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 Status
Claims 1-2, 4-19 and 22 are pending.
Claims 13-19 are withdrawn.
Claims 1, 2, 4-12, and 22 are under examination.
Election/Restrictions
Applicant’s election without traverse of the following invention
Invention
Group I, claims 1, 2, 4-12, and 22, drawn to a method of culturing cells in the reply filed on 24th, August, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112 (b)
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.
Claim 22 is 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.
Claim 22 recites the method “further comprising a step of processing the cells into a meat product for consumption.” The scope of claim 22 is indefinite because there is no nexus between the step of processing the cells into a meat product recited in claim 22 and the preamble of claim 1, upon which claim 22 depends, of “a method of culturing cells.” In other words, it is unclear how the method steps of claim 22 are integrated into the method of claim 1 because they appear to be drawn to unrelated method steps of processing the cells and there is no link between these steps and the culturing method steps of claim 1. Specifically, it is unclear how and where the method steps of “processing the cells into a meat product for consumption” occur relative to the method steps of culturing cells recited in claim 1, upon which claim 22 depends. It is unclear whether these steps occur before introducing the cells or after introducing the cells, and it is also unclear whether these steps could occur at any point on the claimed method.
Generally, when the claims are indefinite, vague or unclear, they cannot be construed without speculation or conjecture; therefore, the indefinite claims are not treated on the merits with respect to prior art. See In re Steele, 305 F.2d 859, 862 (CCPA 1962) (A prior art rejection cannot be sustained if the hypothetical person of ordinary skill in the art would have to make speculative assumptions concerning the meaning of claim language.); see also In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970) ("If no reasonably definite meaning can be ascribed to certain terms in the claim, the subject matter does not become obvious-the claim becomes indefinite."). Notwithstanding Steele, the Office has made every attempt to construe the claims in what the Office believes is the intent of the Applicants in the interest of compact prosecution.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-7, 9-10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ozbolat et al. (US-2016288414-A1; see IDS filed 11th, October, 2024; henceforth “Ozbolat”).
Regarding claim 1, Ozbolat discloses a method of culturing cells, wherein the method comprises the following steps:
obtaining a substrate assembly (“tissue construct produced by a bioprinter” para. [0027]; Figure 13 and also as part of a perfusion apparatus in Figure 56), wherein the substrate assembly comprises
(i) a plurality of fibres (vascular network-530 with at least one tubular filament,
paragraph [0124]),
wherein each fibre has an internal channel running along its length (channel-532);
(ii) a first support at a first end of the plurality of fibres;
(iii) a second support at a second end of the plurality of fibres (vascular network and perfusion matrix have a support on either side such as in Figure 56 which correspond to first and second support, see for example paragraph [0127], last sentence, disclosing said vascular network functioning as "a perfusion matrix"; or paragraphs [0128] and [0399] with reference to figure 56, wherein the vascular network is disclosed in combination with perfusion chamber/receptacle comprising inlet/outlet and tubing system fluidly connected to media reservoir for supplying cell culture media);
wherein at least one of the first support and the second support allows fluid communication across the support into the internal channels while preventing fluid communication across the support to the external surfaces of the plurality of fibres (“The vascular network can be positioned within the receptacle such that the outlet of the receptacle is positioned in alignment with an inlet opening of the vascular network of the tissue construct that is in communication with the center channel of the vascular network and the inlet of the receptacle is positioned in alignment with an outlet opening of the vascular network that is in communication with the center channel of the vascular network” para. [0128]; see also para. [0186]; Figure 56);
introducing a first type of cells into the internal channels of the plurality of fibres (paragraph [0126], last sentence, disclosing that "vascular conduit can comprise cellular components"; and paragraph [0456], wherein "cell sheets were formed on[ ... ] luminal surfaces" and "cell sheets were closely
attached on the conduit walls):
introducing a second type of cells onto the external surfaces of the plurality of fibres (see paragraph [0125] with reference to figure 13: "outerwall portions-536 of the vascular network define void space-534"; paragraph [0126]: plurality of cellular elements-540 positioned within said void space-534); and
culturing cells on the substrate assembly in a bioreactor (“the printed tissue construct can
be connected to a bioreactor for media perfusion” paragraph [0027]; see also figure 13; and paragraph [0399], Figure 56; Figure 15).
Regarding claim 2, further to the discussion of claim 1 above, Ozbolat discloses the step of culturing cells comprises introducing a first cell culture medium into the internal channels of the plurality of fibres (“the printed tissue construct can be connected to a bioreactor for media perfusion” para. [0027] and Figure 13 and “the tissue constructs 500 disclosed herein can be per
fused with cell growth media: para. [0128] and Figure 56; see also para. [0028, 0036, 0047, 0052-0053, 0070-0071, 0074, 0121, 0127-0130, 0153, 0186, 0194, 0209, 0244, 0255-256, 0262, 0269, 0278]; Figures 14A-C, 22A-C, 33, 38A-E, 39A-D, 56-57, 60B; Example Two;) and introducing a second cell culture medium onto the external surfaces of the substrate assembly (“Submerged in cell culturing medium” para. [0246]).
Regarding claim 4, further to the discussion of claim 1, Ozbolat discloses the plurality of fibers (filaments) include alginate and a cross-linker (para. [0124] and “alginate was deposited in the core” para. [0218]), where the cross liker comprises calcium chloride (“calcium chloride was deposited from the outer sheath” para. [0218])(see also “Viscous Sodium alginate Solution was extruded
through the sheath section of the coaxial nozzle with low pressure compressed air, while the calcium chloride Solution was dispensed through the core section of the coaxial nozzle (see FIG. 21A)” para. [0264]; para. [0260, 0268, 0278]). Because both alginate and calcium chloride can be eaten, these disclosed fibers with alginate and calcium chloride fall under the broadest reasonable interpretation of the term “edible” and therefore meet instant claims.
Regarding claims 5-6, further to the discission of claim 1 above, Ozbolat discloses a step of an extrusion step to obtain the plurality of fibres (instant claim 5) which is a co-extrusion step to obtain the plurality of fibres, wherein each of the plurality of fibres has a first outer material and a second inner
material (instant claim 6) (“when the vascular network is produced using a co-axial nozzle assembly as disclosed herein, it is contemplated that the cross-linker can be applied by the inner nozzle, while alginate (or another biomaterial) can be applied by the outer nozzle” para. [0124]; see also para. [0220]).
Regarding claim 7, further to the discussion of claims 1 and 6 above, as stated above (see claim 4 rejection above), Ozbolat discloses the first outer material comprises alginate and the second inner material comprises calcium chloride (para. [0124] and “alginate was deposited in the core” para. [0218]), where the cross liker comprises calcium chloride “calcium chloride was deposited from the outer sheath” para. [0218])(see also “Viscous Sodium alginate Solution was extruded
through the sheath section of the coaxial nozzle with low pressure compressed air, while the calcium chloride Solution was dispensed through the core section of the coaxial nozzle (see FIG. 21A)” para. [0264]; para. [0260, 0268, 0278]).
Regarding claim 9, further to the discussion of claim 1 above, Ozbolat discloses the first type of
cells and/or the second type of cells independently comprise myocytes (“muscle cells” or “human umbilical vein Smooth muscle cells (HUVSMCs)” para. [0126]). Ozbolat also disclosed the cells can be “any desired cell, including for example and without limitation, muscle cells, cartilage cells, bone cells, skin cells, fibroblasts, tissue-specific cells, endothelial cells, and the like” (para. [0126]). Since these disclosed cells can be turned into iPSCS, which are capable of being differentiated into myocytes and/or adipocytes, these disclosed cells fall under the broadest reasonable interpretation of “cells capable of differentiating into myocytes and/or adipocytes” and meet instant claims.
Regarding claim 10, further to the discussion of claim 1 above, as stated above (see claims 1 and 7 above), Ozbolat discloses the plurality of fibres comprise alginate (para. [0022, 0025, 0037-0038, 0040, 0043-0044, 0048-0051, 0053, 0058, 0075-0078, 0124, 0158, 0207, 0209, 0211, 0218, 0229, 0238-0239, 0253, 0257, 0260, 0262, 0264, 0268, 0273, 0275, 0278, 0280-0282]; Figure 8A, 11A, 23A, 24A-B, 29-30, 34A-B, 35B, 36A-C, 39A-D, 61A-61D, 62A-D, 63A-D, 64A-E; Example One, Example 3).
Regarding claim 12, further to the discussion of claim 1 above, Ozbolat discloses both the first
support and second support allow fluid communication across the support into the internal channels, such that fluid can flow across the first support, through the internal channels, and then across the second support (see figure 56 where fluid can flow across one side into the internal chambers, then across the second support).
Accordingly, Ozbolat anticipates instant claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim 8 is rejected under 35 U.S.C. s103 as being unpatentable over Ozbolat et al. (US-2016288414-A1; see IDS filed 11th, October, 2024; henceforth “Ozbolat”) in view of Kuo et al. (Food Hydrocolloids, Volume 111, February 2021, 106262; henceforth “Kuo”).
The teachings of Ozbolat above are incorporated herein in their entirety.
Regarding claim 8, further to the discussion of claim 1 above, although, as stated above, Ozbolat teaches obtaining fibers that comprise alginate by 3D bioprinting (para. [0022, 0025, 0037-0038, 0040, 0043-0044, 0048-0051, 0053, 0058, 0075-0078, 0124, 0158, 0207, 0209, 0211, 0218, 0229, 0238-0239, 0253, 0257, 0260, 0262, 0264, 0268, 0273, 0275, 0278, 0280-0282]; Figure 8A, 11A, 23A, 24A-B, 29-30, 34A-B, 35B, 36A-C, 39A-D, 61A-61D, 62A-D, 63A-D, 64A-E; Example One, Example 3), Ozbolat is silent to a step of freeze-drying step to obtain the plurality of fibres.
Nevertheless, regarding claim 8, Kuo teaches a method step of obtaining a scaffold that comprises alginate for cell culture including 3D bioprinting followed by freeze-drying (pg. 2-3 Material and methods “2.3. 3D printing and freeze-drying”). Kuo teaches freeze drying the scaffold extends the shelf life and enhances the mechanical properties of the fabricated structure, and reduces moisture content and water activity significantly (abstract; see also Figures 4-5, Table 3, and pg. 8 col. 2 “Conclusions”).
Therefore, regarding claim 8, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method of Ozbolat and combine the known prior art element of the freeze-drying step of Kuo to obtain the predictable result of a scaffold for cell culture. One of ordinary skill would have been motivated to do so as taught by Kuo to extend the shelf life of the alginate fibres, enhance the mechanical properties, and reduce moisture content and water activity. Regarding the reasonable expectation of success, Kuo evidences freeze-drying alginate scaffolds after 3D bioprinting (pg. 2-3 Material and methods “2.3. 3D printing and freeze-drying”).
Hence, the claimed invention as a whole was prima facie obvious.
Claims 11 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ozbolat et al. (US-2016288414-A1; see IDS filed 11th, October, 2024; henceforth “Ozbolat”) in view of Arin et al. (WO-2021158105-A1; published 12th, August 2021 with priority to 3rd, February, 2020; henceforth “Arin”) and Fish et al. (Trends Food Sci Technol. 2020 Feb 11;98:53–67.; see IDS filed 11th, October, 2024; henceforth “Fish”).
The teachings of Ozbolat above are incorporated herein in their entirety.
Regarding claim 11, further to the discussion of claims 1 and 10 above, although Ozbolat teaches the cells in the substrate can be muscle cells (para. [0127]), Ozbolat is silent to using the muscle cells for making cultured meat, and Ozbolat is silent to a method step of disassociating the cells from the substrate by using alginate-lyase after culturing cells on the substrate.
Nevertheless, regarding claim 11, Arin teaches culturing muscle cells on an alginate hydrogel as a sacrificial biopolymer substrate for the production of cultured meat (pg. 10), and Arin teaches a method step of disassociating the muscle cells from the substrate by using alginate-lyase after culturing cells on the substrate (“Selective removal may be achieved by… using a chelator (e.g. EDTA) and/or enzymatic degradation (e.g. Alginate Lyase)” pg. 9 and Figure 7; see also description of the alginate hydrogel as a sacrificial biopolymer in abstract; pg. 4, 9-11; claim 9). Arin teaches the alginate as sacrificial biopolymer can be selectively removed from the tissue (pg. 9 4th para.).
Additionally, regarding claim 11, Fish teaches some taste panels noted off flavors of meat products that include alginate which was attributed to incomplete homogenization of alginate into the meat (pg. 16 2nd para.).
Therefore, regarding claim 11, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method of Ozbolat and combine the known prior art element of the step of using alginate-lyase after culturing cells on the substrate of Ozbolat to obtain the predictable result of removal of alginate. One of ordinary skill would have been motivated to do so because Fish teaches that alginate that has incomplete homogenization of alginate into the meat can cause off flavors to meat products (pg. 16 2nd para.). Regarding the reasonable expectation of success, Arin evidences a method step of disassociating the cells from the substrate by using alginate-lyase after culturing cells on the substrate (“Selective removal may be achieved by… using a chelator (e.g. EDTA) and/or enzymatic degradation (e.g. Alginate Lyase)” pg. 9 and Figure 7; see also description of the alginate hydrogel as a sacrificial biopolymer in abstract; pg. 4, 9-11; claim 9).
Regarding claim 22, further to the discussion of claim 1 above, as stated above (see claim 11 rejection above), Arin teaches and makes obvious combing a step of disassociating muscle cells from the substrate by using alginate-lyase after culturing cells on the substrate for the reasons set forth above. Because a step of using alginate-lyase is an additional step that processes the meat product, this step falls under the broadest reasonable interpretation of “a step of processing the cells into a meat product for consumption” and meets instant claims.
Hence, the claimed invention as a whole was prima facie obvious.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ozbolat et al. (US-2016288414-A1; see IDS filed 11th, October, 2024; henceforth “Ozbolat”) in view of Leung et al. (US-20210145031-A1; Published 20th, May, 2021 and filed 20th, November, 2020 with benefit to 20th, November, 2019; henceforth “Leung”).
The teachings of Ozbolat above are incorporated herein in their entirety.
Regarding claim 22, further to the discussion of claim 1 above, although Ozbolat teaches the cells in the substrate can be muscle cells (para. [0127]), and Ozbolat teaches using bovine cells for cell preparation (para. [0494]), Ozbolat is silent to culturing the muscle cells for making a meat product, and Ozbolat is silent to a step of processing the cells into a meat product for consumption.
Nevertheless, regarding claim 22, Leung teaches culturing muscle cells on an apparatus for making a meat product suitable for consumption (abstract; Figures 1, 2C, 3A, 7A-D, 8A-C, 9A-B, 13A, 17A, 18A-E and 19; para. [0002-0005, 0009-0011, 0017-0018, 0020-0021, 0023-0024, 0026, 0029-0030, 0032-0034, 0038-0040, 0044, 0048, 0050-0053, 0055-0057, 0059, 0061, 0077-0078, 0080, 0083, 0088, 0090, 0103-0105, 0110, 0113, 0117-0123, 0126-0128, 0130, 0132, 0141, 0143, 0150-0151, 0153-0154, 0156-0159, 0165-0167, 0169-0170, 0172-0176, 0181-0183, 0198, 0202-0203, 0208-0209, 0211, 0215-0216, 0218-0220, 0224, 0227-0236]; claims 1, 4, 6, 8 and 23) and Leung teaches steps of processing the cells into a meat product for consumption (see Figure 19 steps of “separate the meat product” 1916 and “collect the meat product” 1918; see also abstract “separation of a meat product from an enclosed substrate” and Figures 1, 17A, ; para. [0004, 0009-0010, 0018, 0020-0021, 0024, 0029, 0048, 0053, 0055, 0056-0058, 0066, 0077, 0081-0082, 0102-0117, 0122, 0126-0128, 0132, 0150, 0152, 0154, 0156, 0166, 0170-0171, 0181, 0208, 0211-0213, 0218-0219, 0231, 0233-0235]; claims 4-6 and 23).
Therefore, regarding claim 22, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method of Ozbolat and combine the known prior art elements of culturing muscle cells for making a meat product suitable for consumption and steps of processing the cells into a meat product for consumption of Leung to obtain the predictable result of a meat product for consumption. One of ordinary skill would have been motivated to do so as taught by Leung to obtain a meat product for consumption (abstract; Figures 1, 2C, 3A, 7A-D, 8A-C, 9A-B, 13A, 17A, 18A-E and 19; para. [0002-0005, 0009-0011, 0017-0018, 0020-0021, 0023-0024, 0026, 0029-0030, 0032-0034, 0038-0040, 0044, 0048, 0050-0053, 0055-0057, 0059, 0061, 0077-0078, 0080, 0083, 0088, 0090, 0103-0105, 0110, 0113, 0117-0123, 0126-0128, 0130, 0132, 0141, 0143, 0150-0151, 0153-0154, 0156-0159, 0165-0167, 0169-0170, 0172-0176, 0181-0183, 0198, 0202-0203, 0208-0209, 0211, 0215-0216, 0218-0220, 0224, 0227-0236]; claims 1, 4, 6, 8 and 23). Regarding the reasonable expectation of success, Leung evidences culturing muscle cells into a meat product a subsequent processing steps of isolation and collection of the meat product (see Figure 19 steps of “separate the meat product” 1916 and “collect the meat product” 1918; see also abstract “separation of a meat product from an enclosed substrate” and Figures 1, 17A, ; para. [0004, 0009-0010, 0018, 0020-0021, 0024, 0029, 0048, 0053, 0055, 0056-0058, 0066, 0077, 0081-0082, 0102-0117, 0122, 0126-0128, 0132, 0150, 0152, 0154, 0156, 0166, 0170-0171, 0181, 0208, 0211-0213, 0218-0219, 0231, 0233-0235]; claims 4-6 and 23).
Hence, the claimed invention as a whole was prima facie obvious.
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.
Provisional Non-Statutory Double Patenting
U.S. Co-pending Application No. 18/837,172
Claims 1, 4-12, and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-13 and 18 of copending application No. 18/837,172 (claim set filed 8th, August, 2024).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method for culturing cells makes obvious the method of culturing cells of instant application.
Although the claims at issue are not identical, they are not patentably distinct for the reasons stated below.
Regarding claims 1 and 4, U.S. Co-pending App ‘172 claims a method of culturing cells, wherein the method comprises the following steps:
obtaining a substrate assembly, wherein the substrate assembly comprises
(i) a plurality of edible fibres (instant claim 4), wherein each fibre has an internal channel running
along its length;
(ii) a first support at a first end of the plurality of fibres;
(iii) a second support at a second end of the plurality of fibres; wherein at least one of the first support and the second support allows fluid communication across the support into the internal channels while preventing fluid communication across the support to the external surfaces of the plurality of fibres; and
culturing cells on the substrate assembly in a bioreactor (claims 4-5).
Regarding claim 1, while U.S. Co-pending App ‘172 does not directly claim introducing a first type of cells into the internal channels of the plurality of fibres, introducing a second type of cells onto the external surfaces of the plurality of fibres, U.S. Co-pending App ‘172 separately claims first and second cells in the culture method (claim 10 and 13), and it would therefore be obvious to combine these separately claimed steps of culturing these first and second cells of U.S. Co-pending App ‘172 with the method as claimed by U.S. Co-pending App ‘172.
Regarding claim 5, further to the discussion of claim 1 above, U.S. Co-pending App ‘172 claims the step of obtaining the substrate assembly comprises an extrusion step to obtain the plurality of fibres (claim 6).
Regarding claim 6, further to the discussion of claim 1 above, U.S. Co-pending App ‘172 claims the step of obtaining the substrate assembly comprises a co-extrusion step to obtain the plurality of fibres, wherein each of the plurality of fibres has a first outer material and a second inner material (claim 7).
Regarding claim 7, further to the discussion of claim 1 above, U.S. Co-pending App ‘172 claims the first outer material comprises alginate and the second inner material comprises calcium chloride (claim 8).
Regarding claim 8, further to the discussion of claim 1 above, U.S. Co-pending App ‘172 claims the step of obtaining the substrate assembly comprises a freeze-drying step to obtain the plurality of fibres (claim 9).
Regarding claim 9, further to the discussion of claim 1 above, U.S. Co-pending App ‘172 claims the first type of cells and/or the second type of cells independently comprise myocytes, adipocytes, and/or cells capable of differentiating into myocytes and/or adipocytes (claim 10).
Regarding claim 10, further to the discussion of claim 1 above, U.S. Co-pending App ‘172 claims the plurality of fibres comprise alginate (claim 11).
Regarding claim 11, further to the discussion of claims 1 and 10 above, U.S. Co-pending App ‘172 claims after the step of culturing cells on the substrate, of disassociating the cells from the substrate by using alginate-lyase (claim 12).
Regarding claim 12, further to the discussion of claim 1 above, U.S. Co-pending App ‘172 claims both the first support and second support allow fluid communication across the support into the
internal channels, such that fluid can flow across the first support, through the internal channels, and then across the second support (claim 13).
Regarding claim 22, further to the discussion of claim 1 above, U.S. Co-pending App ‘172 claims a step of processing the cells into a meat product for consumption (claim 18).
Since the instant application claims are obvious over cited application claims, said claims are not patentably distinct.
Provisional Non-Statutory Double Patenting
U.S. Co-pending Application No. 18/837,172
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-13 and 18 of copending application No. 18/837,172 (claim set filed 8th, August, 2024) as applied to claim 1 above, in view of Ozbolat et al. (US-2016288414-A1; see IDS filed 11th, October, 2024; henceforth “Ozbolat”).
The teachings of U.S. Co-pending App ‘172 are incorporated herein in their entirety.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method for culturing cells makes obvious the method of culturing cells of instant application.
Although the claims at issue are not identical, they are not patentably distinct for the reasons stated below.
Regarding claim 2, further to the discussion of claim 1 above, U.S. Co-pending App ‘172 claims the method is for culturing cells and therefore, although U.S. Co-pending App ‘172 does not specifically claim introducing cell culture medias, it would be obvious to include these.
Additionally, regarding claim 2, Ozbolat teaches culturing cells comprising introducing a first cell culture medium into the internal channels of the plurality of fibres (“the printed tissue construct can be connected to a bioreactor for media perfusion” para. [0027] and Figure 13 and “the tissue constructs 500 disclosed herein can be perfused with cell growth media: para. [0128] and Figure 56; see also para. [0028, 0036, 0047, 0052-0053, 0070-0071, 0074, 0121, 0127-0130, 0153, 0186, 0194, 0209, 0244, 0255-256, 0262, 0269, 0278]; Figures 14A-C, 22A-C, 33, 38A-E, 39A-D, 56-57, 60B; Example Two;) and introducing a second cell culture medium onto the external surfaces of the substrate assembly (“Submerged in cell culturing medium” para. [0246]) as part of a method of culturing cells on an assembly to perfuse the media for the cells.
Therefore, regarding claim 2, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method as claimed by U.S. Co-pending App ‘172 and combine the known prior art element of introducing a first cell culture medium into the internal channels of the plurality of fibres and introducing a second cell culture medium onto the external surfaces of the substrate assembly to obtain the predictable result of a method of culturing cells. One of ordinary skill would have been motivated to do so as taught by Ozbolat to perfuse the cells with culture media. Regarding the reasonable expectation of success, Ozbolat evidences culturing cells comprising introducing a first cell culture medium into the internal channels of the plurality of fibres (“the printed tissue construct can be connected to a bioreactor for media perfusion” para. [0027] and Figure 13 and “the tissue constructs 500 disclosed herein can be perfused with cell growth media: para. [0128] and Figure 56; see also para. [0028, 0036, 0047, 0052-0053, 0070-0071, 0074, 0121, 0127-0130, 0153, 0186, 0194, 0209, 0244, 0255-256, 0262, 0269, 0278]; Figures 14A-C, 22A-C, 33, 38A-E, 39A-D, 56-57, 60B; Example Two;) and introducing a second cell culture medium onto the external surfaces of the substrate assembly (“Submerged in cell culturing medium” para. [0246]) as part of a method of culturing cells.
Since the instant application claims are obvious over cited application claims, in view of Ozbolat, said claims are not patentably distinct.
Conclusion
No claim is allowable.
Correspondence
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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