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 .
Applicant's amendments to the claims and arguments filed on 07-14-2025 have been received and entered. Claims 1, 15, 32-33, 37, 76 have been amended. Claims 2-5, 7-14, 17-29, 31, 35-36, 38-75, 77-81, 83-131, 133-134 have been canceled. Claims 135 has been added. Claims 1, 6, 15-16, 30, 32-34, 37, 76, 82, 132, 135 are pending.
Election/Restrictions
Applicant’s election of group I, claims 1-3, 6, 10, 15-16, 21, 26, 30, 32-34, 37, 66, 76-78, and 82 in the reply filed on October 17, 2023 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 106-107, and 129-130 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 17, 2023. It is noted that claims 106-107, and 129-130 have been canceled
Applicant's election with traverse of species: A) Subcortical white matter stroke (from claim 6); and D) Inflammatory demyelinating disease (from claim 82) in the reply filed on October 17, 2023 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 6, 15-16, 30, 32-34, 37, 76, 82, 132, 135 and species subcortical white matter stroke and Inflammatory demyelinating disease are under consideration.
Priority
This application claims priority from US provisional application no PRO 63/151,009 filed on 02/18/2021. This application is also a CIP of 15/763,817 filed on 03/27/2018 that is a 371 of PCT/US2016/054007 filed on 09/27/2016 that claims priority from US provisional application no 62/236,642 filed on 10/02/2015.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08-05-2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn-Claim Rejections - 35 USC § 112
Claims 10, 15, 21, 133 were 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. Applicant's amendments to claim 15 and cancelation of claims 10, 21, 133 obviates the basis of the rejection. Applicants' arguments with respect to the withdrawn rejections are thereby rendered moot.
Claims 1, 6, 10, 15-16, 21, 30, 32-34, 37, 76, 82, 132-134 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification fails to provide an enablement for the full scope of the claimed invention. Applicant's amendment to the claims limiting the scope of the claim to enabling scope obviates the basis of the rejection.
Withdrawn-Claim Rejections - 35 USC § 103
Claims 1, 6, 10, 15-16, 21, 32-34, 37, 76, 82, 132-134 were rejected under 35 U.S.C. 103 as being unpatentable over Carmichael et al (WO 2012/121971 A2, 13 September 2012) in view of Goldman et al (Herein after Goldman _2012 ,Science. 2012 Oct 26;338(6106):491-5. doi: 10.1126/science.1218071.) / Goldman et al (Herein after Goldman _2009, WO 2009/137674 A2, 12 November 2009) and Xie et al (Stem Cell Reports, Vol. 3, 743–757, October 30, 2014, Doi: 10.1016/j.stemcr.2014.09.021). In view of Applicants' amendment of base claim 1and 76, the previous rejections of claims are hereby withdrawn. Applicants' arguments with respect to the withdrawn rejections are thereby rendered moot.
Claim Objections
Claim 15 is objected to because of the following informalities:
There’s no noun following the adjective “differentiated” (see below). It appears from the language of claim 1 that the term “cells” should follow the term “differentiated” in claim 15.
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Appropriate correction is required.
New-Double Patenting - necessitated by amendments
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, 15-16, 30, 32-34, 37, 76, 82, 132, 135 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 11-12, 17 of copending Application No. 15763817 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of improving recovery of a human after a cerebral ischemic injury (instant pending claim 1) and the method of slowing myelin loss, and/or promoting myelin repair, and/or promoting remyelination in a human having a demyelinating pathology that effects the central nervous system (instant pending claim 76) of the instant application are anticipated and/or are obvious in light of the reference application's claim 1 as evidenced by Marin et al (Neurobiology of Disease 126 (2019) 5–12, Doi: 10.1016/j.nbd.2018.07.023) and Carmichael et al (WO 2012/121971 A2, 13 September 2012, applicant own work) and Goldman et al (Goldman _2012 ,Science. 2012 Oct 26;338(6106):491-5. doi: 10.1126/science.1218071.)
Reference application's claim 1 (copending Application No. 15763817 ) is directed to a method of improving recovery of a human after a subcortical white matter stroke (WMS), said method comprising:
producing induced pluripotent stem cell-derived glial-enriched progenitor cells (iPSC-GEPs) expressing glial fibrillary acidic protein (GFAP), Growth Differentiation Factor 15 (GDF15), and vascular endothelial growth factor alpha (VEGFA); and
directly administering a therapeutically effective amount of the iPSC-GEPs that express GFAP and VEGFA into about 0.05 mm to about 3 mm from the infarct core in the brain of said human,
wherein the induced glial-enriched progenitor cells (iPSC-GEPs) are obtained from culturing human induced pluripotent stem cells (hiPSCs) in neural progenitor cell (NPC} medium to produce neural rosette that is then cultured in NPC medium containing epidermal growth factor (EGF), basic fibroblast growth factor (bFGF), and deferoxamine (DFX) for 3 to 5 days to produce iPSC-GEPs whose differentiation potential is restricted to astrocytes;
wherein the iPSC-GEPs are allogenic to the human;
wherein said iPSC-GEPs are administered during the subacute time period after the white matter stroke;
wherein said administration promotes neurological recovery and improves white matter preservation after WMS.
Instant pending claims 1, 6, 30, 32 and 135 are directed to a method of improving recovery of a human after a cerebral ischemic injury, said method comprising cerebrally administering a therapeutically effective amount of differentiated cells to said human, wherein the differentiated cells are derived from human induced pluripotent stem cells (hiPSCs) or human embryonic stem cells (hESCs) that have been differentiated and cultured in NPC medium containing DFX for 3-5 days to produce cells whose differentiation potential is restricted to astrocytes; wherein the differentiated cells are syngeneic, allogenic, or are derived from the human; and wherein said differentiated cells are directly injected administered into or at about 0.05 mm to about 3 mm from adjacent to the infarct core in the brain of said human during the subacute time period after a white matter stroke (Claim 1).
Wherein the cerebral ischemic injury is subcortical white matter stroke (Claim 6).
Wherein said differentiated cells are derived from universal donor cells (Claim 30).
Wherein said differentiated cells are derived from cells obtained from a human that is not the human being treated to provide cells that are allogenic to the human being treated (Claim 32).
wherein the cells express glial fibrillary acidic protein (GFAP), Growth Differentiation Factor 15 (GDF 15), and vascular endothelial growth factor alpha (VEGFA) (Claim 135).
Thus, reference application's claim 1 anticipate instant pending claims 1, 6, 30, 32 and 135.
Instant pending claim 76 and 82 are directed to a method of slowing myelin loss, and/or promoting myelin repair, and/or promoting remyelination in a human having a demyelinating pathology that effects the central nervous system, said method comprising cerebrally administering a therapeutically effective amount of differentiated cells to said human, wherein the differentiated cells are derived from human induced pluripotent stem cells (hiPSCs) or human embryonic stem cells (hESCs) that have been differentiated and cultured in NPC medium containing DFX for 3-5 days to produce cells whose differentiation potential is restricted to astrocytes; wherein the differentiated cells are syngeneic, allogenic, or are derived from the human; and wherein said differentiated cells are directly injected into brain of said human (Claim 76).
wherein said pathology is selected from the group consisting of multiple sclerosis, an inflammatory demyelinating disease, a leukodystrophic disorder, a CNS neuropathy, central pontine myelinolysis, a myelopathy, a leukoencephalopathy, and a leukodystrophy (Claim 82).
The instant pending claim 76 and 82 are directed to a demyelinating pathology” The subcortical white matter stroke (WMS) recited in reference application's claim 1 cause a demyelinating pathology in a subject as evidenced by Marin et al (Neurobiology of Disease 126 (2019) 5–12, Doi: 10.1016/j.nbd.2018.07.023). Marin et al teach loss of white matter as a consequence of stroke: the disruption of myelin architecture is the pathological hallmark of white matter stroke (WMS), a recurrent neurovascular disease which results in ischemia of small blood vessels in white matter tracts (Page 6, right column, 2nd para.). White matter stroke is increasingly common with age and these white matter lesions expand locally. In fact, the expansion of ischemic white matter disease is most prominent in the corpus callosum and immediately adjacent callosum-frontal lobe white matter tracts. These data suggest a temporally coupled sequence of pathological events by which nodal and paranodal domains are disrupted first, resulting in later demyelination followed potentially by axonal degeneration (Page 6, right column, 3rd para.). Therefore, a person having “white matter stroke (WMS)” as recited in claim 1 of the reference application is inherently “having a demyelinating pathology” as recited in claim 76 and claim 82 of the instant application. Thus, reference application's claim 1 anticipate instant pending claim 76 and claim 82.
Instant pending claim 37 is directed to method comprises a method for improving motor or cognitive function of a human after a cerebral ischemic injury. As evidenced by previous cited reference Carmichael et al (WO 2012/121971 A2, 13 September 2012, applicant own work) teach locally released growth factors to mediate motor recovery after stroke (title). Carmichael et al teaches methods for improving recovery (e.g., motor recovery) of a mammal after cerebral ischemia, and the improvement in motor recovery comprises an improvement in motor coordination, and/or balance, and/or speech ([0004], page 2, lines 3-13). In certain embodiments mammal is a human ([0005], page 4, line 28). Thus, method of improving recovery of a human after a subcortical white matter stroke of reference application would inherently improve motor or cognitive function of a human after a cerebral ischemic injury.
Instant pending claim 132 is directed to the cerebral ischemic injury is vascular dementia. As evidenced by previous cited reference Goldman et al (Goldman _2012 ,Science. 2012 Oct 26;338(6106):491-5. doi: 10.1126/science.1218071.) who teach vascular leukoencephalopathies: Subcortical Stroke (Figure 1, page 492), and vascular and inflammatory demyelinating disorders of adulthood, as well as the childhood leukodystrophies and cerebral palsy (Abstract). Oligodendrocytic loss is prominent in the degenerative dementia associated with age-related white matter loss (Page 494, 1st column, last para). Thus, a person of ordinary skill in the art would recognize that method of improving recovery of a human after a subcortical white matter stroke of reference application claim 1 would also inherently improve vascular dementia.
Reference application's claims 11 - 12 (co-pending Application No. 15763817 ) are directed to wherein said progenitor cells are administered using a depot delivery system. Wherein the depot delivery system comprises a hydrogel. Instant pending claims 15 - 16 are directed to said differentiated cells are administered using a depot delivery system. Wherein the depot delivery system comprises a hydrogel. Thus, reference application's claim 11 and 12 anticipate instant pending claims 15 – 16, respectively.
Claims 33-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 11-12, 17 of copending Application No. 15763817 (reference application) in view of Goldman et al (Goldman _2009, WO 2009/137674 A2, 12 November 2009).
Instant pending claim 33-34 are directed to method comprise administering one or more immunosuppressants to said human and said one or more immunosuppressants comprise an immunosuppressant selected from the group consisting of anti-thymocyte globulin (ATG), cyclosporine, tacrolimus, cyclophosphamide, and prednisone. Previous cited reference Goldman et al (Goldman _2009, WO 2009/137674 A2, 12 November 2009) teach treating a subject having an inflammatory or inherited demyelinating disorder (Page 2, line 17-20), and immunosuppressant agents and their dosing regimens are known to one of skill in the art and include such agents as … Cyclosporine…. Tacrolimus (Page 13, line 15-18). Thus, it would have been prima facie obvious for a person of ordinary skill in the art to combine the teachings of prior arts to use immunosuppressants to treat demyelinating disease such as white matter stroke.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is 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 KHOA NHAT TRAN whose telephone number is (571)270-0201. The examiner can normally be reached M-F (9-5).
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/KHOA NHAT TRAN/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632