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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 35 and 37, in the reply filed on 03/14/2025 is acknowledged. All remaining claims have been amended to depend from the method of Group II. No claims are withdrawn.
Claim Status
Claims 1-2, 4-7, 12-25, 27-28, 32, 34, 36, and 38-44 have been canceled, claim 35 is currently amended, 3, 8-11, 26, 29-31, 33, 35 and 37 have been considered on their merits.
Withdrawn Objections/Rejections
The objections to the drawings have been withdrawn in view of the updated Figures 8a and 8b on 11 December 2025.
The rejections under 112(b) have been withdrawn in view of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 3, 8, 33, 35, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krieger et al. (WO 2020/237021, published 11/20/2020, IDS ref., of record).
This is a new rejection necessitated by Applicant’s amendments to the claims. A response to Applicant’s traversal regarding Krieger et al. follows the rejection below.
Regarding claims 33, 35, and 37, Krieger et al. teach methods of producing a cultured meat product from cells isolated from an animal (para. [0023]). Krieger et al. teach the methods of immortalizing primary cells, insertion of genes capable of enhancing proliferative capacity, modifying cells to improve properties of color, taste and/or texture of the cultured meat product, and excising of inserted genes to decrease proliferative capacity of the cell to revert to normal cell cycle progression, allowing cells to undergo differentiation (para. [0023]). Krieger et al. teach the animal cells may comprise a genetic modification resulting in immortalization (para. [0029]). Krieger et al. teach bovine myoblasts (cells of the genus Bos) are modified by integrating an immortalization gene cassette (immortalized non-tumorigenic cells) comprising a BMI-l coding sequence under the control of the native BMI-1 promoter flanked by FRT sites at a neutral locus/safe harbor locus (para. [0226]). Krieger et al. teach the animal cells are sourced from livestock cells to include bovine cells (para. [0050]). Krieger et al. teach the differentiation of bovine myoblasts was started once the medium is replaced with serum-free (no serum) growth-factor-free basal medium (claim 35a and 37) and cells are grown for another 24 hours (para. [0202]). Krieger et al. teach the animal cells may be grown in bioreactor systems in a single cell suspension, in cell aggregates, on microcarriers, or undergo a biofabrication step where they are synthesized together into tissue to form a cultured meat product (para. [0128]). Cells grown in a bioreactor reads as suspension culture (claim 33). Krieger et al. teach the differentiated cells will be harvested (recovering the cells from the growth medium) (claim 35b) to form a cultured meat product (edible food product) (claim 35c) (para. [0228]).
Regarding claim 8, Krieger et al. teach methods using cells from cows (genus Bos) including fibroblasts, myogenic cells (muscle cells) , or adipocytes (fat cells) (para. [0027]).
Thus, the reference anticipates the subject matter of claims 3, 8, 33, 35, and 37.
Response to Traversal
Applicant's arguments filed 11 December 2025 have been fully considered but they are not persuasive.
Applicant argues Krieger fails to disclose or describe all of the elements of the amended claim and asserts Krieger does not anticipate claim 35. Krieger clearly anticipates all of the elements of the amended claim as seen in the rejection above.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., teach continuous culturing of immortalized, non-tumorigenic cells) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., sustained culture conditions) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues Krieger’s immortalization strategies rely on transgenic expression of oncogenic factors. This argument is not persuasive because the presence of oncogenic factors does not necessarily equate to tumorigenic cells, oncogenic factors alone are generally insufficient on its own to cause tumor formation.
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 26 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Krieger et al. (WO 2020/237021, published 11/20/2020, IDS ref., of record) as applied to claims 3, 8, 33, 35, and 37 above, and further in view of Hickman et al. (US 10,160,953, published 12/25/2018, of record).
Krieger et al. anticipate the subject matter of claims 3, 8, 33, 35, and 37, and thus, also render them obvious.
This is a new rejection necessitated by Applicant’s amendments to the claims. A response to Applicant’s traversal follows the rejection below.
Regarding claims 26 and 29-31, Krieger et al. is silent to a growth medium comprising one or more growth factors, fatty acids, proteins, elements, and small molecules (claim 26), wherein the protein comprises transferrin (claim 29), the element comprises selenium (claim 30), and the small molecule is ethanolamine (claim 31).
However, Hickman et al. teach tissue engineering and a method of extending the in vitro useful life of a culture of muscle cells (column 1, Field of Invention). Hickman et al. teach a method culturing mammalian muscle cells on one or more carrier in suspension in a serum-free medium (column 3, lines 18-28). Hickman et al. teach culturing cells in a serum-free medium (column 6, Skeletal Muscle Culture and Serum Free Medium). Hickman et al. teach the full medium was replaced after four days with NBactiv4® medium, which comprises B-27™ (column 7, lines 1-6). Hickman et al. teach the B-27™ serum-free supplement media comprised Human transferrin (protein), Ethanolamine HCl (small molecule), and Sodium Selenite (an element comprising selenium) (Table 3, column 20).
Therefore, it would have been obvious to one of ordinary skill in the art to use the growth medium of Hickman et al. with the method of Krieger et al. with a reasonable expectation of success because both references teach method of tissue culture using mammalian muscle cells. One would have been motivated to utilize the medium of Hickman et al. with the method of Krieger et al. because Hickman et al. may not discuss tissue culture for the purposes of food production but the end result is the same, culturing muscle cells for the purpose of tissue engineering and methods of extending the useful life of a culture of muscle cells in vitro.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Traversal
Applicant's arguments filed 11 December 2025 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that Hickman does not teach food-safe proliferation of Bos-derived cells, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Hickman was not incorporated as a reference to show food-safe proliferation of cells, but to support the primary reference in demonstrating methods of extending the useful life of a culture of muscle cells in vitro via the B-27™ serum-free supplement media.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., immortalized Bos cells adapted for long-term propagation) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that Krieger and Hickman are non-analogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both references are in the field of tissue culture. The intended use of said tissue does not hold patentable weight.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Krieger et al. (WO 2020/237021, published 11/20/2020, IDS ref., of record) as applied to claims 3, 8, 33, 35, and 37 above, and further in view of Choi et al. (Compr Rev Food Sci Food Saf. 2021, published 11/06/2020, of record).
Krieger et al. anticipate the subject matter of claims 3, 8, 33, 35, and 37, and thus, also render them obvious.
This is a new rejection necessitated by Applicant’s amendments to the claims. A response to Applicant’s traversal follows the rejection below.
Regarding claim 9, Krieger et al. is silent to the muscle cells endogenously expressing a cell surface receptor CD29, CD56, or CD82.
However, Choi et al. teach cultured muscle tissue-based protein products, also known as cultured meat, are produced through in vitro myogenesis involving muscle stem cell culture and differentiation, and mature muscle cell processing for flavor and texture (Abstract). Choi et al. teach the method comprises (1) muscle sampling for stem cell collection, (2) muscle tissue dissociation and muscle stem cell isolation, (3) primary cell culture, (4) upscaled cell culture, (5) muscle differentiation and maturation, and (6) muscle tissue harvest (Abstract). Choi et al. teach muscle stem cells are also known as satellite cells, which are precursors responsible for the generation of the muscle tissue, including quiescent stem cells and their progeny such as proliferating myoblasts (p. 430, 1st para.). Choi et al. teach cattle muscle stem cell markers are CD29 and CD56 which are used in isolating muscle stem cells (bottom of p. 434-435 and Table 2). Therefore, Choi et al. teach muscle cells endogenously expressing cell surface receptor CD29 and CD56.
Regarding claim 10, Krieger et al. is silent to the muscle cells endogenously expressing a transcription factor Pax3, Pax7, Myf5, Mrf4, MyoD, or MyoG.
However, Choi et al. teach treating in vitro-cultured bovine muscle stem cells with p38 inhibitor SB203580 prevents PAX7 downregulation and enables extended maintenance of their differentiation capacity (p. 444, column 2). This reads as the muscle cells endogenously express Pax7.
Regarding claim 11, Krieger et al. is silent to the muscle cells do not endogenously express desmin or myosin heavy chain 2 (MyHC2).
However, Choi et al. teach cell growth media generally contain basal media, serum or serum replacements, and cell signaling molecules and basal media, composed of basic elements such as nutrients (amino acids, carbohydrates, and lipids), vitamins, inorganic salts, and trace minerals, provide a soluble microenvironment for the cells in vitro (p. 436, Basal media). Choi et al. teach different metabolites and components are required for maintaining different cell types, various basal media have been developed for specific purposes (p. 436, Basal media). Choi et al. teach F10 nutrient medium suppressed myoblast myogenic differentiation, which would suppress myosin heavy chain expression (p. 443, Basal media). Therefore, it is reasonable to expect muscle cells grown in the F10 nutrient medium would not endogenously express MyHC2. The expression of MyHC2 or desmin would depend on the state of differentiation of the cell, as MyHC2 and desmin are markers for mature myoblasts as indicated by the instant specification (para. [0200]).
Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Choi et al. with the method of Krieger et al. with a reasonable expectation of success because both references teach method of tissue culture using muscle cells and both references teach similar methods. Choi et al. teach in step (4), upscaled culture of muscle stem cells is completed in suspension in a bioreactor (Figure 1). Choi et al. teach, in the absence of serum, cattle (genus Bos) muscle stem cells attach to the substrate fibronectin (p. 436 column 2, Table 3). Choi et al. teach bioreactors are commonly employed for mass culture and enable the maintenance of high-density cell cultures using microcarriers (p. 446, Upscaled muscle stem cell culturing). The cell markers taught by Choi et al. are typical cell markers for muscle stem cells depending on the state of differentiation, thus the cells used in the method of Krieger et al. would necessarily endogenously express the same cell markers. One would have been motivated to combine the teachings of Choi et al. with the method of Krieger et al. because both references teach culturing muscle cells for the purpose of cultured meat production.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Traversal
Applicant's arguments filed 11 December 2025 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Support from Choi was utilized to show the cell markers taught by Choi are typical cell markers for muscle stem cells depending on the state of differentiation, thus the cells used in the method of Krieger et al. would necessarily endogenously express the same cell markers. Thus, the reference is not required to provide concrete culture conditions nor immortalization methods suitable for food-safe, non-tumorigenic cells lines, as those elements were taught by Krieger. Additionally, one of ordinary skill would have been motivated combine the teachings of Choi et al. with the method of Krieger et al. because both references teach culturing muscle cells for the purpose of cultured meat production.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Relevant prior art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ding et al. (Scientific Reports (2018) 8:10808, published 07/17/2018, of record)
Ding et al. teach isolating and maintaining the appropriate stem cell for large scale cell culture essential in tissue engineering or cultured meat production using bovine satellite cells.
Conclusion
No claims are 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.
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/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631