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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 23 Dec. 2025 has been entered.
Claims 1, 3-13, 29 and 30 are currently pending.
Claims 3 and 5 are withdrawn as being drawn to a nonelected species.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Any rejection not reiterated herein is withdrawn.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 23 Dec. 2025 have been fully considered but they are moot in view of the new grounds of rejection herein.
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 1 recites the term “non-extinct descendant to the mammoth”. The metes and bounds of the term “descendant” are unclear in the context of the claimed method – e.g., it is unclear what type/degree of phylogenetic relationship would be required to qualify as a “descendant to the mammoth”. For purposes of applying prior art, the term “descendant” is construed herein to include any species that temporally exists beyond the presence of the mammoth species in question (e.g., any non-extinct animal having a corresponding genomic portion that allows for identification of the absent gene in claim 1).
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, identifying and combining steps in which a “foundational genome comprising at least a portion of a genome of a non-extinct descendant” 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”.
Claim Rejections - 35 USC § 112(a) (new matter)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 4, 6-13, 29 and 30 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the term “non-extinct descendant to the mammoth”. The term “descendant” was added via amendment in the Response of 28 Feb. 2025, and is not present in the original claims. The instant specification uses the term “descendant” only in the context of describing “cells from sibling extant taxa that comprise a common ancestral species may be fused to form multi-nucleated syncytia known as heterokaryons” such that “biochemical features of extinct progenitors species may be resurrected in their extant descendant species by altering gene expression from the extant species genome” (US20220333081, [0099]). The specification does not describe use of a “non-extinct descendant to the mammoth” in the context of the instantly claimed method (rather, the specification describes use of a non-extinct “ancestor” to the extinct animal (US20220333081, [0106]-[0113])). The claims thus comprise new matter. The rejection can be overcome by deleting the term “descendant” from the 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.
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 an extinct mammoth genome, selecting a foundational genome of a non-extinct descendant to the mammoth species, identifying an absent gene that is present in the extinct genome and absent from the foundational genome, and combining the foundational genome and the at least one absent gene to generate the hybridized genome (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 steps in claims 1 (and 13) of generating the hybridized genome by selecting a portion of an extinct mammoth genome, selecting a foundational genome of a non-extinct descendant to the mammoth species, identifying an absent gene that is present in the extinct genome and absent from the foundational genome, and combining the foundational genome and the at least one absent gene to generate the hybridized genome, the instant specification describes the claimed steps 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) and then modifying the non-extinct gene to introduce the sequence changes to form the “hybridized genome” which is expressed in a cultured host cell (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 sequence to incorporate 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 descendant” 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.
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.
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/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657