Leung teaches planar substrates (see rejection to claim 1).
Regarding claim 6, Leung does not disclose wherein the outlet has a diameter sized to allow cell sheets to pass therethrough.
Spielmann teaches the outlet has a diameter sized to allow cells to pass therethrough (col. 8, lines 15-20, “cell or microorganism harvesting”).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify modified Leung with the outlet of Spielmann in order to harvest cells for the production of biological substances (Spielmann, col. 1, lines 14-20).
Regarding the limitation “wherein the outlet has a diameter sized to allow cell sheets to pass therethrough”, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. Additionally, it would have been obvious to one skilled in the art before the effective filing date to modify the outlet of modified Leung to have a larger-sized diameter in order to have harvest an intact cell sheet as a product.
Regarding claim 8, Leung discloses wherein the plurality of planar substrates comprise grooves.
Spielmann discloses wherein the plurality of planar substrates comprise grooves (col. 5, lines 25-30 “corrugated surface contour”).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify modified Leung with the corrugations of Spielmann in order to increase the exchange surface area and to make cell or microorganism culture very efficient (Spielmann, col. 5, lines 25-30).
Claims 2-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 18-20 of U.S. Patent No. 12256761 (Leung) in view of Castillo (US 20180282678) (previously cited) and Spielmann (US 5650325) (newly cited).
Regarding claim 2, Leung discloses wherein the three-dimensional lattice is porous (claim 18).
If it is deemed that claims 14 and 19-20 as well as claim 18 of Leung need an obviousness statement to be combined, it would have been obvious to one skilled in the art before the effective filing date to modify Leung’s 14 and 19-20 with Leung’s claim 18 in order to create a porous three-dimensional lattice for the growth of meat-product cells so as to increase the surface area of the cells so that more meat-product can be produced and be better perfused for perfusion culture.
Regarding claim 3, Leung does not disclose wherein the apparatus enables perfusion of fluid between the plurality of planar substrates.
Castillo teaches wherein the apparatus enables perfusion of fluid between the plurality of substrates (paragraph [0065] “perfusion bioreactor”).
Modified Leung teaches planar substrates (see rejection to claim 1 above).
In the analogous art of cell growth matrices and their bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify Leung with the perfusion bioreactor of Castillo in order to perfuse the cells in the bioreactor with new media and discharge the spent media so that the cells can continue to grow at an optimal growth rate.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 19-20 of U.S. Patent No. 12256761 (Leung) in view of Castillo (US 20180282678) (previously cited) and Spielmann (US 5650325) (newly cited) as applied to claim 1, further in view of Krabbe (US 3193460) (newly cited).
Regarding claim 5, Leung does not disclose wherein the substantially cylindrical enclosure comprises a volume between 25 liters and 20,000 liters.
Castillo discloses the substantially cylindrical enclosure (paragraph [0065] “cylindrical bioreactor”).
In the analogous art of cell growth matrices and their bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify Leung with the substantially cylindrical enclosure of Castillo in order to create a bioreactor enclosure that is easily rotatable and does not have corners in the bioreactor to have to sterilize during decontamination or to clean out during harvesting of the cells and their products.
Krabbe discloses a volume between 25 liters and 20,000 liters (col. 3, lines 27-34 “a stainless steel drum 10 of standard 55-gallon capacity and of conventional construction”).
In the analogous art of apparatuses for culturing micro-organisms, it would have been obvious to one skilled in the art before the effective filing date to modify the size of modified Leung to be able to hold between 25 liters and 20,000 liters in order to reduce the number of containers required to be handled in production, facilitate sterilization of the containers, and reduce the danger of contamination (Krabbe, col. 1, lines 33-45).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 17, and 19-20 of U.S. Patent No. 12256761 (Leung) in view of Castillo (US 20180282678) (previously cited) in view of Spielmann (US 5650325) (newly cited), as applied to claim 1, further in view of Birch (US 4343904) (newly cited).
Regarding claim 7, arguably, Leung discloses wherein the plurality of planar substrates are angled relative to the horizontal longitudinal axis of the apparatus (claim 17).
If it is deemed that claims 14 and 19-20 as well as claim 17 of Leung need an obviousness statement to be combined, it would have been obvious to one skilled in the art before the effective filing date to modify Leung’s 14 and 19-20 with Leung’s claim 26 in order to mount the plates at an angle so that more effective mixing occurs (Birch, col. 2, lines 61-68).
If it deemed that Leung does not disclose the limitation above, Castillo discloses the plurality of substrates (paragraphs [0053]-[0054]) and the horizontal longitudinal axis of the apparatus (Fig. 6; paragraph [0080]).
In the analogous art of cell growth matrices and their bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify modified Leung with the plurality of substrates and the horizontal longitudinal axis of the apparatus in order to rotate the bioreactor so that all the substrates can be submerged over time (e.g., similarly to a roller bottle).
Birch discloses wherein the plurality of planar substrates are angled relative to a longitudinal axis of the apparatus (Fig. 3; col. 5, lines 9-11).
In the analogous art of apparatuses for growing animal cells, it would have been obvious to one skilled in the art before the effective filing date to modify modified Leung with the inclined angle of the planar substrates of Birch in order to mount the plates at an angle so that more effective mixing occurs (Birch, col. 2, lines 61-68).
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 17, and 19-20 of U.S. Patent No. 12256761 (Leung) in view of Castillo (US 20180282678) (previously cited) in view of Spielmann (US 5650325) (newly cited), as applied to claim 1.
Regarding claim 9, Leung discloses wherein the plurality of planar substrates are oriented at a non-parallel and a non-perpendicular angle relative to the inlet (claim 17).
If it is deemed that claims 14 and 19-20 as well as claim 17 of Leung need an obviousness statement to be combined, it would have been obvious to one skilled in the art before the effective filing date to modify Leung’s 14 and 19-20 with Leung’s claim 17 in order to mount the plates at an angle so that more effective mixing occurs (Birch, col. 2, lines 61-68).
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 19-20 of U.S. Patent No. 12256761 (Leung) in view of Castillo (US 20180282678) (previously cited) and Spielmann (US 5650325) (newly cited) as applied to claim 1, further in view of Banks (US 20110195462) (previously cited).
Regarding claim 10, Leung does not disclose further comprising one or more fluid nozzles that introduce fluid to the cavity.
Banks discloses further comprising one or more fluid nozzles that introduce fluid to the cavity (paragraphs [0030], [0033], and [0035] “spray nozzles 18 assists in removing both the biomass and substrate 42 from the support structure”).
In the analogous art of using spray nozzles in a bioreactor for harvesting biomass, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of modified Leung with the nozzles of Banks in order to remove the biomass from the support structure (Banks, paragraph [0035]).
Claims 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 19-20 of U.S. Patent No. 12256761 (Leung) in view of Castillo (US 20180282678) (previously cited), Spielmann (US 5650325) (newly cited), and Banks (US 20110195462) (previously cited), as applied to claim 10, further in view of Edwards (US 20090311777) (previously cited).
Regarding claim 11, Leung does not disclose further comprising a fluid separator.
Edwards discloses further comprising a fluid separator (Fig. 3, elements 38 “fluid distribution plate”; paragraphs [0053]-[0054]).
In the analogous art of fluid distribution plates in bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of modified Leung with the fluid separator of Edwards in order to enable equal entry velocities from a fluid source into the bioreactor at different membrane conduits (Edwards, paragraph [0054]).
Regarding claim 12, Leung does not disclose wherein the fluid separator is configured to distribute fluid across the plurality of planar substrates in accordance with a fluid flow pattern.
Modified Castillo teaches planar substrates (see rejection to claim 1).
Edwards discloses wherein the fluid separator (Fig. 3, elements 38 “fluid distribution plate”; paragraphs [0053]-[0054]) is configured to distribute fluid across the plurality of substrates (paragraph [0054], Fig. 2, element 37 “membrane conduits”) in accordance with a fluid flow pattern (Fig. 3, elements 38 “fluid distribution plate”; paragraphs [0053]-[0054], perforations in the fluid distribution plate).
In the analogous art of fluid distribution plates in bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of modified Leung in order to enable equal entry velocities from a fluid source into the bioreactor at different membrane conduits (Edwards, paragraph [0054]).
Claims 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 19-20 of U.S. Patent No. 12256761 (Leung) in view of Castillo (US 20180282678) (previously cited), Spielmann (US 5650325) (newly cited), Banks (US 20110195462) (previously cited), and Edwards (US 20090311777) (previously cited) as applied to claim 12, further in view of Swanda (US 20130168296) (previously cited).
Regarding claim 13, Leung does not disclose wherein the fluid flow pattern comprises a fan-like fluid flow pattern.
Banks discloses wherein the fluid flow pattern comprises a fan-like fluid flow pattern (Fig. 2, element 18 “sprayer nozzles”; paragraph [0033]-[0034]).
In the analogous art of using spray nozzles in a bioreactor for harvesting biomass, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Leung with the nozzles of Banks in order to remove the biomass from the support structure (Banks, paragraph [0035]).
If it is deemed that the phrase “a fan-like fluid flow pattern” is not disclosed by modified Leung, Edwards discloses wherein the fluid flow pattern comprises a fan-like fluid flow pattern (Figs. 2-3, elements 38 “fluid distribution plate”; paragraphs [0053]-[0054], the perforations are fanned out throughout the plate).
In the analogous art of fluid distribution plates in bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of modified Leung in order to enable equal entry velocities from a fluid source into the bioreactor at different membrane conduits (Edwards, paragraph [0054]).
If it is deemed that the phrase “a fan-like fluid flow pattern” is not disclosed by modified Leung, Swanda discloses this limitation (paragraph [0032]).
In the analogous art of spray apparatuses, it would have been obvious to one skilled in the art before the effective filing date to modify modified Leung with the rotating spray apparatus of Swanda in order to facilitate the washing off of culture from different media such as water or a nutrient solution (Swanda, paragraph [0024]).
In addition, if it is deemed that the phrase “a fan-like fluid flow pattern” is not disclosed by modified Leung, the claim limitation is obvious, as the configuration of the claimed shape is a matter of choice, absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the shape of the nozzle to emit a fan-shape in order to wash off planar substrates, such as the discs of Banks or the planar substrates of modified Leung.
Regarding claim 14, Leung does not disclose wherein the fluid separator is positioned perpendicularly to the plurality of planar substrates.
Modified Leung teaches the plurality of substrates; and the planar substrates (see rejection to claim 1).
Edwards discloses wherein the fluid separator (Fig. 3, elements 38 “fluid distribution plate”; paragraphs [0053]-[0054]) is positioned perpendicularly (Figs. 2-3) to the plurality of substrates (Fig. 2, element 37 “membrane conduits”; paragraphs [0053]-[0054]).
In the analogous art of fluid distribution plates in bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of modified Leung in order to enable equal entry velocities from a fluid source into the bioreactor at different membrane conduits (Edwards, paragraph [0054]).
Claims 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 19-20 of U.S. Patent No. 12256761 (Leung) in view of Spielmann (US 5650325) (newly cited).
Regarding claim 21, Leung discloses a bioreactor configured to grow a cell-based meat product (claim 14), comprising:
an interior cavity (claim 14), a longitudinal axis (claim 20), an inlet at a first end of the longitudinal axis (claim 20), an outlet at an opposing second end of the longitudinal axis (claim 20), and a plurality of planar substrates arranged into a three-dimensional lattice (claim 19), wherein:
the plurality of planar substrates (claim 14) is arranged within the interior cavity in the three-dimensional lattice (claim 19) to support growth of the cell-based meat product (claim 14).
Leung does not disclose:
a horizontal longitudinal axis;
the planar substrates of the plurality of planar substrates each have a substantially rectangular shape and substantially horizontally-oriented; and
the plurality of planar substrates forms a substantially cylindrical shape.
Spielmann discloses features 1-3:
the horizontal longitudinal axis (Fig. 6B, elements 67, rotating axis along these ports; col 7., line 65 to col. 8, line 15 “inlet/outlet ports”)
the planar substrates (col. 4, lines 44-64 “trays 12 are constituted by a planar base sheet 12a which has a substantially rectangular shape, and are normally rigid”); planar substrates of a plurality of planar substrates each have a substantially rectangular shape (col. 4, lines 44-64 “trays 12 are constituted by a planar base sheet 12a which has a substantially rectangular shape, and are normally rigid”) and [are] substantially horizontally-oriented (Fig. 1A, elements 12 “trays”); and
the plurality of planar substrates forms a substantially cylindrical shape (col. 4, lines 44-64 “external cylindrical housing 11”; and Fig. 1A, elements 12 “trays”).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Leung with the planar substrates in a cylindrical housing of an embodiment of Spielmann in order to rotate the bioreactor while causing fluid to move over both sides of the planar substrates for an increased surface area for the cultivation of cells (Spielmann, col. 4, lines 30-43).
If it is deemed that claims 14 and 19 and claims 14 and 20 of Leung need an obviousness statement to be combined, it would have been obvious to one skilled in the art before the effective filing date to modify Leung’s 14 and 19 with Leung’s 14 and 20 in order to create a three-dimensional lattice for the growth of meat-product cells so as to increase the surface area of the cells so that more meat-product can be produced.
Regarding claim 22, Leung discloses wherein the bioreactor is configured to rotate (claim 20).
Regarding the phrase “after seeding of cells on the plurality of planar substrates to grow the cell-based meat 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 Leung would be fully capable of operating in this manner given the structures of modified Leung.
Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 19-20 of U.S. Patent No. 12256761 (Leung) in view of Spielmann (US 5650325) (newly cited) as applied to claim 21, further in view of Banks (US 20110195462) (previously cited).
Regarding claim 23, Leung does not disclose further comprising a plurality of fluid nozzles that direct fluid at the plurality of planar substrates to separate the cell-based meat product from the plurality of planar substrates.
Banks discloses a plurality of fluid nozzles that direct fluid at a plurality of planar substrates (paragraphs [0030], [0033], and [0035] “spray nozzles 18 assists in removing both the biomass and substrate 42 from the support structure”).
In the analogous art of using spray nozzles in a bioreactor for harvesting biomass, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Leung with the nozzles of Banks in order to remove the biomass from the support structure (Banks, paragraph [0035]).
Regarding the limitation “to separate the cell-based meat product from the plurality of planar substrates”, this is an intended use or manner of operating the claimed invention. 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 Leung would be fully capable of operating in this manner given the bioreactor of Leung and the fluid nozzles of modified Leung.
Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 19-20 of U.S. Patent No. 12256761 (Leung) in view of Spielmann (US 5650325) (newly cited) and Banks (US 20110195462) (previously cited), as applied to claim 23, further in view of Swanda (US 20130168296) (previously cited).
Regarding claim 24, Leung does not disclose wherein fluid nozzles of the plurality of fluid nozzles are configured to rotate about a predetermined axis.
Swanda discloses wherein fluid nozzles of the plurality of fluid nozzles (paragraph [0008]) are configured to rotate about a predetermined axis (paragraphs [0016] and [0047] and Fig. 6).
In the analogous art of spray apparatuses, it would have been obvious to one skilled in the art before the effective filing date to modify modified Leung with the rotating spray apparatus of Swanda in order to facilitate the washing off of culture from different media such as water or a nutrient solution (Swanda, paragraph [0024]).
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 17, and 19-20 of U.S. Patent No. 12256761 (Leung) in view of Spielmann (US 5650325) (newly cited), as applied to claim 1, further in view of Castillo (US 20180282678) (previously cited) and Birch (US 4343904) (newly cited).
Regarding claim 25, arguably, Leung discloses wherein the plurality of planar substrates are angled relative to the horizontal longitudinal axis of the apparatus (claim 17).
If it is deemed that claims 14 and 19-20 as well as claim 17 of Leung need an obviousness statement to be combined, it would have been obvious to one skilled in the art before the effective filing date to modify Leung’s 14 and 19-20 with Leung’s claim 17 in order to mount the plates at an angle so that more effective mixing occurs (Birch, col. 2, lines 61-68).
If it deemed that Leung does not disclose the limitation above, Castillo discloses the plurality of substrates (paragraphs [0053]-[0054]) and the horizontal longitudinal axis of the apparatus (Fig. 6; paragraph [0080]).
In the analogous art of cell growth matrices and their bioreactors, it would have been obvious to one skilled in the art before the effective filing date to modify modified Leung with the plurality of substrates and the horizontal longitudinal axis of the apparatus in order to rotate the bioreactor so that all the substrates can be submerged over time (e.g., similarly to a roller bottle).
Birch discloses wherein the plurality of planar substrates are angled relative to a longitudinal axis of the apparatus (Fig. 3; col. 5, lines 9-11).
In the analogous art of apparatuses for growing animal cells, it would have been obvious to one skilled in the art before the effective filing date to modify modified Leung with the inclined angle of the planar substrates of Birch in order to mount the plates at an angle so that more effective mixing occurs (Birch, col. 2, lines 61-68).
Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 19-20 of U.S. Patent No. 12256761 (Leung) in view of Spielmann (US 5650325) (newly cited), as applied to claim 1, further in view of Castillo (US 20180282678) (previously cited).
Regarding claim 26, Leung discloses wherein the plurality of planar substrates (claim 14) arranged into the three-dimensional lattice (claim 19); and the inlet (claim 14) and the outlet (claim 14).
Leung does not disclose wherein the bioreactor is configured to cause fluid to flow one or more of across or through the plurality of planar substrates arranged into the three-dimensional lattice as the fluid flows from the inlet to the outlet.
Castillo discloses wherein the bioreactor (abstract) is configured to cause fluid to flow one or more of across or through the plurality of planar substrates arranged into the three-dimensional lattice as the fluid flows (paragraph [0018]).
Castillo does not specifically disclose the inlet and the outlet.
Regarding features 1-2, Spielmann discloses an inlet (Fig. 6B, elements 67 or 68; col 7., line 65 to col. 8, line 15 “inlet/outlet ports”) and an outlet (Fig. 6B, elements 67 or 68; col 7., line 65 to col. 8, line 15 “inlet/outlet ports”).
In the analogous art of rotatable bioreactors having culturing surfaces, it would have been obvious to one skilled in the art before the effective filing date to modify the bioreactor of Castillo with the inlets and outlets of an embodiment of Spielmann in order to fill or empty the bioreactor without having to open it, reducing the risk of contamination (Spielmann, col. 8, lines 5-15).
Additional Prior Art References
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
McAleer (US 3905865) (newly cited) – This invention is a rotating disc bioreactor for cell and vaccine production.
Cornforth (US 20150322397) (newly cited) – This invention is a bioreactor cartridge and system.
Response to Arguments
Applicant’s arguments, see pgs. 7-8 of 16 filed 09/26/2025, with respect to the rejections of the claims under 35 U.S.C. § 102 (with Kitayama as the primary reference and with Castillo as the primary reference in the second set of rejections under 35 U.S.C. § 102) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Castillo in view of Spielmann in rejections under 35 U.S.C. § 103.
Regarding claim 12, the claim states the limitation “wherein the fluid separator is configured to distribute fluid across the plurality of planar substrates in accordance with a fluid flow pattern”. The “configured to” language describing the fluid separator is to be interpreted to have structural limitations due to its “distribution [of] fluid across the plurality of planar substrates”. Because not all fluid separators would include a separator this far-reaching (“across the plurality of substrates” inclusive of all substrates), the separator is to be given structural weight for this limitation. However, the remaining portion of the limitation, “in accordance with a fluid flow pattern” does not provide patentable weight and can be interpreted to be an intended use of the separator. The nozzle of a hose would be an example of how multiple fluid flow patterns could emerge from the same structure, and because the fluid flow pattern is not claimed in claim 12, the separator’s intended fluid flow pattern should not be given patentable weight as it is a manner of intended use. Dependent claim 13 distinctly claims a “fan-like fluid flow pattern” which should be given patentable weight, even if it is arguably considered an obvious change in shape under 35 U.S.C. § 103.
Regarding pgs. 9-11 of the Applicant Remarks, modified Castillo teaches the limitations in view of Spielmann as well as other references in some dependent claims. The Hutmacher reference has been removed from the rejection due to the direct relevance of newly found Spielmann to the claim set.
Regarding pgs. 7-8 of Applicant’s arguments, Kitayama was found to be of a different size and material composition than the claimed invention and could not serve as a primary reference. However, newly found Spielmann is found to directly remove these arguments, as Castillo already comprises stainless steel, and Spielmann’s invention is relevant to scale-up (see Spielmann, col. 9, lines 5-15).
Regarding the dependent claims, these claims are rejected for the same reason as the base claim upon which they depend.
Conclusion
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