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 .
Receipt is acknowledged of Applicant’s Amendment filed on 03/02/2026; and IDS filed on 03/02/2026.
Claims 76, 87, 92 have been amended.
Claims 2, 4, 7-9, 17, 29, 31-33, 36, 42, 58, 61-62, 64, 66, 71, 76, 84, 86-87, 89-92 are pending in the instant application.
Claims 2, 4, 7-9, 17, 29, 31-33, 36, 42, 58, 61-62, 64, 66, 71 have been previously withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 76, 84, 86-87, 89-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 16/301,933 (reference application) in view of BERNDT et al (Fabrication and characterization of microspheres encapsulating astrocytes for neural regeneration. ACS Biomater Sci Eng. 2017 July 10; 3(7): 1313–1321).
The co-application recites a composition comprising of a human, neuronal, three-dimensional functional network, which reads on a synthetic tissue, obtained by the method as claimed in claim 1 (see claim 11), wherein claim 1 recites a method for forming a functional network of human neuronal and glial cells, comprising the steps of introducing a mixture of cells and polyethylene glycol or heparin are introduced into a synthetic hydrogel system, said hydrogel system containing the components polyethylene glycol (PEG) and heparin and culturing the cells such that during the formation of the three-dimensional hydrogel, the cells are already present in the three-dimensional hydrogel system (see claim 1), wherein the human neuronal cells are human neuronal stem and progenitor cells (see claim 2).
The co-application does not teach using astrocytes, which are a subset of glial cells.
BERNT teaches the prior art had known that astrocytes are the most abundant glial cells in the central nervous system (see pg. 2) and can promote nerve regeneration in injured neural tissue, wherein microparticle hold promise in tissue regeneration (see pg. 9). Additional disclosures include: microgels with sizes of 916.2 um (see pg. 6).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate astrocytes and form the composition into microparticles. The person of ordinary skill in the art would have been motivated to make those modifications, because it would promote nerve regeneration in injured neural tissue, and reasonably would have expected success because astrocytes are a subset of glial cells.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 76, 86-87, 89-91 is/are rejected under 35 U.S.C. 103 as being unpatentable over FREUDENBERB et al (A star-PEG–heparin hydrogel platform to aid cell replacement therapies for neurodegenerative diseases. Biomaterials 30 (2009) 5049–5060) as evidenced by WIKIPEDIA (https://en.wikipedia.org/wiki/Neuron (downloaded on 11/27/2025)) in view of JIANG et al (Cell-laden Microfluidic Microgels for Tissue Regeneration. Lab Chip. 2016 November 15; 16(23): 4482–4506).
Regarding claims 76 and 86, FREUDEBERG teaches using PEG-heparin hydrogel to culture neural stem cells (“NSC”; see abstract; pg. 5055-5059), which reads on neural progenitors in Applicant’s part (ii), for regenerative therapies (see pg. 5050, 1st col). The NSC differentiated into neurons (see pg. 5055-5058, under Section 3.2.2), which reads on mature neurons in Applicant’s part (i). Additional disclosures include: the experiments were conducted on rats and mice neural stem cells, but not human cells; however, FREUDEBERG discloses the applicability of neuronal cell replacement strategies, such as those required to treat Parkinson’s or Huntington’s disease (see pg. 5059, under Conclusion). Thus; it would have been obvious to use human neural progenitor cells for treating humans with Parkinson’s disease, because humans unfortunately can acquire Parkinson’s disease.
WKIPEDIA teaches a neuron is an excitable cell that fires electric signals called action potentials across neural network in the nervous system (see pg. 1), which reads on “exhibit intrinsic electrical activity” and “exhibit synaptic connectivity”.
FREUDENBERB does not teach that the hydrogel is the size of a microparticle.
JIANG teaches “hydrogels, which are three-dimensional polymer matrices formed by crosslinking hydrophilic homopolymers, copolymers, or macromers, can be delivered into the body in a minimally invasive manner. Moreover, hydrogels are not only biocompatible but also structurally and compositionally similar to the extracellular matrix. Despite these favorable properties, encapsulation of cells within macroscopic hydrogels often leads to limited cell-cell contact and communication as well as poor nutrient exchange due to a low rate of diffusion and suboptimal distance between extracellular molecules. This issue can be resolved by forming hydrogel microspheres, or microgels, whose large surface area-to-volume ratio promotes effective nutrient and water transfer as well as improve cell-matrix interactions, thereby maintaining long-term viability of the encapsulated cells (see pg. 2-3, under Introduction). An example of microgels include a combination of heparin and PEG (see pg. 16), which reads on polyethylene glycol and glycosaminoglycan, with sizes of about 200 um (see pg. 37, Fig. 6D). The microgels are for tissue regeneration and are size tunable (see abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate making FREUDENBERB’s macroscopic hydrogel into a microgel/microparticle with a size of 200 um. The person of ordinary skill in the art would have been motivated to make those modifications, because the microgel size would promotes effective nutrient and water transfer as well as improve cell-matrix interactions, thereby maintaining long-term viability of the encapsulated cells, and reasonably would have expected success because the references dealt in the same field of endeavor, such as regenerative therapy.
Regarding claim 87 and 89, WKIPEDIA teaches a neuron is an excitable cell that fires electric signals called action potentials across neural network in the nervous system (see pg. 1), which reads on “exhibit intrinsic electrical activity” and “exhibit synaptic connectivity”.
Regarding claims 90-91, as discussed above, the references teach glycosaminoglycan, such as heparin.
Claim(s) 76, 84 86-87, 89-92 is/are rejected under 35 U.S.C. 103 as being unpatentable over FREUDENBERB et al (A star-PEG–heparin hydrogel platform to aid cell replacement therapies for neurodegenerative diseases. Biomaterials 30 (2009) 5049–5060) as evidenced by WIKIPEDIA (https://en.wikipedia.org/wiki/Neuron (downloaded on 11/27/2025)) in view of JIANG et al (Cell-laden Microfluidic Microgels for Tissue Regeneration. Lab Chip. 2016 November 15; 16(23): 4482–4506), GUAN et al (Development of hydrogels for regenerative engineering. Biotechnol J. 2017 May ; 12(5): pg. 1-33) and BERNDT et al (Fabrication and characterization of microspheres encapsulating astrocytes for neural regeneration. ACS Biomater Sci Eng. 2017 July 10; 3(7): 1313–1321).
As discussed above, the references teach Applicant’s invention.
FREUDEBERG further teaches the hydrogel culture was supplemented with growth factor (see pg. 5051, Section 2.12); “a key challenge in the advent of in vivo tissue engineering strategies is to design bioartificial matrices capable of inducing desired processes, such as the localized recruitment and controlled differentiation of progenitor cells (see pg. 5049, under Introduction); “materials to modulate survival, differentiation and axo-dendritic integration of nerve cells and neuronal progenitors could be instrumental in the further optimizing current approaches” (see pg. 5050, 1st col) and could be used for targeted neuronal differentiation (see pg. 5059, under Conclusion).
Regarding claims 84 and 92, the reference does not teach the NSC differentiating into human astrocytes.
GUAN teaches the prior art had known of using hydrogel for regenerative tissue engineering to support cell growth, such as nervous tissue (see title and abstract). Hydrogels include: collagen, chitosan (see pg. 3), and PEG-crosslinked heparin hydrogel (see pg. 14). To promote stem cell proliferation, maturation, and differentiation for building tissues and organs, developmental biologists have utilized growth factors (GFs), which can interact with a membrane receptor and trigger various intracellular signal transduction systems (see pg. 12), wherein the stem cells can differentiate into neurons, oligodendrocytes, and astrocytes (see pg. 33, Figure 3).
BRENDT teaches astrocytes play a critical role in supporting the normal physiological function of neurons (see abstract) and can promote nerve regeneration in injured neural tissue, wherein microparticle hold promise in tissue regeneration (see pg. 9) and the astrocytes are encapsulated in collagen hydrogels (see abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate NSC differentiating into human astrocytes by culturing with growth factor or directly incorporating the astrocytes. The person of ordinary skill in the art would have been motivated to make those modifications, because astrocytes play a critical role in supporting the normal physiological function of neurons, and reasonably would have expected success because the references dealt in the same field of endeavor, such as tissue engineering.
Conclusion
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.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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