DETAILED ACTION
This action is pursuant to the claims filed on 07/02/2026. Claims 1-27 are pending. A final action on the merits of claims 1-27 is as follows.
Response to Amendment
Applicant’s amendment to the claims are acknowledged and entered accordingly. As a result, the 35 USC 101 and 112 rejections of the previous office action are withdrawn.
Response to Arguments
Applicant's arguments filed 07/02/2026 have been fully considered but they are not persuasive.
Applicant argues, on page 4 of the remarks, that the hydrogel lumens or columnar hydrogel encasements of Serruya fail to read on “a microwell array including a plurality of discrete microwells having microwell openings”. The Examiner respectfully disagrees. Section 2.3.2 of Serruya as cited in the Office Action, discloses the microcolumns as comprising at least an inner ECM lumen and an outer hydrogel shell. The inner ECM lumen provides “structural support for the neuronal aggregates without inhibiting axonal penetration and outgrowth through the ECM”. The Examiner notes the recitation of the “microwell openings” in claim 1 do not recite any further details to the structure and/or positioning of the openings as it relates to the microwell. As such, the ECM lumen of the hydrogel microcolumns can be reasonably interpreted as a plurality of microwells, wherein the microwell openings can reasonably be interpreted as both the openings of the lumen as well as the pores within the ECM being “microwell openings” that allow for axonal penetration and outgrowth.
Applicant further states that the claimed “probe guide” is a separate element from “a microwell array”, and therefore regardless of whether Serruya teaches the hydrogel structures as the microwell array, then Serruya cannot disclose a separate probe guide because the Examiner relied upon the hydrogel structures to also read upon the probe guide. The Examiner respectfully disagrees. It appears the Applicant is narrowly reading the disclosed microcolumns of Serruya as single component, rather than a collection of distinct structures. As stated above, Section 2.3.2 of Serruya discloses the microcolumns as comprising at least an inner ECM lumen and an outer hydrogel shell. In this case, the outer hydrogel shell is functionally disclosed in Serruya as a bioerodible probe guide oriented over at least a portion of the microwell openings of the microwell array (i.e., the pores of the ECM) that “degrades over a period of several weeks.” This interpretation is supported by Section 2.3.2 of Serruay stating that:
“Agarose is stable in vitro, and the pore size is large enough to allow for lateral diffusion of oxygen and nutrients from media, but small enough to prevent the escape of neurite growth cones … Also, this hydrogel encasement protects the construct throughout the transplantation process and acts as a physical barrier between the construct neurons/axons and the potentially “hostile environment” of the microstab wound”.
Again, as stated above, this hydrogel encasement clearly reads upon a bioerodible probe guide oriented over at least a portion of the microwell openings as claimed.
Applicant further argues, on page 5 of the remarks, that Serruya fails to teach “electrically coupling neuronal soma to an electrode through a conductive microwell wall, conductive inner microwell surface, or electrode-connected microwell backplane.” Examiner notes none of these structures are recited in independent claim 1. Claim 1 simply recites “an electrode electrically connected with the plurality of microwells”. In the instant case, Section 2.2.3 of Serruya as cited in the Office Action, states (emphasis added): “these constructs may also be used to facilitate a sort of “recording”, such that a facsimile of neural activity within the brain is synaptically relayed to neurons within the living electrode. This activity could be reflected on the aspect of the construct externalized to the surface of the brain where nonpenetrating subdural, epidural or subgaleal multielectrode arrays could record and transmit these signals”. As such, these arguments are unpersuasive.
Applicant’s remaining arguments are unpersuasive for all of the reasons stated above.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 4-7, 10, 12, 16-17, 19-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Serruya (Serruya, Mijail, et. al, “Engineered Axonal Tracts as “Living Electrodes” for Synaptic-Based Modulation of Neural Circuitry”, Advanced Functional Materials, 2018).
Regarding claim 1, Serruya teaches a transition microelectrode, comprising: a microwell array including a plurality of microwells having microwell openings (See Figs 2-4; Pg 10, section 2.3.2 disclosing array of hydrogel columnar structures for receiving neuronal soma); b) a plurality of neuronal soma oriented within the plurality of microwells (see Figs 2-4); c) a bioerodible probe guide oriented over at least a portion of the microwell openings of the microwell array (Pg 6 section 2.1 disclosing columnar hydrogel encasement of microwell array being resorbed); and d) an electrode electrically connected with the plurality of microwells (Pg 9, section 2.2.3 multielectrode arrays record signals from neuronal soma within microwells).
Regarding claims 4-6, Serruya teaches wherein a single neuronal soma is oriented within each of the plurality of microwells (Section 2.3.2); wherein the neuronal soma is a neuronal stem cell (Pg 14 section 2.4 discussing neuronal stem cells; examiner notes the microwell is capable of holding a neuronal stem cell); wherein at least one of: the neuronal soma arises from a genome of a subject in which the microelectrode will be implanted (Fig 3 caption discussing living electrode neuron integration at 1 week and 1 month post implantation); the neuronal soma all have a common genetic profile; and the neuronal soma are of heterogeneous genetic profiles.
Regarding claim 7, Serruya teaches wherein the plurality of microwells are sized to accommodate a single neuronal soma (microwell is sized to receive a single neuronal soma).
Regarding claim 10, Serruya teaches wherein the plurality of microwells further include extracellular matrix hydrogel within the microwells (Beginning of section 2.3.2 on Pg 10 disclosing exracellular matrix “cocktail” within microwells to promote axonal outgrowth).
Regarding claim 12, Serruya teaches the device of claim 1 above and further teaches wherein the bioerodible probe guide is formed of at least one of a biodegradable polymer and a meltable material (Pg 6 section 2.1 disclosing columnar hydrogel which comprises a biodegradable polymer and a meltable material (i.e., water)).
Regarding claim 16, Serruya teaches wherein at least one of the plurality of microwells and the bioerodible probe guide further comprises inhibitors, anti-inflammatory agents and growth factors (Pg 10 hydrogel-ECM is functionalized with compounds to mitigate inflammation, facilitate growth).
Regarding claim 17, Serruya teaches wherein the microwells are coated with a biofilm layerthat provides at least one of nourishment for the plurality of soma (Pg 11 section 2.3.4 disclosing structure releasing glutamate; examiner notes glutamate is an example of a substance that facilitates nourishment in applicant’s own specification), binding proteins to facilitate attachment of the soma to the microwell, proteins to prevent oxidative stress from stimulation, and proteins to aid in cell differentiation.
Regarding claim 19, Serruya teaches a signal processor unit operatively connected to receive electrical signals from the electrode (Pg 9 section 2.2.3 disclosing connection to external microprocessor to facilitate recording), wherein the signal processor unit is capable of receiving information including measurements and an identifiable signature identifying the electrode as source of the information (Pg 9 section 2.2.3).
Regarding claim 20, Serruya teaches wherein the electrode is a composite electrode comprising multiple electrodes, each corresponding to a subset of soma (see Fig 6A disclosing multiple electrodes each corresponding to a subset of soma).
Regarding claims 21-23, Serruya teaches wherein each soma within the subset contributes equally to its corresponding electrode's reading (Fig 6A, each soma contributes equally to corresponding electrode’s reading (i.e., each soma fully contributes to reading of corresponding electrode when addressed)); wherein each soma contributes differentially to its corresponding electrode's reading (Fig 6A, certain somas and electrodes are “silenced” (i.e., contributes differently to corresponding electrode reading)); wherein the electrodes are each individually addressable (Fig 6A each electrode is individually addressable with own input channel and channel selection).
Regarding claim 24, Serruya teaches A transition microelectrode array comprising an electrode array having a plurality of the transition microelectrodes of claim 1 (See Fig 6 and Pg 10 section 2.3.2 contemplating an array of the living electrodes).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2, 8, 11, 14, 15, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Serruya.
Regarding claims 2 and 25, Serruya teaches wherein the plurality of microwells are oriented in a 2D array having the microwell openings oriented toward the bioerodible probe guide (See Figs 2-4; Pg 10, section 2.3.2 disclosing plurality of microwells as microcolumns and teaches “we can apply multiple living electrodes in an array to achieve a multifasciculated structure”). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Serruya to incorporate the microwells in a 2D array to arrive at claims 2 and 25 respectively. Doing so would have advantageously provided a multifasciculated structure (Pg 10 section 2.3.2).
Regarding claim 8, Serruya teaches wherein the plurality of microwells each have a width from 3 um to 100 um (Pg 10 section 2.3.2 inner diameter is 150-400 micrometers).
Serruya discloses substantially all the limitations of the claim(s) except for a width from 3 to 100 micrometers. It would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention to have modified the width of the microwells of Serruya to be from 3 to 100 microns, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One would have done so to advantageously design for specific bulk mechanical properties, degradation times, and the “dose” of neurons/axons that can be delivered per living electrode (Section 2.3.2 disclosing these result effective variables based on diameter of microwells).
Regarding claims 11 and 14, Serruya teaches wherein the bioerodible probe guide has a conical shape extending from the microwell array (Figs 1-3 living electrode with bioerodible probe has columnar shape). Serruya discloses substantially all the limitations of the claim(s) except the conical shape. It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have modified the shape of the bioerodible probe guide of Serruya to be conical in shape with a tapered profile tip, since applicant has not disclosed that the shape solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the columnar shape disclosed by Serruya.
Regarding claim 15, Serruya teaches wherein the probe tip has an opening, permitting axons from the soma to extend outside of the opening (Figs 1-4, probe tip has opening to allow axonal outgrowth within probe)
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Serruya in view of Bergo (U.S. PGPub No. 2020/0011877).
Regarding claim 3, Serruya teaches the device of claim 2.
Serruya fails to explicitly disclose wherein the 2D array is a regular array having 36 to 1600 microwells.
In related prior art, Bergo teaches wherein the 2D array is a regular array having 36 to 1600 microwells (Fig 2 microwells 2; [0120-0121] number of microwells is between 36 and 1600). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the number of microwells to have 36 to 1600 microwells to arrive at claim 3. Doing so would have been obvious to one of ordinary skill in the art as the use of microwells between 36 and 1600 microwells is well-known to yield predictable results therein. Furthermore, as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 9 and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Serruya in view of Zhu (U.S. Patent No. 8,901,913).
Regarding claim 9, Serruya teaches the device of claim 1 as stated above.
Serruya fails to explicitly teach wherein the plurality of microwells include a conductive metal coating on an inner surface.
In related prior art, Zhu teaches a similar device wherein the plurality of microwells include a conductive metal coating on an inner surface (Col 4 lines 18-24; Fig 3A, recording electrodes 306 define microwells with metal coating to communicate with neurons). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modfieid the microwells of Serruya in view of Zhu to incorporate the conductive metal coating on the inner surface to arrive at claim 9. Doing so would advantageously enable for the microwells to electrically couple to and communicate with the neurons to record and/or stimulate.
Regarding claim 26, Serruya teaches the device of claim 24 as stated above.
Serruya fails to explicitly teach wherein the plurality of transition microelectrodes are separated by an electrically insulating material.
In related prior art, Zhu teaches a similar array wherein the plurality of transition microelectrodes are separated by an electrically insulating material (Fig 5A-D recording electrodes 306 and Col 1 lines 35-51). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Serruya in view of Zhu to incorporate the insulating material separating the plurality of transition microelectrodes. Doing so would be obvious to one of ordinary skill in the art as the use of insulation to electrically separate and insulate electrodes from one another in an array is well-known in the art to yield the predictable result of electrically insulating said electrodes to avoid unintended contact and interference between conductive surfaces.
Regarding claim 27, Serruya/Zhu teach the device of claim 26 as stated above. Serruya further teaches wherein the electrodes of each transition microelectrode are individually addressable (Fig 6A each electrode is individually addressable with own input channel and channel selection).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Serruya in view of Ibrahim (U.S. PGPub No. 2020/0061214).
Regarding claim 13, Serruya teaches the device of claim 1 above and further teaches the use of polymers and water (Pg 6 section 2.1 disclosing columnar hydrogel which comprises a biodegradable polymer and a meltable material (i.e., water)).
Serruya fails to teach wherein the bioerodible probe guide further comprises a rigidity enhancing coating, wherein the rigidity enhancing coating is ice.
In related prior art, Ibrahim teaches that the cold polymerization of a hydrogel to yield ice crystal formation yields an increased in toughness of the hydrogel ([0064]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hydrogel of Serruya in view of Ibrahim to incorporate the cold polymerization such that the hydrogel comprises an ice rigidity enhancing coating to arrive at claim 13. Doing so would advantageously increase the toughness of the hydrogel to allow for it to be implanted within a tissue of a subject ([0064]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Serruya in view of O’Brien (U.S. PGPub No. 2005/0075708).
Regarding claim 18, Serruya teaches the device of claim 1 as stated above.
Serruya fails to teach wherein the plurality of microwells have amorphous indentations to facilitate attachment of the soma to the plurality of microwells.
In related prior art, O’Brien teaches wherein the plurality of microwells have amorphous indentations to facilitate attachment of the soma to the plurality of microwells ([0007] [0016] amorphous carbon coating allows for increased biocompatibility and allows for growth of nanotubes). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microwells of Serruya in view of O’Brien to incorporate sputtered amorphous carbon on the microwells to arrive at claim 18. Doing so would advantageously provide a more biocompatible microwell array with increased surface area for axonal attachment.
Conclusion
THIS ACTION IS MADE FINAL. 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 Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
Prosecution Insights