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 I, claims 1-9, 11, 15-18, and 56-57 in the reply filed on 12/29/2025 is acknowledged.
Claims 21, 26, 43, 46, and 54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/29/2025.
Status of the Claims
Claims 1-9, 11, 15-18, 21, 26, 43, 46, 54, and 56-57 are currently pending.
Claim 2 is amended.
Claims 21, 26, 43, 46, and 54 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 10, 12-14, 19-20, 22-25, 27-42, 44-45, 47-53, and 55 are cancelled.
Claims 1-9, 11, 15-18, and 56-57 have been considered on the merits.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The specification contains multiple references to color when describing the drawings. References to the color blue are made on pg. 3 in regards to Fig. 7 and references to the color green are made on pg. 2 in regards to Fig. 2 and on pg. 57 in regard to Fig. 2. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 1 is objected to because of the following informalities: “adipose triglyceride lipase (ATGL, receptor for PEDF), mechanogrowth factor (MGF, splice variant of IGF)” in lines 16-17 should be amended to “adipose triglyceride lipase (ATGL), mechanogrowth factor (MGF)”. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6-7, 9, 15-18, and 56-57 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Genovese (WO2019014652A1).
Regarding claim 1, Genovese teaches a modified non-human cell ([0016]) ectopically expressing two or more factors, two of which are IGF and albumin ([0016]/[0102]).
Regarding claim 2, Genovese teaches that the cells display a “descrease[d] dependency on exogenous addition of factors such as glutamine, albumin, and IGF to the media” ([0059]), which is interpreted to meet the limitation of “the cell does not need exogenous supplementation with eh ectopically expressed growth factors or cytokines”.
Regarding claim 3, Genovese teaches that the cells expressing IGF and albumin are grown, also “capable of” growing, in a growth/proliferation media that does not contain any exogenous recombinant protein components (media taught in [0165], application of media taught in [0179] and Example 2).
Regarding claims 6 and 7, Genovese teaches that the two factors which are ectopically expressed are IGF and albumin ([0016]/[0102]).
Regarding claim 9, Genovese teaches that the two or more factors are expressed by one or more exogenous vectors in the cell ([0021]).
Regarding claims 15 and 16, Genovese teaches that the cell is a muscle cell, fat/adipose cell, or fibroblast, which is being interpreted to meet the limitations of “connective tissue” cell ([0047]). Additionally, the cell is taught to be chosen from bovine, piscine, porcine, or galline origin ([0042]).
Regarding claims 17 and 18, Genovese teaches a composition of the cell of claim 1 and that the composition is considered an edible product/cultured meat ([0144]/[0102]).
Regarding claims 56 and 57, Genovese teaches that the two factors can be expressed by polynucleotide sequences which are integrated into the genome ([0107]) and can be expressed by polynucleotide sequences not integrated into the genome ([0107]).
Therefore, Genovese anticipates the claims.
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.
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, 4-5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Genovese (WO2019014652A1), in view of Elfenbein et al (US20200140821A1).
With regards to claims 4-5 and 8, the limitations of the independent claim have been taught above.
Genovese does not teach wherein the cell comprises three and/or four or more factors selected from the list presented in claim 1 as required by claims 4 and 5.
Genovese teaches a non-human cell for use in the production of cultured meat which expresses IGF and albumin, thereby creating a cell which conditions its own media with IGF and albumin ([0102]/ abstract).
Elfenbein teaches about the use of conditioned media in the production of cultured meat products ([0253]/[0254]).
Regarding claims 4-5 and 8, Elfenbein teaches that cells which overexpress factors such as FGF2, HGF, and LIF can improve cost-efficiency of cultured meat products because they can be used to produce conditioned medium containing the factors necessary for culturing meat products without the need for purchasing them or separately producing and isolating the growth factors to be included in culture media ([0250]-[0254]). Additionally, Elfenbein teaches that the cost of recombinant transferrin, TGF-beta, insulin, and FGF2 far outweigh the costs of basal media and other components such as ascorbic acid, selenium, and sodium bicarbonate media ([0250]-[0254]).
One of ordinary skill in the art prior to the effective filling date of the instant application would find it obvious at the effective filling date of the instant invention to combine the IGF and albumin expressing non-human cell of Genovese with the FGF2 and HGF expressing cell used form conditioned media for cultured meat products of Elfenbein to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Elfenbein teaches that cells which overexpress factors such as FGF2, HGF, and LIF can improve cost-efficiency of cultured meat products because they can be used to produce conditioned medium containing the factors necessary for culturing meat products without the need for purchasing them or separately producing and isolating the growth factors to be included in culture media ([0250]-[0254]). Additionally, Elfenbein teaches that the cost of recombinant transferrin, TGF-beta, insulin, and FGF2 far outweigh the costs of basal media and other components such as ascorbic acid, selenium, and sodium bicarbonate media ([0250]-[0254]). One of ordinary skill in the art would have a reasonable expectation of success when combining Genovese with Elfenbein because Genovese teaches all the necessary information to produce a non-human edible cell composition which expresses growth factors to condition the media in which they reside and Elfenbein teaches about cells which express growth factors for the expressed purpose of conditioning medium for use in cultured meat products.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 1, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Genovese (WO2019014652A1), in view of Ibrahimi et al (Human Gene Therapy, 2009).
With regards to claim 11, the limitations of the independent claim are taught above.
As described above, regarding claim 9, Genovese teaches that the two or more factors are expressed by one or more exogenous vectors in the cell ([0021]).
Genovese does not teach that the vector comprises ribosomal skipping sites to express the two or more factors as required by claim 11.
However, Ibrahimi teaches a comparison of protein expression in various constructs including ribosomal skipping sites in multicistronic vectors (abstract and pg. 846, para spanning col. 1-2).
Regarding claim 11, Ibrahimi teaches that the ribosomal skipping sites may include IRES, peptide 2A, or a bidirectional promoter (abstract). Ibrahimi teaches that the “peptide 2A constructs performed best in vitro and in vivo, providing effective noninvasive follow-up of transgene expression and having reporter gene expression levels in line with that of the single reporter constructs. The intrinsic ‘cleavage’ property of the peptide 2A sequences allows each protein to be produced at proportional levels, opening ample possibilities for functional genomics and future gene therapeutic applications” (abstract).
One of ordinary skill in the art prior to the effective filling date of the instant application would find it obvious at the effective filling date of the instant invention to combine the IGF and albumin expressing non-human cell of Genovese with the ribosomal skipping sites taught by Ibrahimi to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Ibrahimi teaches that the “peptide 2A constructs performed best in vitro and in vivo, providing effective noninvasive follow-up of transgene expression and having reporter gene expression levels in line with that of the single reporter constructs. The intrinsic ‘cleavage’ property of the peptide 2A sequences allows each protein to be produced at proportional levels, opening ample possibilities for functional genomics and future gene therapeutic applications” (abstract). One of ordinary skill in the art would have a reasonable expectation of success when combining Genovese with Elfenbein because Genovese teaches all the necessary information to produce a non-human edible cell composition which expresses growth factors to condition the media in which they reside and Ibrahimi teaches the necessary ribosomal skipping sites to engineer a vector which is able to reliably express multiple proteins.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/DAVID A MONTANARI/Examiner, Art Unit 1632