DETAILED ACTION
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 IV, presently claims 10 and 12, in the reply filed on 7/07/2026 is acknowledged.
Claims 1-9, 11, 13, and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/07/2026
Claims 10 and 12 are under consideration on the merits.
Claim Rejections - 35 USC § 112
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 10 and 12 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.
Independent claims 10 and 12 incorporate limitations from withdrawn claims 8 and 11, respectively, and so are not self-contained. Therefore, the claims are rejected as indefinite for failing to particularly pointing out and distinctly claim the subject matter which the applicant regards as his invention or discovery. See M.P.E.P. § 608.01(i). Correction is required.
Claim Rejections - 35 USC § 102
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 10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamiya et al. (SSRN Electronic Journal, Preprint Research Paper No. 3741231 (Dec. 10, 2020; provided in the IDS dated 6/06/2024).
The teachings of Kamiya qualifies as prior art under 35 U.S.C. 102(a)(1) under the rebuttable presumption that Kamiya is the work of another based on the differences in authorship as compared to the instant application; see M.P.E.P. § 2155.01. See M.P.E.P. § 717 and 2153 for guidance on submitting declarations under 37 CFR 1.130(a) to disqualify Kamiya as available prior art. At this time, Applicant cannot rely upon the existing certified copy of the foreign priority application to overcome this rejection at this time because a translation of said application has not been made of record in accordance with 37 CFR 1.55. See MPEP §§ 215 and 216. It is noted that to overcome this rejection, Applicant must 1) provide a translation of the certified copy of foreign priority document with a statement that said translation is accurate (see M.P.E.P. § 214) so that Kamiya is then prior art less than a year before the effective filing date of the Application, and 2) provide a declaration under 37 CFR 1.130(a) to disqualify Kamiya as available prior art as Applicant’s own work published less than a year before the effective filing date of the Application under the 35 U.S.C. § 102(b)(1)(A) exception (see M.P.E.P. § 2153.01).
Kamiya teaches a method for producing mesenchymal stem cells, the method comprising 1) differentiating human pluripotent stem cells (hPSCs) into crest cells (the 1st paragraph of the “Results” spanning pages 7-9 and Fig. 1), 2) differentiating the neural crest cells into mesenchymal stem cells (the paragraph spanning pages 12-13 and Fig. 4), wherein 3) the neural crest cells are TWIST+ and DLX1+ (Fig. 3D), and wherein 4) wherein expression PAX3 and SOX10 expression in the neural crest cells expression rapidly decreases to zero after 2 passages (Fig. 3D), anticipating claims 10 and 12.
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 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.
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Fukuta et al. (PLoS One (2014), 9(12), e112291, 25 pages plus appended S.I. figures and tables; Reference U).
Fukuta teaches a method for producing mesenchymal stem cells, the method comprising 1) differentiating human pluripotent stem cells (hPSCs) into p75high and p75low neural crest cells (the 1st paragraph under “Results” on page 8), 2) differentiating the neural crest cells into mesenchymal stem cells (page 18, subheading “Derivation of hMSCs from hNCCs”), wherein 3) the neural crest cells are TWIST+ (Fig. 1A), and wherein 4) wherein expression SOX10 expression in the neural crest cells expression rapidly decreases after the first cell passage (page 18, the paragraph starting “Cranial NCCs”, Fig. S5, and the Figure S5 legend spanning pages 21-22), reading on claims 10 and 12.
Regarding the negative expression of SOX10 of claim 10 (incorporated from claim 8), a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of Amer. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). In this case, Fukuta teaches SOX10 expression in the neural crest cells is reduced to almost zero after the first passage, and so absent any showing to the contrary one skilled in the art would expect Fukuta’s intermediate neural crest cells and the claimed neural crest cells to have the same properties in their respective downstream methods of differentiating neural crest cells into mesenchymal stem cells.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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