DETAILED ACTION
This action is pursuant to the claims filed on December 6, 2024. Claims 21-38 are pending. Claims 1-20 is/are canceled. A first action on the merits of claims 21-38 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-22 and 25 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Mercanzini et al. (hereinafter ‘Mercanzini’, U.S. PGPub. No. 2011/0301665).
In regards to independent claim 21, Mercanzini discloses a brain depth electrode device (microelectrode shaft structure 950 comprising interconnects which connect electrodes to electronics as shown in Fig. 37, [0218]) comprising:
a shaft (electrical lead 954) configured to be inserted deep within a human brain for neurostimulation and record neural activity, [0012]); and
a multi-scale electrode array (microelectrode assembly 956) disposed along a length of the shaft (the microelectrode assembly 956 is disposed along the lead 954) and configured to sense electrical activity of the brain at multiple scales using electrodes of different sizes (the assembly 956 can have various embodiments as shown in Figs. 38A-39B, where each embodiment includes a large stimulation electrode and four small electrodes for recording, [0222]-[0230]), the multi-scale electrode array including:
a plurality of macroelectrodes for sensing electrical sensing electrical activity of the brain at a first scale (four stimulating electrodes 1054 in exemplary embodiment of Fig. 39B, [0229]; [0092]: all stimulating electrodes can be used for recording neural activities); and
a respective plurality of microelectrodes arranged within each macroelectrode for sensing electrical activity of the brain at a second scale smaller than the first scale (four recording electrodes 1044 within each of the stimulating electrodes 1054, [0229]).
In regards to claim 22, Mercanzini further discloses wherein each microelectrode of the respective plurality of microelectrodes and each macroelectrode of the plurality of macroelectrodes is electrically insulated (all of the electrodes 1054 and 1052 are spaced apart along the insulative probe explained in [0086]).
In regards to claim 25, Mercanzini further discloses wherein the brain depth electrode device is configured for permanent implantation in contact with a brain of a human patient (abstract: “the neurological probe can be used to facilitate location of the neurological target and remain implanted for long-term monitoring and/or stimulation”).
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 23, 26 & 28 are rejected under 35 U.S.C. 103 as being unpatentable over Mercanzini as applied to claim 21 above.
In regards to claim 23, Mercanzini discloses substantially all the limitations of the claim(s) except further comprising a respective plurality of additional electrode within each macroelectrode of the plurality of macroelectrodes, wherein each additional electrode of the respective plurality of additional electrodes is larger than each microelectrode of the respective plurality of microelectrodes, wherein the respective plurality of additional electrodes within each macroelectrode of the plurality of macroelectrodes includes a respective first subset of additional electrode shaving a first size and a respective second subset of additional electrodes having a second size larger than the first size.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide any number of microelectrodes, since it has been held that mere duplication of essential working parts of the device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In this case, Mercanzini contemplates that “[t]he number, shape, orientation, size, and spacing of the microelectrode elements 103 of the array 104 can be defined in response to the intended neurological target” ([0083]); therefore, providing additional electrodes comprising a size that is smaller than the microelectrodes within the macroelectrodes to increase the spatial resolution of neuronal signals involves routine skill in the art.
In regards to claim 26, Mercanzini discloses substantially all the limitations of the claim(s) except for providing at least ten macroelectrodes. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide any number of macroelectrodes, since it has been held that mere duplication of essential working parts of the device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In this case, Mercanzini discloses that higher number of electrodes will increase the number of neurons that are captured by the electric field for either stimulation or inhibition ([0077]) and further increase the brain area targeted for stimulation and/or recording.
In regards to claim 27, Mercanzini discloses substantially all the limitations of the claim(s) except for the plurality of microelectrodes within each macroelectrode comprising at least 16 microelectrodes. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide any number of microelectrodes, since it has been held that mere duplication of essential working parts of the device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In this case, Mercanzini contemplates that “[t]he number, shape, orientation, size, and spacing of the microelectrode elements 103 of the array 104 can be defined in response to the intended neurological target” ([0086]); therefore, increasing the number of microelectrodes to increase the spatial resolution of neuronal signals involves routine skill in the art.
Claims 28-38 are rejected under 35 U.S.C. 103 as being unpatentable over Worrell et al. (hereinafter ‘Worrell’, U.S. PGPub. No. 2010/0292602), and further in view of Mercanzini.
In regards to independent claim 28, Worrell discloses a method of stimulating and mapping activity of a brain of a human patient ([0045]), the method comprising:
inserting a brain electrode device within the brain of the person ([0045], [0049]),
providing an electrical stimulation to the brain from a plurality of macroelectrodes ([0045], [0054]: macroelectrodes permit stimulation); and
after providing the electrical stimulation, detecting, using a plurality of microelectrodes, micro-EEGs from the brain ([0050], [0077]: continuous iEEG recordings during stimulation).
However, Worrell does not disclose the brain electrode device comprises a shaft and a multi-scale electrode array as claimed in claim 28.
Mercanzini discloses a brain depth electrode device (microelectrode shaft structure 950 comprising the interconnects that connect from electrodes to the electronics 956 in Fig. 37, [0218]) comprising:
a shaft (electrical lead 954 configured to be inserted deep within a human brain for neurostimulation and record neural activity, [0012]); and
a multi-scale electrode array (microelectrode assembly 956) disposed along a length of the shaft (the microelectrode assembly 956 is disposed along the lead 954) and configured to sense electrical activity of the brain at multiple scales using electrodes of different sizes (the assembly 956 can have various embodiments from embodiments 38A-39B, each embodiment including larger stimulation electrode and four small electrodes for recording, [0222]-[0230]), the multi-scale electrode array including:
a plurality of macroelectrodes for sensing electrical sensing electrical activity of the brain at a first scale (four stimulating electrodes 1054 in exemplary embodiment of Fig. 39B, [0229]); and
a respective plurality of microelectrodes arranged within each macroelectrode for sensing electrical activity of the brain at a second scale smaller than the first scale (four recording electrodes 1044 within each of the stimulating electrodes 1054, [0229]).
Given that the method of using a brain electrode device is generally known in the art by Worrell, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method step of Worrell and substitute the brain electrode device with the brain depth electrode device of Mercanzini to be inserted into a person’s brain for stimulating and recording neural tissue, as substituting one known brain electrode device with another known brain electrode device for commonly known methods involving recording neural activities, diagnosing based upon the neural activities and treating various neurological conditions involves routine skill in the art and a predictable result would ensue (Worrell, seizure, [0004]; Mercanzini, epilepsy, [0003]).
In regards to claim 29, Worrell/Mercanzini combination discloses recording EEGs from the brain using the one or more macroelectrodes ([0092]: stimulating electrodes can also be used for recording neural activities).
In regards to claim 30-31, Worrell/Mercanzini combination further discloses determining micro-seizures, one or more seizure loci ([0011], [0049]).
In regards to claim 32, Worrell/Mercanzini combination further discloses one or more loci based on determining the patient is having one of more of: (i) changes in pathological biomarkers recorded on the brain electrode device, (ii) micro epileptiform discharges, (iii) pathological high frequency oscillations, (iv) focal slow-wave oscillations, (v) micro DC-shifts, and (vi) micro-seizures ([0022], [0045], [0049]:epileptiform activities are detected and recorded including microseizures, DC offsets, high frequency local field oscillations, and so forth using a multiscale recording device).
In regards to claim 33, in view of the combination in claim 28, Mercanzini further discloses wherein each microelectrode of the respective plurality of microelectrodes and each macroelectrode of the plurality of macroelectrodes is electrically insulated (all of the electrodes 1054 and 1052 are spaced apart along the insulative probe explained in [0086]).
In regards to claim 34, Worrell/Mercanzini combination is silent as to a respective plurality of additional electrode within each macroelectrode of the plurality of macroelectrodes, wherein each additional electrode of the respective plurality of additional electrodes is larger than each microelectrode of the respective plurality of microelectrodes, wherein the respective plurality of additional electrodes within each macroelectrode of the plurality of macroelectrodes includes a respective first subset of additional electrode shaving a first size and a respective second subset of additional electrodes having a second size larger than the first size.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide any number of microelectrodes, since it has been held that mere duplication of essential working parts of the device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In this case, Mercanzini contemplates that “[t]he number, shape, orientation, size, and spacing of the microelectrode elements 103 of the array 104 can be defined in response to the intended neurological target” ([0086]); therefore, providing additional electrodes comprising a size that is smaller than the microelectrodes within the macroelectrodes to increase the spatial resolution of neuronal signals involves routine skill in the art.
In regards to claim 36, in view of the combination in claim 28, Mercanzini further discloses wherein the brain depth electrode device is configured for permanent implantation in contact with a brain of a human patient (abstract: “the neurological probe can be used to facilitate location of the neurological target and remain implanted for long-term monitoring and/or stimulation”).
In regards to claim 37, Worrell/Mercanzini combination is silent as to providing at least ten macroelectrodes. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide any number of macroelectrodes, since it has been held that mere duplication of essential working parts of the device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In this case, Mercanzini discloses that higher number of electrodes will increase the number of neurons that are captured by the electric field for either stimulation or inhibition ([0077]) and increasing the number of macroelectrodes would thus increase the brain area targeted for stimulation.
In regards to claim 38, in view of the combination in claim 28 above, Mercanzini discloses substantially all the limitations of the claim(s) except for the plurality of microelectrodes within each macroelectrode comprising at least 16 microelectrodes. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide any number of microelectrodes, since it has been held that mere duplication of essential working parts of the device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In this case, Mercanzini contemplates that “[t]he number, shape, orientation, size, and spacing of the microelectrode elements 103 of the array 104 can be defined in response to the intended neurological target”([0086]); therefore, increasing the number of microelectrodes to increase the spatial resolution of neuronal signals involves routine skill in the art.
Allowable Subject Matter
Claims 24 and 34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to claims 24 and 34, Mercanzini and Worrell, whether alone or in combination with another prior art, fail to disclose, teach, or suggest the claimed fractal pattern of the one or more macroelectrodes, the respective plurality of microelectrodes, and the first and second subset of additional electrodes. Mercanzini reference is only limited to additional electrodes having different sizes arranged within each macroelectrode ([0225]). However, there is no motivation to modify Worrell/Mercanzini combination to arrange the macroelectrodes and the microelectrodes to arrive at the claimed fractal pattern arrangement.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 24-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,193,825 and further in view of Mercanzini. Although the claims at issue are not identical, they are not patentably distinct from each other.
In regards to independent claim 24, Patent ‘835 claims a brain electronic device comprising a multi-scale electrode array (although not explicitly recited, the arrangement of the one or more macroelectrodes and the plurality of microelectrodes form the multi-scale electrode array) comprising a plurality of macroelectrodes and a plurality of microelectrodes within each macroelectrodes (see claim 1).
However, Patent ‘835 does not claim a shaft configured to penetrate a depth into a brain of a person.
Mercanzini teaches providing a multi-scale electrode array at an end of a shaft configured to penetrate a depth of a brain of a person (microelectrode shaft structure 950 comprising the interconnects that connect from electrodes to the electronics 956 in Fig. 37 and configured to be inserted deep within a human brain for neurostimulation and recording neural activity, [0218]). 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 multi-scale electrode array of Patent ‘835 and provide at a distal end of a shaft as taught by Mercanzini as doing to allows for inserting the device to penetrate a depth into a brain of a person for deep brain neurostimulation and sensing ([0218]).
In regards to claim 22, claim 1 of Patent ‘835 recites the same limitation of claim 22 of the instant application.
In regard to claims 23-24, claim 1 of Patent ‘835 recites the same limitation of claim claims 23 and 24 in the instant application.
In regards to claim 25, claim 3 of Patent ‘835 recites the same limitation of claim 25 of the instant application.
In regards to claim 26, claim 4 of Patent ‘835 recites the same limitation of claim 26 of the instant application.
In regards to claim 27, claim 5 of Patent ‘835 recites the same limitation of claim 27 of the instant application.
In regards to independent claim 28, Patent ‘835 claims a method of stimulating and mapping activity of a brain of a person, the method comprising:
providing an electrical stimulation to the brain from a plurality of macroelectrodes (claim 7, “providing an electrical stimulation to the brain from the one or more macroelectrodes”); and
after providing the electrical stimulation, detecting, using the plurality of microelectrodes, micro-EEGs from the brain (claim 7, “after providing the electrical stimulation, detecting, using the plurality of microelectrodes, micro-EEGs from the brain”).
However, Patent ‘835 does not claim a brain depth electrode device and inserting into the person’s brain.
Mercanzini teaches inserting a brain depth electrode device comprising a shaft and a multi-scale electrode array at an end of a shaft (microelectrode shaft structure 950 comprising the interconnects that connect from electrodes to the electronics 956 in Fig. 37 and inserted deep within a human brain for neurostimulation and recording neural activity, [0012], [0218]). 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 multi-scale electrode array of Patent ‘835 and provide along a shaft as taught by Mercanzini as doing to allows for inserting the device to penetrate a depth into a brain of a person for deep brain neurostimulation and sensing ([0218]).
In regards to claim 29, claim 8 of Patent ‘835 recites the same limitation of claim 29 of the instant application.
In regards to claim 30, claim 9 of Patent ‘835 recites the same limitation of claim 30 of the instant application.
In regards to claim 31, claim 10 of Patent ‘835 recites the same limitation of claim 31 of the instant application.
In regards to claim 32, claim 11 of Patent ‘835 recites the same limitation of claim 32 of the instant application.
In regards to claim 33, claim 7 of Patent ‘835 recites the same limitation of claim 33 of the instant application.
In regards to claim 34-35, claim 7 of Patent ‘835 recites the same limitation of claim 34-35 of the instant application.
In regards to claim 36, Mercanzini further discloses wherein the brain depth electrode device is configured for permanent implantation in contact with a brain of a human patient (abstract: “the neurological probe can be used to facilitate location of the neurological target and remain implanted for long-term monitoring and/or stimulation”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Patent ‘835 to be used for long-term deep brain implantation as taught by Mercanzini.
In regards to claim 37, Patent ‘835 does not claim wherein the plurality of macroelectrodes comprises at least ten macroelectrodes. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide any number of macroelectrodes, since it has been held that mere duplication of essential working parts of the device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In this case, Mercanzini discloses that higher number of electrodes will increase the number of neurons that are captured by the electric field for either stimulation or inhibition ([0077]) and increasing the number of macroelectrodes would thus increase the brain area targeted for stimulation.
In regards to claim 38, Patent ‘835 does not claim wherein the plurality of microelectrodes within each macroelectrode comprises at least 16 microelectrodes. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide any number of microelectrodes, since it has been held that mere duplication of essential working parts of the device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In this case, Mercanzini contemplates that “[t]he number, shape, orientation, size, and spacing of the microelectrode elements 103 of the array 104 can be defined in response to the intended neurological target”; therefore, increasing the number of microelectrodes to increase the spatial resolution of neuronal signals involves routine skill in the art.
Conclusion
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 7/13/2026
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