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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/18/2026 has been entered.
1. Claims 3, 13, 14, 17, 18, 23 – 34, and 37 remain pending. Claims 3, 13, 14, 17, 18, and 37 are under consideration.
Withdrawn Claim Rejections
2. The rejection of claims 35, 36, 38, and 39 under 35 U.S.C. 103 is rendered moot in view of Applicant’s cancellation of these claims.
3. The rejection of claims 3, 13, 14, and 17 under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendment to claim 3 requiring culturing in a suspension above a surface of a silicon-based organic polymer.
4. The rejection of claim 18 under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendment to claim 3.
Claim Interpretation
5. For the purpose of applying prior art, recitation of “self-organize to be located spaced apart” of claim 3 is interpreted to not be an active method step because the claim recites the spacing is due to the self-organization of the neurospheres. Therefore, claim 3 is interpreted as culturing precursor cells in a suspension above a surface of a silicone-based organic polymer, wherein the surface is substantially planar, non-adhesive, and flat, wherein the surface is not a plurality of microwells, and allowing the cells to settle. “Allowing the cells to settle” is interpreted as static culturing as opposed to dynamic culturing.
6. For the purpose of applying prior art, claims 13 and 14 are interpreted to not be active method steps because claim 3 recites that the spacing is due to the self-organization of the neurospheres.
7. For the purpose of applying prior art, “iPSC-derived neuronal progenitors” is interpreted as neuronal progenitors where “iPSC-derived” is interpreted as a product-by-process limitation where the claim is not limited to the manipulations of the recited steps (“iPSC-derived”), only the structure implied by the steps (“neuronal progenitors”).
Rejections Necessitated by Amendment
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
8. Claim(s) 3, 13, 14, 17, 18, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Su (Su, Wen-Ta, et. al. Journal of Neural Engineering 13.4 (2016): 046005.), hereinafter Su in view of Morin (Kato-Negishi, Midori, et al. "Fabrication of transplantable 3D-neuronal network." 14th International Conference on Miniaturized Systems for Chemistry and Life Sciences 2010, MicroTAS 2010. 2010; previously cited), hereinafter Kato-Negishi which is cited on the IDS filed 12/01/2020.
Regarding claims 3, 13, 14, and 37, Su teaches culturing stem cells from human exfoliated deciduous teeth (SHEDs) (“precursor cells” of claim 3, 13, 14) in static culture (“in a suspension” of claim 3, 13, 14) on a PDMS surface (“silicone-based organic polymer” of claim 3, 13, 14, and PDMS of claim 37) that is planar, non-adhesive, and flat and not a plurality of microwells (Abstract; Figure 1; page 2, right col. para. 3; page 4, left col. para. 2 – 3 and right col. last para.; page 5, left col. para. 1; page 7, left col. para. 2; page 7, right col. last para.; page 10, left col. para. 1). Su teaches culturing the SHEDs in RSC medium in static culture (“allowing the cells to settle”) led to the formation of neurospheres (page 6, left col.; Figure 3; page 7, right col. para. 2; page 10, left col. para. 1).
Regarding claim 18, Su teaches the SHED-derived spheres are neural progenitors (page 7, left col. para. 2; and right col. para. 1; page 12, right col. para. 1).
Su does not teach “growing axons among neurospheres” of claim 3, 13, and 14 or “wherein the neurospheres are interconnected by axons” of claim 17. However, Su teaches the SHED-derived spheres were suspended and re-seeded onto glass coverslips and cultured in RSC medium to form mature neurons, oligodendrocyte precursor cells, and neuroglial cells in static culture (page 7, right col. para. 2; Figure 6a; page 12, right col. para. 1). Su teaches NSCs can differentiate into neurons, astrocytes and oligodendrocytes in vitro but NSCs reside in the deep brain and this inaccessible source restricts the clinical applications of these cells (page 10, left col. para. 2 and right col.). Su teaches the design of forming neurospheres from SHEDs with RSC culture medium can promote the SHEDs to differentiate into neural progenitor neurospheres and mature to neuron cells is easy, cheap, and fast, and can be applied to treat neurological diseases and to provide an efficient tool for regenerative medicine (page 12, right col. para. 1; page 13, left col. para. 1 – 2).
Regarding “growing axons among neurospheres” of claim 3, 13, and 14 and “wherein the neurospheres are interconnected by axons” of claim 17, Kato-Negishi teaches a method of forming a 3D-neuronal network by culturing cortical cell suspension onto PDMS and culturing in media where the neurospheroids grew axons (claims 3, 13, 14) and formed an interconnected neurospheroid network connected by axons (claim 17) (page 632, left col. last para.; Figure 1 and 3). Kato-Negishi teaches transplanting the neurospheroid network on rat embryonic brain tissue and the network adhered strongly one the cortex of the rat brain, the cells were alive, and the cells extended neuronal process into cortical tissue (Figure 6; page 633, left col. para. 3; page 632, para. 2). Kato-Negishi teaches the method provides a practical capability for in vitro neural tissue engineering and presents useful advantages for the development of neural transplantation (Abstract; page 634, left col. para. 1).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to combine the teachings of Su regarding a method of culturing SHEDs in suspension on flat, planar, non-adhesive PDMS surface that self-organize into neurospheres and can be further differentiated into neurons when plated on a glass coverslip with the teachings of Kato-Negishi regarding a method of culturing cortical neurons in suspension on a non-adhesive PDMS surface where the cells self-organize to form a neural network of neurospheres interconnected by axons to arrive at the claimed method of making a 3D neurosphere network, comprising: forming a plurality of interconnected neurospheres, optionally artificial neurospheres, by
culturing precursor cells in a suspension above a surface of a silicone-based organic polymer, wherein the surface is substantially planar, non-adhesive, and flat, wherein the surface is not a plurality of microwells, and allowing the cells to settle, wherein the neurospheres self-organize to be located spaced apart on the surface by varying distances and by an average of 2, 5, 10, or 15 mm, and growing axons among neurospheres under culture conditions to form a 3D neurosphere network. One would have been motivated to combine the teachings of Su and Kato-Negishi in a method of forming a 3D neural network for tissue engineering as Su teaches the method is easy, cheap, and fast, and can be applied to treat neurological diseases and to provide an efficient tool for regenerative medicine and Kato-Negishi teaches Kato-Negishi teaches the method provides a practical capability for in vitro neural tissue engineering and presents useful advantages for the development of neural transplantation. One would have a reasonable expectation of success in combining the teachings as Su teaches the formation of neurospheres on PDMS that can be further differentiated to neurons and Kato-Negishi teaches neurospheroids formed on PDMS grow axons that interconnect the neurospheroids and Kato-Negishi teaches the neural network could be transplanted onto a rat brain where the cells from the neurospheroids were alive and extended into neuronal process into cortical tissue.
Applicant’s Arguments/ Response to Arguments
9. Applicant Argues: Applicant asserts that amended claim 3 is not obvious over the teachings of Park and Kanner.
Response to Arguments: The previous rejection of the claims using the teachings of Park and Kanner have been withdrawn in view of the amendment to claim 3 requiring “culturing precursor cells in a suspension above a surface of a silicone-based organic polymer”. In the new rejection set forth above, Su in view of Kato-Negishi make obvious the limitations of amended claim 3 as Su teaches culturing SHEDs in suspension on PDMS where they self-organize to form neurospheres and Kato-Negishi teaches neural cells cultured in suspension on PDMS self-organize to form a 3D neural network of neurospheroids interconnected by axons.
Conclusion
No claims allowed.
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/ZANNA MARIA BEHARRY/Examiner, Art Unit 1632
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