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 of Group I, presently claims 1-31, in the reply filed on 6/09/2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 32, 38, 40, 42, 44 and 53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. The election is treated as being made without traverse in the reply filed on 6/09/2026.
Claims 1-31 are under consideration on the merits.
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 1-8, 13-29, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al. (WO 2011/056971; provided in the IDS dated 2/28/2024) as evidenced by Yu et al. (Science (2009), 324, 797-801; Reference U, and hereafter referred to as “Yu 2009”).
Yu teaches a method of maintaining pluripotency (e.g. preventing differentiation) of human induced pluripotent stem cells the method comprising reprogramming human foreskin fibroblasts into iPS cells by transfecting said fibroblasts with episomal vectors pEP4EO2SCK2MEN2L and pEP4EO2SET2 which inherently encode for OCT4, SOX2,NANOG, LIN28, c-Myc, and KLF4 as evidenced by Yu 2009 (see Fig. 1A of Yu 2009), and then culturing the transfected fibroblasts on mouse embryonic fibroblasts and with a culture media composition comprising DMEM/F12, PD0325901 (i.e. a MEK inhibitor), CHIR99021 (i.e. a GSKβ inhibitor), and A-83-01 (i.e. a TGFβ inhibitor) and human LIF and lacking any growth factor(s) wherein the iPS cells are not further passaged (Yu at [00219]-[00222], anticipating claims 1, 2-4 (e.g. the iPS cells made for claim 2, and the iPS cells made by a TGFβ inhibitor for claims 3 and 4), 6-8, 13-24, 26, 27, and 31.
In a separate embodiment, Yu teaches a method of maintaining pluripotency (e.g. preventing differentiation) of human induced pluripotent stem cells the method comprising reprogramming human foreskin fibroblasts into iPS cells by transfecting said fibroblasts with episomal vectors pEP4EO2SCK2MEN2L and pEP4EO2SET2 which inherently encode for OCT4, SOX2,NANOG, LIN28, c-Myc, and KLF4 as evidenced by Yu 2009 (see Fig. 1A of Yu 2009), and then culturing the transfected fibroblasts on a feeder-free (3D) Matrigel® substrate with conditioned medium comprising zebrafish bFGF (i.e. zbFGF) or mTeSR®1 supplement to obtain human ES cell-like iPS cells and with a culture media composition comprising PD0325901 (i.e. a MEK inhibitor), CHIR99021 (i.e. a GSKβ inhibitor), and A-83-01 (i.e. a TGFβ inhibitor) and human LIF and lacking any growth factor(s) wherein the iPS cells are not further passaged (Yu at [00219]-[00222], anticipating claims 1, 2-4 (e.g. the iPS cells made for claim 2, and the iPS cells made by a TGFβ inhibitor for claims 3 and 4), 6-8, 13-24, 29, and 31.
In a separate embodiment, Yu teaches a method of maintaining pluripotency (e.g. preventing differentiation) of human induced pluripotent stem cells the method comprising reprogramming human foreskin fibroblasts into iPS cells by transfecting said fibroblasts with episomal vectors pEP4EO2SCK2MEN2L and pEP4EO2SET2 which inherently encode for OCT4, SOX2,NANOG, LIN28, c-Myc, and KLF4 as evidenced by Yu 2009 (see Fig. 1A of Yu 2009), and then culturing with a culture media composition comprising DMEM, N2B27 supplement or CM, and PCAL to obtain partially reprogrammed iPS cells (i.e. piPSC), PD0325901 (i.e. a MEK inhibitor), CHIR99021 (i.e. a GSKβ inhibitor), and A-83-01 (i.e. a TGFβ inhibitor) and human LIF and lacking any growth factor(s), wherein the piPSCs are cultured under feeder-free conditions, and wherein piPSCs are further passaged such as to yield a 16-cell embryo signature and/program (Yu at [00219]-[00221], [00232], and [00234] and “16CE” in Fig. 6), anticipating claims 1, 5-8, 13-25, 27, 28, and 31.
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 1-8 and 13-31 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (WO 2011/056971; provided in the IDS dated 2/28/2024).
The teachings of Yu as evidenced by Yu 2009 are relied upon as set forth above in rejected claims 1-8, 13-29, and 31 as anticipated under 35 U.S.C. § 102.
Regarding claim 30, Yu further teaches envisions suspension culturing of the stem cells ([00144]). As such, it would have been obvious to a person of ordinary skill in the art before the invention was filed to culture the ES, iPS, and or pISPCs of Yu in suspension culture. A person of ordinary skill in the art would have had a reasonable expectation of success to do so and the skilled artisan would have been motivated to do so because Yu expressly considers the substitution of adherent and/or cell feeder methods with suspension culture methods as an alternative embodiment. Therefore, the substitution would simply and predictably yield suspension culture methods in Yu’s methods of maintaining pluripotency in various species of stem cells; see M.P.E.P. § 2143(I)(B).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yu as evidenced by Yu 2009 to claim 1 above, and further in view of Jaenisch et al. (US 2020/0239855; provided in the IDS dated 2/28/2024).
The teachings of Yu as evidenced by Yu 2009 are relied upon as set forth above.
Regarding claim 9, Yu as evidenced by Yu 2009 does not teach a non-human mammalian cell. Regarding claim 10, Yu as evidenced by Yu 2009 does not teach a ruminant cell. Regarding claim 11, Yu as evidenced by Yu 2009 does not teach wherein the cell is a bovine cell, an ovine cell, or a caprine cell, a cervine cell. Regarding claim 12, Yu as evidenced by Yu 2009 does not teach wherein the cell is a murine cell, an equine cell, a feline cell, or a canine cell.
Jaenisch teaches methods of reprogramming somatic cells to generate multipotent or pluripotent cells (Abstract). Jaenisch teaches starting mammalian somatic cells comprising human, mouse (e.g. murine), bovine, ovine, sheep and goats (e.g. caprine), canine, feline, and horse (e.g. equine) ([0089]-[0090] and claim 24), reading on claims 9-12. Jaenisch teaches fibroblasts as an exemplary species of somatic cell ([0032]), reading on claims 9-12.
Regarding claims 9-12, a person of ordinary skill in the art would have had a reasonable expectation of success in substituting the different sources of mammalian somatic cells such as fibroblasts of Jaenisch for the human fibroblasts Yu because all of the sources of mammalian cells are explicitly taught as being useful for THE SAME PURPOSE as starting somatic cells in methods of reprogramming said somatic cells to pluripotent cells. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
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).
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, 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.
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.
/Sean C. Barron/Primary Examiner, Art Unit 1653
Prosecution Insights