DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 11, 2026 has been entered.
Claims 1, 3-5, 8, and 10-20 are pending. A complete action on the merits of claims 1, 3-5, 8, and 10-20 is as follows.
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 . 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 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.
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.
Claims 1, 3-5, 8, and 10-20 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 1, ln. 15 recites “the water-soluble polymer”. However, there is insufficient basis for said claim limitation.
In addition, claim 8, ln. 3 recites “a water-soluble polymer”. It is unclear whether the two polymers are two distinct polymers or the same polymer.
Claim 17, ln. 15 recites “the water-soluble polymer”. However, there is insufficient basis for said claim limitation.
Accordingly, claims 3-5, 8, and 10, 12-19 are rejected by virtue of its dependency on independent claim 1 or 17.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 3-5, 8, 10 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gardner et al. (hereinafter ‘Gardner’, U.S. PGPub. No. 2018/0368712), and further in view of Yoon et al. (hereinafter ‘Yoon’, U.S. PGPub. No. 2014/0288458).
In regards to independent claim 1 and claim 8, Gardner discloses a three-dimensional (3D) nanoprobe device (neural interface device in Fig. 21) comprising:
a body portion comprising a plurality of body layers that are stacked (two microelectrode bodies 100a & 100b comprising connection bodies 120a & 120b stacked in a face-to-face orientation);
a plurality of nanoprobes respectively extending longitudinally from the body portion (probes 105 extending longitudinally from the connection bodies 120a & 120b), with each of the plurality of nanoprobes comprising a plurality of extension layers that are stacked (Figs. 1, 13 & 14 illustrate a plurality of extension layers including 110, 145 and 135, [0018]); and
an electrode portion disposed on a portion of the body portion ([0018]: the probe 105 comprises an interface pad 115 defined by an opening in an amorphous silicon carbide layer 135),
wherein each of at least two of the plurality of extension layers is longitudinally continuous with a corresponding one of the body layers ([0018], [0041]: the amorphous silicon carbide layer 135 forms the connection body 120a,b portions and the neural interface probe 105; the examiner notes that each of the neural interface probe 105 which comprises amorphous silicon carbide layer 135, layers 110 and 145 which are stacked above the silicon carbide layer 135, is longitudinally continuous with its corresponding body layer 120a or 120b), such that each extension layer and its corresponding body layer are of a single continuous layer extending from the body portion to a respective nanoprobe (the silicon carbide layer 135 defines both the connection bodies and the neural interface probes),
wherein each of the plurality of body layers is in contact with an adjacent layer (the examiner notes that ‘an adjacent layer’ is broad and that the spacer 195 reads on the adjacent layer; each of the bod layer 120a and 120b contacts the spacer 195 as shown in Fig. 21); and
wherein, each of two or more of the plurality of nanoprobes, comprise a separation region respectively between two or more of the plurality of extension layers, and the separation region is empty (the gap between the probes 105 in Fig. 21);
Gardner discloses substantially all the limitations of the claim(s) except for the separation region has a height of about 10 nm to about 3 um. Instead, Gardner discloses that the separation region has a height of about 5 um to about 1000 um ([0058]: the probes 105 are spaced from about 0.005 mm to 1 mm since the spacer 194 in between the two connection body 120a,b is 0.005 mm to 1 mm thick). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Gardner and reduce the spacer height to be less than 3 um, 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, 105 USPQ 233. Furthermore, the specification does not disclose any criticality to the claimed range as per paragraph [0068] and the adjustment of the spacer is merely the adjustment of the spacing between the vertically stacked nanoprobes which involves routine skilled in the art.
However, Gardner does not disclose wherein a portion or tip regions of the separation region is empty and another portion of the separation region comprises a water-soluble polymer.
Yoon teaches a neural probe for implantation (probe 10 in Fig. 1) and providing a biodegradable coating (18) disposed on disposed over a tip of the probe to provide the probe tip with sufficient integrity for insertion into the biological tissue and to degrade after insertion since the biodegradable coating can have an anti-inflammatory drug or other bioagent distributed therein for localized release to further reduce the immune response ([0002 0024], [0027], [0029]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the portion or tip regions of the nanoprobe of Gardner with the biodegradable coating of Yoon, thereby providing the separation region with a biodegradable coating/polymer which inherently is a water-soluble polymer to assist in insertion of the nanoprobes and to reduce immune response ([0002 0024], [0027], [0029]). The examiner notes that when the nanoprobe device of Gardner/Yoon combination is inserted in vivo, as the water-soluble polymer disposed between the plurality of nanoprobes degrades over time, regions with no water-soluble polymer as a result of biodegradation reads on the separation region that is empty.
In regards to claim 3, Gardner further discloses wherein each nanoprobe of the plurality of nanoprobes is spaced apart from a nearest other nanoprobe of the plurality of nanoprobes by about 10 nanometers (nm) to about 100 millimeters (mm) in a transverse direction of the body portion ([0058]: the probes 105 are spaced from about 0.005 mm to 1 mm since the spacer 194 in between the two connection body 120a,b is 0.005 mm to 1 mm thick).
In regard to claim 4, Gardner further discloses wherein the plurality of nanoprobes has any one or any combination of any two or more of a thickness of about 10 nm to about 200 micrometers (um), a width of about 10 nm to about 100 mm, or a length of about 0 nm to about 100 mm ([0042] & [0046]: b corresponding to the horizontal width of the probe is 5 microns; [0045]: h corresponding to the thickness of the probe is 10 microns; [0050]: neural interface probes has a length from 0.05 mm to 20 mm).
In regards to claim 5, Gardner further discloses wherein each of two or more of the plurality of nanoprobes has an aspect ratio of about 0.000005 to about 200000 ([0042], [0044]-[0045]: width and height ratio; 5 microns/10 microns = 0.5 which falls under the claimed range).
In regards to claim 10, Gardner further discloses wherein, for each of two or more of the nanoprobes, respective extension layers, of the two or more of the nanoprobes, are sequentially stacked such that adjacent nanoprobes overlap each other, or are cross-stacked such that the adjacent nanoprobes cross each other ([0059]: probes 105 are sequentially stacked or stacked in a face-to-face orientation).
In regards to claim 12, Gardner further discloses wherein, for each of two or more of the nanoprobes, respective extension layers of adjacent nanoprobes are cross-stacked such that the adjacent nanoprobes overlap each other with an overlap width corresponding to 0% to less than 100% of an average width of the nanoprobes ([0059]: probes 105 are stacked in a face-to-face orientation which meets that 100% overlap in width).
In regards to claim 13, Gardner further discloses wherein each nanoprobe of the plurality of nanoprobes comprise:
a base layer having a shape of the nanoprobe (a first layer of amorphous silicon carbide 160 in Fig. 16, [0060]);
an electrode pattern layer disposed on the base layer (thin film metal trac 165 in Fig. 16, [0060]); and
a protective layer (a second layer of amorphous silicon carbide 170 in Fig. 16, [0060]), disposed on the electrode pattern layer, having an exposed tip region, wherein the base layer extends from the body portion (opening is formed in the second amorphous silicon carbide layer 170, [0060]),
wherein the base layer extends from the body portion (the first layer 160 of the probe portion 105 extends from the connection body 120a,b).
In regards to claim 14, Gardner further discloses wherein each of the two or more of the plurality of nanoprobes, the plurality of extension layers comprise:
a base layer having a shape of the nanoprobe (thin film of polyimide 155 in Fig. 16);
an electrode pattern layer disposed on the base layer (thin film metal trace 165 which includes the electrode pattern 110 which is best shown in exemplary Figs. 13 and 14, [0054]-[0056]);
a first protective layer disposed on the electrode pattern layer (a first layer of amorphous silicon carbide 160 disposed on a lower surface of the trace 165);
an electrode pad layer disposed on the first protective layer (the trace 165 includes the interface pad 115, which is best shown in exemplary Figs. 13 and 14, [0054]-[0056], [0058] & [0060]);
a second protective layer disposed on the electrode pad layer (a second layer of amorphous silicon carbide 170 disposed over trace 165);
wherein the base layer extends from the body portion (the probe 105 portion of the thin film of polyimide 155 extends from the connection body 120a or 120b);
wherein the tip region of the corresponding nanoprobe is exposed in the first protective layer and the second protective layer (in the tip region, the first and second layers of amorphous silicon carbide 160 and 170 form the edges of each of the probes and therefore, are exposed to the neural environment);
wherein an electrode pad of the electrode pad layer is exposed in the second protective layer (opening is formed in the second amorphous silicon carbide layer 170 to provide for the interface pad 115, [0054]-[0056] & [0060]).
In regards to claim 15, Gardner further discloses wherein, for each of two or more of the plurality of nanoprobes, each of the base layer, the protective layer, the first protective layer, and the second protective layer has a thickness of about 10 nm to about 200 microns (note that the examiner takes the interpretation that each of the nanoprobes having each of the claimed layers has a total thickness of about 10 nm to about 200 microns; [0045]: h corresponding to the thickness of the probe is 10 microns).
In regards to claim 16, Gardner further discloses wherein the electrode pattern layer comprises an electrode pattern comprising any one or any combination of any two or more of a straight line, an oblique line, a zigzag, a streamline, a curve, or a comb profile (see exemplary Fig. 1 illustrating a straight line thin metal film 110), and the electrode pad layer comprises an electrode pad having a shape of any one or any combination of any two or more of a circle, an ellipse, a doughnut, or a polygon (see Fig. 13 illustrating the polygon or rectangular nature of the interface pad 115).
In regards to independent claim 17, Gardner discloses a three-dimensional (3D) nanoprobe device (neural interface device in Fig. 21) comprising:
a body portion comprising a plurality of body layers that are stacked (connection bodies 120a & 120b stacked in a face-to-face orientation; note that each of the connection bodies are formed from different layers as shown in Fig. 16);
an extension portion longitudinally from the body portion and in which a plurality of extension layers having a plurality of nanoprobes is stacked (probes 105 extending longitudinally from the connection bodies 120a & 120b; Figs. 1, 13 & 14 illustrate a plurality of extension layers including 110, 145 and 135, [0018]); and
an electrode portion disposed on a portion of the body portion ([0060]: the connection bodies 120a & 120b each comprises an opening for electrical contact pads 125 as shown in exemplary Fig. 21),
wherein each of at least two of the plurality of extension layers is longitudinally continuous with a corresponding one of the body layers ([0018], [0041]: the amorphous silicon carbide layer 135 forms the connection body 120a,b portions and the neural interface probe 105; the examiner notes that each of the neural interface probe 105 which comprises amorphous silicon carbide layer 135, layers 110 and 145 which are stacked above the silicon carbide layer 135, is longitudinally continuous with its corresponding body layer 120a or 120b).
such that each extension layer and its corresponding body layer are of a single continuous layer extending from the body portion to a respective nanoprobe (the silicon carbide layer 135 defines both the connection bodies and the neural interface probes),
wherein each of the plurality of body layers is in contact with an adjacent layer (the examiner notes that ‘an adjacent layer’ is broad and that the spacer 195 reads on the adjacent layer; each of the bod layer 120a and 120b contacts the spacer 195 as shown in Fig. 21); and
wherein, each of two or more of the plurality of nanoprobes, comprise a separation region respectively between two or more of the plurality of extension layers, and the separation region is empty (the gap between the probes 105 in Fig. 21).
Gardner discloses substantially all the limitations of the claim(s) except for the separation region has a height of about 10 nm to about 3 um. Instead, Gardner discloses that the separation region has a height of about 5 um to about 1000 um ([0058]: the probes 105 are spaced from about 0.005 mm to 1 mm since the spacer 194 in between the two connection body 120a,b is 0.005 mm to 1 mm thick). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Gardner and reduce the spacer height to be less than 3 um, 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, 105 USPQ 233. Furthermore, the specification does not disclose any criticality to the claimed range as per paragraph [0068] and the adjustment of the spacer is merely the adjustment of the spacing between the vertically stacked nanoprobes which involves routine skilled in the art.
However, Gardner does not disclose wherein a portion or tip regions of the separation region is empty and another portion of the separation region comprises a water-soluble polymer.
Yoon teaches a neural probe for implantation (probe 10 in Fig. 1) and providing a biodegradable coating (18) disposed on disposed over a tip of the probe to provide the probe tip with sufficient integrity for insertion into the biological tissue and to degrade after insertion since the biodegradable coating can have an anti-inflammatory drug or other bioagent distributed therein for localized release to further reduce the immune response ([0002 0024], [0027], [0029]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the portion or tip regions of the nanoprobe of Gardner with the biodegradable coating of Yoon, thereby providing the separation region with a biodegradable coating/polymer which inherently is a water-soluble polymer to assist in insertion of the nanoprobes and to reduce immune response ([0002 0024], [0027], [0029]). The examiner notes that when the nanoprobe device of Gardner/Yoon combination is inserted in vivo, as the water-soluble polymer disposed between the plurality of nanoprobes degrades over time, regions with no water-soluble polymer as a result of biodegradation reads on the separation region that is empty.
In regard to claims 18-19, Gardner further discloses wherein the electronic device is configured to measure any one or any combination of any two or more of a biosignal, a biomaterial, and a brain signal and apply an external stimulus to a living body or is an implantable device ([0005], [0059]: neural interface device is an implantable device configured to measure biosignal or brain signal).
In regards to independent claim 20, Gardner discloses a three-dimensional (3D) nanoprobe device (neural interface device in Fig. 21) comprising:
a body portion comprising a plurality of body layers that are stacked (connection bodies 120a & 120b stacked in a face-to-face orientation; note that each of the connection bodies are formed from different layers as shown in Fig. 16);
an extension portion extending from the plurality of body layers in a first direction to configure nanoprobes (probes 105 extending longitudinally from the connection bodies 120a & 120b, where the probes 105 are stacked; Figs. 1, 13 & 14 illustrate a plurality of extension layers including 110, 145 and 135, [0018]), wherein each of the nanoprobes is spaced apart from another in the first direction (Fig. 21 illustrates a gap between the probes 105); and
an electrode portion extending from the body portion in a second direction different from the first direction ([0018]: the probe 105 comprises an interface pad 115 defined by an opening in an amorphous silicon carbide layer 135; the electrode opening extends perpendicular to the gap between the probes 105),
wherein each of at least two of the plurality of extension layers is longitudinally continuous with a corresponding one of the body layers, such that each extension layer and its corresponding body layer are of a single continuous layer extending from the body portion to a respective nanoprobe ([0018], [0041]: the amorphous silicon carbide layer 135 forms the connection body 120a,b portions and the neural interface probe 105; the examiner notes that each of the neural interface probe 105 which comprises amorphous silicon carbide layer 135, layers 110 and 145 which are stacked above the silicon carbide layer 135, is longitudinally continuous with its corresponding body layer 120a or 120b).
wherein each of the plurality of body layers is in contact with an adjacent layer (the examiner notes that ‘an adjacent layer’ is broad and that the spacer 195 reads on the adjacent layer; each of the bod layer 120a and 120b contacts the spacer 195 as shown in Fig. 21); and
wherein, each of two or more of the plurality of nanoprobes, comprise a separation region respectively between two or more of the plurality of extension layers, and the separation region is empty (the gap between the probes 105 in Fig. 21).
Gardner discloses substantially all the limitations of the claim(s) except for the separation region has a height of about 10 nm to about 3 um. Instead, Gardner discloses that the separation region has a height of about 5 um to about 1000 um ([0058]: the probes 105 are spaced from about 0.005 mm to 1 mm since the spacer 194 in between the two connection body 120a,b is 0.005 mm to 1 mm thick). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Gardner and reduce the spacer height to be less than 3 um, 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, 105 USPQ 233. Furthermore, the specification does not disclose any criticality to the claimed range as per paragraph [0068] and the adjustment of the spacer is merely the adjustment of the spacing between the vertically stacked nanoprobes which involves routine skilled in the art.
However, Gardner does not disclose wherein a portion or tip regions of the separation region is empty and another portion of the separation region comprises a water-soluble polymer.
Yoon teaches a neural probe for implantation (probe 10 in Fig. 1) and providing a biodegradable coating (18) disposed on disposed over a tip of the probe to provide the probe tip with sufficient integrity for insertion into the biological tissue and to degrade after insertion since the biodegradable coating can have an anti-inflammatory drug or other bioagent distributed therein for localized release to further reduce the immune response ([0002 0024], [0027], [0029]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the portion or tip regions of the nanoprobe of Gardner with the biodegradable coating of Yoon, thereby providing the separation region with a biodegradable coating/polymer which inherently is a water-soluble polymer to assist in insertion of the nanoprobes and to reduce immune response ([0002 0024], [0027], [0029]). The examiner notes that when the nanoprobe device of Gardner/Yoon combination is inserted in vivo, as the water-soluble polymer disposed between the plurality of nanoprobes degrades over time, regions with no water-soluble polymer as a result of biodegradation reads on the separation region that is empty.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gardner and Yoon as applied to claim 1 above, and further in view of Campbell et al. (hereinafter ‘Campbell’, U.S. PGPub. No. 2022/0175278).
In regards to claim 11, Gardner/Yoon combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, Gardner/Yoon combination does not disclose wherein, for each of two or more of the nanoprobes, respective extension layers of adjacent nanoprobes are cross-stacked such that the adjacent nanoprobes are free of overlapping regions.
Campell discloses an electrode array comprising a plurality of electrode probes (device 100 comprising electrodes 135 in Fig. 1, [0029]) comprising a 3-D electrode array in which the probes are cross-stacked such that the adjacent probes are free of overlapping in the direction perpendicular to a surface of a substrate (100). Although Gardner discloses a nanoprobe arrangement in which the probes are cross-stacked such that the adjacent probes are overlapping in a face-to-face arrangement (see Fig. 21), it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the nanoprobe arrangement of Gardner so that the nanoprobe arrangement is free of overlapping as taught by Campbell, as it would have been an obvious matter of design choice, since applicant has not disclosed that overlapping or non-overlapping stacked configuration solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with both configurations for neural sensing.
Response to Arguments
Applicant's arguments filed on May 11, 2026 is acknowledged.
Applicant’s argument with respect to claims 1-6, 9-10, and 12-20 as being rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Gardner et al. (U.S. PGPub. No. 2018/0368712) has been fully considered. Applicant argues that Gardner fails to disclose, teach, or suggest in part, “wherein each of at least two of the plurality of extension layers is longitudinally continuous with a corresponding one of the body layers, such that each extension layer and its corresponding body layer are of a single continuous layer extending from the body portion to a respective nanoprobe, wherein each of the plurality of body layers is in contact with an adjacent layer, wherein each of two or more of the plurality of nanoprobes, comprises a separation region respectively between two or more of the plurality of extension layers, wherein a portion of the separation region is empty and another portion of the separation region comprises the water-soluble polymer, and wherein the separation region has a height of about 10 nanometers (nm) to about 3 micrometers (um)” as required in independent claims 1, 17 and 20.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., any particular structure(s) associated with “the body layers” to differentiate from merely being “stacked” and “each of the plurality of body layers is in contact with an adjacent layer”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant argues that the claimed invention and Gardner’s device are two fundamentally different structural architectures. However, the examiner is in the position that Gardner meets the claimed limitation since the body layers (assemblies 100a and 100b) are in a stacked configuration and in contact with an adjacent layer, which reads on the spacer (194) since the claim does not specifically correlate that the adjacent layer is one of the body layers.
Applicant further argues that Gardner fails to disclose “wherein a portion of the separation region is empty, and another portion of the separation region comprises the water-soluble polymer” is persuasive. However, previously cited Yoon reference teaches a biodegradable coating that encapsulates the entire probe to assist in insertion of the nanoprobes and to reduce immune response involves routine skill in the art ([0002 0024], [0027], [0029]). The examiner notes that when the nanoprobe device of Gardner/Yoon combination is inserted in vivo, the water-soluble polymer disposed between the plurality of nanoprobes, specifically within the separation region, would naturally degrade over time and form empty pockets, and the resultant empty pockets in the separation region read on the separation region that is empty. Therefore, the combination of Gardner and Yoon discloses the limitation. Accordingly, a new ground of rejection is made above in view of Gardner and Yoon for independent claims 1, 17 and 20.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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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.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 6/2/2026
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