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 I, presently claims 85-100, in the reply filed on 1/06/2026 is acknowledged.
Claims 101-104 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 1/06/2026.
Claims 85-100 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 85-100 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 85 recites a step of “differentiating the starting cell population into beta cells, comprising a step of increasing the proliferation of pancreatic progenitor cells.”, which blurs the metes and bounds of the claim because the claim recites two species of cells as a starting population, but the differentiation step only requires the pancreatic progenitor cells. For the embodiment of pluripotent stem cells, it is unclear if a step of differentiation is or is not required by the claim. Clarification and/or correction is required
Because claims 86-100 depend from claim 85 and do not resolve the point of confusion, these claims must be rejected with claim 85 as indefinite.
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 85, 88-90, and 98-100 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kunisada et al. (Stem Cell Research (2012), 8, 274-284; cite number CB4** as provided in the IDS dated 9/12/2024) as evidenced by Kim et al. (US 2007/0155661; cite number AZ1 as provided in the IDS dated 9/12/2024).
This rejection addresses the embodiment of human induced pluripotent stem cells as a species of pluripotent cell capable of differentiating into beta cells. This rejection addresses the embodiment of activin A as a species of BMP activator and thus cell cycle activator inhibiting cyclin-dependent kinases as evidenced by Kim for claim 89 (see Kim at ¶0007, ¶0040, and ¶0042). This rejection addresses embodiment of dorsomorphin and noggin as species of BMP inhibitors and thus cell cycle inhibitor by inhibiting cyclin-dependent kinases as evidenced by Kim for claim 90 (see Kim at ¶0007 and ¶0040).
Kunisada teaches a method of generating insulin-producing beta cells, the method comprising: 1) providing human induced pluripotent stem cells, 2) differentiating the starting cell population into beta cells and further comprising a step of increasing the proliferation of pancreatic progenitor cells wherein said progenitor cells express PDX1 (p282, paragraph starting “For pancreatic differentiation…”; Abstract; Fig. 3 for insulin-producing beta cells), anticipating claims 85, 88, and 100. Kunisada teaches adding activin A (), anticipating claim 89. Kunisada teaches adding either dorsomorphin or noggin with retinoic acid to inhibit BMP type I receptors and increase the PDX1+ cells when generating pancreatic progenitor cells (p275, paragraph starting “Dorsomorphin inhibits BMP … “ and Fig. 2), anticipating claim 90. Kunisada teaches contacting the human induced pluripotent stem cells with FGF2 (p282, paragraph starting “For pancreatic differentiation…”;), anticipating claims 98 and 99.
Claims 85-100 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by and Ameri et al. (Cell Reports (April 4th, 2017), 19, 36-49 with appended supplemental information; cite number CI** as provided in the IDS dated 9/12/2024).
The teachings of Ameri qualifies as prior art under 35 U.S.C. 102(a)(1) under the rebuttable presumption that this non-patent literature reference 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 Ameri as available prior art. Also note that Affidavits or declarations, such as those submitted under 37 CFR 1.130, 1.131 and 1.132, filed during the prosecution of the prior application do not automatically become a part of this application. Where it is desired to rely on an earlier-filed affidavit or declaration, the applicant should make the remarks of record in this application and include a copy of the original affidavit or declaration filed in the prior application.
Ameri teaches a method of generating beta cells, comprising the steps of: providing a starting cell population comprising human embryonic stem cells (hESCs), and differentiating the starting cell population into beta cells, comprising a step of increasing the proliferation of pancreatic progenitor cells (Figure S4 and Fig. 5 and their respective legends; “differentiation protocol C” in the supplemental information), anticipating claim 85.
Ameri teaches a method of differentiating human embryonic stem cells into beta cells, the method comprising i) incubating said cell population in RPMI medium comprising Activin A and a glycogen synthase kinase (GSK3) inhibitor for a duration sufficient to differentiate at least part of the cell population into definitive endoderm cells; ii) incubating the cell population of 1) in RPMI medium comprising B27- insulin, for a duration sufficient to further differentiate the cell population into definitive endoderm cells; iii) incubating the cell population of ii) in DMEM/F12 medium comprising B27+insulin and retinoic acid, for a duration sufficient to differentiate at least part of the cell population into gut tube cells; iv) incubating the cell population of iii) in DMEM/F12 medium comprising B27+insulin and human FGF2, and optionally human Noggin, for a duration sufficient to differentiate at least part of the cell population into posterior foregut cells; v) incubating the cell population of iv) in DMEM/F12 medium comprising B27+insulin, ((2S,5S)-(E,E)-8-(5-(4-(Trifluoromethyl)phenyl)-2,4- pentadienoylamino)benzolactam) (TPB), and human Noggin for a duration sufficient to differentiate at least part of the cell population into early pancreatic progenitor cells; vi) incubating the cell population of v) in DMEM/F12 medium comprising B27+insulin, Forskolin, Alk5 inhibitor, Nicotinamide, and human Noggin for a duration sufficient to differentiate at least part of the cell population into mature GP2+ pancreatic progenitor cells expressing PDX1 and NK X6.1 and sufficient to enhance viability of the mature GP2+ pancreatic progenitor cells expressing PDX1 and NK X6.1; and vii) incubating the cell population obtained in vi) in DMEM/F12 medium comprising B27+insulin, Forskolin, Alk5 inhibitor, Nicotinamide, human Noggin without Rock inhibitor for a duration sufficient to differentiate at least part of the cell population into glucose-responsive, insulin-producing beta cells (Figure S4 and Fig. 5; “differentiation protocol C” in the supplemental information; see Figure 3 for GP2, PDX1, and NKX6.1 expression on hESCs differentiation into pancreatic progenitor cells; Figure S4A for glucose-responsive beta cells and Figure 5H for insulin producing beta cells), anticipating claims 86 and 88, and 98-100.
Ameri teaches an alternative embodiment relative to the preceding paragraph wherein ROCK inhibitor is omitted differentiating unsorted cultures (of hESCs) (Figure 5 legend), anticipating claim 87.
Ameri teaches a step of increasing the proliferation of pancreatic progenitor cells further comprising the addition of a cell cycle activator and/or increasing activity of a cell cycle activator inhibiting a cell cycle inhibitor by knocking down RNA expression of CDKN1a and CDKN2a (paragraph starting “To examine whether blocking …” on p42 through paragraph ending “…PECs enhances their proliferative capacity.” which skips p43, and Figure S6-S7), anticipating claims 89-96.
Ameri teaches that inhibition of CDKN1a and/or CDKN2a results in an increase in proliferative pancreatic progenitor cells and/or in an increase in total cell number of pancreatic progenitor cells (paragraph starting “To examine whether blocking …” on p42 through paragraph ending “…PECs enhances their proliferative capacity.” which skips p43, and Figure S7F), anticipating claim 97.
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 85, 86, 88, and 98-100 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, and 14 of U.S. Patent No. 11,060,062 (cite number AU1 as provided in the IDS dated 9/12/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘062 patent is the narrower embodiment of claims 85, 86, and 100 of the instant application. Claim 14 of the ‘062 patent is the narrower embodiment of claim 88 of the instant application, and claim 6 of the ‘062 patent is the narrower embodiment of claims 98 and 99 of the instant application.
Conclusion
No claims are allowed. No claims are free of the art.
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/Sean C. Barron/Primary Examiner, Art Unit 1653