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 .
DETAILED ACTION
Applicant’s response filed on 10/29/2025 is duly acknowledged.
Claims 1-30 and 38-44 have been canceled by applicants (including groups I and III; withdrawn claims 1-6 and 38-44).
Claims 31-37 and 45-57 (elected invention of Group II, taken as without traverse; directed to “A method of generating a non-naturally occurring satellite cell…”) as currently amended/presented, have been examined on their merits in this action hereinafter.
Priority
This application is a CON of 17/993,690 (filed on 11/23/2022; now a USPAT 11,859,211), which is a DIV of 16/297,548 (filed on 03/08/2019; now a USPAT 11,512,291), which is a CON of PCT/US2018/034458 (filed on 05/24/2018), which claims domestic benefit from a US PRO 62/510,617 filed on 05/24/2017.
Claim Terms
It is to be noted that instant claims 31-37 and 45-57 variously recite several terms such as “non-naturally occurring” satellite cell, “myoblast medium”, “spin medium”, “differentiation medium”, “de-differentiation”, for instance, which have not been specifically defined and/or specifically delineated in the claims, i.e. in terms of the cellular markers, or components of the recited media per se. Applicants are advised that instant claims for the BRI have been interpreted in light of the disclosure of record (see Summary, pages 1-3 and 53 in parent US application 16/297,548; now a USPAT 11,512,291), however, the plain meaning of the terms have been relied upon for the prior art purposes in this office action, hereinafter.
The following contains new grounds of objection/rejection necessitated by applicant’s current amendments to pending claims as discussed below:
Claim Objections - New
1. Claim 52 (as currently amended) is objected to because of the following informalities: claim 52 (an independent claim) as currently amended recites the abbreviations “FBS”, “FGF” in line 5, which should be recited in their full forms at least the first time they appear in a claim or claim set. Appropriate correction is required.
NOTE: 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.
Claim Rejections - 35 USC § 103 – Made/Maintained
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.
1. Claims 31-37 and 45-57 (as amended/presented) are/remain rejected under 35 U.S.C. 103 as being unpatentable over Parent et al (US 2011/0250691 A1; PGPUB cited in IDS dated 04/01/2024) taken with Oh et al (US 2014/0193903 A1; PGPUB cited in IDS dated 04/01/2024).
Claim 31 (Previously Presented) is directed to “A method of generating a non-naturally occurring satellite cell comprising contacting a population of skeletal muscle organoids in spin culture with at least one differentiation medium for at least 5 days to induce the dedifferentiation of at least one proliferative cell of the skeletal muscle organoids in the spin culture into a non-naturally occurring satellite cell.”
Claim 45 (Previously Presented) is directed to “A method of generating a non-naturally occurring satellite cell comprising:
contacting a population of cells comprising myoblasts with a myoblast medium to form an expanded myoblast population;
contacting the expanded myoblast population in spin culture with a spin medium to form at least one skeletal muscle organoid comprising differentiated and proliferative cells;
and
contacting the at least one skeletal muscle organoid in spin culture with a
differentiation medium for a time sufficient to induce the dedifferentiation of at least one
proliferative cell of the at least one skeletal muscle organoid into a non-naturally occurring
satellite cell.”
Claim 52 (Currently Amended) is directed to “A method of generating a non-naturally occurring satellite cell comprising:
isolating a population of cells comprising myoblasts;
contacting the population of cells comprising myoblasts with a myoblast medium comprising a cell growth medium, FBS, FGF and non-essential amino acids to form an expanded myoblast population;
contacting the expanded myoblast population with a spin medium comprising a cell culture medium, FBS, FGF and non-essential amino acids for 10 to 30 days to form at least one skeletal muscle organoid comprising differentiated and proliferative cells; and
contacting the at least one skeletal muscle organoid in spin culture with a differentiation medium comprising at least a cell culture medium and non-essential amino acids for at least 5 days to induce the dedifferentiation of at least one proliferative cell of the at least one skeletal muscle organoid in the spin culture into a non-naturally occurring satellite cell.”
See also dependent claim limitations as currently presented in claims 32-37, 46-51 and 53-57.
Parent et al (2011), while teachings culture medium for myoblasts, precursors and derivatives thereof (see Title, Abstract, Summary of the Invention; paragraphs [0069]-[0070], for instance), disclose the method of dedifferentiation of satellite cells in culture from myoblasts by contacting the cell with a specific medium (see [0011] “..the present invention provides an in vitro method of culturing a cell of the myogenic lineage. The method can comprise contacting the cell of the myogenic lineage with the culture medium described herein thereby culturing said cell. In an embodiment, the cell of the myogenic lineage is at least one of a muscular stem cell, a myoblast and a myoblast-derived cell…In yet another embodiment, the myoblast-derived cell is at least one of a muscle cell, a satellite cell and a myocyte of the myogenic lineage”; also see disclosure in paragraph [0027] “the culture medium provided herein is for a cell of the myogenic lineage. As used herein, the term “cell of the myogenic lineage” refers to a cell capable of expressing genes and proteins specific to myoblasts or to a cell having a myoblastic phenotype. Myoblast specific genes and proteins include, but are not limited to, MyoD, Myf5, MRF4, myogenin, Pax3, Pax7,…and MyBP-C. The myoblastic phenotype encompasses the ability of a myoblast to fuse to generate a muscle cell and form myotubes or to de-differentiate into a satellite cell”); wherein the cell of the myogenic lineage is derived from a biopsy, is a mammalian cell and/or is a human cell (see paragraph [0011], for instance); and wherein said satellite cells are expandable in culture (see disclosure in paragraph [0032] “The second component of the culture medium is a cytokine. As it is known in the art, cytokines play a crucial role in the activation, growth, proliferation and differentiation of myoblasts…. These cytokines activate quiescent satellite cells who then enter the cellular cycle and proliferate”) and cause muscle regeneration following transplantation (see disclosure in paragraph [0028] Myoblast-derived cells include, but are not limited to, muscle cells and satellite cells…Satellite cells are able to differentiate and fuse to augment existing muscle fibers and to form new fibers…Satellite cells express a number of distinctive genetic markers such as Pax7 and Pax3. Activated satellite cells also express myogenic transcription factors, such as Myf5 and MyoD”).
However, the method of generating “a non-naturally occurring satellite cell”, wherein “spin culture” in a “spin medium” is used to generate “skeletal muscle organoids”, which is contacted with a “differentiation medium” for at least 5 days to induce “dedifferentiation” of proliferative cells into the “non-naturally occurring satellite cell”, has not been explicitly disclosed by the cited reference of Parent et al, as discussed above.
Oh et al (2014), while teaching microcarriers for stem cell culture (see Title, Abstract, and Summary, [0017]-[0020], and disclosure page 21 in section “Culture of Stem Cells”, paragraphs [0503-[0507]; section “Media and Feeder Cells” on page 24; and section “Differentiation/Embryoid Bodies” on page 28, paragraphs [0622]-[0623], [0625], [0630], for instance), disclose the method for stable and long term culturing of human or primate stem cells (such as embryonic stem cells, ESCs; and embryoid bodies; taken as organoids; see disclosure in paragraph [0623]…”We describe a process for producing differentiated cells, the method comprising propagating a stem cell by a method as described herein, and then differentiating the stem cell in accordance with known techniques. For example, we provide for methods of differentiating to ectoderm, mesoderm and endoderm, as well as to cardiomyocytes, adipocytes, chondrocytes and osteocytes, etc. We further provide embryoid bodies and differentiated cells obtainable by such methods…”; see also paragraph [0503].. “Any suitable method of culturing stem cells, for example as set out in the Examples, may be used in the methods and compositions described here"; see paragraph [0505]…Containers may include bioreactors and spinners, for example. A "bioreactor", as the term is used in this document, is a container suitable for the cultivation of eukaryotic cells, for example animal cells or mammalian cells, such as in a large scale. A typical cultivation volume of a regulated bioreactor is between 20 ml and 500 ml”; see paragraph [0507].. “…suitable containers include spinners. Spinners are regulated or unregulated bioreactors, which can be agitated using various agitator mechanisms, such as glass ball agitators, impeller agitators, and other suitable agitators”).
Although, Oh et al do not explicitly disclose and/or demonstrate the culture of myoblasts using spin medium per se, given the combined disclosure from Parent et al and Oh et al, an artisan of ordinary skill in the art would have been able to adjust and/or optimize the cultivation conditions using spin culture with suitable medium for obtaining the organoids that provide Non-naturally occurring” satellite cells upon dedifferentiation in culture, as already suggested by the teachings from Parent et al, as discussed above. Unless evidence/data provided on record to the contrary, such variation in days or time period for culturing myoblasts and organoids in order to obtain satellite cells having appropriate structural-functional features, would have been obvious and/or fully contemplated by an artisan in the art with the motivation provided by Parent et al, at least for downstream clinical applications, and for large scale production as taught/suggested by Oh et al, as discussed above. The limitations of culturing in myoblast medium, spin medium and differentiation medium comprising cell growth medium with fetal bovine serum (FBS), fibroblast growth factor (FGF) and/or non-essential amino acids as currently recited in instant claims 47, 49 and 52 as currently amended, would have been obvious to an artisan in the art of stem cell culture because such cell growth medium and cell growth factors were already disclosed suitable for use by Parent et al (see [0006], [0010], [0040], for instance) and Oh et al (see Oh et al, [0560]-[0561], [0568]-[0569], [0853], [0873], for instances) in order to cultivate myoblasts, and could be optimized for their amounts and/or respective concentrations in order to generate satellite cells via de-differentiation in culture as already suggested by the combined disclosure from the cited prior art references of parent et al and Oh et al, as discussed above. Therefore, the process as generically presented (see independent claims 31, 45 and 52, in particular) fails to distinguish itself over the combined teachings and/or suggestions from the cited prior art references of record, as discussed above.
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as generically claimed.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
Double Patenting- Made/Maintained
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.
1. Claims 31-37 and 45-57 (as amended/presented) are/remain rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 8-11 of U.S. Patent No. 11,512,291 B2 (issued on Nov. 29th, 2022; from parent US application 16/297,548 filed by the same inventors and assignee). Although the claims at issue are not identical, they are not patentably distinct from each other because issued claim 8 is also directed to “a method of generating a non-naturally occurring satellite cell” using a population of myoblasts in spin culture (see also issued claims 9-11), reproduced as follows:
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It is to be noted that issued claim 1 (from which process claim 8 directly depends from) is directed to a composition comprising a “non-naturally occurring satellite cell” having specific cellular markers as structural-functional feature, that are not expressed in “endogenous satellite cells”. Since, the issued method claims 8-11 were re-joined in the parent application 16/297,548 (i.e. obviating the restriction requirement of record at the time of NOA by the office), and since the scope of the instant claims in currently examined application are clearly co-extensive with the issued claims (in a genus-species relationship), an ODP rejection is still deemed proper, and is therefore made/maintained.
Response to Applicant’s Arguments
Applicant’s arguments with respect to pending claims 31-37 and 45-57 of record (see REM dated 10/29/2025, pages 6-7) have been considered but are moot because the new ground of objection/rejection made in this office action as discussed above. However, applicant’s main arguments have been considered and responded to hereinafter for the record as follows:
Regarding the 103(a) rejection of record, applicants mainly appear to argue references individually (see REM, page 6-7), and regarding the cited prior art of Oh et al, states that “Oh allegedly discloses "the differentiation of pluripotent stem cells attached to microcarriers." Id. at paragraph [0027]. However, Oh provides no disclosure of culturing or producing myoblasts or non-native satellite cells, much less utilizing the claimed methods. Rather, Oh merely examines the differentiation of hESCs into cardiomyocytes using microcarriers. See id. at Example 41. There is no teaching or suggestion of contacting a population of skeletal muscle organoids with at least one differentiation medium to induce the dedifferentiation of at least one proliferative cell of the skeletal muscle organoids into a non-naturally occurring satellite cell, as required by independent claim 31, and further there is no suggestion of using three separate mediums for preparing a non-naturally occurring satellite cell from a myoblast, as required by independent claims 45 and 52”, which is duly noted and considered. However, as noted in the 103(a) rejection above, the use of serum-supplemented cell culture medium with or without the supplementation of suitable growth factors including fibroblast growth factor and non-essential amino acids was already disclosed by Parent et al as well as suggested for the growth of stem cell embryoid bodies by Oh et al (see teachings/discussion above), and would have been obvious to an artisan in the stem cell culture art to optimize the growth medium specifically for use in myoblast cell culture in order to generate satellite cells via de-differentiation as suggested by the combined teachings from parent et al when taken with Oh et al as discussed above. It is to be noted that instant claims 31 and 45, as presented do not require any specific medium with growth factor component(s) and/or combination(s) thereof, as currently alleged by the applicants. Also, instant claim 52 as amended, recites the media (myoblast medium, spin medium, differentiation medium) comprising the medium with non-essential medium that is supplemented with FGF using comprising language, and therefore, do not specifically delineate and/or differentiate from the culture media disclosed in the cited prior art references that are being used for the same purposes of culturing stem cells and embryoid bodies derived therefrom using the same culture media components (see also rejection/discussion above). Thus, the argument as currently presented by the applicants is duly noted and considered, but is not found to be persuasive.
The 103(a) rejection of record is therefore properly made and/or maintained.
Regarding the ODP rejection of record applicants state the following:
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However, since the claims are still co-extensive in scope, in the absence of a Terminal disclaimer from applicants, the ODP rejection of record is deemed proper, and is therefore made/maintained.
Conclusion
NO claims are currently 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657