DETAILED ACTION
This action is in reply to papers filed 1/26/2026. Claims 1-6, 8-12 and14 are pending and examined herein.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20200377860A1, Published 12/3/2020.
Withdrawn Claim Objections
The objection to claim 13 is withdrawn in view of the cancellation of claim 13.
Moot Claim Rejections
The 112 (b) rejection of claim 13 is moot in view of the cancellation of claim 13.
Maintained Rejection(s)
The nonstatutory double patenting rejection of instant claims 1-6, 8-12 and 14 over claims 22-23,26-28 and 31 of copending Application No.17055535 (reference application) in view of Hoppensack et al. (Tissue Eng. Part C Methods. 2014 Jul;20(7):599-609.) is maintained. Applicant’s arguments will be addressed following maintained rejection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 8-12 and 14 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-23,26-28 and 31 of copending Application No. 17055535 (reference application) in view of Hoppensack et al. (Tissue Eng. Part C Methods. 2014 Jul;20(7):599-609.).
Note that the rejection is maintained for reasons previously advanced in the office action and will not be reiterated herein.
Applicant’s Arguments/Response to Arguments
Applicant argues: Applicant submits that independent claims 1 and 14 of the instant application require that "the tubular organoids are formed without exogenous bone morphogenetic protein, fibroblast growth factor 2 (FGF2), or activin." This element is not found in the claims of Application No. 17/055535, which is now issued U.S. Patent No. 12,320,800, and would not be obvious therefrom. It is noted that the methods of generating tubular organoids described in the '800 patent include the addition of BMP, FGF2 and activin.
Hoppensack fails to address these differences relative to the claims of U.S. Patent No. 12,320,800.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. Critically, Independent claim 1 recites the transitional term “comprising” which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Therefore, while not explicitly excluding the method step of the tubular organoids being formed without exogenous bone morphogenetic protein, fibroblast growth factor 2 (FGF2), or activin, the scope of the claim- when taken with the transitional term ‘comprising’ which does not exclude any method step- embraces the formation of the tubular organoids without exogenous bone morphogenetic protein, fibroblast growth factor 2 (FGF2), or activin.
Regarding the description in the ‘800 patent regarding the inclusion of BMP, FGF2 and activin, note that double patenting, governed by MPEP § 804, prohibits issuing multiple patents on the same or an obvious variation of a claimed invention by the same applicant/assignee to prevent extending patent terms. That is, the inclusion of FGF2, activin and BMP are not in the ’800 patent claims. And while these elements are recited in the specification, the inclusion of these elements are recited in the alternative. Indeed, para. 134 of the PgPub of the patent is copied below. Note that in the organoid differentiation protocol only Protocol B requires FGF2.
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Finally, Hoppensack need not cite a reason to exclude FGF2, activin and BMP as it was not cited for such. Rather, Hoppensack was cited for teaching .
Because Applicant’s arguments were not found persuasive, the rejection is maintained.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632