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 of species 1, drawn to a method of extending the replicative capacity of a bovine cell in a population of bovine cells and subspecies b (claim 7) drawn to a population of bovine cells from a cell bank or subculture of a bovine cell culture in the reply filed on May 18, 2026 is acknowledged. Applicant did not indicate traversal and therefore the election is being treated as without traverse.
Claims 6 and 13-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 18, 2026.
Claims 1-5, 7-12, and 22 are examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The instant application claims domestic benefit from U.S. provisional application 63/387854 filed on December 16, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 18, 2024 is in compliance with the provisions of 37 CFR 1.97 and is being considered by the examiner.
Objections to the Drawings
The drawings are objected to because:
FIG. 5 is in black and white while Para [118] indicates that red, yellow, and blue lines in FIG. 5 which correspond to various cell types.
FIG. 9B indicates the figure is data from 4C cells transfected with TERT and BMI-1 (i.e., TBMI1) while Para. [334] indicates the FIG. 9B is data from 4C cells transfected with TERT and CC.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Objections to the Specification
The disclosure is objected to because of the following informalities:
Para [118] detailing FIG. 5 indicates that red, yellow, and blue lines in FIG. 5 correspond to various cell types. However, FIG. 5 is in black and white.
Para. [280] indicates FIGS. 15A-15D show vectors for use in the method. This appears to be a typographical error, as FIGS. 16A-16D show vectors for use in the method.
Para. [312] indicates FIGS. 15A-15D show plasmids used in the method. This appears to be a typographical error, as FIGS. 16A-16D show plasmids for use in the method.
Para. [334] indicates FIG. 9B is data from 4C cells transfected with TERT and CC while the figure title indicates FIG. 9B is data from 4C cells transfected with TERT and BMI-1 (i.e., TBMI1)
The use of the term “Gateway vectors” in Para. [277], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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.
Claims 1-5 and 7-12 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.
Claim 1 recites “a method of extending the replicative capacity of a bovine cell…in a population of bovine cells in cell culture” in lines 1-2, “culturing the population of bovine cells…” in line 9, and “wherein the population of bovine cells has a population doubling level…” in line 10. The first recitation of a population of bovine cells appears to refer to bovine cells which have not been immortalized by the instantly claimed method whereas the third recitation of a population of bovine cells appears to refer to a different population of immortalized bovine cells which exhibit increased population doubling level rendering the claim indefinite. Appropriate correction is required.
Claims 2-5 and 7-12 which depend from claim 1 are included in the rejection for incorporating limitations of a rejected claim while failing to correct the deficiency.
Claim 3 recites the limitation "the first polypeptide" and “the second polypeptide” in line 1. There is insufficient antecedent basis for this limitation in the claim as the prior recitation is to “the first polynucleotide” and “the second polynucleotide”. As polypeptides are amino acid sequences, it is also unclear how a polypeptide would be integrated into the genome of any cell. Appropriate correction is required.
Claim 5, which depends from claim 1, recites “said population of bovine cells” in line 1. As there are multiple populations of bovine cells in claim 1 as detailed above, it is unclear to which population of bovine cells the limitations are intended to apply.
Claim 7, which depends from claim 1, recites “the population of bovine cells” in line 1. As there are multiple populations of bovine cells recited in claim 1 as detailed above, it is unclear to which population of bovine cells the limitations are intended to apply.
Claim 11, which depends from claims 10, 2, and 1, recites the limitation "the one or more regulatory elements" in line 1. It appears, based on claim dependency that the one or more regulatory elements recited in claim 11 is intended to refer to the one or more regulatory elements operably linked to the second polynucleotide. However, as claim 11 ultimately depends from claim 1, which recites a first polynucleotide operably linked to one or more regulatory elements and a second polynucleotide operably linked to one or more regulatory elements. Therefore, as claimed, it is unclear whether the limitations of claim 11 are intended to refer to the one or more regulatory elements operably linked to the first polynucleotide, one or more regulatory elements operably linked to the second polynucleotide, or both. Appropriate correction is required.
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.
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 1-5, 7-12, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan et al. (WO 2023/087033 A1, found in IDS dated 07/18/2024 and assigned a filing date of 11/15/2022, hereafter “Kaplan”) and as evidenced by Stout et al. (2021, Simple and effective serum-free medium for sustained expansion of bovine satellite cells for cell cultured meat. bioRxiv 446057; doi: https://doi.org/10.1101/2021.05.28.446057).
With regard to claim 1, Kaplan teaches a method of expanding and propagating cells including bovine cells in vitro without genetic modification via delivery of one or more transient immortalizing factors to a population of cells and subsequently culturing the cells (Para. [0008]). Kaplan teaches that these transient immortalizing factors control cellular replication and prevent senescence of cells in culture (Para. [0026]), which is considered to reasonably read on extending the replicative capacity of a bovine cell, which Kaplan teaches typically stop dividing (Para. [0007], [0020]).
Kaplan teaches that the one or more transient immortalizing factors can be at least two immortalizing factors which can be a TERT and CDK4 which is considered to reasonably read on a protein that modulates cell proliferation (see Para. [0018]), and that the immortalizing factors can be delivered as a plasmid (Para. [0008], [0017], [0031]), can be exogenous DNA (Para. [0030]), and can be episomally delivered (Para. [0047]). Kaplan further teaches that DNA molecules encoding TERT and CDK4 which comprise promoters can be delivered to the cells (Para. [0041]), which is considered to reasonably read on a first polynucleotide encoding TERT comprising one or more regulatory elements that promote expression and a second polynucleotide encoding a protein that modulates cell proliferation comprising one or more regulatory elements which promote expression. Additionally, Kaplan teaches that promoters are adjacent to target genes, which is considered to reasonably read on the regulatory elements being operably linked to the polynucleotide (Para. [0045]).
Based on the instant specification’s definition of “cultivation infrastructure” as the environment in which cells are cultured (See Spec. Para. [0149]), one of ordinary skill in the art would understand that all cell culture requires a cultivation infrastructure as instantly defined and Kaplan teaches that cell culture “refers to laboratory methods that enable growth of…cells in physiological conditions…” (Para. [0020]). Kaplan teaches that the method can be used for controlled “unlimited expansion” (Para. [0020]) and that the proliferation of cells exposed to immortalizing factors is “at least about 50 doublings” (Para. [0008]) and, further, that transiently immortalized cells are able to undergo 100 or more or indefinite doublings (Para. [0031]), which is considered to reasonably read on cells having a population doubling level of at least 60. Additionally, Kaplan teaches that transient immortalization allows cells to return to wild-type state by removal of immortalizing factors (Para. [0016]), therefore a skilled artisan could easily envision transiently immortalizing cells for a sufficient time such that the cells have a population doubling level of at least 60. Kaplan further teaches that transient immortalization does not alter the sequence of the targeted cells (Para. [0028]) that the method does not require modification of the genome or the host cell or insertion of specific DNA sequences (Para. [0016]), which is considered to reasonably read on the first and/or second polynucleotide not being integrated into the genome of the cell.
With regard to claim 2, Kaplan teaches use of CDK4 as an immortalizing factor (Para. [0008], [0017], [0018], [0031], [0033], [0041]).
With regard to claim 3, Kaplan teaches that transient immortalization does not alter the sequence of the targeted cells (Para. [0028]) and that the method does not require modification of the genome or the host cell or insertion of specific DNA sequences (Para. [0016]), which is considered to reasonably read on a method in which neither the first or second polynucleotides are integrated into the genome of the host cell.
With regard to claim 4, Kaplan teaches that immortal cells are able to undergo 100 or more doublings (Para. [0031]), which is considered to reasonably read on cells having a population doubling level of at least 100.
With regard to claim 5, Kaplan teaches that proliferation of cells exposed to immortalizing factors is at least 50% of the doubling rate of non-engineered cells (Para. [0008], [0009], [0031]) which is faster than non-engineered cells (Para. [0031]). Although Kaplan is silent as to the specific doubling time, a skilled artisan would understand that population doubling time would be dependent upon the type of bovine cell as well as the specific culture conditions, Kaplan teaches that the bovine cell could be primary satellite cells (Para. [0008], [0009], [0018]). Stout et al. evidences that the population doubling time of primary bovine satellite cells grown in Beefy-9 media is an average of 39 hours (Abstract) and 50% of 39 hours is 19.5 hours.
With regard to claim 7, as Kaplan teaches that the population of cells is propagated from primary cells which are derived from living tissue and established for in vitro growth. Kaplan further teaches that primary cells typically have undergone several population doublings in culture (Para. [0021]), which is considered to reasonably read on a subculture of a bovine cell culture.
With regard to claim 8, Kaplan teaches that the polynucleotides can be introduced into a cell via transfection (Para. [0029]).
With regard to claim 9, Kaplan teaches use of bovine TERT having SEQ ID NO: 1 (Para. [0032], [0041]), which is at least 80% identical to instantly claimed SEQ ID NO: 1 (See search results, SEQ ID NO: 1, .rag file, result 2, Duplicates result 2).
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With regard to claim 10, Kaplan teaches use of a bovine CDK4 protein having an amino acid sequence of SEQ ID NO: 2 (Para. [0033]) which is at least 80% identical to instantly claimed SEQ ID NO: 5 (See search results, SEQ ID NO: 5, .rag file, result 2).
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With regard to claim 11, Kaplan teaches that use of promoters, including a GAPDH promoter (Para. [0043]).
With regard to claim 12, Kaplan teaches that cells can be washed of the transient immortalization factors by culturing cells for a suitable time without transient immortalization factors such that the factors aren’t detectable (Para. [0084]). The instant claims do not define a method of detection, therefore, since these transient immortalization factors encompass DNA polynucleotides, they would not be considered to be detectable to the naked eye.
With regard to claim 22, Kaplan teaches an in vitro derived cell population produced by the method (Para. [0009]) and a foodstuff comprising the population of cells produced by the method (Para. [0010]) and that the population of cells is grown for the purpose of producing edible products (Para. [0022]), which is considered to reasonably read on a population of cells which can be bovine suitable for consumption.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN V PAULUS whose telephone number is (571)272-6301. The examiner can normally be reached Mon-Fri 8 AM-5 PM.
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/ERIN V PAULUS/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631
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