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, Amendments, And/Or Claims
The Applicants amendments/remarks received 11/24/2025 are acknowledged. Claims 1, 7, 17 and 23 are amended; claims 2-3, 10-16, 21-22, 24-26, 30, 32-36 and 39-42 are canceled; claims 1, 4-9, 17-20, 23, 27-29, 31 and 37-38 are pending; claims 29, 31 and 37-38 are withdrawn; claims 1, 4-9, 17-20, 23 and 27-28 will be examined on the merits.
Claim Objections
The objection to claims 1, 7, 17 and 23, as set forth at p. 5 of the previous Office Action, is withdrawn in view of the amendment of the claims.
Claim 19 is objected to because of the following informalities:
Claim 19 recites “wherein the induced pluripotent stems cells” which should be “wherein the induced pluripotent stem cells” for consonance with claim 18 from which claim 19 depends. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claims 1, 4-9, 17-20, 23 and 27-28 under 35 U.S.C. § 112(a), as set forth at pp. 5-6 of the previous Office Action, is withdrawn in view of the amendment of the claims.
The rejection of claims 1, 4-9, 17-20, 23 and 27-28 under 35 U.S.C. § 112(b), as set forth at p. 7 of the previous Office Action, is withdrawn in view of the amendment of the claims.
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.
Claims 1, 4-9, 17-20, 23 and 27-28 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.
Claim 1 recites the limitation "the network event waves" in line 9. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not disclose network event waves; hence, the limitation lacks antecedent basis. Claims 4-9, 17-20, 23 and 27-28 depend from claim 1 and do not remedy the indefiniteness; hence, claims 1, 4-9, 17-20, 23 and 27-28 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 5-7 and 9 under 35 U.S.C. § 102(a)(1)/102(a)(2) over Bolognin et al., US 2018/0298330 (US Patent Application Publication cite 2, IDS, 10/10/2023; herein “Bolognin”) as set forth at pp. 8-10 of the previous Office Action, is withdrawn in view of the amendment of the claims and the persuasive arguments of Applicant on pp. 7-10 of the Remarks received 11/24/2025.
Claim Rejections - 35 USC § 103
The rejection of claims 1, 4-9, 17-20, 23 and 27-28 under 35 U.S.C. § 103(a) over Bolognin in view of Andersen et al., US 2018/0282689 (US Patent Application Publication cite 1, IDS, 10/10/2023; herein “Andersen”) as set forth at pp. 10-14 of the previous Office Action, is withdrawn in view of the amendment of the claims and the persuasive arguments of Applicant on pp. 10-11 of the Remarks received 11/24/2025.
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, 4-9, 17-20, 23 and 27-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 12-16 and 18-23 of U.S. Patent No. 11821895 (herein “’895”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are prima facie obvious over the claims of ‘895.
Claim 1 of ‘895 recites an in vitro method of generating functional cortical organoids from neural progenitor cells (NPCs) comprising: culturing NPCs in media consisting of serum-free supplemented neurobasal media supplemented with penicillin/streptomycin, L-alanyl-L-glutamine, corticosterone, linoleic acid, linolenic acid, progesterone, (±)-α-tocopherol acetate, (±)-α-tocopherol, lipoic acid, L-carnitine, ethanolamine, D-galactose, putrescine, sodium selenite, low-endotoxin BSA, catalase, reduced glutathione, insulin, human-holo-transferrin, superoxide dismutase, T3, ethanol, NaOH, HCl, non-essential ammo acids, brain-derived neurotrophic factor (BDNF), glial cell-derived neurotrophic factor (GDNF), neurotrophin-3 (NT-3), L-ascorbic acid, and dibutyryl-cAMP to generate functional cortical organoids, wherein the functional cortical organoids are able to produce oscillatory waves upon differentiation; claim 12 of ‘895 recites the method of claim 1, wherein the NPCs are differentiated from stem cells comprising the steps of: (i) culturing stem cells in feeder-free media comprising inhibitors for bone morphogenetic protein (BMP) and transforming growth factor-β (TGF-β) pathways; (ii) subculturing the stem cells of (i) in suspension under rotation in the presence of a ROCK inhibitor to form free-floating spheres; (iii) culturing the free-floating spheres in serum-free supplemented neurobasal media comprising inhibitors for BMP and TGF-β pathways to obtain neuronal progenitor cells (NPCs); and (iv) expanding/proliferating the NPCs by first culturing the NPCs in serum-free supplemented neurobasal media comprising a fibroblast growth factor (FGF) and then culturing the NPCs in serum-free supplemented neurobasal media comprising the FGF and an epidermal growth factor (EGF); and claim 22 of ‘895 recites the method of claim 12, wherein for (iv) the fibroblast growth factor is FGF2; hence, claims 1, 12 and 22 of ‘895 make obvious an in vitro method comprising culturing NPCs in serum-free supplemented neurobasal media comprising brain-derived neurotrophic factor (BDNF), glial cell-derived neurotrophic factor (GDNF), neurotrophin-3 (NT-3), a fibroblast growth factor, L-ascorbic acid, and dibutyryl-cAMP to generate functional cortical organoids, wherein the functional cortical organoids are able to produce nested oscillatory waves upon differentiation, wherein the fibroblast growth factor is FGF2, wherein the NPCs are differentiated from stem cells comprising the steps of: (i) culturing stem cells in feeder-free media comprising inhibitors for bone morphogenetic protein (BMP) and transforming growth factor-β (TGF-β) pathways; (ii) subculturing the stem cells of (i) in suspension under rotation in the presence of a ROCK inhibitor to form free-floating spheres; (iii) culturing the free-floating spheres in serum-free supplemented neurobasal media comprising inhibitors for BMP and TGF-β pathways to obtain neuronal progenitor cells (NPCs); and (iv) expanding/proliferating the NPCs by first culturing the NPCs in serum-free supplemented neurobasal media comprising a fibroblast growth factor (FGF) and then culturing the NPCs in serum-free supplemented neurobasal media comprising the FGF and an epidermal growth factor (EGF), wherein for (iv) the fibroblast growth factor is FGF2; therefore, instant claims 1, 4, 17 and 27 are prima facie obvious over claims 1, 12 and 22 of ‘895.
Regarding the limitation of instant amended claim 1 that “wherein the functional cortical organoids are able to produce periodic and regular spontaneous network events upon differentiation, and a frequency and an amplitude of the network event waves increases over time”, the oscillatory waves produced by the cortical organoids produced by the method of claims 1, 12 and 22 of ‘895 constitute periodic and regular spontaneous network events wherein a frequency and an amplitude of the network events increases over time as demonstrated in Fig. 4B wherein the frequency and amplitude of the network events increases from 6 week old organoids to 8 month old organoids.
MPEP 804(II)(B)(1) states “The specification can be used as a dictionary to learn the meaning of a term in the claim.” and "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
Hence, it is proper to consult the disclosure of ‘895, in particular Fig. 4B, to confirm that the oscillatory waves produced by the cortical organoids produced by the method of claims 1, 12 and 22 of ‘895 constitute periodic and regular spontaneous network events wherein a frequency and an amplitude of the network events increases over time; thus, instant claims 1, 4, 17 and 27 are prima facie obvious over claims 1, 12 and 22 of ‘895.
Instant claims 5, 6, 7, 8, 9, 18, 19, 20, 23 and 28 are essentially the same as claims 2, 3, 4, 5, 6, 13, 14, 15, 18 and 23, respectively; therefore, instant claims 5-9, 18-20, 23 and 28 are prima facie obvious over claims 2-6, 13-15, 18 and 23 of ‘895.
Response to Arguments
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive. Arguments of the Applicant’s Response on pp. 6-11 regarding the objections and rejections under 35 U.S.C. §§ 112(b), 112(a), 102(a)(1)/102(a)(2) and 103 are moot as the rejections have been withdrawn. The claim amendments have necessitated the claim objection and claim rejections under 35 U.S.C. 112(b) set forth above. All claims under examination are rejected on the ground of non-statutory double patenting in the rejection set forth above which has been modified to address the amended claims.
Allowable Subject Matter
Claims 1, 4-9, 17-20, 23 and 27-28 comprise allowable subject matter; hence, upon the resolution of the claim objection and claim rejection under 35 U.S.C. 112(b) and the approval of a terminal disclaimer over U.S. Patent No. 11821895, claims 1, 4-9, 17-20, 23 and 27-28 will be allowed.
NOTE: Withdrawn claims 29, 31 and 37-38 will not be rejoined upon allowance of claims 1, 4-9, 17-20, 23 and 27-28 because product claims encompass product made by other methods other than the method of making which has been allowed, i.e., product claims relying on a product-by-process limitation (e.g., a functional cortical organoid made by the method of claim 1) are met by the product regardless of the method of production; thus, withdrawn claims 29, 31 and 37-38 do not require all the limitations of the method of making, i.e., the method of claims 1, 4-9, 17-20, 23 and 27-28 (see MPEP 821.04 and 608.01(n)(III)); hence, they will NOT be rejoined upon the allowance of claims 1, 4-9, 17-20, 23 and 27-28. Claims 29, 31 and 37-38 should be cancelled so that claims 1, 4-9, 17-20, 23 and 27-28 can be allowed.
NOTE: Applicant would have been contacted with a proposal to a) fix the claim objection and rejection by examiner’s amendment, cancel claims 29, 31 and 37-38 and file a TD over U.S. Patent No. 11821895; however, the signer of the Remarks, Joseph R. Baker, Jr., does not appear to be an attorney of record or have a power of attorney on record for the instant application. It is recommended that the communicating attorney have power of attorney over the application so that substantial communications, such as the approval of proposed examiner’s amendments, can facilitate the allowance of the application.
Conclusion
No claims are 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 Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651