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 Status
Claims 1-20 are pending in this application.
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.
Claim 6 is 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. The claim fails to mention which claim that it is dependent on. However, for the sake of compact prosecution, claim 1 will be used as the reference claim.
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.
Claims 1-3, 13-16, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Odorico et al. (U.S. Patent No. 9,540,613 B2), herein after Odorico.
Regarding claim 1, Odorico teaches (col 21, claims 2 and 3) contacting a culture including human induced pluripotent stem cells (hiPSCs) with at least one cofactor (Activin A or selenium); differentiating at least a portion of the hiPSCs to endocrine pancreatic β-cells; and measuring expression of a biomarker selected from PDX1, NKX6, NGN3, (col. 22, claim 15 and Figure 7) or a combination thereof to identify the endocrine pancreatic P-cells, wherein expression of said biomarkers indicates differentiation to endocrine pancreatic β-cells. A cofactor as defined by the Biology Dictionary is a non-protein chemical that assists with a biological chemical reaction, which includes but is not limited to vitamins and minerals.
Regarding claim 2, Odorico teaches (col 11, lines 19-32) the method of claim 1, wherein the hiPSCs are contacted with at least one cofactor (col 11, lines 19-32, selenium in ITSFINE medium at stage 4) during the pancreatic progenitor stage (S4) of differentiation of the hiPSCs.
Regarding claim 3, Odorico teaches (col 21, claim 2) the method of claim 2, wherein the at least one cofactor (selenium in ITSFINE medium for about 4 days in claims) is contacted with the hiPSCs for a period of at least 4 days.
Regarding claim 13, Odorico teaches (col 21, claim 2 and 3, col. 15, lines 33 and 34, ~80-90%; “about” is defined in col 8, line 2) the method of claim 1, wherein the contacting of the culture including human induced pluripotent stem cells (hiPSCs) with at least one cofactor is conducted when the hiPSCs are about 70% confluent.
Regarding claim 14, Odorico teaches (Table 3, col. 14, lines 60-64, a composition which includes
Activin A) a kit for use in producing endocrine pancreatic β-cells from a culture of human induced pluripotent stem cells (hiPSCs) comprising a composition comprising at least one cofactor.
Regarding claims 15, 16, and 20, Odorico teaches (in the ‘seventh aspect’ of the invention, col. 4, lines 30-35) a method for treating diabetes in a subject comprising implanting a therapeutically effective amount of endocrine pancreatic β-cells, prepared according to the method of claim 1 (col. 4, lines 30-35, provides methods of using the cultured cells for transplant in mammalian patients), in the subject in need thereof and a therapeutic product prepared according to the method for producing endocrine pancreatic β-cells.
Regarding claim 18, Odorico teaches (col. 21, claims 2 and 3) a composition comprising endocrine pancreatic β-cells and at least one cofactor.
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.
Claims 4-6, 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Odorico in view of Yoneyama et al. (U.S. Patent Application Publication No. 2020/0208120 A1) and Tramonti et al. (“The MocR-like transcription factors: pyridoxal 5'-phosphate-dependent regulators of bacterial metabolism” The FEBS Journal 285 (2018) 3925-3944), herein after Yoneyama and Tramonti.
Regarding claims 4-6, Odorico teaches all of the elements of the current invention as stated above except, the method of claim 1, wherein the at least one cofactor is Flavin Adenine Dinucleotide (FAD), Pyridoxal 5' -phosphate (PLP), or a combination thereof.
Yoneyama teaches the use for FAD (paragraph [0044]) in the culture medium of iPS cells is to avoid lowering performance in cell proliferation. Tramonti teaches (abstract) that the fusion between DNA-binding proteins and PLP-dependent enzymes in certain transcription factors, results in PLP being a dependent cofactor in their mode of transcription regulation. This article provides motivation for the use of PLP for manipulating gene regulation.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Odorico to incorporate the teachings of Yoneyama and Tramonti to add FAD and PLP to Odorico’s protocol. Doing so would make the protocol for differentiating pancreatic β-cells from iPS cells more efficient, as recognized by Yoneyama.
Regarding claim 12, Odorico teaches all of the elements of the current invention as stated above except, the method of claim 1, wherein the at least one cofactor is PLP at a concentration of about 8 µM.
Yoneyama teaches (paragraph [0065]) the specific range: 5 nM to 20 µM of use for FAD in the culture medium of iPS cells for the best performance in culture. Tramonti teaches the advantages of using PLP.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Odorico to incorporate the teachings of Yoneyama and Tramonti, by optimizing the cofactor within the range pointed out for the best performance of FAD.
Regarding claim 19, Odorico teaches all of the elements of the current invention as stated above except, the composition of claim 18 except, wherein the at least one cofactor is FAD, PLP, or a combination thereof. Yoneyama teaches (paragraph [0044]) the use for FAD in the culture medium of iPS cells is to avoid lowering performance in cell proliferation. Tramonti teaches (abstract) that the fusion between DNA-binding proteins and PLP-dependent enzymes in certain transcription factors, results in PLP being a dependent cofactor in their mode of transcription regulation. This article provides motivation for the use of PLP for manipulating gene regulation.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Odorico to incorporate the teachings of Yoneyama and Tramonti to add FAD and PLP to Odorico’s protocol. Doing so would make the protocol for differentiating pancreatic β-cells from iPS cells more efficient, as recognized by Yoneyama
Claims 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Odorico in view of Yoneyama.
Regarding claims 7-11, Odorico teaches all of the elements of the current invention as stated above except, the method of claim 1, wherein the at least one cofactor (FAD) is in a specific concentration range.
Yoneyama teaches (paragraph [0065]) the specific range: 5 nM to 20 µM of use for FAD in the culture medium of iPS cells for the best performance in culture. The aforementioned (paragraph [0065]) range covers the ranges of claims 7-11.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Odorico to incorporate the teachings of Yoneyama by adding the cofactors within the range pointed out for the best performance in culture.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Odorico in view of Matthias et al. (E.S. Patent No. 2329583), herein after Matthias.
Regarding claim 17, Odorico teaches all of the elements of the current invention as stated above except, a method for treating pancreatic cancer in a subject, the method comprising implanting a therapeutically effective amount of endocrine pancreatic β-cells, prepared according to the method of claim 1, in the subject in need thereof. Matthias teaches (last paragraph on page 17 – page 18) that the treatment of patients with regenerate β-cells will be effective. This patent provides motivation for the use of regenerate β-cells and treating pancreatic cancer, in a subject in need thereof.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Odorico to incorporate the teachings and the motivation from Matthias for treating pancreatic cancer patients with regenerate β-cells.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached Monday-Friday 9:00A - 5:00P.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638