DETAILED ACTION
This action is pursuant to claims filed on 3/6/2026. Claims 1-10 and 15-23 are pending, claims 11-14 have been cancelled. A final action on the merits of claims 1-10 and 15-23 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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the plurality of micromanipulator pads must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 21 and 23 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.
Claims 21 and 23 claim “a plurality of micromanipulator pads.” The claim is indefinite because it is unclear what this structure is intended to be. “Micromanipulator pads” are recited as if they are a commonly known structure in the art, however, after a thorough search, this term is not a commonly used term in the art. The specification does not provide any clarity regarding this structure, either. It simply states the same statement as the claims. It is unclear if these are simply locations for a micromanipulator to attach to the microelectrode array or if they are some form of stiffener that simply provide rigidity to the array during insertion. The claim reads as if they are a form of stiffener because they reduce the likelihood of buckling, but the specification of the instant application states that the array is implanted without using a rigid shuttle or stiffening layer ([0037]). Therefore, because this is not a standard structure in the art and it is unclear what the structure is intended to be from the disclosure, the claims are rejected. For the purposes of compact prosecution, the “micromanipulator pads” will be interpreted simply as locations where a micromanipulator contacts the probe.
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.
Claim(s) 1, 3-10 and 15-21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (hereinafter ‘Park’, US 20210244304 A1) in view of Kuzum et al. (hereinafter ‘Kuzum’, US 20170172446 A1), and in further view of Fedder et al. (hereinafter ‘Fedder’, US 20130131482 A1).
Regarding independent claim 1, Park discloses a microelectrode array (microelectrode array 100 of Figs. 1 and 2) comprising:
a flexible substrate layer (layer 110 in Fig. 1; [0085]: the substrate is sufficiently thin to provide a device that is sufficiently transparent and mechanically flexible; [Abstract]: the device is a transparent bio-electrode – if the entire device is flexible, the substrate inherently has a degree of flexibility) including a shank member (elongate section of substrate 110 that extends from the rectangular end and terminates at the pointy, tip end as seen in Fig. 1) and extending in a first direction (extends in a first direction terminating at the tip in Fig. 1) and a tapered tip at an end of the shank member (the end of the tip of the shank member of the substrate 110 tapers as seen in Fig. 1);
a plurality of electrode conductors (conductors 141 terminating in electrodes 120 as seen in Figs. 1 and 2 – this appears to be consistent with the “electrode wires” of the specification of the instant application as the wires themselves are not actually sensing but are rather connected to the sensing electrodes) arranged in the first direction on the flexible substrate layer (arranged to extend towards the tip of the substrate as seen in Figs. 1 and 2), wherein the plurality of electrode conductors includes adjacent electrode conductors having different lengths from each (multiple adjacent conductors 141 as seen in Fig. 1; the lengths of the conductors 141 vary as seen in Fig. 1) other such that an electrode conductor arranged closer to a centerline of the flexible substrate layer is longer than an adjacent electrode conductor arranged further away from the centerline of the flexible substrate (the conductor 141 in the center of the substrate is longer than those that are closer to the edges as seen in Figs. 1 and 2), and an encapsulation layer (encapsulation layer 150 in Fig. 1) disposed over the plurality of electrode conductors (encapsulation layer 150 overlays the conductors as seen in Fig. 1 and described in paragraph [0086]), wherein:
the shank member is bendable to allow the shank member to be bent in a horizontal direction when the microelectrode array is inserted in a vertical direction into a tissue (this is a functional limitation and the substrate of Park is made of PET, [0082]: the polymer substrate may be PET, may be 50µm thick, [0024], and is flexible, [0081]; this is the same composition, thickness and properties of the claimed substrate shank [instant application 00135]; therefore, the shank of the substrate of Park is capable of bending in the same way as the claimed shank).
Park discloses that the conductors 141 are circuits for transmitting the electrical signals of the electrode sites that may be formed of metal ([0071]-[0072]). They are shown as wire or trace shaped components in Figs. 1 and 2. Furthermore, the circuits of Park are not disclosed to contain any processing components. They are only disclosed to be made of metal and transmit the signal, which is what a wire does. However, Park does not specifically disclose that the conductors are wires.
Kuzum discloses a flexible, optically transparent electrode array where the electrodes are positioned on a substrate and may be used for electrophysiological monitoring, which is very similar to the device of Park ([Abstract]). Kuzum further discloses that the electrodes are connected to a device through graphene wires ([0037]). Furthermore, the wires are optically transparent, which would maintain the transparent nature of the device when combined with Park ([Claim 1]). Therefore, the substitution of one known element (the wires of Kuzum) for another (the conductive circuits of Park) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of wires of Kuzum would have yielded predictable results, namely, forming a conductive connection to transmit the signals sensed by the electrodes while maintaining the flexibility and transparency of the device.
However, the Park/Kuzum combination is silent to the shank member having a length that is selected to provide a stiffness for insertion of the shank member in the vertical direction into the tissue without buckling and without a need for inclusion of a rigid shuttle or stiffening layer.
Fedder teaches an ultra-compliant probe array that allows for insertion of the probes to the tissue ([Abstract]). Fedder further teaches that to obtain the required strength and resistance to buckling and fracture during tissue insertion, the probe length must be taken into account ([0045]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to select a length to provide adequate stiffness to prevent buckling, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Furthermore, Fedder teaches that selecting an appropriate length is important to preventing buckling and fracture during insertion. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select the optimum length to prevent buckling during tissue insertion without the need for an additional stiffener.
Regarding claim 3, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 1, wherein the encapsulation layer includes one or more electrode openings (electrode openings 151 in Fig. 1) structured to expose a portion of one or more electrode wires (openings 151 expose the electrodes 120 at the ends of the electrode wires 141 as seen in Fig. 1 and described in [0086]).
Regarding claim 4, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 3, wherein the one or more electrode openings are arranged along the tapered tip (the openings are arranged along the tapered tip as seen in Fig. 1).
Regarding claim 5, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 3, wherein the one or more electrode openings are spaced apart from the tapered tip (openings are spaced from the very tip as highlighted below).
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Regarding claim 6, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 5, wherein the electrode opening corresponding to the electrode wire arranged closer to the centerline of the flexible substrate layer is spaced apart from the tapered tip by a first distance (first distance is the spacing of the single, center line highlighted in the annotated image above), and the electrode opening corresponding to another electrode wire is spaced apart from the tapered tip by a second distance (the second distance is the spacing of the two outer lines highlighted in the annotated image above), wherein the first distance is shorter than the second distance (the first distance is shorter than the second distance as can be seen in the annotated image above).
Regarding claim 7, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 1, wherein the plurality of electrode wires is arranged in the first direction at a uniform interval (the electrode wires are arranged in the first direction as seen in Fig. 1 and the ends terminate in uniform intervals – this is interpreted as the uniform spacing between electrodes at the end of the electrode wires in the first direction since the claim does not define how or which parts of the electrode wires are arranged at a uniform interval).
Regarding claim 8, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 1, wherein the flexible substrate layer includes a transparent material ([0080]: the substrate 110 may be formed of a transparent material).
Regarding claim 9, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 1, wherein the plurality of electrode wires includes microelectrodes (electrode sites 120 in Figs. 1 and 2; [0009]: the embodiments teach a method of producing microelectrodes).
However, the Park/Kuzum/Fedder combination does not state the microelectrodes are optically transparent graphene microelectrodes.
Kuzum further teaches that the electrodes are made of graphene and are from 10 to 500 micrometers in size, thus making them microelectrodes ([0037]). Kuzum further teaches that the electrodes are optically transparent ([Claim 1]). Furthermore, the optically transparent graphene electrodes enable high signal-to-noise ration recording of electrophysiological activity ([0010]). While Park does state that the electrodes produced using a conductive polymer and metal nanowire are inexpensive and allow for advantages in mass production compared to transparent graphene electrodes (Park [0101]), this reads simply as a preferable embodiment. While the electrodes of Park may be cheaper to produce, transparent graphene electrodes would maintain functionality, flexibility, and transparency which are the critical aspects of Park. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the electrodes of Park for the optically transparent microelectrodes of Kuzum as doing so is merely a simple substitution of one known component for another that would maintain conductivity, transparency, and flexibility while also providing for a high signal-to-noise ration.
Regarding claim 10, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 1, wherein the flexible substrate layer includes a polyethylene terephthalate (PET) substrate ([0082]: the polymer substrate may be PET).
Regarding independent claim 15, Park discloses a microelectrode array (microelectrode array 100 of Figs. 1 and 2) comprising:
a flexible substrate layer (layer 110 in Fig. 1; [0085]: the substrate is sufficiently thin to provide a device that is sufficiently transparent and mechanically flexible; [Abstract]: the device is a transparent bio-electrode – if the entire device is flexible, the substrate inherently has a degree of flexibility) extending in a first direction (extends in a first direction terminating at the tip in Fig. 1) and including a tapered tip at an end of the flexible substrate layer (the end of the tip of the substrate 110 tapers as seen in Fig. 1);
a plurality of electrode conductors (conductors 141 terminating in electrodes 120 as seen in Figs. 1 and 2 – this appears to be consistent with the “electrode wires” of the specification of the instant application as the wires themselves are not actually sensing but are rather connected to the sensing electrodes) arranged in the first direction at an interval on the flexible substrate layer (arranged to extend towards the tip of the substrate as seen in Figs. 1 and 2; the plurality of electrode wires are arranged in the first direction as seen in Fig. 1 and the ends terminate in uniform intervals – this is interpreted as the interval spacing between electrodes at the end of the electrode wires in the first direction since the claim does not define how or which parts of the electrode wires are arranged at an interval), wherein the plurality of electrode conductors includes a first electrode conductor arranged along a centerline of the flexible substrate layer (center wire of the electrode conductors 141 as seen in Fig. 1) and a second electrode conductor arranged along an edge of the flexible substrate layer (side electrode conductor 141 as seen in Fig. 1), wherein the first electrode conductor is longer than the second electrode conductor (the center electrode conductor is the longest as seen in Fig. 1); and
an encapsulation layer (encapsulation layer 150 in Fig. 1) disposed over the plurality of electrode conductors (encapsulation layer 150 overlays the conductors as seen in Fig. 1 and described in paragraph [0086]) and including one or more electrode openings (electrode openings 151 in Fig. 1) structured to expose a portion of one or more electrode wires (openings 151 expose the electrodes 120 at the ends of the electrode wires 141 as seen in Fig. 1 and described in [0086]).
the shank member is bendable to allow the shank member to be bent in a horizontal direction when the microelectrode array is inserted in a vertical direction into a tissue (this is a functional limitation and the substrate of Park is made of PET, [0082]: the polymer substrate may be PET, may be 50µm thick, [0024], and is flexible, [0081]; this is the same composition, thickness and properties of the claimed substrate shank [instant application 00135]; therefore, the shank of the substrate of Park is capable of bending in the same way as the claimed shank).
Park discloses that the conductors 141 are circuits for transmitting the electrical signals of the electrode sites that may be formed of metal ([0071]-[0072]). They are shown as wire or trace shaped components in Figs. 1 and 2. Furthermore, the circuits of Park are not disclosed to contain any processing components. They are only disclosed to be made of metal and transmit the signal, which is what a wire does. However, Park does not specifically disclose that the conductors are wires.
Kuzum discloses a flexible, optically transparent electrode array where the electrodes are positioned on a substrate and may be used for electrophysiological monitoring, which is very similar to the device of Park ([Abstract]). Kuzum further discloses that the electrodes are connected to a device through graphene wires ([0037]). Furthermore, the wires are optically transparent, which would maintain the transparent nature of the device when combined with Park ([Claim 1]). Therefore, the substitution of one known element (the wires of Kuzum) for another (the conductive circuits of Park) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of wires of Kuzum would have yielded predictable results, namely, forming a conductive connection to transmit the signals sensed by the electrodes while maintaining the flexibility and transparency of the device.
However, the Park/Kuzum combination is silent to the shank member having a length that is selected to provide a particular stiffness for insertion of the shank member in the vertical direction into the tissue without buckling and without a need for inclusion of a rigid shuttle or stiffening layer.
Fedder teaches an ultra-compliant probe array that allows for insertion of the probes to the tissue ([Abstract]). Fedder further teaches that to obtain the required strength and resistance to buckling and fracture during tissue insertion, the probe length must be taken into account ([0045]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to select a length to provide adequate stiffness to prevent buckling, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Furthermore, Fedder teaches that selecting an appropriate length is important to preventing buckling and fracture during insertion. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select the optimum length to prevent buckling during tissue insertion without the need for an additional stiffener.
Regarding claim 16, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 15, wherein the one or more electrode openings are arranged along the tapered tip (the openings are arranged along the tapered tip as seen in Fig. 1).
Regarding claim 17, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 16, wherein the electrode opening of the first electrode wire is spaced apart from the tapered tip by a first distance (first distance is the spacing of the single, center line highlighted in the annotated image above), and the electrode opening of the second electrode wire is spaced apart from the tapered tip by a second distance (the second distance is the spacing of the two outer lines highlighted in the annotated image above), wherein the first distance is shorter than the second distance (the first distance is shorter than the second distance as can be seen in the annotated image above).
Regarding claim 18, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 15, wherein the flexible substrate layer includes a transparent material ([0080]: the substrate 110 may be formed of a transparent material).
Regarding claim 19, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 15, wherein the plurality of electrode wires includes microelectrodes (electrode sites 120 in Figs. 1 and 2; [0009]: the embodiments teach a method of producing microelectrodes).
However, the Park/Kuzum/Fedder combination does not state the microelectrodes are optically transparent graphene microelectrodes.
Kuzum further teaches that the electrodes are made of graphene and are from 10 to 500 micrometers in size, thus making them microelectrodes ([0037]). Kuzum further teaches that the electrodes are optically transparent ([Claim 1]). Furthermore, the optically transparent graphene electrodes enable high signal-to-noise ration recording of electrophysiological activity ([0010]). While Park does state that the electrodes produced using a conductive polymer and metal nanowire are inexpensive and allow for advantages in mass production compared to transparent graphene electrodes (Park [0101]), this reads simply as a preferable embodiment. While the electrodes of Park may be cheaper to produce, transparent graphene electrodes would maintain functionality, flexibility, and transparency which are the critical aspects of Park. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the electrodes of Park for the optically transparent microelectrodes of Kuzum as doing so is merely a simple substitution of one known component for another that would maintain conductivity, transparency, and flexibility while also providing for a high signal-to-noise ratio.
Regarding claim 20, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 15, wherein the flexible substrate layer includes a flexible polyethylene terephthalate (PET) substrate ([0082]: the polymer substrate may be PET).
Regarding claim 21, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 1. Fedder further teaches a tab 22 that provides an attachment region for a micromanipulator ([0041]). Each side of the tab 22 is considered a pad because each side is a planar surface to which a micromanipulator can grasp, similar to the clamp grasping either side of the shank of the instant application in Fig. 2A. Utilizing a micromanipulator allows for controlled and repeatable insertion for single probes and 1D array probes ([0041]). This tab would improve resistance of the shank to buckling because it provides a place for the micromanipulator to grasp the electrode array for delicate insertion, and when attached to the side of the shank of Park would provide increased width, thus increasing the cross-sectional area and the strength against buckling. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the tab of Fedder with the device of the Park/Kuzum combination in order to provide pads for a micromanipulator to grasp so the array can be inserted into desired location which allows for controlled and repeatable insertion.
While it is the examiner’s opinion that either side of the tab would form two pads, thus meeting the claimed “plurality of micromanipulator pads”, duplicating the tab to form two distinct tabs would be of routine skill in the art. This would very clearly form a plurality of pads, one on either side of the shank. It would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the tab 22 onto either side of the shank of Park to form a plurality of pads, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 23, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 15. Fedder further teaches a tab 22 that provides an attachment region for a micromanipulator ([0041]). Each side of the tab 22 is considered a pad because each side is a planar surface to which a micromanipulator can grasp, similar to the clamp grasping either side of the shank of the instant application in Fig. 2A. Utilizing a micromanipulator allows for controlled and repeatable insertion for single probes and 1D array probes ([0041]). This tab would improve resistance of the shank to buckling because it provides a place for the micromanipulator to grasp the electrode array for delicate insertion, and when attached to the side of the shank of Park would provide increased width, thus increasing the cross-sectional area and the strength against buckling. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the tab of Fedder with the device of the Park/Kuzum combination in order to provide pads for a micromanipulator to grasp so the array can be inserted into desired location which allows for controlled and repeatable insertion.
While it is the examiner’s opinion that either side of the tab would form two pads, thus meeting the claimed “plurality of micromanipulator pads”, duplicating the tab to form two distinct tabs would be of routine skill in the art. This would very clearly form a plurality of pads, one on either side of the shank. It would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the tab 22 onto either side of the shank of Park to form a plurality of pads, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 2 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over the Park/Kuzum/Fedder combination as applied to claims 1 and 15, respectively, in further view of Srikantharajah et al. (hereinafter ‘Srikantharajah’, “Minimally-invasive insertion strategy and in vivo evaluation of multi-shank flexible intracortical probes”).
Regarding claim 2, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 1 as described above. Fedder further states that the maximum force required to penetrate the tissue is a factor affecting buckling and modifying the needle can reduce this maximum force [0045].
However, the combination is specifically silent to the square of the length of the shank member is inversely proportional to a maximum force needed for insertion of the shank into the tissue without buckling.
Srikantharajah teaches a tissue-friendly insertion system for reducing the effective shank length of a flexible neural probe ([Abstract]). Srikantharajah further teaches that the shank length plays a key role when considering the buckling force, based on Euler’s formula. Euler’s formula teaches that the buckling force threshold is proportional to 1/L2 (Page 3). Furthermore, Srikantharajah states that the flexible shanks should withstand a minimum insertion force of 1mN for successful insertion (Page 3). The claim does not state the specific length or insertion force required of the probe. The combination of record also teaches modifying the length of the shank to prevent buckling upon insertion into the tissue. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length such that it is inversely proportional to the maximum force needed for insertion into the tissue without buckling as taught by Srikantharajah such that the electrode array can be successfully inserted into the brain without buckling under the required force.
Regarding claim 22, the Park/Kuzum/Fedder combination discloses the microelectrode array of claim 15 as described above. Fedder further states that the maximum force required to penetrate the tissue is a factor affecting buckling and modifying the needle can reduce this maximum force [0045].
However, the combination is specifically silent to the square of the length of the shank member is inversely proportional to a maximum force needed for insertion of the shank into the tissue without buckling.
Srikantharajah teaches a tissue-friendly insertion system for reducing the effective shank length of a flexible neural probe ([Abstract]). Srikantharajah further teaches that the shank length plays a key role when considering the buckling force, based on Euler’s formula. Euler’s formula teaches that the buckling force threshold is proportional to 1/L2 (Page 3). Furthermore, Srikantharajah states that the flexible shanks should withstand a minimum insertion force of 1mN for successful insertion (Page 3). The claim does not state the specific length or insertion force required of the probe. The combination of record also teaches modifying the length of the shank to prevent buckling upon insertion into the tissue. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length such that it is inversely proportional to the maximum force needed for insertion into the tissue without buckling as taught by Srikantharajah such that the electrode array can be successfully inserted into the brain without buckling under the required force.
Response to Arguments
Applicant’s arguments, see page 6, filed 3/6/2026, with respect to the 112b rejection of claim 1 have been fully considered and are persuasive in light of the amendments. The 112b rejections of claims 1-10 have been withdrawn.
Applicant's arguments filed 3/6/2026 regarding the 103 rejections of claims 1-10 and 15-20 have been fully considered but they are not persuasive. Applicant initially argues that Park fails to teach or suggest the shank member is bendable to allow the shank member to be bent in a horizontal direction due to the nanowires and conductive polymer layer. This is unpersuasive. The nanowires are part of the electrode sites 120, not the shank of the substrate. Park discusses that the shank of the substrate is flexible which would allow for bending of the shank ([0081]). Park further states that the substrate is made of PET ([0082]), and may be 50µm thick ([0024]). This is the same composition, thickness and properties of the claimed substrate shank (instant application [00135]). Furthermore, this is claimed functionally, rather than as a structural limitation. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the claim, then it meets the claim. Therefore, the shank of the substrate of Park is capable of bending in the same way as the claimed shank because it is stated to be flexible, made of the same materials, and is the same thickness as the shank of the instant application.
Applicants arguments regarding the Park/Kuzum combination are not persuasive. Applicant argues that Park teaches away from using graphene for the wires and points to paragraph [0101] of Park. This is not persuasive. The nanowires the applicant is referring to are part of the electrodes, not the conductors 141 which are what the combination substitutes for the wires taught by Kuzum. Paragraph [0101] simply states that conductive polymer and metal nanowire are used in place of the typical graphene. Park does not state that graphene would render the device inoperable or effect functionality, it simply states that the conductive polymer and nanowires are cheaper. The conductive polymer and metal nanowires form the electrode sites 120 as stated in paragraph [0069]. In fact, Park explicitly states that the interconnector 140, which the conductors 141 are a part of, is made of a carbon material ([0072]). Park explicitly states that the interconnector 140 is made of 1 to 10 layers of graphene ([0077]). Therefore, Park does not teach away from using graphene for the conductors 141, but rather explicitly states graphene is used for the interconnectors, thus the combination is obvious.
Applicant’s arguments regarding the limitation around the shank length have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Fedder has been used to teach the added limitation.
Applicant’s arguments regarding claims 2, and 21-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Srikantharajah and Fedder have been used to teach the added limitations.
Therefore, because the prior art still discloses the newly amended claims, the rejections to claims 1 and 15 remain. The rejections to claims 2-10 and 16-23 remain because the rejections to the independent claims remain.
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 WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794
Prosecution Insights