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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 1, 2026, has been entered.
Election/Restrictions
Applicant’s election of Group I (Claims 1-4, 7-14, and 17-18; drawn to a method comprising contracting a population of cells comprising pancreatic progenitor cells or precursors thereof with a composition comprising an inhibitor IL-4/JAK3 signaling pathway) in the reply filed on June 23, 2025, 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)).
Applicant further elected the following species:
a. 10 μM concentration for the IL-4/JAK3 inhibitor
DETAILED ACTION
The amended claims filed on May 1, 2026, have been acknowledged. Claims 2, 5-8, 15-16, and 19-24 were cancelled. Claims 1 and 4 were amended. Claims 1, 3-4, 9-14, and 17-18 are pending and examined on the merits.
Priority
The applicant claims domestic priority from U.S. provisional application No. 62/886,049, filed on August 13, 2019. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1, 3-4, 9-14, and 17-18 receive domestic benefit from U.S. provisional application No. 62/886,049, filed on August 13, 2019.
Information Disclosure Statement
The information disclosure statement (IDS) filed on May 1, 2026, has been considered.
Withdrawn Claim Rejections - 35 USC § 112
The prior rejection of claims 1-4, 7-14, and 17-18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s amendments to claim 1 to remove the language “differentiating said pancreatic progenitor cells into NKX6.1 positive and ISL1 negative”.
The prior rejection of claims 1-4, 7-14, and 17-18 under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling is withdrawn in light of Applicant’s amendments to claim 1 to remove the language “differentiating said pancreatic progenitor cells into NKX6.1 positive and ISL1 negative”.
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, 3-4, and 12-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by United States Patent Application No: 20170349884 (Karp).
Regarding claims 1, 3-4, and 14, Karp teaches a method for increasing the insulin expression of a population of mammalian cells, such as progenitor cells, by treating the population with a plurality of small molecules that induce the cells to increase the insulin expression. Karp teaches that one of the small molecules can be EGFR inhibitors, such as WHI-P154. Karp teaches that as part of their method for increasing the insulin expression, they screened a multitude of compounds to asses which molecules increase enteroendocrine cell differentiation and insulin production. Cells were cultured with EGF (an EGF growth factor), Noggin (a TGFβ inhibitor), and DAPT (END), as well as small molecules. Figure 31 and Example 31 show that the starting cell population expressed Pdx1 and Nkx6.1 and did not express Ins1 at day 0 of the culture (i.e. before addition of the small molecules) (paragraphs 0007, 0084, 0144-0170, Examples 3, 9-10, and 31). Therefore, Karp teaches that their starting population of progenitor cells expressed Pdx1 and Nkx6.1 and did not express Ins1 and identifies that these cells can be cultured with WHI-P154 to assess changes in insulin expression.
Regarding claims 12-13, Karp teaches that cells are cultured with the small molecules for 2-3 days (Example 10).
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 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application No: 20170349884 (Karp).
Karp does not specifically teach the concentration of WHI-P154.
However, Karp does teach that another EGFR inhibitor, Gefitinib, was effective in their screen using a concentration of 1 μM. Therefore, it would have been obvious to one of ordinary skill in the art that 1 μM could also be used with the related EGFR inhibitor WHI-P154 (paragraph 0084, Table 2, and Example 11). Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Specifically regarding claim 11, the specification discloses that about encompasses within an order of magnitude (paragraph 0026). The 1 μM of Karp
Is within an order of magnitude of 10 μM. Therefore, 1 μM reads on the about 10 μM of claim 11.
Claims 1 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application No: 20170349884 (Karp) as applied to claim 1 above, and further in view of Sinagoga et al. (Development 145: 1-11. 2018).
The teachings of Karp are as discussed above. Karp teaches that they collected isolated crypts and single cells from mice. Karp teaches that organoids can be used as part of their method of screening (paragraphs 0079 and 0151 and Examples 1-5 and 8).
Karp does not teach wherein the pancreatic progenitor is derived from embryonic or pluripotent stem cells.
However, Sinagoga teaches that enteroendocrine cells (EECs) are a minor cell population in the intestine yet they play a major role in digestion, satiety and nutrient homeostasis. Recently developed human intestinal organoid models include EECs, but their rarity makes it difficult to study their formation and function. Here, they used the EEC-inducing property of the transcription factor NEUROG3 in human pluripotent stem cell (embryonic and induced pluripotent stem cells)-derived human intestinal organoids and colonic organoids to promote EEC development in vitro and generate vast amounts of EECs (abstract and page 2, column 1, paragraphs 1-page 8, column 1, paragraph 1 and Figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used induced pluripotent stem cells or embryonic stem cells for deriving pancreatic progenitor cells to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to use induced pluripotent stem cells or embryonic stem cells for deriving pancreatic progenitor cells with a reasonable expectation of success because Sinagoga teaches that enteroendocrine cells (EECs) are a minor and rare cell population in the intestine whereas their method of generating EECs from embryonic and induced pluripotent stem cells allowed for them to generate vast amounts of EECs. Therefore, it would have been obvious to use embryonic and induced pluripotent stem cells to produce the pancreatic progenitor cells as Karp and Sinagoga are both interested in generating EECs and Sinagoga teaches that their method using embryonic and induced pluripotent stem cells produces vast amounts of EECs compared to what is normally found in the intestines. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
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/KEENAN A BATES/Examiner, Art Unit 1631 /JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
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