DETAILED ACTION
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 .
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 8, 11-14, 16, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Bernard (US 5,873,849, hereinafter “Bernard”) in view of Heller et al. (US 6,778,853, hereinafter “Heller”).
In regards to claims 1, 11 and 20, Bernard discloses a system/method/computer-readable medium comprising: memory configured to store parameters defining electric field therapy configured to treat cancer of a patient (col. 6, lines 7-28); and processing circuitry configured to control an implantable medical device (col. 6, lines 49-64; col. 8, lines 30-37) to deliver the electric field therapy according to the parameters by controlling the implantable medical device to deliver in an alternating sequence, at least a first electric field between an electrode of a first adjacent lead pair and a second electric field between an electrode of a second adjacent lead pair, wherein a plurality of implantable leads comprises the first the first adjacent lead pair and the second adjacent lead pair (e.g., Fig. 12), wherein the plurality of implantable leads are disposed in tissue adjacent to a resection cavity of the patient (col. 7, lines 40-54). Although Bernard implies that the lead pairs each comprise multiple electrodes (col. 5, lines 34-38, “[o]ptionally, there can be a plurality of conductive and non-conductive regions established in the electrode 34”; and lines 61-63, “effective electrode length established by the conductive region(s)”), Bernard does not expressly and explicitly disclose that the plurality of implantable leads each comprise two or more electrodes and controlling the device to deliver the fields between multiple electrodes of the lead pairs. However, Heller in the same field of endeavor of electrical therapy for electroporation to provide a plurality of implantable leads each comprising two or more electrodes (Figs. 4 and 6) and controlling the device to deliver the fields between multiple electrodes of the lead pairs (col. 3, lines 43-46; col. 5, lines 1-5; col. 6, lines 20-45; claim 10) to provide the predictable results of more accurate and precise three-dimensional control of the electric field (col. 3, lines 1-6; col. 6, lines 33-45). 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 Bernard by providing a plurality of implantable leads each comprising two or more electrodes and controlling the device to deliver the fields between multiple electrodes of the lead pairs to provide the predictable results of more accurate and precise three-dimensional control of the electric field.
In regards to claims 2 and 12, Bernard’s invention as modified above discloses the processing circuitry is configured to control the implantable medical device to deliver the electric field therapy by at least controlling the implantable medical device to deliver the alternating sequence of the first and second electric fields between at least two electrodes of each lead in each of the first adjacent lead pair and the second adjacent lead pair of the plurality of implantable leads (Fig. 12, col. 8, lines 17-38, col. 10, lines 17-25; alternating as in alternating between combinations 1, 2 and 3) to provide the same predictable results as set forth above.
In regards to claim 3, Bernard’s invention as modified above discloses the processing circuitry is configured to control the implantable medical device to deliver the electric field therapy by at least controlling the implantable medical device to deliver the alternating sequence of the first and second electric fields by at least controlling the implantable medical device to deliver, in the alternating sequence of the first and second electric fields, at least a third electric field between multiple electrodes of a third lead pair disposed across the resection cavity, the plurality of implantable leads comprising the third lead pair (Fig. 12, col. 8, lines 17-38, col. 10, lines 17-25) to provide the same predictable results as set forth above.
In regards to claims 4 and 13, Bernard’s invention as modified above, to alternate sequence of the first electric field and the second electric field, the processing circuitry is configured to control the implantable medical device to interleave delivery of the first electric field with the second electric field between the first adjacent lead pair and the second adjacent lead pair (Fig. 12, col. 8, lines 17-38, col. 10, lines 17-25; all of the positive and negative electrodes apply signals interleaved with each other in space and are interleaved with other in time between combinations 1, 2 and 3) to provide the same predictable results as set forth above.
In regards to claims 5 and 14, the plurality of implantable leads comprises at least six implantable leads (e.g., Fig. 12), wherein the processing circuitry is configured to deliver, in the alternating sequence, a plurality of electric fields from respective adjacent lead pairs of the at least six implantable leads, wherein the respective adjacent lead pairs comprises the first adjacent lead pair and the second adjacent lead pair (Fig. 12; col. 10, lines 18-25).
In regards to claim 8, the system further comprises a spacer (Fig. 7; col. 7, lines 23-39), wherein the plurality of implantable leads are configured to be positioned such that a first lead of the plurality of implantable leads is positioned with respect to a second lead of the plurality of implantable leads via a spacer through which the first lead is inserted (Fig. 7, center electrode), wherein the spacer comprises at least one flange extending radially outward from a channel of the spacer through which the first lead is disposed (flange portions extending outward to each of the peripheral electrodes), the at least one flange extending radially outward a distance corresponding to a target distance between the first lead and the second lead (Fig. 7).
In regards to claim 16, the method further comprises implanting the plurality of implantable leads through at least a portion of tissue defining the resection cavity (col. 7, lines 40-54, Fig. 16).
In regards to claim 18, implanting the plurality of implantable leads comprises implanting the plurality of implantable leads such that at least one electrode carried by the plurality of implantable leads is positioned within the resection cavity (Fig. 16, col. 7, lines 40-54, “into the peripheral regions of the cavity”).
Claims 6, 7, 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bernard and Heller, and further in view of Duijsens et al. (US 2015/0142090, hereinafter “Duijsens”). Bernard discloses the essential features of the claimed invention except for wherein the processing circuitry is configured to control the implantable medical device to deliver the electric field therapy by at least controlling a multiplexer separate from the implantable medical device to select subsets of leads from the plurality of implantable leads for respective electric fields of the electric field therapy, wherein the plurality of implantable leads are coupled to the multiplexer, and wherein the multiplexer is coupled to the implantable medical device via few conductors than the plurality of implantable medical leads coupled to the multiplexer; the system further comprising the implantable medical device, and wherein the implantable medical device is configured to receive operational power wirelessly from an external power device, wherein the implantable medical device comprises the processing circuitry. However, Duijsens in the same field of endeavor of electrical stimulation of the brain teaches wherein the processing circuitry is configured to control the implantable medical device to deliver the electric field therapy by at least controlling a multiplexer separate from the implantable medical device to select subsets of leads from the plurality of implantable leads for respective electric fields of the electric field therapy, wherein the plurality of implantable leads are coupled to the multiplexer, and wherein the multiplexer is coupled to the implantable medical device via fewer conductors than the plurality of implantable medical leads coupled to the multiplexer (par. 0084) to provide the predictable results of allowing the lead to include fewer conductors than electrodes, while allowing each of the electrodes to be independently activated (par. 0084); the system further comprising the implantable medical device, and wherein the implantable medical device is configured to receive operational power wirelessly from an external power device (par. 0070) to provide the predictable results of use with a rechargeable battery to allow extended operation (par. 0070); and the system further comprising the implantable medical device, wherein the implantable medical device comprises the processing circuitry (pars. 0028, 0029) to provide the predictable results of the ability to treat a variety of conditions at a variety of locations without wires entering/exiting the patient’s body (pars. 0028, 0029, 0070). 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 Bernard by providing processing circuitry that is configured to control the implantable medical device to deliver the electric field therapy by at least controlling a multiplexer separate from the implantable medical device to select subsets of leads from the plurality of implantable leads for respective electric fields of the electric field therapy, wherein the plurality of implantable leads are coupled to the multiplexer, and wherein the multiplexer is coupled to the implantable medical device via fewer conductors than the plurality of implantable medical leads coupled to the multiplexer to provide the predictable results of allowing the lead to include fewer conductors than electrodes, while allowing each of the electrodes to be independently activated; the system further comprising the implantable medical device, and wherein the implantable medical device is configured to receive operational power wirelessly from an external power device to provide the predictable results of use with a rechargeable battery to allow extended operation; and the system further comprising the implantable medical device, wherein the implantable medical device comprises the processing circuitry to provide the predictable results of the ability to treat a variety of conditions at a variety of locations without wires entering/exiting the patient’s body.
Claims 9 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bernard and Heller, and further in view of Duijsens and Sauter-Starace et al. (US 2010/0161018, hereinafter “Sauter-Starace”). Bernard’s modified invention discloses the essential features of the claimed invention, except for the system further comprising primary fixation configured to secure each lead of the plurality of implantable leads to brain tissue of the patient and secondary fixation configured to secure each lead of the plurality of implantable leads to a skull of the patient, wherein the secondary fixation comprises a structure defining a plurality of curved channels configured to retain respective individual leads of the plurality of implantable leads via a friction fit. However, Duijsens in the same field of endeavor of brain electrodes teaches providing a system further comprising primary fixation configured to secure each lead to brain tissue of the patient (par. 0234) to provide the predictable results of actively or passively securing a lead in an implantation location thus avoiding lead migration (par. 0234) and secondary fixation configured to secure each lead to a skull of the patient (par. 0060) to provide the predictable results of fixing and directing the lead through the skull interface and minimizing the number of conductors for multiple leads (par. 0060). Further, Sauter-Starace in the same field of endeavor of brain stimulation teaches providing a fixation structure wherein the fixation comprises a structure defining a plurality of curved channels configured to retain respective individual leads of the plurality of implantable leads via a friction fit (Figs. 2, 4A and 4B; see the curved channels of Fig. 4B in its “locked” state) to provide the predictable results of a securing device that can simply and reproducibly secure one or, as is preferable, several leads (for example in the range 1 to 10, typically 4 or 5) that critically need to be positioned relative to targets having millimeter-scale dimensions (par. 0008). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Bernard by providing a system further comprising primary fixation configured to secure each lead to brain tissue of the patient to provide the predictable results of actively or passively securing a lead in an implantation location thus avoiding lead migration and secondary fixation configured to secure each lead to a skull of the patient to provide the predictable results of fixing and directing the lead through the skull interface and minimizing the number of conductors for multiple leads, wherein the fixation comprises a structure defining a plurality of curved channels configured to retain respective individual leads of the plurality of implantable leads via a friction fit to provide the predictable results of a securing device that can simply and reproducibly secure one or, as is preferable, several leads (for example in the range 1 to 10, typically 4 or 5) that critically need to be positioned relative to targets having millimeter-scale dimensions.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Bernard and Heller, and further in view of Hendricks (US 2024/0173546, hereinafter “Hendricks”). Bernard discloses the essential features of the claimed invention, but does not expressly disclose wherein implanting the plurality of implantable leads comprises implanting the plurality of implantable leads such that each electrode of each implantable lead of the plurality of implantable leads is surrounded by the tissue defining the resection cavity. However, Hendricks in the same field of endeavor of electrical stimulation of resection cavities teaches implanting a plurality of implantable leads comprising implanting the plurality of implantable leads such that each electrode of each implantable lead of the plurality of implantable leads is surrounded by the tissue defining the resection cavity (Fig. 2) to provide the predictable results of leads that conform to the target tissue and allow more precise control of both electric field strength and orientation (par. 0024). 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 Bernard by teaches implanting a plurality of implantable leads comprising implanting the plurality of implantable leads such that each electrode of each implantable lead of the plurality of implantable leads is surrounded by the tissue defining the resection cavity to provide the predictable results of leads that conform to the target tissue and allow more precise control of both electric field strength and orientation.
Response to Arguments
Applicant's arguments filed 10/14/2025 have been fully considered but they are not persuasive in part and moot in part. Applicant argued that (i) Bernard is not disclosed as treating cancer of a patient, (ii) does not apply stimulation between lead pairs (but instead applies stimulation in a series of triangles), or (iii) that the leads comprise at least two electrodes. In regards to the first argument, Bernard discloses at column 6, lines 7-28 that the electrical stimulation is used to treat cancer (“delivery of electrical waveforms in vivo to patients expected to benefit from such treatment…particularly chemotherapeutic treatment of brain tumors”). This appears to fall squarely within the scope of “to treat cancer of a patient” per paragraph 0058 of Applicant’s disclosure (“the therapy delivered by IMD 106 is designed to enhance and/or enable cell membrane permeabilization for the purpose of mediating cell transfection by enhancing viral delivery to target cells, enhancing the bioavailability of serologically available pharmaceuticals, enhancing the delivery of tumor-specific marker agents, such as 5-aminolevulinic acid (5-ALA), or for combinatorial efficacy with additional therapy modalities through imparting cellular stress on those cells selectively vulnerable to permeabilization”). It is further noted that claim 20 does not include this limitation. In regards to the second argument, the claims do not appear to preclude the provision of a third field, and claim 3 appears to expressly include such an embodiment. The fields provided in Figure 12 of Bernard are performed in succession and deliver a first and second fields between adjacent lead pairs in a sequence (col. 12, line 62 to col. 13, line 2) in the form of a bipolar oscillating pulse train (col. 8, line 54). In regards to the third argument, please see the new rejection, necessitated by amendment in view of Heller.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schulte et al. (US 2005/0182464) is another example of a cranial fixation structure with curved channels for a friction fit.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792