DETAILED ACTION
This action is in reply to papers filed 4/14/2025. Claims 51-63 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 US20250066719A1, Published 2/27/2025
Claim Objections
Claim 58 is objected to because of the following informalities: The term ‘or’ is recited twice in claim 58 in the fifth and sixth line.
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Appropriate correction is required.
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 51- 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12139722. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Instant claims are drawn to a method comprising: introducing an induced pluripotent stem cell (iPSC) into a cell culture medium lacking a three-dimensional matrix, the culture medium comprising: a chemically defined maintenance cell culture medium, and hyaluronic acid in an amount effective to induce the iPSC to differentiate; and transferring the iPSC and culture medium to a non-microfluidic bioreactor, the bioreactor comprising a non-adherent culture without the use of a three-dimensional matrix; culturing the iPSC in the bioreactor for at least 1 week at a temperature from 32°C to 40°C; and producing a three-dimensional multi-tissue organoid comprising a cell that expresses type 2 collagen (T2Col), a cell that expresses aggrecan, or both.
Claim 1 of U.S. Patent ‘722 is drawn to a method comprising: introducing an induced pluripotent stem cell (iPSC) into a cell culture medium lacking a three-dimensional matrix, the culture medium comprising: a chemically defined maintenance cell culture medium, and hyaluronic acid in an amount effective to induce the iPSC to differentiate; and transferring the iPSC and culture medium to a non-microfluidic bioreactor, the bioreactor comprising a non-adherent culture without the use of a three-dimensional matrix; culturing the iPSC in the bioreactor for at least 1 week at a temperature from 32° C. to 40° C.; and producing a three-dimensional multi-tissue organoid comprising cartilage, bone, fibrous connective tissue, brain tissue, or epithelial tissue, or a combination thereof.
Dependent claim 9 is drawn to the method of claim 1, the organoid comprising: a cell expressing glial fibrillary acidic protein (GFAP); a cell expressing microtubule associated protein 2 (MAP2); a cell expressing myelin basic protein (MBP); a cell expressing type 1 collagen (T1Col); a cell expressing type 2 collagen (T2Col); a cell expressing aggrecan; or or a cell expressing cytokeratins, or a combination thereof.
It is clear that all of the elements of the patented claims can be found in the pending claims. Accordingly, instant claims are prima facie obvious over the patented claims.
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.
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/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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