CTNF 18/263,934 CTNF 98210 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 1. Claims 35 – 53 are pending. Election/Restrictions 08-25-01 AIA 2. Applicant’s election without traverse of Group I (claims 35 – 47) in the reply filed on 02/09/2026 is acknowledged. 08-06 AIA 3. Claim s 48 – 53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim.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 02/09/2026 . Priority 4. This application claims the benefit to U.S. Patent Application Serial No. 63/145,380, filed February 3, 2021. Information Disclosure Statement 5. The information disclosure statement (IDS) submitted on 12/09/2024, 09/28/2023, and 08/02/2023 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. 6. Non Patent Literature citation number 1 on the IDS filed 12/09/2024 is listed as containing 23 pages, however, only 2 pages are provided. 06-49-06 AIA 7. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Drawings 06-22 AIA 8. The drawings are objected to because the last figure is labeled “FIGURE 41” but should be labeled “FIGURE 37E” because Applicant’s specification describes FIGS 37A-37E at para. 0045 but does not teach a Figure 41 . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification 9. The use of the term CellTracker, LinBit, Plasmalyte, Accumax, Click-iT, Gelfoam, Histopaque, OneTouch Ultra2, RNeasy, Stempro, SuperScript, TaqMan, Li-Cor Pearl Impulse, Excel, GraphPad Prism, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. 07-29-04 10. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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. 06-49-06 AIA 11. It is noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 12. Claim 40 and 46 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. 13. The metes and bounds of “more than 100 doses of cell clusters sufficient for the treatment of diabetes are formed” in claims 40 and 46 is unclear because it is unclear how many cells are in a dose. Applicant’s specification teaches various number of cells of therapeutically sufficient number of cell clusters at para. 0076 and therefore the number of cell clusters in more than 100 doses depends on the number of cell clusters in a dose. Claim Rejections - 35 USC § 112 07-36 AIA The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 07-36-01 AIA 14. Claim 44 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 44 fails to further limit claim 42 because claim 44 requires the pancreatic islet cells are human cells but claim 42 requires the pancreatic islet cells have a NAIDS and NAIDS is only for human cells . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 07-30-03-h AIA Claim Interpretation 15. For the purpose of applying prior art, “cell clusters” of claims 35 and 42 are interpreted to include neo-islets based on Applicant’s specification at para. 0001and 0086. 16. Claim 35 and 42 broadly recite “forming cell clusters”. For the purpose of applying prior art, “forming cell clusters” is interpreted as co-culturing pancreatic islets and mesenchymal stem cells or adipose stem cells based on Applicant’s Figure 1 and specification at para. 0009, 0013, and 00114. 17. For the purpose of applying prior art, “for at least five population doublings” of claims 35 and 43 is interpreted as culturing for 70 hours based on Applicant’s specification at para. 0033 and Figure 25A and 25B. 18. For the purpose of applying prior art, “classified as research grade” of claims 37 and 45 is interpreted as “not suitable for therapeutic use” or “not intended for therapeutic” use based on Applicant’s specification at para. 0051 – 0052. 19. For the purpose of applying prior art, claims 41 and 47 are interpreted as the method of claim 35 (for claim 41) and claim 42 (for claim 47) produces at least 7.00E+09 expanded pancreatic islet cells. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15-aia AIA 20. Claim(s) 35 – 41 is/are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Westenfelder (WO-2017044847-A1; Filed 09/09/2016; Published 03/16/2017), hereinafter Westenfelder as evidenced by Prodo (Prodo: (10/19/2019). "Human Islets for Research." [Prodo Laboratories], https://prodolabs.com/human-islets-for-research/. Accessed 03/31/2026), hereinafter Prodo and Golebiewski (Gołębiewska JE, et. al. Cell Transplant. 2019 Feb;28(2):185-194), hereinafter Golebiewski which is cited on the IDS filed 08/02/2023 . Claim 35 is drawn to a method of making a cell cluster, the method comprising: expanding pancreatic islet cells for at least five population doublings; and forming cell clusters comprising: the expanded pancreatic islet cells; and mesenchymal stem cells or adipose stem cells. Regarding claim 35 , Westenfelder teaches a method of making neo-islets (“cell clusters”) comprising expanding pancreatic islet cells for one to two weeks (“for at least five population doublings”) and forming neo-islets by co-culturing mesenchymal stem cells or adipose stem cells (page 25, lines 20 – 33; page 26, lines 1 – 10; Figure 1; page 29, lines 28 – 33; page 30, lines 1 – 4 and 27 – 30; page 31, lines 1 – 11). Regarding claim 36 , Westenfelder teaches the pancreatic islets were obtained from Prodo Laboratories (page 23, line 24). The human pancreatic islets from Prodo Laboratories are adult primary pancreatic islet cells obtained from an adult human donor as evidenced by Prodo (page 3, para. 1). Regarding claim 37 , Westenfelder teaches the pancreatic islets were obtained from Prodo Laboratories (page 23, line 24). The human pancreatic islets from Prodo Laboratories are approved for research (“research grade”) but not for clinical transplantation as evidenced by Prodo (page 3, para. 1 and first bulletpoint). Regarding claim 38 , Westenfelder teaches the pancreatic islets were obtained from Prodo Laboratories (page 23, line 24). The human pancreatic islets from Prodo Laboratories are approved for research but not for clinical transplantation as evidenced by Prodo (page 3, para. 1 and first bulletpoint) and therefore the adult donor had a NAIDS of less than 80 where NAIDS <50 is a poor-quality donor with 0% chance for success of clinical islet isolation from donor pancreas for transplant and between 50 and 80 points the chance for success is approximately 34% as evidenced by Golebiewski (Abstract; page 188, right col. para. 1). Regarding claim 39 , Westenfelder teaches pancreatic islet cells are obtained from more than one donor (page 22, lines 14 – 33; page 23, lines 3 – 23). Regarding claim 40 , Westenfelder teaches the pancreatic islets were obtained from Prodo Laboratories (page 23, line 24) which are from a single donor (“from a single donor”) as evidenced by Prodo (page 1; page 2, para. 1 – 2). Westenfelder teaches the expansion method is highly efficient where it is estimated that 1,000 to 2,000 doses of neo-islets for a 70 kg human can be obtained per human pancreas (page 17, lines 5 – 7). Regarding claim 41 , as the instantly claimed method is anticipated by Westenfelder and the cell clusters produced by the method of Westenfelder are the same as the claimed cell clusters, the limitation of the amount of the resulting cell clusters is inherent to the method of Westenfelder. Therefore, Westenfelder anticipates claims 35 – 41 . 07-15-aia AIA 21. Claim(s) 42 – 47 is/are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Westenfelder (WO-2017044847-A1; Filed 09/09/2016; Published 03/16/2017), hereinafter Westenfelder as evidenced by Prodo (Prodo: (10/19/2019). "Human Islets for Research." [Prodo Laboratories], https://prodolabs.com/human-islets-for-research/. Accessed 03/31/2026), hereinafter Prodo and Golebiewski (Gołębiewska JE, et. al. Cell Transplant. 2019 Feb;28(2):185-194), hereinafter Golebiewski which is cited on the IDS filed 08/02/2023 . Claim 42 is drawn to a method of making a cell cluster, the method comprising: expanding pancreatic islet cells; and forming cell clusters comprising: the expanded pancreatic islet cells; and mesenchymal stem cells or adipose stem cells; wherein the pancreatic islet cells are primary pancreatic islet cells obtained from an adult donor; and wherein the adult donor had a North America Islet Donor Score (NAIDS) of less than 80. Regarding claims 42 – 44 , Westenfelder teaches a method of making neo-islets (“cell clusters”) comprising expanding pancreatic islet cells (“expanding pancreatic islets” of claim 42 ) for one to two weeks (“for at least five population doublings” of claim 43 ) and forming neo-islets by co-culturing mesenchymal stem cells or adipose stem cells (“forming cell clusters” of claim 42 ) (page 25, lines 20 – 33; page 26, lines 1 – 10; Figure 1; page 29, lines 28 – 33; page 30, lines 1 – 4 and 27 – 30; page 31, lines 1 – 11). Westenfelder teaches the human pancreatic islets were obtained from Prodo Laboratories (page 23, line 24). The human pancreatic islets from Prodo Laboratories are adult primary pancreatic islet cells (“primary pancreatic islet cells” of claim 42 and “human cells” of claim 44 ) obtained from an adult human donor as evidenced by Prodo (page 3, para. 1). The human pancreatic islets from Prodo Laboratories are approved for research but not for clinical transplantation as evidenced by Prodo (page 3, para. 1 and first bulletpoint) and therefore the adult donor had a NAIDS of less than 80 (“wherein the adult donor had a” NAIDS “of less than 80” of claim 42 ) where NAIDS <50 is a poor-quality donor with 0% chance for success of clinical islet isolation from donor pancreas for transplant and between 50 and 80 points the chance for success is approximately 34% as evidenced by Golebiewski (Abstract; page 188, right col. para. 1). Regarding claim 45 , Westenfelder teaches the pancreatic islets were obtained from Prodo Laboratories (page 23, line 24). The human pancreatic islets from Prodo Laboratories are approved for research (“research grade”) but not for clinical transplantation as evidenced by Prodo (page 3, para. 1 and first bulletpoint). Regarding claim 46 , Westenfelder teaches the pancreatic islets were obtained from Prodo Laboratories (page 23, line 24) which are from a single donor (“from a single donor”) as evidenced by Prodo (page 1; page 2, para. 1 – 2). Westenfelder teaches the expansion method is highly efficient where it is estimated that 1,000 to 2,000 doses of neo-islets for a 70 kg human can be obtained per human pancreas (page 17, lines 5 – 7). Regarding claim 47 , as the instantly claimed method is anticipated by Westenfelder and the cell clusters produced by the method of Westenfelder are the same as the claimed cell clusters, the limitation of the amount of the resulting cell clusters is inherent to the method of Westenfelder. Therefore, Westenfelder anticipates claims 42 – 47 . Conclusion No claims allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZANNA M BEHARRY whose telephone number is (571)270-0411. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ZANNA MARIA BEHARRY/Examiner, Art Unit 1632 Application/Control Number: 18/263,934 Page 2 Art Unit: 1632 Application/Control Number: 18/263,934 Page 3 Art Unit: 1632 Application/Control Number: 18/263,934 Page 4 Art Unit: 1632 Application/Control Number: 18/263,934 Page 5 Art Unit: 1632 Application/Control Number: 18/263,934 Page 6 Art Unit: 1632 Application/Control Number: 18/263,934 Page 7 Art Unit: 1632 Application/Control Number: 18/263,934 Page 8 Art Unit: 1632 Application/Control Number: 18/263,934 Page 9 Art Unit: 1632 Application/Control Number: 18/263,934 Page 10 Art Unit: 1632 Application/Control Number: 18/263,934 Page 11 Art Unit: 1632