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 .
Claims 1-20, of record 3/9/2023, are pending and subject to prosecution.
Priority
Acknowledgement is made of the applicant’s claim for benefit to provisional application 63/318402, filed 3/10/2022.
Claim Interpretation
Independent claim 1 recites the limitation “adult stem cells induced pluripotent stem cells (IPSC)”. Independent claim 19 recites the limitation “induced pluripotent stem cells (IPSC) adult stem cells”. For the purpose of compact prosecution, these limitations are interpreted as requiring adult stem cells and/or iPSCs.
Claim Rejections - 35 USC § 112
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 1-20 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 the limitation “adult stem cells induced pluripotent stem cells (IPSC)”. Claim 19 recites the limitation “induced pluripotent stem cells (IPSC) adult stem cells”. It is unclear whether the claims require adult stem cells, iPSCs, or both adult stem cells and iPSCs, therefore the metes and bounds of the claims cannot be determined. Dependent claims 2-18 and 20 are included in the rejection.
Claim 5 recites the limitation "the MyoD1". There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the C/EBPα". There is insufficient antecedent basis for this limitation in the claim.
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 1-7 and 15-19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Elfenbein et al. (WO 2020123876 A1), evidenced by Kitzmann et al. (Molecular and Cellular Biology, 1999), Michowski et al. (Molecular Cell, 2020), Ross et al. (Molecular and Cellular Biology, 2004), and Liu et al. (Cells, 2021).
Elfenbein et al. teach methods for the production of cultured meats that include muscle and/or fat cells (See Abstract).
Regarding claims 1-4, 6, and 15-19: Elfenbein et al. teach methods for making an edible meat product (See Abstract). A starting population of self-renewing cells is obtained or created (See ¶086 and 089). The cells can be iPSCs, adult stem cells, MSCs, and/or myosatellite cells (which read on “satellite cells”) (See ¶089, 0271, and 0303). The cells are induced to differentiate into myocytes and/or adipocytes (See ¶089-090). Differentiation can be induced by incorporation of at least one gene for expressing a differentiation protein into the self-renewing cells (See ¶007, 0117, and 0136). Myogenic factors include PAX-7, Myf5, MyoD1, and Myogenin (which read on “muscle-inducing peptide/protein”) (See ¶007). Adipogenic factors include CEBPα (which reads on “C/EBPα”) and PPAR-γ (which read on “fat-inducing peptide/protein”) (See ¶007). The culture medium can comprise at least one nutritional supplement (which reads on “supplemental ingredients”) such as the unsaturated fatty acids oleic acid and linoleic acid (See ¶021 and 0141).
Regarding claim 5: Following the discussion of claims 1-4, 6, and 15-19, Elfenbein et al. do not expressly teach post-translational modification of MyoD1. However, Kitzmann et al. provide evidence that MyoD (which reads on “MyoD1”) is phosphorylated (which reads on “engaging in post-translational modification”) by cdk1 and cdk2 (See fig. 2A). Michowski et al. teach that iPSCs express cdk1 and cdk2 (See fig. 6A). MyoD expressed in iPSCs in the method of Elfenbein et al. would therefore inherently be phosphorylated.
Regarding claim 7: Following the discussion of claims 1-4, 6, and 15-19, Elfenbein et al. do not expressly teach post-translational modification of CEBPA. However, Ross et al. provide evidence that CEBPA is phosphorylated (which reads on “engaging in post-translational modification of the C/EBPα”) by ERK1/2 (See Abstract and page 676, col. 1, ¶1). Liu et al. teach that iPSCs express ERK1/2, which is active (See fig. 3-4). CEBPA expressed in iPSCs in the method of Elfenbein et al. would therefore inherently be phosphorylated.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Elfenbein et al. (WO 2020123876 A1), evidenced by Kitzmann et al. (Molecular and Cellular Biology, 1999), Michowski et al. (Molecular Cell, 2020), Ross et al. (Molecular and Cellular Biology, 2004), and Liu et al. (Cells, 2021), in view of Sung et al. (Biochemical and Biophysical Research Communications, 2013).
The teachings of Elfenbein et al., Kitzmann et al., Michowski et al., Ross et al., and Liu et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claims 8-14 and 20: Following the discussion of claims 1-7 and 15-19, Elfenbein et al., evidenced by Kitzmann et al., Michowski et al., Ross et al., and Liu et al., teach the production of a synthetic meat from stem cells using transcription factors but do not expressly teach modifying the transcription factors with cell-penetrating peptides.
Sung et al. teach the use of a MyoD (which reads on “the muscle-inducing peptide/protein” and “MyoD1”) fusion protein for the myogenic differentiation of adipose-derived stem cells (See Abstract). A vector for expression of MyoD1 fused to INF7 (which reads on “a linker DNA sequence”) and TAT (which reads on “cell penetrating peptide” and “trans-activator of transcription (TAT) signal peptide”) along with a His-tag or Halo-tag (which read on “a purifying peptide gene sequence”) was used to transform bacteria (See fig. 1). The expressed protein was collected and purified for addition to cells (See page 157, col. 2, ¶1-2). The protein enabled efficient nuclear localization and myogenic differentiation (See fig. 2-3).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Elfenbein et al., evidenced by Kitzmann et al., Michowski et al., Ross et al., and Liu et al., to comprise myogenic differentiation using the MyoD fusion protein taught by Sung et al. One would be motivated to make this modification because Sung et al. teach that the fusion protein demonstrated enabled efficient nuclear targeting and myogenic differentiation (See Abstract and fig. 2-3). There would be a reasonable expectation of success in doing so because the MyoD fusion protein of Sung et al. could be readily used in the method of Elfenbein et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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/J.S.S./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633