DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of claims 17-18 in the reply filed on June 11, 2025 is acknowledged. Applicant's election with traverse of Myc1 gene and SEQ ID NO:3 in the reply filed on November 11, 2025 is acknowledged. The traversal is on the ground(s) that there is no undue burden to examine all claims. This is not found persuasive because search/examination burden is not a criterion for election/restriction requirement under PCT Rule 13.1 for this national stage application.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 1-24 are pending in the instant application. Claims 1, 3-4, 6, 8-12, 15-16, 19-20, and 22-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions/species, there being no allowable generic or linking claim. Accordingly, claims 2, 5, 7, 13-14, 17-18, 21, and 24 are under examination on the merits in the instant application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on October 12, 2022, February 7, 2024, and August 21, 2024 have been considered by the examiner. Note that foreign patent document citation number 1 is not considered as the copy submitted by applicant is in non-English language.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See paragraphs 0024 and 0055. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 2, 5, 7, 13-14, and 17-18 are objected to as being in an unacceptable dependent claim form because the claims do not refer to a preceding claim. See MPEP § 608.01(n).
Claim 2 is objected to because of the following informalities: “complimentary” in line 6 should be “complementary”. Appropriate correction is required.
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 2 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.
Claim 2 recites that the Myc1 gene includes “(2) a nucleic acid that hybridizes with a nucleic acid including the nucleotide sequence compl[e]mentary to the nucleotide sequence represented by SEQ ID NO: 1 or 3”. As confusingly written, it appears that a nucleic acid that is hybridizing with (thus complementary to) a nucleotide sequence that is “complementary to” SEQ ID NO:1 or 3 is essentially a nucleic acid that is represented by SEQ ID NO:1 or 3. That is, the convoluted manner of claim language in (2) appears to be essentially claiming SEQ ID NO:1 or 3, if the claimed words are correctly interpreted. Hence, it is unclear how the aforementioned limitation pertaining to the nucleic acid in (2) differs from that in (1).
Claim 2 also recites that the nucleic acid “encodes a polypeptide having activity of promoting insulin production”. It is unclear whether the nucleic acid of SEQ ID NO:1 or 3 itself encodes the claimed polypeptide or whether the nucleic acid in (2) requires additional nucleotide sequences in order to encode the claimed polypeptide. If no additional nucleotide sequence other than SEQ ID NO:1 or 3 is required to encode the claimed polypeptide, it is unclear how the structure of the nucleic acid in (1) and that in (2) are different from each other to justify that the two structures are recited as alternatives: (1) or (2).
Claim 2 recites “its expression” in line 8. It is unclear what is exactly referred to by “its”, which is not normally used in a U.S. patent claim.
Claim 18 recites “RNA encoding the Myc1 gene”. It is unclear how an RNA (e.g., mRNA transcript) encodes the DNA of the Myc1 gene. For examination purpose, the aforementioned limitation will be interpreted as an RNA encoding Myc1 protein.
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 5, 7, 17, 21, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Noguchi et al. (Molecular Therapy Methods & Clinical Development, 2019, 13:243-252, applicant’s citation).
The term “pancreatic islet-like cells” claimed in the instant case is defined as “pancreatic islet cells in which the Myc1 gene or its gene product has been introduced.” See paragraph 0011 of the specification. Hence, the claimed subject matter will be interpreted consistent with the specification’s definition of the term.
It is noted that Myc1 is also known as L-Myc. See paragraph 0026 of the specification.
Noguchi teaches a method in which stem cells from human pancreatic islet tissue are transfected with an episomal plasmid vector encoding reprogramming factors including L-MYC, which is transiently expressed in the cells, which are cultured and differentiated into insulin-producing cells, wherein the stem cells can be induced tissue-specific stem cells or induced pluripotent stem cells. See pages 243-245.
Accordingly, claims 5, 7, 17, 21, and 24 are described by Noguchi et al.
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.
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.
Claims 2, 5, 7, 13-14, 17-18, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Noguchi et al. (Molecular Therapy Methods & Clinical Development, 2019, 13:243-252) in view of Yuasa (US 2018/0298346 A1).
Noguchi teaches a method in which stem cells from human pancreatic islet tissue are transfected with an episomal plasmid vector encoding reprogramming factors including L-MYC, which is transiently expressed in the cells, which are cultured and differentiated into insulin-producing cells, wherein the stem cells can be induced tissue-specific stem cells or induced pluripotent stem cells. See pages 243-245.
Noguchi does not teach that L-MYC gene sequence included in the episomal plasmid vector comprises SEQ ID NO:3 claimed in the instant case. Noguchi also does not teach RNA encoding L-MYC protein.
Yuasa teaches that human L-MYC-encoding nucleotide sequence is known and available in the art under GenBank accession number “NM_001033081”, which is disclosed as SEQ ID NO:53. See paragraphs 0046-0047. It is noted that Yuasa’s SEQ ID NO:53 is 100% identical to SEQ ID NO:3 claimed in the instant case.
Yuasa teaches that the reprogramming factor L-MYC (SEQ ID NO:53) can be introduced into cells including induced pluripotent (iPS) cells and somatic cells comprising using an expression vector comprising a promoter or an enhancer and an mRNA encoding L-MYC protein. See paragraphs 0050 and 0057-0061.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to reasonably consider Noguchi’s nucleotide sequence encoding human L-MYC sequence comprises Yuasa’s SEQ ID NO:53 (same as the art-recognized sequence under NM_001033081) because it is a scientific fact that the human nucleic acid sequence for L-MYC was known as GenBank accession number NM_001033081 that is represented as Yuasa’s SEQ ID NO:53. It would also have been obvious to one of ordinary skill in the art to use an mRNA sequence with a promoter/enhancer for expressing L-MYC that induces stem cells to differentiate into insulin-producing islet cells with a reasonable expectation of success because use of a vector comprising a promoter/enhancer and an mRNA encoding L-MYC was an art-recognized technique for overexpressing L-MYC in stem cells as evidenced by Yuasa.
Accordingly, claims 2, 5, 7, 13-14, 17-18, 21, and 24 taken as a whole would have been prima facie obvious before the effective filing date.
Claims 2, 5, 7, 13-14, 17-18, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over German (US 2004/0142901 A1) in view of Jiang (US 2016/0045554 A1) and Yuasa (US 2018/0298346 A1).
German teaches a method for producing a pancreatic islet cell including the b cell comprising transfecting a plasmid or a viral vector comprising a DNA or “RNA (e.g., mRNA)” encoding an islet transcription factor (e.g., “Ngn3 or other islet transcription factor of interest”) into a cell including islet cells and “non-islet cells” such as pancreatic stem cells or embryonic stem cells, which are cultured up to several weeks and are “capable of developing into b cells”, wherein the transfecting is able to “provide at least transient expression” of the islet transcription factor, wherein the transcription factor further comprises “promoters” and “enhancers”. See paragraphs 0017, 0070, 0072-0073, 0092, 0104-0106, 0110-0112, 0129, 0141, and 0182; claims 25-26.
German does not teach that “other islet transcription factor of interest” is Myc1, also known as L-Myc.
Jiang teaches that Myc1 and Ngn3 are islet progenitor regulator genes and that differentiated islet progenitor cells are “functionally similar to b cells in adult islets.” See FIG. 3F; paragraphs 0130, 0135 and 0174.
Yuasa teaches that human L-MYC-encoding nucleotide sequence is known and available in the art under GenBank accession number “NM_001033081”, which is disclosed as SEQ ID NO:53. See paragraphs 0046-0047. It is noted that Yuasa’s SEQ ID NO:53 is 100% identical to SEQ ID NO:3 claimed in the instant case.
It would have been obvious to one of ordinary skill in the art before the effective filing date to replace German’s Ngn3 DNA/mRNA sequence with Myc1 (or L-Myc) DNA/mRNA sequence or further include Myc1 nucleotide sequence into German’s plasmid or viral vector encoding islet transcription factors when practicing German’s method of producing pancreatic islet b cells. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Myc1 was deemed functionally equivalent to Ngn3 in regulating islet progenitor as suggested by Jiang, and because German taught that “Ngn3 or other islet transcription factor of interest” can be transiently expressed in a pancreatic cell or a stem cell for producing pancreatic islet b cells, wherein one of ordinary skill in the art would have readily recognized that Jiang’s Myc1 sequence is synonymous with the art-recognized L-myc sequence of NM_001033081, which is disclosed as SEQ ID NO:53 by Yuasa.
Accordingly, claims 2, 5, 7, 13-14, 17-18, 21, and 24 taken as a whole would have been prima facie obvious before the effective filing date.
Conclusion
No claim is allowed.
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/DANA H SHIN/Primary Examiner, Art Unit 1635