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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/20/26 has been entered.
Election/Restriction
Applicant’s election without traverse of Group IV, claims 24-25 and 35-38 in the reply filed on 08/22/2024 is acknowledged.
Claims 17-19,22-23, 28-34 and 39-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/22/2024.
Claim Rejections - 35 USC § 112
New Matter
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 24 and 35-38 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. 37 CFR 1.118 (a) states that “No amendment shall introduce new matter into the disclosure of an application after the filing date of the application”.
To the extent that claim 24 and the specification are unclear, this new matter rejection is held over potential embodiments that do not appear to be supported by the specification. Claim 24 is amended to limit the extracellular matrix to a gel. Previously, the claim recited fibrillar collagen and thus, chondrocyte conditioned medium met the limitation. As amended, the claim is interpreted as the media is made with a synthetic ECM gel dispersed within the medium. Looking to the specification, there are embodiments where the ECM gel is coated on a plate and liquid expansion media is added atop the gel. The claims recite that the intended use is for expanding myogenic precursor cells and thus is referring to expansion medium as opposed to differentiation medium. Page 6 of the specification discusses medium for expanding the cells at lines 18-24. There is no mention of ECM in this embodiment. Page 6, line 25-page 7, line 9 discusses differentiation of the myogenic precursor cells with expansion steps (a) and (b). Expansion step (a) refers plating cells on a plate preferably coated with ECM coating followed by step (b), adding expansion media that optionally comprises an ECM protein. The claims would be drawn to the media of step (b) as that of step (a) does not have the ECM as part of the media. The media added to the plated cells (step b), is a liquid. It is added to cells plated atop an ECM coating. It cannot be added to the plated cells if it is a gel, which is now claimed. Thus, while the specification does teach use of an ECM gel, it does not appear to be part of the expansion media as claimed. It is noted that the media in (a) is not cell-free. It is also noted that cells can be dispersed within an ECM gel with media atop the gel. This potential embodiment, however, would not be cell-free, as is claimed.
Applicants are reminded that it is their burden to show where the specification supports any amendments to the claims. See 37 CFR 1.121 (b)(2)(iii), the MPEP 714.02, 3rd paragraph, last sentence and also the MPEP 2163.07, last sentence.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure [or point to case law supporting incorporation of such a limitation as in the instant case]” (emphasis added).
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 24 and 35-38 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 24 is unclear as described above. It is not clear if the gel ECM is intended to be, literally, part of the medium such that the culture medium is a gel or if the gel ECM is dispersed withing the medium but has not yet gelled, of if the claim is directed to a “system” where the ECM gel is separate, as in coating a dish, and the medium is atop the gel coating. Claims 35-38 are also clear as they depend from claim 24.
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.
The rejection of claim(s) 24 and 35-38 under 35 U.S.C. 103 as being unpatentable over Sachs (JOURNAL OF CELLULAR PHYSIOLOGY 11251-59 (1982)) in view of Matsumoto (Biochemical and Biophysical Research Communications 420 (2012) 124–129) is withdrawn because the references did not teach inclusion of an ECM gel.
The rejection of claim(s) 24 and 35-36,38 under 35 U.S.C. 103 as being unpatentable over da Liu (THE ANATOMICAL RECORD 295:1109–1116 (2012)) in view of Matsumoto (Biochemical and Biophysical Research Communications 420 (2012) 124–129) is withdrawn because the references did not teach inclusion of an ECM gel.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALARIE BERTOGLIO whose telephone number is (571)272-0725. The examiner can normally be reached M-F 6AM-2:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632