Notice of Pre-AIA or AIA Status
The present application, 18554136, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-16, 18, 23, 45, 46 are pending.
Objection to Amendment
The form of the Claim amendments, entered 10/5/2026, is objected to because the latest amendments appear to have been typed and submitted in other than black ink (purple ink?), which causes them to appear faint in the official digital file. Appropriate correction is suggested.
Priority
The filing receipt, mailed 3/20/2024, states that this application, 18554136, was filed 10/05/2023, and claims domestic priority benefit as a 371 of PCT/EP2022/059516, filed 04/08/2022, which claims benefit of 63/173,622, filed 04/12/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/5/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 13 and 14 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 13 states the language “wherein the non-viral vector comprises gene editing”, which renders unclear claim 13 and its dependent claim 14, because a vector cannot comprise gene editing.
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.
1. Claim(s) 1-5, 8, 10, 11, 12, 13, 14, 23 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yoshihara, US 20210363490.
Yoshihara, US 20210363490, teaches throughout the publication and abstract, and e.g., at para 229 teach engineered pancreatic islet organoids, comprising a recombinant expression vector, wherein the recombinant expression vector comprises (a) a nucleic acid sequence encoding a polypeptide, and (b) a suitable control sequence, operatively linked to the nucleic acid sequence, which is present in pancreatic islet organoid cells that do not endogenously express the polypeptide and wherein the polypeptide is not endogenously expressed in pancreatic islet cells and wherein the polypeptide is PD-L1 and which reduces the immunogenicity of the islet cells expressing same by suppressing the activity of T-effector cells and is considered to be a therapeutic and a hormone type of polypeptide or an analog thereof.
Yoshihara, at para 114, 225, teaches plasmid vectors, as in claim 12; at [225], teaches PD-L1 immune suppression by vector expression of a checkpoint protein in human islet like organelles (HILOS):
[0225] In embodiments, the immune checkpoint protein molecule is, without limitation, PD-L1 or the extracellular domain of PD-L1, which binds to PD-1 expressed by T cells. In an embodiment, a polynucleotide encoding an immune checkpoint protein is utilized to molecularly engineer a cell to express a checkpoint protein, or one or more checkpoint proteins, such as by infecting the cell with a viral or bacterial vector containing the checkpoint protein-encoding polynucleotide. In some embodiments, a cell (e.g., a beta-cell, or HILO cell) expresses more than one immune checkpoint protein, or a ligand binding portion thereof. In some embodiments, the cell is molecularly engineered to contain one, or more than one immune checkpoint protein, or ligand binding portion thereof, which is expressed by the cell. In an embodiment, the cell is infected with a viral vector, e.g., a lentiviral vector or adeno-associated viral vector, or more than one viral vector, that contains one or more polynucleotide(s) that encode(s) one or more immune checkpoint proteins or a ligand binding portion thereof, using procedures and methods that are well-known in the art. In an embodiment, the cell is transformed or transfected with a plasmid vector, or more than one plasmid vector, that contains one or more polynucleotide(s) that encode(s) one or more immune checkpoint proteins or a ligand binding portion thereof, using procedures and methods that are well-known in the art.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claim(s) 5-9, 15, 16, is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshihara, US 20210363490, as applied to claims 1-5, 8, 10, 11, 12, 13, 14, 23, above, and further in view of Staerz, US 20230235354, Powers, US 20050048040.
Yoshihara does not teach vector delivery of particular genes as set forth in the Markush Groups of claims 5-9, which were examined as such. Yoshihara does not teach encoding proteins under the particular control of a promoter that is RIP1 or RIP2.
Staerz, US 20230235354, throughout the publication and abstract, teaches the use of delivery vectors in the transfer of genes and the expression of proteins and cell engineering. Staerz, at para 82, teaches target cells that are pancreatic islets; at para 111, teach gene transfer carrying a gene of interest, including thyroid stimulating hormone (TSH), prolactin, as in instant claim 6; Wnt family members, cytokines, neurotransmitters, oncogenes, hormones, enzymes, particularly , ACTH, as in claim 7; including factor VII, VII, IX, as in instant claim 8, hormones including endorphin, as in claim 9.
Powers, US 20050048040, throughout the publication and abstract, teaches insulin-producing cells for treatment of diabetes. Powers, teaches at [0070], vectors encoding proteins positioned under the transcriptional control of a promoter; at [0082]-[0083], rat insulin gene promoters RIP1 and RIP2, as in instant claims 15 and 16. Powers, at para [0135]-[138], [146], [0147], teaches recombinant adenovirus and adeno-associated virus comprising for gene transfer into isolated rat islets.
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined vector delivery of particular genes, that are thyroid stimulating hormone (TSH), prolactin, as in instant claim 6; Wnt family members, cytokines, neurotransmitters, oncogenes, hormones, enzymes, particularly , ACTH, as in claim 7; including factor VII, VII, IX, as in instant claim 8, hormones including endorphin, as in claim 9 and a vector promoter that is RIP1 or RIP2.
One of ordinary skill in the art would have motivated to have combined to express proteins in the engineered pancreatic islet organoids, in order to express proteins that needed for treatment of disease, and would have been motivated to use promoters RIP1 or RIP2 because they are pancreatic promoters.
2. Claim(s) 18, 45, 46, is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshihara, US 20210363490, Powers, US 20050048040 and Staerz, US 20230235354, as applied to claims 1-5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 23, above, and further in view of Ong, US 20180051255.
Yoshihara, US 20210363490 and Staerz, US 20230235354 do not teach engineered pancreatic organoid and a silk matrix.
Yoshihara does not teach silk scaffold for culturing pancreatic islet organelles.
Ong, US 20180051255, throughout the publication and abstract, teaches A cell culture system including a silk fibroid scaffold, culture media, and pancreatic cells. The pancreatic cells grown in the tissue culture system comprising a silk fibroid scaffold have physiological and morphological features like those of in vivo pancreatic cells. The cell culture system comprising a silk fibroid scaffold can be used to produce a pancreatic tissue-specific extracellular matrix capable of inducing differentiation of pancreatic cell precursors into pancreatic cells.
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined silk scaffold for culturing with recombinant engineered pancreatic islet organoids.
One of ordinary skill in the art would have motivated to have combined a cell culture system comprising engineered pancreatic islet organoids with a silk fibroid scaffold because silk scaffolding can be used to produce a pancreatic tissue-specific extracellular matrix capable of inducing differentiation of pancreatic cell precursors into pancreatic cells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark L Shibuya whose telephone number is (571)272-0806. The examiner can normally be reached M-F, 9AM-4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz, can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MARK L. SHIBUYA
Primary Patent Examiner
Art Unit 1631
/MARK L SHIBUYA/Primary Patent Examiner, Art Unit 1631