DETAILED ACTION
This action is pursuant to the claims filed on 10/21/2022. Claims 1-40 are pending. Claims 28-40 are withdrawn. A first action on the merits of claims 1-27 is as follows.
Election/Restrictions
Claims 28-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/28/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is/are 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.
Claim 13 recites the limitation " wherein the rigidity enhancing coating is optionally ice". The phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes the rigidity enhancing coating will be interpreted to be ice.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-27 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites “a plurality of neuronal soma oriented within the plurality of microwells”. This limitation positively recites and encompasses a human organism. For examination purposes, this limitation will be interpreted as functional language in which the microwells are configured to receive a plurality of neuronal soma. Claims 2-27 inherit this deficiency.
Claims 4-6 recites limitations that positively recite and encompasses a human organism. For examination purposes, these limitations will be interpreted as functional language.
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 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.
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
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.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794