DETAILED ACTION
This action is pursuant to RCE filed on 7/20/2026. Claims 1-2, 7-10, 15, 18-20, 22, and 24-25 are pending, claims 3-6, 11-14, 16-17, 21, and 23 have been cancelled. Claims 24 and 25 have been newly added by the Applicant. A non-final action on the merits of claims 1-2, 7-10, 15, 18-20, 22, and 24-25 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/20/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 24 and 25 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, claims 24 and 25 introduce new subject matter not present in the original filing.
Claims 24 and 25 claim “the interval between adjacent electrode openings is greater than or equal to two times the diameter of each electrode opening and less than or equal to ten times the diameter of each electrode opening.” This range is not stated in the original filing. Throughout the specification of the instant application, the diameter of the electrodes is stated to be 10 microns. The spacing is stated to be 20, 50, or 100 micron spacing ([0049], [0083], Figs. 8A-8D). The specification of the instant application makes no mention of any other spacing distances. The claimed range includes a wide range of spacings, such as 25 microns, 30 microns, 35 microns, 40 microns, 45 microns, 55 microns, 60 microns, etc. The claimed range is much broader than the spacings provided in the original disclosure and therefore, does not have support. Additionally, the specific relationship claimed is not defined in the original disclosure. Only a single diameter is stated and only three potential spacing arrangements are given. The relationship requires the spacing to be directly related to the diameter of the openings within a defined range. This relationship is not provided in the original disclosure and thus lacks support. Therefore, claims 24 and 25 are rejected because they introduce new subject matter not present in the original filing.
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, 7-10 and 15, 18-20 and 24-25 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), in view of Fedder et al. (hereinafter ‘Fedder’, US 20130131482 A1), and in further view of Jamieson et al. (hereinafter ‘Jamieson’, US 20140018639 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]), the encapsulation layer including a plurality of electrode openings (electrode openings 151) structured to expose a portion of each of the plurality of electrode wires (expose electrodes as seen in Figs. 1, 2, and 6), wherein the plurality of electrode openings are arranged along edges of the tapered tip (the electrode openings follow along the edges of the tapered tip as seen in Figs. 1 and 2; this is consistent with Figs. 1A-1E and 8A-8B of the instant application where the electrode openings follow along the edge of the tapered tip but are spaced away from the edge by a distance), wherein adjacent electrode openings are spaced apart by an interval (spacing between openings as seen in Fig. 1), 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.
However, the Park/Kuzum/Fedder combination is silent to the spacing interval between electrode openings being greater than a diameter of each of the plurality of electrode openings.
Jamieson teaches an implantable probe for sensing in the brain ([Abstract]). The recording sites can be configured for recording neuronal electrical impulses or stimulation of electrical activity in neuronal populations, similar to the device of the Park/Kuzum/Fedder combination ([0016]). The locations of the recording sites can take many forms, as seen in Figs. 3-8. The recording sites can follow the taper of the tip as seen in Figs. 3 and 8 in a similar manner to Park. The site arrangements can vary in any pattern to make them useful for a particular target tissue or in vivo measurement ([0056]). Furthermore, as seen in Fig. 8, the electrical recording sites can be 100s of microns^2 in size with a spacing of 20-100 microns. To have an area of 100s of microns^2, the diameters of the recording sites ranges from approximately 12 microns (corresponding to an area of approximately 113 microns^2) to approximately 36 microns (corresponding to an area of approximately 1017 microns^2) since they are circular as seen in Fig. 8. Modifying the spacing of the electrodes, and in turn the openings in the encapsulation layer to ensure the electrodes remain exposed, would be a simply change in the size of the electrodes and electrode openings and/or the spaces between them. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). This change in size results in the spacing between electrodes and openings being greater than the diameter since even in the largest diameter case, the spacing can be up to 100 microns. 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 size of the electrodes and electrode openings and/or the spaces between them of the Park/Kuzum/Fedder combination as taught by Jamieson such that the spaces between openings are greater than the diameter in order to better perform in the desired use location.
While it is the examiner’s opinion that Park discloses the plurality of openings arranged along the edges of the tapered tip, as described above, Jamieson also teaches this limitation. As seen in both Figs. 3 and 8 of Jamieson, the electrode sites are arranged on the edges of the tapered tip. In Park, the electrode sites correspond to the openings in the encapsulation layer. Jamieson states that the site arrangements can vary in any pattern to make them useful for a particular target tissue or in vivo measurement ([0056]). Modifying the electrode site location is simply a change in the shape of the tip. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. 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 to the electrode sites and openings of the Park/Kuzum/Fedder/Jamieson combination to follow the edges of the tip in order to better perform in the desired use location.
Regarding claim 7, the Park/Kuzum/Fedder/Jamieson 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/Jamieson 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/Jamieson 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/Jamieson 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/Jamieson 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 a plurality of electrode openings (electrode openings 151 in Fig. 1) structured to expose a portion of each of the plurality of 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]) wherein the plurality of electrode openings are arranged along edges of the tapered tip (the electrode openings follow along the edges of the tapered tip as seen in Figs. 1 and 2; this is consistent with Figs. 1A-1E and 8A-8B of the instant application where the electrode openings follow along the edge of the tapered tip but are spaced away from the edge by a distance), wherein adjacent electrode openings are spaced apart by an interval (spacing between openings as seen in Fig. 1), wherein:
the flexible substrate is bendable 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 flexible substrate having a length that is selected to provide a particular stiffness for insertion of the microelectrode array 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 of the flexible substrate to prevent buckling during tissue insertion without the need for an additional stiffener.
However, the Park/Kuzum/Fedder combination is silent to the spacing interval between electrode openings being greater than a diameter of each of the plurality of electrode openings.
Jamieson teaches an implantable probe for sensing in the brain ([Abstract]). The recording sites can be configured for recording neuronal electrical impulses or stimulation of electrical activity in neuronal populations, similar to the device of the Park/Kuzum/Fedder combination ([0016]). The locations of the recording sites can take many forms, as seen in Figs. 3-8. The recording sites can follow the taper of the tip as seen in Figs. 3 and 8 in a similar manner to Park. The site arrangements can vary in any pattern to make them useful for a particular target tissue or in vivo measurement ([0056]). Furthermore, as seen in Fig. 8, the electrical recording sites can be 100s of microns^2 in size with a spacing of 20-100 microns. To have an area of 100s of microns^2, the diameters of the recording sites ranges from approximately 12 microns (corresponding to an area of approximately 113 microns^2) to approximately 36 microns (corresponding to an area of approximately 1017 microns^2) since they are circular as seen in Fig. 8. Modifying the spacing of the electrodes, and in turn the openings to ensure the electrodes remain exposed, would be a simply change in the size of the electrodes and electrode openings and/or the spaces between them. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). This change in size results in the spacing between electrodes and openings being greater than the diameter since even in the largest diameter case, the spacing can be up to 100 microns. 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 size of the electrodes and electrode openings and/or the spaces between them of the Park/Kuzum/Fedder combination as taught by Jamieson such that the spaces between openings are greater than the diameter in order to better perform in the desired use location.
While it is the examiner’s opinion that Park discloses the plurality of openings arranged along the edges of the tapered tip, as described above, Jamieson also teaches this limitation. As seen in both Figs. 3 and 8 of Jamieson, the electrode sites are arranged on the edges of the tapered tip. In Park, the electrode sites correspond to the openings in the encapsulation layer. Jamieson states that the site arrangements can vary in any pattern to make them useful for a particular target tissue or in vivo measurement ([0056]). Modifying the electrode site location is simply a change in the shape of the tip. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. 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 to the electrode sites and openings of the Park/Kuzum/Fedder/Jamieson combination to follow the edges of the tip in order to better perform in the desired use location.
Regarding claim 18, the Park/Kuzum/Fedder/Jamieson 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/Jamieson 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/Jamieson 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/Jamieson 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 24, the Park/Kuzum/Fedder/Jamieson combination discloses the microelectrode array of claim 1. The combination further teaches that the diameter can range from approximately 12 microns to 36 microns and the spacing can range from 20 microns to 100 microns as explained above and taught in Fig. 8 of Jamieson. This encompasses the majority of the claimed range. Jamieson further teaches that the site arrangements can vary in any pattern to make them useful for a particular target tissue or in vivo measurement ([0056]).
However, the combination exactly disclose the interval between adjacent electrode openings being greater than or equal to two times the diameter of each electrode opening and less than or equal to ten times the diameter of each electrode opening.
It would have been an obvious matter of design choice to make the interval between adjacent electrode openings greater than or equal to two times the diameter of each electrode opening and less than or equal to ten times the diameter of each electrode opening, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Additionally, the instant application does not provide any criticality to this spacing and Jamieson teaches that the electrode sites can be modified in any way to fit the desired use case.
Regarding claim 25, the Park/Kuzum/Fedder/Jamieson combination discloses the microelectrode array of claim 15. The combination further teaches that the diameter can range from approximately 12 microns to 36 microns and the spacing can range from 20 microns to 100 microns as explained above and taught in Fig. 8 of Jamieson. This encompasses the majority of the claimed range. Jamieson further teaches that the site arrangements can vary in any pattern to make them useful for a particular target tissue or in vivo measurement ([0056]).
However, the combination exactly disclose the interval between adjacent electrode openings being greater than or equal to two times the diameter of each electrode opening and less than or equal to ten times the diameter of each electrode opening.
It would have been an obvious matter of design choice to make the interval between adjacent electrode openings greater than or equal to two times the diameter of each electrode opening and less than or equal to ten times the diameter of each electrode opening, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Additionally, the instant application does not provide any criticality to this spacing and Jamieson teaches that the electrode sites can be modified in any way to fit the desired use case.
Claim(s) 2 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over the Park/Kuzum/Fedder/Jamieson 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/Jamieson 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/Jamieson 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 regarding the objections to the drawings have been fully considered and are persuasive in light of claims 21 and 23 being cancelled. The drawing objections regarding the micromanipulator pads have been withdrawn.
Applicant’s arguments regarding the 112b rejections of claims 21 and 23 have been fully considered and are persuasive in light of claims 21 and 23 being cancelled. The 112b rejections of claims 21 and 23 have been withdrawn.
Applicant’s arguments regarding claim 1 have been fully considered but are not persuasive.
Applicant initially argues that Park does not disclose any relationship between the diameter of the openings 151 and the spacing between the openings. These arguments 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, Jamieson is used to teach the relationship between opening diameter and spacing.
Applicant’s arguments that the combination of record does not teach the openings arranged along the edges of the tapered tip are not persuasive. The openings 151 of Park follow the tapered edge of the tip as seen in Fig. 1. This is consistent with all of the drawings of the instant application. The openings follow along close to the edge, but do not directly touch the edge of the tapered tip. Additionally, Jamieson teaches this limitation and for the purposes of advancing prosecution, the rejection is included above.
Therefore, the prior art discloses the amended claims 1 and 15 and the rejections to claims 1 and 15 remain. The rejections to claims 2, 7-10, 18-20, and 22 remain because the rejections to the independent claims remain and the prior art as applied to those claims was not specifically challenged by the applicant.
New claims 24 and 25 are rejected for the reasons stated above.
Conclusion
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.
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.
/W.M./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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