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 .
Status of the Claims
Claims 1-18 are pending.
Claims 1-5, and 11-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/18/2026
Election/Restrictions
Applicant's election with traverse of the restriction requirement of 11/19/2025 in the reply filed on 2/18/2026 is acknowledged. The traversal is on the grounds that the subject matter of each of the claim groups is linked by an inventive concept, and as a result a search of the prior art would be so related that separate search efforts would not be necessary. This is not found persuasive because Applicant has effectively argued that there would be a lack of a search burden on the examiner.
In response, the examiner respectfully notes that search burden is not an issue herein, since the instant case is a 371 national stage entry of a PCT case, and search burden is only applicable in restriction practice for applications which enter under, for example, 35 U.S.C. 111. See also, MPEP §801, which explicitly states that, “applications entering the National Stage under 35 U.S.C. 371 as a Designated or Elected Office in the U.S. Patent and Trademark Office is covered in Chapter 1800.” Wherein Chapter 1800, and specifically, 1893.03 (d), clearly states that, “Examiners are reminded that unity of invention (not [US] restriction practice pursuant to 37 CFR 1.141 -1.146)) practice is applicable …in national stage applications submitted under 35 U.S.C. 371.” (Emphasis added). Therefore, an argument for rejoining groups on an alleged lack of undue search burden is not persuasive.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Hochedlinger (US20190161731A1) (Provided in IDS of 8/22/2025).
Regarding claim 6, Hochedlinger teaches a composition of matter (Hochedlinger [0005]) comprising a mammalian cell culture media (Hochedlinger [0008]), wherein the cell culture media comprises a supplement comprising forskolin and RepSox (Hochedlinger [0080-0081]).
Hochedlinger teaches a method of deriving expandable myogenic stem cells (which they refer to as induced myogenic progenitor cells iMPC) from different somatic tissues (Hochedlinger [0065], [0230])).
Hochedlinger teaches a method of generating induced Myogenic Progenitor Cells (iMPCs) (i.e., myogenic stem cells), comprising treating a population of somatic cells obtained from a subject with cyclic AMP agonist, and a TGF-β inhibitor for a time and under conditions that induce dedifferentiation of the somatic cells to a population of cells comprising iMPCs. Hochedlinger teaches that in one embodiment, the somatic cells may be fibroblasts, and that the cyclic AMP agonist may be forskolin, and that the TGF-β inhibitor may be RepSox. (Hochedlinger [0006]). Hochedlinger teaches that the somatic cells may include muscle cells or fibroblasts (Hochedlinger [0050]).
Hochedlinger anticipates claim 6.
Regarding claim 7, Hochedlinger teaches that their resulting iMPCs overexpress MyoD by at least a 20% compared to control after at least 4 days as compared to control. (Hochedlinger, [0025] FIG. 2E, 3B)
Regarding claim 8, Hochedlinger teaches that in various embodiments, the method further comprises culturing the somatic cells and/or population of cells comprising iMPCs with ascorbic acid. (Hochedlinger [0011]). Hochedlinger teaches that ascorbic acid is an important vitamin in the generation of their progenitor-like cell population, i.e., enhances the induction of the iMPC. (Hochedlinger [0229]).
Regarding claim 9 and 10, Hochedlinger contemplates the treatment of acute or chronic muscle injury (Hochedlinger [0103]). Hochedlinger teaches in various embodiments, the iMPC cell composition can be administered intramuscularly by injection, and that artificially prepared tissues produced by expansion and differentiation of iMPCs in culture, alone or in conjunction with other cells and/or a scaffold comprising extracellular materials that can be implanted at a desired site intradermally, intramuscularly, or subcutaneously. (i.e., disposing the expanded iMPC at a site of injury in vivo) (Hochedlinger [0107]).
Conclusion
Claims 6-10 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS RUSSE AMICK whose telephone number is (571)272-5474. The examiner can normally be reached 7:30-5 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS R. AMICK/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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