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 .
This action is in response to the papers filed January 29, 2026.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/29/2026 has been entered.
Claims 4, 10-11, 15, 17-20, 22, 26 and 30 are pending in the application. Claim 4 is an independent claim.
Claims 4 and 17-20 are amended, claims 1, 9, 16, 21, 23-25 and 27-29 are canceled, and claim 30 is newly added as recited in the claim set filed 01/29/2026.
Claims 10 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/02/2023.
Claims 4, 15, 17-20, 22, 26 and 30 are examined on the merits.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2019/017360 filed February 08, 2019.
Applicant’s claim for the benefit of a prior-filed provisional application 62/628,828 filed February 09, 2018 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is February 09, 2018.
Response to arguments
Maintained rejections in response to Applicants’ arguments or amendments
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 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(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 4, 15, 17-20, 22-26 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Thurmond (US2015/0313961; IDS Reference filed 03/08/2022) as evidenced by Oh (J Clin Endocrinol Metab 99: E866–E870, 2014; IDS Reference) and Oh2 (2015, Cell Metabolism 22, 499–507; IDS Reference).
Regarding claim 4, Thurmond teaches inducing overexpression of the gene Syntaxin 4 (STX4 or Syn4) in beta cells as a means of treating or preventing insulin related diseases via transplantation to a subject (para. 0015-16, 0026-0028, 102, Claim 1). The cells were obtained from 10 different donors’ islets (i.e. a plurality of donor islets) (para. 0040). Thurmond teaches that at least one gene may be overexpressed by means such as introducing nucleic acid sequences encoding said gene (para. 0105-0107). In Example 1, the gene is syntaxin 4 and stx4 cDNA is utilized to generate transgenic mice where Syntaxin 4 is over-expressed (para. 0148). Thurmond additionally presents the nucleic acid sequence for human stx4 as a known alternative for the rat cDNA syntaxin utilized in the Example (para. 0003, 0105). Moreover, Thurmond states that particular tissues such as pancreatic tissue may be targeted by utilizing specific promoters such as the insulin promoter (“Examples of pancreas specific promoters include the insulin promoter” para. [0137]), which is operably linked to the nucleic acid (para. 0035, 0141). Thurmond additionally states that the insulin promoter can be derived from the genome of any mammal, more preferably from a human source.
Though Thurmond does not explicitly teach that the promoter is a human insulin promoter operably linked to a human Stx4 cDNA to overexpress Syntaxin 4, it would have been obvious for one of ordinary skill in the art to overexpress temporally a Stx4 cDNA under the control of an insulin promoter in the pancreatic tissue to treat insulin related diseases in response to high levels of insulin . A skilled artisan would have had a reasonable expectation of success as controlling gene vector expression using a promoter sequence linked to a gene of interest was known in the art before the effective filing date of the invention.
Regarding the limitations of improved life expectancy in Claim 4, Thurmond teaches the mice overexpressing Syn4 live 33% longer than the controls and show increased peripheral insulin sensitivity (para. 0098).
Regarding the limitations of providing cells in an amount fewer than those not overexpressing Syn4, as evidenced by Oh, Syn4 overexpressing cells are known in the art to need fewer cells for transplantation than native cells (Abstract, Conclusions).
Regarding claims 15 and 30, Thurmond teaches that the subject suffers from an insulin-related disease or condition including but not limited to type 1 diabetes, type 2 diabetes, chronic pancreatitis, pancreatectomy, insulin resistance, prediabetes, and age-related insulin resistance (para. 0081).
Regarding claim 17, Thurmond teaches that there is a 33% increase in lifespan, therefore it is interpreted that syntaxin 4 provides protection for cells, moreover, as each and every limitation of producing the cells and administering the cells to the subject is met in claim 4, the protective effect is the same result of the same method steps. Moreover, as evidenced by Oh2, Table S3 shows inflammatory cytokines such as TNF-a and IL-6 reduced in Syn4 mice. Therefore, it is interpreted that there is a level of protection from inflammatory cytokines.
Regarding claim 18, Thurmond teaches that in subjects where the overexpression of Syn4 is present, there is improved insulin and glucose tolerance (para. 0075, 0215)
Regarding claim 19, as evidenced by Oh, beta cells which overexpress Syntaxin 4 significantly improve insulin secretory function (Conclusion). Therefore, the cells would have 25% insulin production higher than native beta cells with a reasonable expectation of success as each and every limitation of claim 4 is met.
Regarding claim 20, Thurmond teaches that Syn4 enriched islet cells have 25% improvement in blood glucose levels (para. 0053).
Regarding claims 22, Thurmond teaches that Stx4 is overexpressed 3-5 – fold (para. 0213).
Regarding claim 26, Thurmond teaches in addition to administration of the cells overexpressing Syn4, a cell therapy described herein can further comprise administration of anti-inflammatory and/or immunosuppressive drugs prior to, concurrently, or following the administration of the cells (para. 0116).
Therefore, Applicant’s claimed invention is rendered obvious by the prior art.
In response to the utilization of Thurmond as a reference in the 103 rejection previously set forth,
Applicant's arguments filed 01/29/2026 have been fully considered but they are not persuasive.
Applicant argues that the amendments made to claim 4 overcome the rejection under Thurmond as Thurmond does not explicitly disclose transplantation into subjects and protection from apoptosis with lifespan extension functionality. Moreover, Applicant argues that no sufficient evidentiary references have been used to support an argument of inherency.
Examiner disagrees. As shown above in the modified 103, Thurmond does provide teachings for lifespan extension and transplantation into subjects. Moreover, the references of Oh and Oh2 have been provided as evidentiary references for Syntaxin 4 overexpression of beta cells and their effects on glucose, insulin, transplantation and lifespan.
New grounds of rejections in response to Applicants’ arguments or amendments
Claim Rejections - 35 USC § 112- Second Paragraph
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 18-20 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite in that they fail to point out what is included or excluded by the claim language
Claim 18 and by dependency 19-20 are dependent on a canceled claim (i.e., claim 16) and are therefore “incomplete.” See MPEP § 608.01(n)(V). Claims 18-20 are incomplete and unclear because they recite the preserved functional of beta-cell mass, however claim 16 has been cancelled.
Claim 18 recites the limitation ( “the preserved functional β-cell mass”), and lacks antecedent basis from canceled base claim 16. See MPEP § 2173.05(e). Applicant is required to cancel the claim(s), or amend the claim(s) to place the claim(s) in proper dependent form, or rewrite the claim(s) in independent form. Therefore, the metes and bounds of claims 18-20 are indefinite.
For the purpose of a compact prosecution claims 18-20 have been interpreted as depending on claim 4 as claim 4 recites “the preserved functional β-cell mass.”
Conclusion
No claims are allowed.
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/ALEXANDRA F CONNORS/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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