DETAILED ACTION
This action is in reply to papers filed 11/10/2025. Claims 1, 29-31, 34,41,43-47,49 and 51-57 are pending with claims 34, 41, 43-47, 49 and 51-57 examined herein.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20220257793A1, Published 8/18/2022.
Maintained Rejection(s)
Applicant's arguments filed 11/10/2025, with respect to the 102 (a)(1)/(a)(2) rejection of claims 34, 41, 43-47, 49 and 55 as being anticipated by Bancel et al. (PgPub US20150315541A1; Published 11/5/2015) has been fully considered but they are not persuasive. Applicant’s arguments will be addressed following maintained rejection.
Applicant's arguments filed 11/10/2025, with respect to the 103 (a) rejection of claims 51-54 and 56 as being anticipated by unpatentable over Bancel et al. (PgPub US20150315541A1, Published 11/5/2015) as applied to claims 34, 41, 43-47, 49 and 55 above, and further in view of Wang et al. (Nature Communications volume 6, Article number: 7916 (2015)).
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.
Claim(s) 34, 41, 43-47, 49 and 55 remain rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Bancel et al. (PgPub US20150315541A1; Published 11/5/2015). Although maintained, the rejection has been updated to reflect amendments to claim 34.
Claim interpretation: Claim 34 recites, inter alia, “…introducing into the adult myogenic cell an embryonic regulator, a telomere-associated regulator, and a cell cycle regulator to provide a transduced myogenic cell…” Examiner is interpreting the “adult myogenic cell” to be an unmodified, naturally occurring cell. Examiner is interpreting the “transduced myogenic cell” to be the result of the introduction of the embryonic regulator, a telomere-associated regulator, and a cell cycle regulator into the adult myogenic cells. Additionally, the term ‘rejuvenated’, in and of itself, does not hold any patentable weight. This is because the intended result of performing the steps of claim 34 is a rejuvenated cell. Said another way, performing the steps of claim 34 results in a rejuvenated cell.
Regarding claim 34a and claim 41, Bancel et al. discloses introducing into a human (Pg. 2, para. 20) adult (Pg. 152 ,para. 1050) (as in claim 55) myocyte (~skeletal muscle cell) (Pg.129, para. 752; Pg. ,para. 144), a nucleic acid encoding Lin28A (as in claim 34b(i))(Pg. 124, para. 711;Pg. 11,para. 120; Pg. 31, para. 233; Pg. 29 Table 6), (b) a nucleic acid encoding a TERT protein (as in claim 34b(ii)) (Pg. 11, para. 119; Pg. 124, para. 711; Pg. 29 Table 6), and (c) a p53 inhibitor (as in claim 34b(iii)) (Pg. 125,para. 721). Regarding, claim 34b Bancel teaches culturing the transduced myogenic cell under conditions to obtain a rejuvenated myogenic cell (Pg. 10, para. 110; Pg. 11, para. 121; Pg. 123, para. 698; Pg. 131-132, para. 768).
As it relates to claim 43, drawn to the rejuvenated d myogenic cell producing a muscle construct and claim 44, drawn to the muscle construct being anon-human meat product for consumption, claim 49, drawn to the rejuvenated myogenic cell being PAX3+, note that these limitations are inherently disclosed in the teachings of Bancel et al. This is because the method steps taught by Bancel are identical to those claimed (emphasis added).
As is established by case law, the author does not need to recognize an effect if the effect is inherent. Indeed, the discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). See M.P.E.P. § 2112.02.
MPEP §2112, states:
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. "The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness." In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983). Emphasis Added.
In the instant case, the prior art myogenic cells are cultured in the same manner as applicant. Therefore, it necessarily follows that the properties of the rejuvenated cells are inherent and present. Applicants have not provided any evidence of record to show that the methods of the art, which are the same steps are instantly required, would not result in the same cell types with the same properties.
Moreover, as it relates to claim 45, drawn to the adult myogenic cells express high levels of p21WAFl, p27KIPI, pl6INK4a, and/or let-7 microRNAs, claim 46, drawn the adult myogenic cell undergoing no more than about 90 population doublings, claim 47, drawn to the adult myogenic cell undergoing no more than about 30 population doublings- these limitations are inherent to the adult myogenic cells. As noted in the ‘Examiner interpretation’ above, the claimed adult myogenic cell is unmodified. Thus, insofar as Bancel teaches an adult myocyte, the limitations of claims 45-47 are disclosed by Bancel et al.
Accordingly, Bancel anticipates the claimed invention.
Applicant’s Arguments/Response to Arguments
Applicant argues: Bancel does not disclose introducing into an adult myogenic ce11 a combination of LIN28A, TERT, and a p53 inhibitor, wherein the adult myogenic cell is selected from the group consisting of a muscle stem cell, a myoblast, a myocyte, and a myotube. The Examiner points to paragraphs [0120], [0233], and [0711] and Table 6 of Bancel for allegedly disclosing a nucleic acid encoding Lin28A, and paragraphs [0119] and [0711] and Table 6 of Bancel for allegedly disclosing a nucleic acid encoding a TERT protein. However, Lin28A and TERT are among a long laundry list of possible reprogramming factors. Nowhere does Bancel disclose the specific combination of LIN28A, TERT, and a p53 inhibitor or provide any actual data.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. Claim 1 of Bancel is drawn to, inter alia, …. a method for altering cell phenotype comprising contacting a cell with a composition comprising at least a first and a second cell phenotype altering polynucleotide. Claim 4 is drawn to, inter alia, wherein the first region of the first cell phenotype altering polynucleotide encodes a first cell phenotype altering polypeptide selected from the group consisting of OCT4, SOX1, SOX2, SOX3, SOX15, SOX18, NANOG, KLF1, KLF2, KLF4, NR5A2, c-MYC, 1-MYC, n-MYC, REM2, TERT, LIN28 and variants thereof. And claim 5 recites, inter alia, wherein the first region of the second cell phenotype altering polynucleotide encodes a second cell phenotype altering polypeptide is selected from the group consisting of OCT4, SOX1, SOX2, SOX3, SOX15, SOX18, NANOG, KLF1, KLF2, KLF4, NR5A2, c-MYC, 1-MYC, n-MYC, REM2, TERT, LIN28 and variants thereof. Note that in addition to citing ‘Table 6’, Examiner cited para. 711 which mirrors claims 4 and 5 of Bancel. Thus, Examiner disagrees with Applicant’s argument that Lin28A and TERT are among a long laundry list of possible reprogramming factors. Moreover, Bancel explicitly notes at para. 721 that in order to reduce the stress response during the reprogramming of cells with the cell phenotype altering polynucleotides, a p53 inhibitor may be used to direct the cell toward reprogramming instead of apoptotic stimulus.
Applicant argues: Regarding the cell type, the Examiner points to paragraphs [144] and [752] for allegedly disclosing myocytes and skeletal muscle cells. However, Paragraph [144] states that the cells can be "differentiated by one skilled in the art into any cell type or lineage," and lists myocytes, among many other types of cells, as exemplary cells of the mesodermal lineage. Paragraph [752] lists skeletal muscle cells, rather than adult myogenic cells recited in the present claims, among a long list of primary somatic cells.
Applicant argues: Applicant’s arguments have been fully considered, but are not found persuasive. Cited para. 1050 teaches a “somatic stem cell” refers to any pluripotent or multipotent stem cell derived from non-embryonic tissue including fetal, juvenile and adult tissue. Cited para. 752 teaches almost any primary somatic cell type can be used to prepare cells with an altered phenotype or altered developmental potential. A primary somatic cell may include, but is not limited to, inter alia, neuronal, adipose, cardiac, skeletal muscle, immune cells and pancreatic cells. A muscle cell is also known as myocyte.
Because Applicant’s arguments were not found persuasive, the rejection is maintained.
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.
Claim(s) 51-54 and 56 remain and new claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Bancel et al. (PgPub US20150315541A1, Published 11/5/2015)as applied to claims 34, 41, 43-47, 49 and 55 above, and further in view of Wang et al. (Nature Communications volume 6, Article number: 7916 (2015)). Although maintained, the rejection has been updated to include teachings of Wang drawn to new claim 57.
The teachings of Bancel et al. are relied upon as above. Note also that Bancel teaches a first nucleic acid encoding a LIN28A protein (Pg. 11,para. 120; Pg. 29, Table 6), a second nucleic acid encoding a TERT protein (as in claim 52, in-part) (Pg. 11, para. 119; Pg. 29, Table 6), comprised in a viral vector (as in claim 53 and claim 54) (Pg. 17,para. 187; Pg. 20, para. 202). However, Bancel fails to teach the p53 inhibitor is a shRNA targeting p53 (as in claim 51 and claim 52).
Before the effective filing date of the claimed invention, , Wang demonstrated the derivation of proliferating progeny from differentiated, multinucleated muscle cells- C2C12 myoblasts (as in claim 57), by first inducing and subsequently intercepting a programmed cell death response (Abstract). Specifically, Wang and colleagues identified, contrary to newt and mouse C2C12 myotubes, extensive cell cycle re-entry by mononucleate fragments of primary mouse myotubes requires knockdown of p53 via a lentiviral vector encoding a short hairpin p53 (as in claim 51, claim 52 and claim 53) (Pg. 4, Col. 2, para. 1), reinforcing a key role for appropriate regulation of p53 during limb regeneration. Wang concludes that cell survival may be manifested by the production of a dedifferentiated cell with broader potential and that the diversion of a programmed cell death response is an instrument to achieve dedifferentiation (Pg. 2, Col. 1, 5). Wang teaches the transduced C2C12 myoblasts are cultured in a medium comprising DMEM and 20% FBS (as in claim 56) (Pg. 9, Col. 1, para. 2).
The combination of prior art cited above in all rejections under 35 U.S.C.103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A, B and G are applicable. Before the effective filing date of the claimed invention, it would have been prima facie obvious to an artisan of ordinary skill to combine the teachings of Bancel et al., wherein Bancel teaches a method of reprogramming an adult muscle cell to a less differentiated state by, inter alia, inhibiting p53 with the teachings of Wang et al., wherein Wang teaches derivation of proliferating progeny from differentiated, multinucleated myoblasts via knockdown of p53 via a shRNA. That is, one of ordinary skill in the art would have found it prima facie obvious to substitute the generic means of inhibiting p53 in the method of Bancel for the shRNA inhibitor of Wang in order to derive the less differentiated muscle cell. The skilled artisan would have been motivated to do so because Wang specifically teaches the shRNA inhibitor intercepted a programmed cell death response in myoblasts. Moreover, the skilled artisan would have found it prima facie obvious to substitute the differentiated muscle cell of Bancel for the myoblast of Wang in order to dedifferentiate the myoblast using Bancel’s method.
Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is 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 extension fee 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 date of this final action.
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/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632