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 .
Applicant's submission filed on 9 April 2026 has been entered.
Claims 1, 3-13 and 29-32 are currently pending.
Claims 3, 5, 31 and 32 are withdrawn as being drawn to a nonelected species.
Claims 1, 4, 6-13, 29 and 30 are considered here with respect to the elected species of chicken as the non-extinct species (the claims have been limited to mammoth as the extinct species).
Any rejection not reiterated herein is withdrawn.
Response to Arguments
Applicant's arguments filed 9 April 2026 have been fully considered but they are moot in view of the new grounds of rejection herein.
Regarding the indefiniteness rejection, Applicant argues that the rejection has been addressed via amendment. This is not persuasive with respect to claim 11 because claim 11 has not been amended.
Regarding the 103 rejection, Applicant argues that it was agreed during the interview of 9 April 2026 that the cited combination does not teach the elements of claim 1. This is not persuasive because no final agreement was reached in the interview; rather, it was indicated that the amended claims were likely distinguishable from the cited art as asserted in the prior office action. Upon further analysis of the references in view of the amended claims, the cited art is found to meet the limitations of the claims as set forth in the modified rejection below.
Applicant further argues that the claimed combination does not teach the step of forming a hybridized genome by integrating an absent gene from an extinct species into a foundational genome. This is not persuasive because Krieger teaches integrating an exogenous gene (e.g., myoglobin from another species) into the host cell (i.e. foundational) genome (see below). Sanctorum further teaches that mammoth myoglobin has advantageous properties for meat products, and it would have thus been obvious to use mammoth myoglobin as the foreign myoglobin in the method of Krieger.
Applicant further argues that Krieger differs from the claimed method in that the foreign gene is subsequently excised from genome. This is not persuasive because, while Krieger teaches that the exogenous gene is integrated into the genome in a manner that allows for subsequent excision of the gene, Krieger teaches excision after growing of the hybridized genome into a cell mass ([0116]; [0178]). The instant claims use a "comprising" transitional phrase and thus do not preclude an additional excision step after the expressing step. Moreover, Krieger expressly teaches that when the exogenous gene is myoglobin, the myoglobin gene may not be subject to excision ([0179]) (as distinguished from cell cycle progression genes, which are excised; see [0167]-[0175]).
Applicant further argues that the cited references fail to teach the steps of comparing the foundational and extinct genomes and identifying an absent gene. This is not persuasive because such steps would have been obvious in view of the cited references. The instant specification describes the claimed steps of selecting and comparing genomes as comprising aligning the amino acid sequence of a gene of interest from an extinct species with a corresponding gene from a non-extinct (foundational) species to identify sequence divergences (e.g., point mutations) (Spec., Examples 2 and 3). Sanctorum teaches aligning a mammoth myoglobin sequence with myoglobin sequences from non-extinct species, including elephant and chicken, and identifying amino acid sequence differences unique to the mammoth myoglobin (Sanctorum, Fig. 2). The heterologous mammoth myoglobin is defined as comprising such unique sequence elements (e.g., p. 19, line 27 to p. 20, line 32). It would have thus been obvious to arrive at the heterologous mammoth myoglobin sequence by such steps, including identifying sequence differences between mammoth myoglobin and a foundational species myoglobin (e.g., chicken or elephant) and then modifying the foundational genome to incorporate the gene with the mammoth-specific sequences.
Applicant further argues that Sanctorum does not identify a gene which is absent in the foundational genome. This is not persuasive because the term "absent gene which does not exist in the foundational genome" is construed herein to include any gene that differs in sequence from a corresponding gene in the non-extinct species, as opposed to a gene with no functional counterpart (which is consistent with dependent claims 6-7, which recite muscle genes which are present in both mammoth and chicken (and all animal species) but may comprise sequence differences). It is further noted that the instant specification does not describe any genes from an extinct mammoth genome which are completely absent from a foundational chicken genome in the sense of having no functional counterpart.
Claim Rejections - 35 USC § 112(b) (indefiniteness)
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.
Claims 1, 4, 6-13, 29 and 30 are rejected under 35 U.S.C. 112(b) 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 11 recites “expressing foundational genes of the hybridized genome”. The meaning of the term “foundational genes” is unclear within the context of the claims. Claim 1 recites selecting, comparing and generating steps in which a “foundational genome comprising at least a portion of a genome of a non-extinct species” is used to identify sequence elements (e.g., point mutations) of the extinct genome (i.e. an absent gene) which are introduced into a “hybridized genome” and expressed in the growing in vitro cell mass (see, Spec., Examples 2 and 3). It is unclear whether the claim requires expression of additional genes beyond the absent gene, and if so what genes would qualify as “foundational genes”. For purposes of applying prior art below, any gene of the foundational species is considered a foundational gene.
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.
Claims 1, 4, 7-9, 11-12, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of US20210037870 to Krieger et al. in view of WO2022144434 to Sanctorum et al.
Regarding claims 1, 8, 9 and 30, Krieger teaches a method of making a cultured meat product, comprising: culturing muscle cells expressing (transfected with) one or more heterologous genes in vitro to form a growing cell mass; and preparing the cell mass for consumption as a cell-based meat product ([0024]-[0051]; [0072]-[0106]; [0127]-[0137]). The cultured cells can be chicken cells, and can be skeletal muscle cells, myoblasts, myogenic cells and the like ([0128]-[0130]). The one or more heterologous genes can improve the quality of the cultured meat product, including taste, texture, color, aroma, nutritional value, etc. ([0016]; [0024]; [0073]-[0078]; [0136]; [0182]).
Regarding claims 4 and 7, Krieger teaches that the heterologous protein can be an animal myoglobin that results in improved biomass yield of the cultured cells ([0028]-[0030]; [0036]; [0095]-[0106]; [0182]).
Regarding claim 12, Krieger teaches overexpression of the heterologous gene(s) using a promoter ([0025]; [0029]; [0042]; [0100]-[0101]; [0109]-[0112]).
Regarding claim 29, Krieger teaches use of a suspension culture ([0130]).
Claims 1, 4, 7-9, 11-12, 29 and 30 differ from Krieger in that: the heterologous gene comprises a “hybridized genome” generated by selecting a portion of a mammoth genome, selecting a foundational genome of a non-extinct species sharing a common ancestor with the mammoth species, comparing the extinct mammoth genome with the foundational genome to identify an absent gene that does not exist in the foundational genome, and generating a hybridized genome by modifying the foundational genome to integrate the at least one absent gene (claim 1).
Sanctorum teaches cultured meat products comprising cultured host cells expressing a heterologous myoglobin protein which can be from an extinct mammoth species, such as a woolly mammoth or a steppe mammoth (p. 1, line 20 to p. 6, line 21; p. 19, lines 10-25). Sanctorum teaches that the mammoth myoglobin is advantageously stable against oxidation especially at low pH, which stabilizes the color of the meat substitute by resisting oxidation and resists conversion into carcinogenic byproducts (p. 18, lines 1-12).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to make a cultured meat product comprising muscle cells expressing a heterologous gene such as myoglobin, as taught by Krieger, wherein the heterologous myoglobin is a mammoth myoglobin as taught by Sanctorum because it would have been obvious to combine prior art elements according to known methods to yield predictable results. One of ordinary skill would have been motivated to use a mammoth myoglobin as the heterologous myoglobin in the method of Krieger because Sanctorum teaches that mammoth myoglobin is advantageously stable against oxidation especially at low pH, which stabilizes the color of the meat substitute by resisting oxidation and resists conversion into carcinogenic byproducts. Using a mammoth myoglobin as the heterologous myoglobin in the method of Krieger would have led to predictable results with a reasonable expectation of success because Krieger teaches expression of a heterologous myoglobin and Sanctorum teaches expression of a heterologous mammoth myoglobin in a substantially similar cultured meat product as taught by Krieger.
Regarding the recitation in claim 1 of "generating a hybridized genome by modifying the foundational genome to integrate the at least one absent gene with the foundational genome", Krieger teaches that the exogenous gene (e.g., myoglobin) is integrated into the host cell (i.e. foundational) genome ([0166]; [0178]). While Krieger teaches that the exogenous gene is integrated into the genome in a manner that allows for subsequent excision of the gene, Krieger teaches that the excision step occurs after growing of the hybridized genome into a cell mass ([0116]; [0178]). The instant claims use a "comprising" transitional phrase and thus do not preclude an additional excision step after the expressing step. Moreover, Krieger expressly teaches that when the exogenous gene is myoglobin, the myoglobin gene may not be subject to excision ([0179]) (as distinguished from cell cycle progression genes, which are excised; see [0167]-[0175]).
Regarding the steps in claims 1 (and 13) of selecting a portion of an extinct mammoth genome, selecting a foundational genome of a non-extinct species sharing a common ancestor with the mammoth, comparing extinct and foundational genomes to identify an absent gene that does not exist in the foundational genome, the instant specification describes the claimed steps of selecting and comparing genomes as comprising aligning the amino acid sequence of a gene of interest from an extinct species with a corresponding gene from a non-extinct (foundational) species to identify sequence divergences (e.g., point mutations) (Spec., Examples 2 and 3). Thus, the term "absent gene which does not exist in the foundational genome" is construed herein to include any gene that differs in sequence from a gene in the non-extinct species, as opposed to a gene with no functional counterpart (which is consistent with dependent claims 6-7, which recite muscle genes which are present in both mammoth and chicken (and all animal species) but may comprise sequence differences). Sanctorum teaches aligning a mammoth myoglobin sequence with myoglobin sequences from non-extinct species, including elephant and chicken, and identifying amino acid sequence differences unique to the mammoth myoglobin (Sanctorum, Fig. 2). The heterologous mammoth myoglobin is defined as comprising such unique sequence elements (e.g., p. 19, line 27 to p. 20, line 32). It would have thus been obvious to arrive at the heterologous mammoth myoglobin sequence by such steps, including identifying sequence differences between mammoth myoglobin and a foundational species myoglobin (e.g., chicken or elephant) and then modifying the foundational genome to incorporate the gene with the mammoth-specific sequences.
Regarding claims 8, 9, 11 and 30, Krieger teaches the use of chicken host cells expressing the heterologous gene/myoglobin, and it would have been obvious in view of the above to use chicken as the “non-extinct species that shares a common ancestor” to identify the unique mammoth sequence elements, as taught by Sanctorum (such that the foundational genome is a chicken and the growing cell mass comprises chicken cells). Regarding claim 11, the chicken host cells would further express host (i.e. foundational) genes during growing of the cell mass.
Claims 6, 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of US20210037870 to Krieger et al. in view of WO2022144434 to Sanctorum, as applied to claims 1, 4, 7-9, 11-12, 29 and 30, further in view of US20230049887 to Audibert et al., as evidenced by Palkopoulou et al., Current Biology 25.10 (2015): 1395-1400.
Claims 6, 7 and 13 differ from the combination of US20210037870 to Krieger et al. in view of WO2022144434 to Sanctorum, as applied to claims 1, 4, 7-9, 11-12, 29 and 30, in that: the absent gene comprises one or more myosin genes (claim 6); the absent gene comprises actin, creatine kinase, tropomyosin, fibronectin, or keratin (claim 7); and the hybridized genome further comprises an additional absent gene from an additional extinct species (claim 13).
Audibert teaches recombinant animal proteins that can be included in food compositions (e.g., via expression as a heterologous protein in a cultured host cell), wherein the protein can be a muscle protein such as myosin, actin, tropomyosin or keratin ([0006]-[0009]; [0049]-[0082]). Audibert teaches that the proteins can originate from a range of species, including wooly mammoth ([0072]-[0078]). Audibert teaches that the inclusion of the proteins can provide a desired nutritional profile to the food composition, e.g. an amino acid profile ([0008]-[0009]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the method of Krieger in view of Sanctorum to make a cultured meat product expressing a heterologous mammoth myoglobin wherein the cells further express one or more additional heterologous muscle proteins (e.g., myosin) from an extinct mammoth species because it would have been obvious to combine prior art elements according to known methods to yield predictable results. One of ordinary skill would have been motivated to express one or more additional heterologous mammoth muscle proteins in the cultured cells of Krieger in view of Sanctorum in order to provide a desired nutritional profile to the food product, as taught by Audibert (e.g., via overexpression of the protein), and/or to provide a desired taste, texture, etc. to the food product. Expressing one or more additional heterologous mammoth muscle proteins in the cultured cells of Krieger in view of Sanctorum would have led to predictable results with a reasonable expectation of success because Audibert teaches that mammoth muscle proteins can be expressed as heterologous proteins in cell-based food products similar to those of Krieger in view of Sanctorum, and Palkopoulou evidences that the genome sequences of mammoth species are known in the art (e.g., Abstract). Moreover, Krieger teaches that the host cells can express additional heterologous proteins (beyond the myoglobin) that improve the quality of the meat product (e.g., [0078]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of US20210037870 to Krieger et al. in view of WO2022144434 to Sanctorum, as applied to claims 1, 4, 7-9, 11-12, 29 and 30, further in view of Abuelanin et al., 2020 2nd Novel Intelligent and Leading Emerging Sciences Conference (NILES). IEEE, 2020.
Claim 10 differs from the combination of US20210037870 to Krieger et al. in view of WO2022144434 to Sanctorum, as applied to claims 1, 4, 7-9, 11-12, 29 and 30, in that: the heterologous gene is codon-optimized for expression by chicken cells.
The teachings of Krieger in view of Sanctorum are set forth above. Regarding claim 10, Sanctorum further teaches that the heterologous sequences are codon-optimized for expression in the host cells (p. 26, lines 25-33; Example 2.1).
Abuelanin teaches codon optimization methodology and exemplifies codon optimization for expression in chickens (under III. Materials and Methods).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the method of Krieger in view of Sanctorum to make a cultured meat product expressing a heterologous mammoth myoglobin wherein the heterologous gene is codon-optimized for expression in chicken cells because it would have been obvious to combine prior art elements according to known methods to yield predictable results. One of ordinary skill would have been motivated to codon-optimize for expression in chicken cells to enhance expression of the heterologous sequences. Making a cultured meat product expressing a heterologous mammoth myoglobin as taught by Krieger in view of Sanctorum wherein the heterologous gene is codon-optimized for expression in chicken cells would have led to predictable results with a reasonable expectation of success because Krieger in view of Sanctorum teaches use of chicken host cells and Sanctorum teaches codon-optimization, while Abuelanin teaches codon optimization for chicken expression (including use of known databases, etc.).
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J YAMASAKI whose telephone number is (571)270-5467. The examiner can normally be reached M-F 930-6 PST.
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/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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