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 .
Election/Restrictions
Applicant's election without traverse of invention group I, a composition of spheroid comprising a combination of neuronal, astrocyte, and glial cells, claims 1-5, 10-13 and 15, in the reply filed on 04/24/2026 is acknowledged.
Claims 35, 39-42, 48-50, 67-68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/24/2026.
Claim Status
Claims 6-9, 14, 16-34, 36-38, 43-47, 51-66 are canceled.
Claims 1-5, 10-13, 15, 35, 39-42, 48-50, 67-68 are pending.
Claims 35, 39-42, 48-50, 67-68 are withdrawn.
Claims 1-5, 10-13 and 15 are under examination.
Claim interpretation
Regarding claim 10, ‘electrical communication’ is not defined in the specification. Therefore the broadest reasonable interpretation was derived in view of the claims, specification, prior art and the context of the invention. Therefore, the term is interpreted as the synchronous electrophysiological activity between the neural spheroids which can be indicated by the synchrony index.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 10-13 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions (product of nature) without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
Step 1 (Statutory Category): This part of the eligibility analysis evaluates whether the claim falls within any statutory category. The independent claim of the instant invention, claim 1 and the dependent claims 5, 10-13 and 15 recite a composition of a spheroid of cells comprising neuronal, astrocyte and glial cells which is a composition. Therefore, the claim falls within a statutory category.
Step 2A (Judicial Exceptions), Prong 1: This part of the eligibility analysis evaluate whether the claim recite a judicial exception. The claims are a composition that have the sole recited structural requirement of “ spheroid of cells comprising one or a combination of cells and/or tissues chosen from: a neuronal cell, an astrocyte, and a glial cell”. Given it’s broadest reasonable interpretation, spheroid of cells is a cluster of cells that grow together, and in vivo brain tissue comprises clusters of one or combination of the recited cells as evidenced by Stoisek et al., 2003 that teaches the presence of neurons and glial-like cells in brain slices of mice that were stained in vivo. Therefore the claims as a whole recite a judicial exception, product of nature , in accordance with MPEP 2106.04 (c).
Thus, the claims recite a judicial exception, a product of nature. Therefore, the analysis proceeds to step 2A prong 2.
Step 2A (Judicial Exceptions), Prong 2: This part of the eligibility analysis evaluates whether the claims as a whole integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claims beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claims as a whole integrate the exception into a practical application.
There are no additional elements recited in claim 1. Claims 2-3 do not further limit the structure of the claimed composition. Claims 4-5, 10-13 and 15 further recite the limitations generally found on neuronal cells/tissue in vivo. The whole claims sole is a spheroid with the structural composition of the brain tissue. Therefore, the claims as a whole do not integrate the exception into a practical application.
Step 2B (Significantly More): This part of the eligibility analysis evaluates whether the claims as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP 2106.05). This is based on an additional consideration of whether the elements in addition to the judicial exception add beyond what was well-understood, routine, and conventional to the claims.
There are no additional elements recited in the claims in addition to the judicial exception, and beyond what was well-understood, routine, and conventional to the claims. Therefore, the claims as a whole fail to amount to significantly more than the recited exception.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1- 5, 10 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park, Yoonseok, et al. ,Science advances 7.12 (2021), as evidenced by Fennema et al., 2013.
Regarding claim 1, Park teaches a composition comprising spheroids of human neuronal and astrocytes (Materials and methods, formation of hiPSC-derived 3D cortical/astrocyte cocultures, page 9).
Regarding claim 2-3, Park teaches the composition of the spheroid/spheroids claimed in the instant application. The method by which the said composition is derived is considered as ‘product-by-process’ and is not given patentable weight.
Regarding claim 4, Park teaches the claimed composition of the spheroids and the spheroids create complex tissue structures as evidenced by Fennema et al., 2013 (abstract).
Regarding claim 5, Park teaches generation of multiple spheroids with neuronal cells derived from, induced pluripotent stem cells and astrocytes (Materials and methods, formation of hiPSC-derived 3D cortical/astrocyte cocultures, page 9).
Regarding claim 10, Park teaches the formation of neurite bridges between neural spheroids of instantly claimed composition, along with synchronous electrophysiological activity indicated by the synchrony index. Wherein the synchrony index was perfect or 1 while the neurites are intact and drops when the neurites between the spheroids were transected (fig 4., page 6, materials and methods acquisition of electrophysiological data , page 9).
Regarding claim 15, Park teaches simulated optical stimulation of spheroids of instantly claimed composition using 470 nm emission wavelength (fig. 5, page 7, Materials and methods, optical simulation by Monte Carlo methods, page 10).
Therefore, the reference anticipates the claimed invention.
Claims 1, 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharma, Anup D., et al., Scientific reports 9.1 (2019): 8921.
Regarding claim 1, Sharma teaches a composition of spheroids comprising human neuronal cells (Materials and methods, spheroid fabrication, page 2).
Regarding claim 11 and 12, Sharma teaches the outgrowth of multiple axons in a parallel orientation (fig 4., page 7) from the spheroids of the claimed composition. By appearance there is a bundle with at least a substantial subset of axons if not the whole claimed range of 3-125 or 10 -120.
Regarding claim 13, Sharma teaches neuronal spheroids of clamed composition having various diameters, including 100-800µm (fig.2, page 5).
Therefore, the reference anticipates the claimed invention.
Conclusion
No claim is allowed.
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/HASHANTHI KOMITIGE ABEYRATNE-PERERA/ Examiner, Art Unit 1632
/MARCIA S NOBLE/ Primary Examiner, Art Unit 1632
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