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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3 February 2026 has been entered.
Claim 1 has been amended. Claim 5 has been cancelled. Claims 57 and 58 are newly added. Claims 1, 2, 6, 12, 14, 57, and 58 are currently pending and under examination.
This application is a Continuation of International Patent Application No. PCT/US2020/030703, filed April 30, 2020, which claims priority to U.S. Provisional Patent Application No. 62/840,956, filed April 30, 2019.
Withdrawal of Rejections:
The rejection of claims 1, 2, 5, 6, 12, and 14 under 35 U.S.C. 102(a)(1) as being anticipated by Finley et al., is withdrawn.
New/Modified Rejections:
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 1, 2, 6, 12, 14, 57, and 58 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 1 as amended recites culturing in glutamine-free medium “and then culturing the cell population in a complete medium.” This limitation is indefinite, because it is unclear if the “complete medium” is required to comprise glutamine or not. The specification recites, for example, in paragraph [0012]:
In certain embodiments, the cell population is cultured in the glutamine-deficient medium for between about 4 hours and about 48 hours. In certain embodiments, the cell population is cultured in the glutamine-deficient medium for about 24 hours. In certain embodiments, the method further comprises culturing the cell population in a complete medium comprising glutamine. In certain embodiments, the method further comprises culturing the cell population in the complete medium after culturing the cell population in the glutamine-deficient medium. In certain embodiments, the cell population is cultured in the complete medium for at least about 24 hours. In certain embodiments, the cell population is cultured in the complete medium for about 48 hours. (emphasis added).
As Applicant has not recited “a complete medium comprising glutamine” in the claims, it is unclear if complete medium as currently claimed is required to include glutamine or not. For the purposes of examination, any culture medium, with or without glutamine is deemed to be a “complete medium” as claimed.
Claim 6 depends on claim 5, which has been cancelled. As such, claim 6 is indefinite, because the dependency is unclear. For the purposes of examination, this claim is deemed to depend from claim 1.
Claim 57 recites “at least about 24 hours” (emphasis added). The noted limitation is indefinite, because the terms “at least” and “about” can encompass mutually exclusive amounts. For example, “about” 24 hours includes amounts less than 24 hours, however, “at least” 24 hours excludes amounts below 24 hours. As such, the metes and bounds of the value as currently claimed is unclear.
Claims 2, 12, 14, and 58 are included in this rejection, as these claims depend from above rejected claims and fails to remedy the noted deficiencies.
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.
Claims 1, 2, 6, 12, 14, 57, and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Finley et al. (IDS; US 2017/0022475, Published 2017), as evidenced by ATCC (Eagle's Minimum Essential Medium (EMEM), 2024, Available online at: www.atcc.org/products/30-2003).
With regard to claims 1, 6, 57, and 58, Finley et al. teach a method of selectively enriching pluripotent cells in a mixed population of cells that includes non-pluripotent cells, the method comprising culturing the mixed cell population in a culture medium that has no exogenous glutamine added and is glutamine-free (Para. 26-28, 31). The pluripotent cells are cultured in the glutamine-free medium for 4 hours or 24 hours (Para. 36-37), which are fully encompassed within about 4 to about 48 hours, about 24 hours, and at least about 24 hours, and which are also deemed to be fully encompassed within about 48 hours, as a narrow definition for the term “about” has not been provided (see Spec., para. 46).
Finley et al. further teach that stem cells, which are pluripotent cells, can be maintained and expanded in culture media, including Eagle’s Minimum Essential Medium® (EMEM) (Para. 104), which has 2 mM L-glutamine (see ATCC, Formulation), and is a complete medium. Additionally, media such as Dulbecco's Modified Eagle's Medium® (DMEM), DMEM F12 Medium®, F-12K Medium®, Iscove’s Modified Dulbecco's Medium®, and RPMI-1640 Medium® may likewise be utilized, and may be further supplemented with amino acids including L-glutamine (Para. 104).
As noted above, Finley et al. teach enriching pluripotent cells in a mixed population of cells including non-pluripotent cells by culturing the mixed population in glutamine-free media, and also teaches that stem cells can be maintained and expanded in culture media containing glutamine. As such, it would have been obvious to one of ordinary skill in the art to maintain and expand enriched pluripotent stem cells in the cell population first cultured in the glutamine-free media, in the taught glutamine-containing media after the enrichment step, to maintain and expand the stem cells enriched from the mixed population.
With regard to claim 2, Finley et al. teach that the pluripotent cells are self-renewing pluripotent cells, such as pluripotent stem cells (Para. 78).
With regard to claims 12 and 14, Finley et al. render obvious the method as claimed, including all components as claimed. As the components cannot be separated from their properties, and the method cannot be separated from its results, practicing the method as rendered obvious by Finley et al. would necessarily provide the results that the pluripotent cells in the cell population are increased between about 10% to about 500% as compared to pluripotent cells in a cell population that has not been cultured in the glutamine-free medium; and the pluripotent cells have an elevated cellular αKG/succinate ratio as compared to the non-pluripotent cells and/or a higher level of Nanog, Oct4, Sox2, Esrrb, Zfp42, Klf4, Tfcp211, Stat3, or combinations thereof as compared to the non-pluripotent cells.
Double Patenting
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.
Claims 1, 2, 6, 12, 14, 57, and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-6 and the disclosure of U.S. Patent No. 11,203,739. Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass methods for selectively enriching pluripotent cells, including self-renewing pluripotent cells, in a cell population comprising non-pluripotent cells and the pluripotent cells, wherein the method comprises culturing the cell population in a substantially glutamine-free medium, which encompasses a glutamine-free medium, for a sufficient amount of time, including 4 hours or 24 hours, which is between about 4 to about 48 hours, about 24 hours, at least about 24 hours, and about 48 hours, to provide the selectively enriched pluripotent cells; and maintaining and expanding the enriched pluripotent stem cells in the cell population in complete media containing glutamine (Instant claims: 1, 2, 6, 57, 58; Cited patent claims: 1, 3-6; Col. 7, line 4-6; Col. 21, line 56 to Col. 22, line 25). Wherein as the components of each method cannot be separated from their properties, and the method cannot be separated from its results, practicing the method as rendered obvious by both the instant claims and cited patent claims and disclosure would necessarily provide the results that the pluripotent cells in the cell population are increased between about 10% to about 500% as compared to pluripotent cells in a cell population that has not been cultured in the glutamine-free medium; and the pluripotent cells have an elevated cellular αKG/succinate ratio as compared to the non-pluripotent cells and/or a higher level of Nanog, Oct4, Sox2, Esrrb, Zfp42, Klf4, Tfcp211, Stat3, or combinations thereof as compared to the non-pluripotent cells (Instant claims: 12, 14; Cited patent claims: 1).
Response to Arguments
Applicant urges that Finley et al. do not teach the claims as amended. Additionally, the nonstatutory double patenting rejection is improper for the same reason.
Applicant’s arguments have been fully considered, and have been found persuasive with regard to the anticipation rejection. However, a new rejection addressing the amendments has been set forth above.
With regard to Applicant’s argument about the nonstatutory double patenting rejection; the modified rejection above addresses the amendments.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653