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 .
Status of Application/Amendment/Claims
This Office action is in response to the communications filed on June 1, 2026.
Currently, claims 1, 4, 6, 8-12, 15-16, and 19-36 are pending in the instant application. Claims 1, 4, 6, 8-12, 15-16, 19-20, and 22-23 are withdrawn from further consideration as being drawn to nonelected inventions/species. Newly added claim, claim 30, is directed to a nonelected species. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 30 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Accordingly, claims 21, 24-29, and 31-36 are under examination on the merits in the instant application.
The following rejections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 103
Claims 21 and 24 remain rejected under 35 U.S.C. 103 as being unpatentable over German in view of Jiang and Yuasa for the reasons as set forth in the Office action mailed on February 5, 2026 and for the reasons stated below.
Applicant's arguments filed on June 1, 2026 have been fully considered but they are not persuasive. Applicant argues that German does not teach using Mycl, replacing Ngn3 with Mycl, or omitting the three reprogramming factors recited in the claims; Jiang does not teach using Ngn3 in place of Mycl; and Yuasa does not teach using Mycl without the recited reprogramming factors. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As set forth in the last Office action, both Mycl and Ngn3 were known to be functionally equivalent islet progenitor transcription factors as taught by Jiang, and German taught producing a pancreatic islet cell by transiently expressing “Ngn3 or other islet transcription factor of interest” in a pancreatic or a stem cell. Hence, the combined teachings of the cited references do render the claimed subject matter prima facie obvious.
Applicant argues that the cited references do not provide “any data or scientific rationale” or a reasonable expectation of success for establishing the obviousness rejection set forth in the last Office action because both German and Jiang suggested that “Ngn3 as a master regulator of endocrine pancreatic fate”, while Mycl “has not been shown, prior to the present application as published, to yield the same cell populations or insulin-producing function as Ngn3.” In response, it is noted that there is no legal requirement that “data” or working examples are required for obviousness under §103. Further, contrary to applicant’s argument, the obviousness rejection set forth in the last Office action is scientifically based gleaned from scientific, objective facts including Mycl being an art-recognized islet progenitor factor, thereby satisfying the “other islet transcription factor of interest” taught by German, thereby providing a motivation and a reasonable expectation of success in arriving at the claimed subject matter. In addition, it is also noted that the claims as written do not exclude Ngn3, which is not included in the newly added negative “wherein” clause, and furthermore, the claims recite “the method comprising”, wherein the phrase “comprising” is open-ended thus does not exclude any unrecited elements unless explicitly claimed. Hence, use of the combination of Ngn3 and Mycl when practicing German’s method would also have been obvious as expressly stated in the last Office action that it would have been obvious “to further include Myc1 nucleotide sequence into German’s plasmid or viral vector”.
Applicant argues that the claims are not obvious because of the “unexpected” and “surprising finding that Mycl alone can induce proliferation of pancreatic islet precursor cell-like cells” by pointing out Examples 1-10 and paragraphs 0060-0177, which are not taught by the cited prior art. In response, it is noted that the rejected claims do not require that “Mycl alone” is introduced into the cells as evidenced by the open-ended “comprising” language. Note that the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” See MPEP §716.02. Further, the results disclosed in the instant specification are not “really unexpected” in view of the art-recognized knowledge that Mycl is an islet progenitor transcription factor (or regulator) gene, which can enrich b-cell progenitor cells as evidenced by Jiang, who experimentally demonstrated that both Mycl and Ngn3 have a similar expression profile during differentiation of islet progenitors as shown in Figure 3F, which demonstrate that Mycl and Ngn3 are significantly suppressed during differentiation, that is, “when islet progenitors developed into adult endocrine cells” or insulin-producing cells similar to b-cells in adult islets. See paragraphs 0130 and 0135 of Jiang as pointed out in the last Office action. As such, a person of ordinary skill in the relevant art would have readily or reasonably understood that overexpression of Mycl alone in pancreatic islet progenitors would produce/differentiate into insulin-producing pancreatic islet cells. Hence, the results disclosed in the instant specification would have been reasonably, if not absolutely, expected thus are not “really unexpected” in view of the teachings of the cited art, Jiang alone or in combination with German.
“Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected.” (emphasis added). See MPEP §716.02.
Note that for obviousness under §103, “all that is required is a reasonable expectation of success”, and it does not require “absolute predictability of success”. See In re O ’Farrell, 853 F.2d 894, 7 USPQ2d 1673 (Fed. Cir. 1988) at 1681.
Applicant argues that the instant rejection is based on impermissible hindsight thus is improper as the examiner used “knowledge of Applicant’s invention”. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Applicant’s attention is directed to the fact that the teachings of the Jiang reference as well as the German reference were not even recognized or cited by the instant applicant but instead were independently identified by the examiner through relevant prior art search pertaining to the claimed subject matter.
In view of the foregoing, this rejection is maintained.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 25-29 and 31-36 are rejected under 35 U.S.C. 103 as being unpatentable over German (US 2004/0142901 A1, of record) in view of Jiang (US 2016/0045554 A1, of record) and Yuasa (US 2018/0298346 A1, of record).
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 teaches that the insulin-producing pancreatic b islet cells during development phase are characterized by the “future beta-cells” expression marker of Nkx6.1, which is “involved in islet development.” See paragraphs 0073, 0082, and 0149.
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.
Jiang teaches that b-cell progenitor cells express and are positive for “Fev” and that the expression levels of Mycl and Ngn3 are not observed with statistical significance in the differentiated insulin-producing islet cells. See FIG. 3F.
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.
It would also have been prima facie obvious for one of ordinary skill in the art to reasonably expect that the progenitor cells to be positive for the transcription factor Fev and that the cells during development into beta cells thus while in the growth phase to be positive for Nkx6.1 because Fev was known to be expressed in progenitor cells as demonstrated by Jiang, and because Nkx6.1 was an art-recognized expression marker for “future beta cells” and was also known to be “involved in islet development” as taught by German. One of ordinary skill in the art would also have reasonably predicted that the progenitor cells overexpressing the plasmid/viral vector encoding Mycl or the combination of Mycl and Ngn3 would differentiate into insulin-producing islet beta cells when the progenitor transcription factors are no longer expressed because Mycl and Ngn3 are each progenitor cell-promoting factors, which are no longer expressed in differentiated islet cells as shown in Jiang.
Accordingly, claims 25-29 and 31-36 taken as a whole would have been prima facie obvious before the effective filing date.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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