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, originally drawn to claims 1-15 and 19, in the reply filed on 11/17/2025 is acknowledged. Claims 17-18 have been amended to depend from claim 1, and are therefore examined as part of Group I. Upon reconsideration, the restriction requirement for Group II, drawn to claim 16, is withdrawn, and claim 16 is examined as a part of Group I. Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claims 1-19 are examined on the merits herein.
Priority
The instant application claims benefit of provisional application 63/293,578 filed 12/23/2021.
Claim Objections
Claims 1, 7, 9, 11, and 16 are objected to because of the following informalities:
Claims 1, 11, and 16 recite the phrase “a culture media.” This should be corrected to “a culture medium.”
Claim 7 has a closing parenthetical in the last line (“fragment thereof)”), which is presumed to be a typographical error.
Claim 9 recited the term “Chrodin” (line 2), which is presumed to be a typographical error for the BMP inhibitor “Chordin.”
Appropriate correction is required.
Claim Interpretation
The phrase “a control” (claim 1) is not defined in the specification. For the purpose of examination, “a control” is interpreted as a cell line which is not subject to the steps recited in claim 1. The same interpretation is used for the phrase “a late passage control cell line” of claim 16.
The phrase “late passage cell line” (claims 4-5 and 16-18) is not defined in the specification. The specification recites that late passage cells include “immortalized cells or cells that have exceed about 60 population doublings” (para 48). In the absence of a definition, the broadest reasonable interpretation of “late passage cell line,” which includes immortalized cells as recited in the instant specification, is used for the purposes of examination.
Claim 16 is drawn to “a method for restoring myogenic differentiation capacity” (line 1). The instant specification recites that “a method for restoring myogenic differentiation capacity” is equivalent to “a method for improving myogenic differentiation capacity” (para 192). For purposes of examination, these two phrases are treated as having the equivalent meaning.
Claim 19 is a product-by-process claim. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP 2113. In the instant case, the method steps of claim 1 do not clearly impart additional structural limitations to the product of claim 19. Therefore, claim 19 is interpreted as “A population of myocytes, myoblasts, myotubes, multinucleated myotubes, satellite cells, skeletal muscle fibers, or any combination thereof.”
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, 4-5 and 16 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 is drawn to a method comprising steps (a) and (b). There is no conjunction between steps (a) and (b) (lines 6-7), so it is unclear whether the claim should be read as “the method comprising (a) and (b),” or “the method comprising (a) or (b).” Based on the contents of the specification and the construction of claim 16, claim 1 is interpreted as having the conjunction “and” at the end of line 6, such the method comprises (a) and (b).
Claims 4-5 and 16 recite the limitation “late passage cell line,” which is not defined in the specification. Paragraphs 185-186 of the specification discuss the limitation of a late-passage cell line, but the information disclosed therein amount to examples and descriptions of particular embodiments, rather than a definition. In the absence of a definition for the phrase “late passage cell line,” the metes and bounds of claims 4-5 and 16 are unclear, and therefore, claims 4-5 and 16 are indefinite.
Claim Rejections - 35 USC § 112(a) Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 and 14-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for improving myogenic differentiation capacity of a self-renewing late-passage cell line that has lost myogenic differentiation capacity following extended culture periods, the method comprising contacting a late-passage myoblast cell line or a fibroblast cell line, does not reasonably provide enablement for the method of claims 1 and 16, wherein any cell line can be used. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to carry out the invention commensurate in scope with these claims.
Analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention without undue or unreasonable experimentation. See Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916). The key word is 'undue,' not experimentation.' " (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
The nature of the invention: The nature of the invention is a method for improving myogenic differentiation capacity of a cell line, wherein the method comprises (a) contacting the cell line with a culture media comprising: (i) at least a first Activin A inhibitor, (ii) at least a first BMP inhibitor, or (iii) at least a first WNT activator, or a combination thereof, and (b) inducing myogenic specific differentiation, comprising inducing formation of myocytes, myoblasts, myotubes, or a combination thereof, thereby improving the cell line’s myogenic differentiation capacity as compared to a control.
The breadth of the claim:
Claim 1 and its dependents, unless otherwise specified below, and claim 16 do not limit the type of cell line to be used in the method. As written, the claim encompasses the use of any cell line, including adipocytes, astrocytes, erythrocytes, hepatocytes, pluripotent stem cells, totipotent stem cells, and non-mitotic senescent cells. Claim 13, which is not included in this rejection, limits the cell line to a fibroblast cell line. Claim 14 limits the cell line to a non-pluripotent stem cell line, but allows for the use of any cell line which is not a pluripotent stem cell line.
The state of the prior art:
The closest prior art is Genovese (US20160227830A1), which discloses a method for contacting a cell line with a culture media comprising an activator of the canonical WNT signaling pathway, such as CHIR90021, to facilitate myogenic differentiation (para 8, 20). Genovese teaches that the cell lines used in the method disclosed therein has the properties of being immortal (self-renewing) and having the potential to differentiate, reprogram, specify or otherwise convert to skeletal muscle lineage (para 57). Genovese teaches that three classes of stem cells may be employed as cell sources for scalable cultivation: (1) lineage-restricted primary adult progenitor stem cell isolations, (2) lineage-restricted immortalized cell lines, and (3) pluripotent stem cells line (para 57). Genovese does not teach the use of any cell type, as encompassed by instant claims 1 and 16. Genovese does not teach, for example, the use of adipocytes, astrocytes, hepatocytes, or another cell with no potential to convert to skeletal muscle lineage, in the method disclosed therein. Furthermore, Genovese does not teach the use of a non-miotic, senescent cell in the method disclosed therein.
Kragl (Nature, 2009, 460: 60-65) teaches that each tissue type produces progenitor cells with restricted potential (Abstract). For example, neither dermis cells nor cartilage cells make muscle (p 60, col 2, para 4 – p 62, col 1, para 2).
Cieslar-Pobuda (BBA Molecular Cell Research, 2017, 1864: 1359-1369) teaches that fibroblasts can transdifferentiate into myocytes upon induction with MyoD, but does not teach that other cells, such as pancreatic cells, hepatocytes, and astrocytes are capable of the same (Table 1).
The level of one of ordinary skill: The level of skill is high, requiring one of ordinary skill to hold a postgraduate degree or equivalent experience in cell and molecular biology or a related discipline.
The level of predictability in the art:
The prior art teaches that myogenic differentiation capacity can be improved for lineage-restricted primary adult progenitor stem cell isolations, lineage-restricted immortalized cell lines, and pluripotent stem cell line (e.g., Genovese, as discussed above). However, the prior art does not teach the use of a differentiated cell line with no potential, such as hepatocytes and astrocytes, to convert into to skeletal muscle lineage (e.g., Cieslar-Pobuda, as discussed above). Furthermore, the prior art does not teach a method for improving myogenic differentiation capacity of a non-mitotic senescent cell (e.g., Genovese, as discussed above). Therefore, there was a high level of unpredictability regarding the use of any cell type in the method of instant claims 1 and 16.
Working examples and the amount of guidance:
The specification recites that the cells may be immortalized cells, including fibroblasts, myoblasts, myotubes, multinucleated myotubes, satellite cells, skeletal muscle fibers, or any combination thereof (para 173, 175). The working examples in the specification are limited to the use of immortalized late-passage myoblasts and fibroblasts (Examples 5-9). The specification does not provide guidance on the use of any other cell type, such as hepatocytes and astrocytes, in the method of claims 1 and 16. Although the specification recites that “In some embodiments, a late-passage cell includes a senescent cell” (para 185), the specification does not provide examples or guidance on how to carry out the method of claims 1 and 16 using a senescent cell line.
The quantity of experimentation necessary:
Based on the content of the disclosure and the state of the prior art, undue experimentation is required to carry out the invention as claimed. As discussed above, the examples disclosed in the specification are limited to the use of self-renewing myoblasts and fibroblasts, and duration in culture medium comprising (i) at least a first Activin A inhibitor, (ii) at least a first BMP inhibitor, or (iii) at least a first WNT activator, or a combination thereof, for 2 to 3 days. The prior art does teach the use of pluripotent stem cells in addition to the cells disclosed in the instant specification, but does not teach the use of a cell line with no myogenic potential, such as hepatocytes or astrocytes, or a non-mitotic senescent cell line.
Given the lack of guidance in the disclosure and the unpredictability of the art, additional experimentation is required to determine how to improve myogenic differentiation capacity of any cell line by contacting the cell line with a culture medium comprising (i) at least a first Activin A inhibitor, (ii) at least a first BMP inhibitor, or (iii) at least a first WNT activator, or a combination thereof. Therefore, in light of the breadth of the claims, the limited guidance in the specification with respect to the breadth, and the state of the art, undue experimentation is required to carry out the invention as broadly claimed.
In conclusion, the evidence provided in the disclosure, in light of the teachings available in the art, does not enable one skilled in the art to carry out the claimed invention without undue or reasonable experimentation. Therefore, the method recited in claims 1 and 16 are is not enabled in its full breadth. Claims 2-12, 14-15, and 17-18 are included in the rejection because they depend from claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 19 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (specifically, a natural phenomenon) without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. Claim 19 is interpreted as “A population of myocytes, myoblasts, myotubes, multinucleated myotubes, satellite cells, skeletal muscle fibers, or any combination thereof, which exhibit improved myogenic differentiation capacity as compared to a control.”
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Here, the claim recites a population of myocytes, myoblasts, myotubes, multinucleated myotubes, satellite cells, skeletal muscle fibers, or any combination thereof. Because a population of myocytes, myoblasts, myotubes, multinucleated myotubes, satellite cells, skeletal muscle fibers, or any combination thereof is a composition of matter, claim 19 falls within a statutory category. (Step 1: YES)
Step 2A, Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II) and the October 2019 Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. Because claim 19 recites a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). MPEP 2106.04(c)(I)(A). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II).
Here, the closest natural counterpart to the cell population of claim 19 is a naturally occurring population of myoblasts derived from satellite cells (e.g., C2C12 myoblast population or another population of satellite cell-derived myoblasts), per se, as exemplified in Grabowska (Cell Biology International, 2011, 35(2): 125-133). The claimed population of a population of myoblasts and satellite cell is identical to a naturally occurring C2C12 myoblast population or a primary culture of satellite cell-derived myoblasts (see, e.g., Abstract and Introduction of Grabowska). Thus, there is no marked difference between the claim and product of nature. Accordingly, the claims recite a judicial exception, and the analysis must therefore proceed to Step 2A, Prong Two.
Step 2A, Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55.
Claim 19 does not integrate the product into a practical application because the claims are to a population of myocytes, myoblasts, myotubes, multinucleated myotubes, satellite cells, skeletal muscle fibers, or any combination thereof, per se, and do not recite additional elements beyond the judicial exception. (Step 2A: NO)
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05.
Claim 19 does not recite any elements in addition to the judicial exception of a population of myocytes, myoblasts, myotubes, multinucleated myotubes, satellite cells, skeletal muscle fibers, or any combination thereof, so there are no additional elements that add significantly more to the judicial exception. (Step 2B: NO)
The claim is not patent eligible.
Claim Rejections - 35 USC § 102
(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) 1-2, 4, 6-7, 10-12, 14-16, and 19 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Genovese (US20160227830A1).
Genovese teaches a scalable platform for skeletal muscle cultivation that utilizes cell lines with the potential to differentiate as skeletal muscle (para 5, 55). Genovese teaches contacting a cell line with a culture media comprising an activator of the canonical WNT signaling pathway, such as CHIR90021, to facilitate myogenic differentiation (para 8, 20) (claims 1, 10, 15-16). Genovese teaches that the culture media may comprise a histone deacetylate inhibitor (para 73, claim 24) (claim 11). Genovese teaches an in-vitro muscle tissue made by the method taught therein (claim 28) (claim 19).
Genovese teaches that the cell line may be a lineage-restricted immortalized cell line (para 59) or a pluripotent stem cell line (para 60), both of which are not subject to the Hayflick Limit and can expand indefinitely for scalable and livestock-autonomous cultivation (para 59, 60), and fall under the definition of “late passage cell line” (see Claim Interpretation) (claims 4, 16). Genovese teaches that the cell line may be derived from adult skeletal muscle progenitor cells, which is harvested from an animal carcass or procured from a biopsy (para 58) (claim 2), which is not a pluripotent stem cell line (claim 14). Genovese teaches that the cell lines may be from livestock, poultry, game, or aquatic animal species (para 5) (claim 12).
Genovese teaches modifying the cell line with a myogenic transcription factor to produce a myogenic-transcription-factor-modified cell line, wherein modifying refers to inserting a nucleic acid vector or construct operably encoding a myogenic transcription factor into the cell line (para 5, 64). Genovese teaches that the myogenic transcription factor may be MYOD1, PAX7, and MYOG, used alone or in combination (para 5, 64) (claims 6, 7).
Claim(s) 1, 8-10, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ulman (Cells, 2021, 10(7): 1671).
Ulman teaches a method for inducing myogenic differentiation of iPS cells (Abstract). Ulman teaches that “Protocol III” taught therein, which comprises culturing cells in media comprising a WNT activator and BMP inhibitor is the most efficient in obtaining myogenic cells (Abstract). Ulman teaches culturing a human iPS cell line generated from fibroblasts (2.1 Cell Culture) (claim 13) in a first medium comprising CHIR99021 and SB431542 (claims 1, 8, 10), then in a second medium, followed by a third medium comprising SB431542 and LDN193189 (claims 1, 8, 9, 15) (2.4 Protocol III Differentiation). Ulman teaches that this method (Protocol III) results in myogenic differentiation by day 23 (Fig 1c) (claim 1).
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.
Claim(s) 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Genovese (US20160227830A1), in view of Genovese-2 (WO2019014652A1).
The teachings of Genovese are set forth above. Genovese renders obvious claim 1.
Regarding claim 3: Genovese does not teach the method of claim 1, further comprising immortalizing the cell line, wherein the immortalizing step comprises introducing into, or incorporating into the genome of, a cell of the cell line a polynucleotide encoding a telomerase reverse transcriptase (TERT) polypeptide.
Genovese-2 teaches a method for extending the renewal capacity of cells by activating TERT activity in the cells (para 51). Genovese-2 teaches that activation of TERT activity may be accomplished by modifying the cells to overexpress a polynucleotide sequence encoding TERT, or by genetically modifying the cells to carry stable integrations of one or more copies of the TERT polynucleotide (para 105-107).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Genovese by modifying the cells to overexpress a polynucleotide sequence encoding TERT or modifying the cells to carry stable integrations of one or more copies of the TERT polynucleotide, as taught in Genovese-2. One of ordinary skill in the art would have been motivated to make this modification because Genovese-2 teaches that activating TERT activity in the cells extends renewal capacity of cells. One of ordinary skill in the art would have had a reasonable expectation of making this modification because Genovese-2 teaches that a polynucleotide encoding a TERT polypeptide can be incorporated into a cell line.
Claim(s) 1, 4-5, 10, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Shahini (Stem Cell Research, 2018, 26: 55-66), in view of Genovese (US20160227830A1).
Shahini teaches a method for restoring the myogenic differentiation capacity of C2C12 myoblasts (reads on late passage cell line) (claims 1, 4, 16), which has lost myogenic differentiation capacity (claim 5), via ectopic expression of NANOG (Abstract). Shahini teaches that NANOG reverses the myotube formation capacity in late passage C2C12 myoblasts, including in those that have undergone 90 to 120 population doublings (Fig 2) (claims 17-18).
Shahini does not teach contacting the C2C12 myoblasts with a culture media comprising at least a first WNT activator.
Genovese teaches a scalable platform for skeletal muscle cultivation that utilizes cell lines with the potential to differentiate as skeletal muscle (para 5, 55). Genovese teaches contacting a cell line with a culture media comprising an activator of the canonical WNT signaling pathway, such as CHIR90021, to facilitate myogenic differentiation (para 8, 20) (claims 1, 10, 16).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Shahini by using a culture medium comprising a WNT activator, such as CHIR90021, as taught by Genovese. One of ordinary skill in the art would have been motivated to make this modification because Genovese teaches that contacting a cell lien with a WNT activator facilitates myogenic differentiation. One of ordinary skill in the art would have had a reasonable expectation of making this modification because Genovese teaches that a cell line can be contacted with a culture medium comprising a WNT activator.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 12, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 9, 17, and 20 of copending Application No. 18/334,266 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other. Copending claim 1 is drawn to a method of making non-natively occurring myogenic cells suitable for consumption, the method comprising: (a) contacting a population of liver-derived cells with a growth media, wherein the growth media comprises a modulator of Activin-A mediated signaling, a modulator of BMP-mediated signaling, a modulator of Wnt-mediated signaling, or a combination thereof; (b) adapting the population of liver-derived cells for suspension culture; and (c) inducing transdifferentiation of one or more liver-derived cells into one or more non-natively occurring myogenic cells suitable for consumption by contacting the population of liver-derived cells with a differentiation media. Instant claim 1 does not specify the type or source of the starting cell line, and therefore, instant claim 1 is generic to copending claim 1. Instant claim 12 is generic to copending claims 2 and 17; instant claim 3 is generic to copending claim 9; and instant claim 19 is generic to copending claim 20. The claim under examination is anticipated by the reference claim(s) when the claim being examined is generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim. See MPEP §804 (II)(B)(2). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Risa Takenaka whose telephone number is (571)272-0149. The examiner can normally be reached M-F, 12-7 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RISA TAKENAKA/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632