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 .
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 4-5, 7, 13-14, 141, and 143 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. Claims 4-5 and 7 recite “derivative” or “derivatives.” It’s unclear how far removed a compound can be from the parent compound in order to be considered a “derivative” and not an entirely different compound all together. Claim 141, which depends from claim 7, is indefinite for the same reasons. Regarding claim 13, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation “0.005% to 0.5% (w/v),” and further recites 0.01% to 0.2% (w/v), 0.02% to 0.1% (w/v), and 0.03% to 0.08% (w/v), which are narrower embodiments of the range. Claim 13 recites the broad recitation 0.01% to 0.2%, and further recites 0.02% to 0.1% (w/v), and 0.03% to 0.08% (w/v), which are narrower embodiments of the range. Regarding claim 14, the claim recites “wherein the PVA is at most 85% hydrolyzed.” This is non-sensical as polyvinyl alcohol (PVA) does not undergo hydrolysis, but PVA is the product after polyvinyl acetate (PVAc) is hydrolyzed. As the claim recites “polyvinyl alcohol,” the artisan would understand this means fully hydrolyzed polyvinyl acetate, which can’t be further hydrolyzed. As PVA is fully hydrolyzed PVAC, it’s unclear how PVA can be no more than 80% hydrolyzed (claim 14) or “about 80% hydrolyzed” (claim 143).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9, 15- 17, and 139-142 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sasaki (Transient FOXO1 inhibition in pancreatic endoderm promotes the generation of NGN3+ endocrine precursors from human iPSCs, Stem Cell Research, Volume 44, April 2020, 101754). Sasaki teaches an in vitro composition comprising a population of pancreatic progenitor cells and a medium comprising a Forkhead Box 01 (FoxO1) inhibitor and a notch signaling pathway inhibitor, wherein the population of pancreatic progenitor cells comprises cells that are PDXl-positive and NKX6. l-negative and cells that are PDXl-positive and NKX6 l-positive (abstract; Introduction) (present claim 1), the medium comprises a tpb (a PKC activator; there is no disclosed Wnt inhibitor in the medium) (Introduction; Section 3.2; Figure 2, A and E, (present claims 2 and 7), the notch signaling pathway inhibitor is a y-secretase inhibitor, wherein the Y-secretase may be DAPT (Section 2.8) (claims 3 and 4), the FOX01 inhibitor may be AS1842856 (Introduction), which corresponds to applicant’s
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(claim 5)
Wherein the FoxO1 inhibit is present in the medium at a concentration of 0.1-10 micromolar (Table 2) (claim 6), wherein the medium further comprises a fibroblast growth factor (Section 2.1), wherein approximately 50% (at least 50%) of the population of pancreatic progenitor cells are PDXl-positive and NKX6. l-negative, and/or no more than 50% of the population of pancreatic progenitor cells are PDXl-positive and NKX6. l-positive, and wherein no more than 50% of the population of pancreatic progenitor cells are PDXl-positive and NKX6. l-negative, and/or at least 50% of the population of pancreatic progenitor cells are PDXl-positive and NKX6.l-positive (Section 3.2), and wherein the medium further comprises a fibroblast growth factor (Section 2.1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-17 and 139-143 are rejected under 35 U.S.C. 103 as being unpatentable over Sasaki (Transient FOXO1 inhibition in pancreatic endoderm promotes the generation of NGN3+ endocrine precursors from human iPSCs, Stem Cell Research, Volume 44, April 2020, 101754) in view of Abazari, PCL/PVA nanofibrous scaffold improve insulin-producing cells generation from human induced pluripotent stem cells, Gene 671, 2018, 50-57). The relevant portions of Sasaki are given above.
Sasaki fails to teach “wherein the medium further comprises a water-soluble synthetic polymer”
Abazari teaches that polyvinyl alcohol (a water-soluble synthetic polymer) is used in the context of pancreatic endocrine cells derived from human pluripotent stem cells (hPSCs) primarily as a biocompatible, hydrophilic scaffold material for 3D culture and as a protective, semipermeable barrier for transplantation (encapsulation), and improves cell-matrix interactions, supports the differentiation of hPSCs into functional pancreatic beta -cells, and helps maintain the structure of islet-like organoids, wherein the PVA is not hydrolyzed (wherein the PVA is at most 85% hydrolyzed) (Abstract; Introduction; Materials and Methods).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to incorporate polyvinyl alcohol into the composition of Sasaki. The motivation for this would be to provide a biocompatible, hydrophilic scaffold material for 3D culture and as a protective, semipermeable barrier for encapsulation. It would have been further obvious to optimize the w/v% of polyvinyl alcohol in the course of optimizing the composition for use in directing the differentiation of pancreatic progenitor cells into functional, insulin-producing pancreatic beta-cells, and in this way would find applicant’s presently claimed w/v range through routine experimentation. The prior art provides sufficient guidance to this end, as Abazari teaches 1.2 g of PVA polymer dissolved in 10 ml (Section 2.2), which is the equivalent of 0.12 w/v polyvinyl alcohol concentration, which reads on applicant’s 0.005% to 0.5% (w/v) (present claim 13).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
January 18, 2026