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 .
Status of Claims
Claims 1-14 are currently pending and under examination. As per the amendments filed on 02/17/2026, claims 1-2, 6, and 10 are amended.
Response to Arguments
Applicant's arguments, see Remarks page 8 (Claim Objections), filed 02/17/2026, with respect to the objection of claim 6 have been fully considered and are persuasive. Therefore, the objection to claim 6 is withdrawn. There is no 35 U.S.C. § 112 rejection of claim 6 to reconsider.
Applicant's arguments, see Remarks pages 8-9 (35 U.S.C. § 101), filed 02/17/2026, with respect to the rejections of Claims 1-14 under 35 USC § 101 been fully considered. Regarding claims 1 and 10, Applicant argues:
The Office asserts that the claimed subject matter is directed to or encompassing a human organism (Office Action, Section 9, Page 3, Line 15 through Page 4, Line 2. Claim 1 has been amended to recite a preamble that includes a "movement monitor sensor, configured to be disposed in a human brain, suitable to connect a processor," as suggested by the Office in the Office Action (Section 9, Page 3, Lines 18-21), to remedy this rejection.
Claim 10 is likewise amended to recite that the "the first surface of the substrate is furnished with a fixing part configured to be disposed at a head bone of the human wherein the brain tissue is located under the head bone of the human," in accordance with the Office interpretation that the fixing part is configured to be positioned at a head bone of the human, without requiring the head bone of the human to be encompassed by the claimed invention. In light of the amendments and explanations above, Applicant respectfully requests that the Office withdraw its rejections predicated upon 35 U.S.C. §101 and issue favorable reconsideration. (02/17/2026 Remarks, Pages 8-9)
These arguments are persuasive because the brain and head bone are no longer being claimed. Therefore, the 35 U.S.C. § 101 rejections of claims 1-14 are withdrawn.
Applicant's arguments, see Remarks pages 9-15 (35 U.S.C. § 103), filed 02/17/2026, with respect to the rejections of Claims 1-14 under 35 USC § 103 been fully considered. Regarding claim 1, Applicant argues:
The current amendments are fully supported by the originally filed specification, inter alia, Paragraphs [0050]-[0059], and [0068]. The currently claimed invention includes the express provision for at least one depth electrode set each having a plurality of depth electrodes, and a flat electrode set having a plurality of flat electrodes as depicted, inter alia, in FIGS. 1-3 of the originally filed specification. The invention measures impedance variation measured between the depth electrodes and a corresponding flat electrode facing in the same direction or the conduction area that is centrally located on the axis of the sensor, as depicted and described in the originally filed specification, inter alia, FIGS. 5-6 and Paragraphs [0048][0054]. That is, there are four directions of the sensor and there are at least two electrodes facing in each direction in which to measure impedance variation, in addition to the centrally located conductive area.
Importantly, there is claimed at least one depth electrode set, each having numerous depth electrodes, e.g., one, two, three, four, or more groups, that form multiple electrode groups composed of a depth electrode and a corresponding flat electrode or conductive area electrode (inter alia, Paragraph [0071]). The number of specific electrodes of the claimed and described sensor can be flexibly adjusted according to practical requirements, (inter alia, Paragraphs [0035], [0071]). The "pairing" of each depth electrode with the conductive area or a corresponding flat electrode provides the measurement of the impedance variation of the brain tissue in which the sensor is placed (inter alia, FIGS. 1-6, and Paragraph [0048]. Further, "pairs" of these sensor pairs may extend opposite to each other with respect to the central axis as described in Paragraph [0034] and claimed in dependent claim 6. As the sensor (and brain tissue) moves, the sensor detects these directional impedance variations according to the configuration of these electrode sets, enabling the invention to control electrical stimulation of the brain tissue (inter alia, Paragraph [0049]-[0051]). (02/17/2026 Remarks, Pages 12-13)
Applicant compares this with the prior art
Osorio is admitted to fail to disclose or suggest that when a movement of a human changes, the processor evaluates and compares impedance variations generated by the at least one depth electrode set, the flat electrode set or the conduction area to determine corresponding electrical stimulation control upon brain tissue of the human (Office Action, Section 35, Page 13, Line 18 through Page 14, Line 2).
Steinke fails to disclose impedance variations, and this, fails to disclose or suggest evaluating and comparing impedance variations to determine a corresponding electrical stimulation control upon brain tissue of a human.
Both Osorio and Steinke, individually or in combination, is unable to compare impedance differences in different directions to determine a corresponding electrical stimulation control of brain tissue of a human.
King is cited to disclose the measurement of impedance between electrodes to provide information about how electrical current flows through tissue, where stimulation amplitude is adjusted based on changes to impedance (Office Action, Section 17, Page 7, Lines 1-3). King specifically measures impedance to "eliminate" the effects of displacement (considered as noise) to stabilize treatment (inter alia, Paragraphs [0058][ 0063]); King also fails to teach or suggest the provision for evaluating and comparing impedance variations to determine a corresponding electrical stimulation control. (02/17/2026 Remarks, Pages 13-14)
These arguments are not persuasive. The claim 1 obviousness rejection uses a combination of Osorio in view of Steinke and King as prior art. As the primary reference, Osorio provides a general structure of a device with both depth (Figure 6D, Col 8, Lines 30-36) and flat (e.g. cortical, Figure 6F, Col 8, Lines 46-54) electrodes where electrodes are connected with conductive wires (Col 13, Col 4-17). Osorio’s depth electrodes are depicted as wrapping the lead’s surface around the longitudinal axis. Steinke teaches the use of segmented depth electrodes to establish directionality of stimulation ([0049]) where either unsegmented or segmented electrodes can be used in the depth electrode (Figs. 3A-3D) and both types of electrodes are recognized for use in the field ([0003-0004]). A depth electrode set is interpreted as segmented electrodes at the same depth which would be able to form a ring around the circumference of the lead.
King is relied on to teach the limitations related to impedance as a tool for assessing changes in settings caused by patient movement, which cause displacement of the electrodes. The instant claim 1 limitation in question is:
wherein, when a movement of a human changes, the processor evaluates and compares impedance variations generated by two or more depth electrodes of the same at least one depth electrode set, the flat electrode set or the conduction area to determine a corresponding electrical stimulation control upon brain tissue of the human.
King teaches “the measurement of impedance changes between the stimulation electrodes or neighboring electrodes provides a relative quantitative measure of the electrode array's theoretical
effectiveness in providing therapeutic stimulation […] knowledge of the measured impedance with
respect to time allows for the system to effectively auto correct the output amplitude, thereby minimizing the occurrence of over-stimulation or under-stimulation” ([0011]), where a comparison of impedance changes over time between electrodes is further discussed in [0041]. King further teaches postural changes are indicated as a source of impedance changes ([0010]). The application of impedance measurements to neighboring electrodes in Osorio in view of Steinke to assess changes in lead position and alter settings to promote more efficacious stimulation is interpreted as teaching on the plain meaning of claim 1 limitation, particularly given the generalized nature of the evaluation and comparison as described in claim 1. Therefore, the prior art rejection of claim 1 is maintained.
Applicant additionally argues (which appears to be most relevant to instant claims 7-9):
In summary, the present invention utilizes impedance changes to actively detect motion actions (as signals) to control electrical stimulation of the brain tissue. One feature is vertical correspondence between "planar electrodes" and "deep electrodes" in orthogonal directions in order to detect the deformation of brain tissue caused by motion. King, even in conjunction with both Osorio and Steinke, fails to disclose or suggest combining ''planar" and "deep" electrode signals and impedance variations so as to perform impedance comparison in a specific direction.
Bradley is relied upon to disclose multiple electrode sets using comparisons to measure directional impedance (Office Action, Section 38, Page 14, Linc 21-23). However, Applicant notes that Bradley only has comparisons within a single lead, implementing a hard threshold to determine whether impedance difference is significant enough to reposition the lead (inter alia, Paragraph [0012)-[0015], [0063]). This displays a lacks of Bradley to disclose or suggest a "planar to depth" comparison path, parallel to the claimed invention.
Dayeh is relied upon to disclose a substrate surface furnished with a microstructure for penetrating electrodes for use in an electrode sensor array facing the cortical surface of the brain (Office Action, Section 30, Page 11, Line 20 through Page 12, Line 3).
Peterson is relied upon to disclose a burr hole cap placed in a skull that anchors stimulation leads to the brain (Office Action, Section 52, Page 20, Line 19 through Page 21, Line 6).
McLaughlin is relied upon to disclose an electrode array containing a seamless substrate containing electrodes (Office Action, Section 59, Page 23, Line 20 through Page 24, Line 11).
None of this prior art can be reasonably held, either alone or in combination, even if such a combination was properly motivated and realizable, in arguendo, to disclose or suggest evaluation and comparing impedance differences in different directions to determine a corresponding electrical stimulation control of brain tissue of a human.
Therefore, for at least these reasons discussed above, Applicant respectfully submits that the cited references, combined or individually, do not disclose every recited limitation in claim 1 as required under 35 USC §103; hence, Applicant respectfully requests the Office to withdraw the rejection over claim 1 accordingly, and to issue favorable re-consideration. (02/17/2026 Remarks, Pages 14-15)
These arguments are not persuasive. As previously discussed, Osorio discloses the general structure of a stimulation device with both depth (Figure 6D, Col 8, Lines 30-36) and flat (e.g. cortical, Figure 6F, Col 8, Lines 46-54) and Steinke teaches the use of segmented depth electrodes to establish directionality of stimulation ([0049]). Bradley teaches a plurality of segmented electrode sets ([0010]) which use comparisons between pairs of electrodes to measure directional impedance ([0046]). Electrode pairs are established between various combinations of electrodes or conductors to receive the return signal:
To facilitate determination of the location of each neurostimulation lead 12, electrical signals can be transmitted between electrodes carried by one of the neurostimulation leads 12 and one or more other electrodes (e.g., electrodes on the same neurostimulation lead 12, electrodes on the other neurostimulation lead 12, the case 40 of the IPG 14, or an electrode affixed to the tissue), and then electrical impedance can be measured in response to the transmission of the electrical signals. [0046]
In this case, the electrode pairs are not limited to combination along a single lead, but can interact with electrodes on other leads, electrodes on the body, or conductive elements more proximal to the segmented depth electrodes such as the pulse generator casing. The directional system in Bradley can be used as part of deep brain or cortical stimulation ([0030]), suggesting the same principles exist between electrodes for both applications and that the same directional impedance analysis would be known as able to be applied between aligned electrode pairs (such as the cortical contacts in Osorio and segmented deep brain stimulation depth electrodes in Osorio in view of Steinke). This analysis is further described in Bradley as determining movement in lead position by comparing changes between impedances from electrode pairs oriented to face different directions ([0075] – the positional changes of the electrodes are used to change electrode stimulation settings). Therefore, the prior art rejections of claims 1 and 7-9 are maintained.
Regarding claims 2-14, Applicant argues:
Claims 2-14 depend directly or indirectly from independent claim 1; thus claims 2-14 incorporate every limitation expressly recited in their respective independent claim. For at least the same reasons stated above, in addition to the further limiting subject matter presented therein, Applicant respectfully requests the Office to withdraw the rejection over claims 2-14, and to issue favorable re-consideration.
This argument is not persuasive because the arguments addressing the rejection of independent claim 1 were not found to be persuasive. Therefore, the prior art rejections of claims 2-14 are maintained.
Summary: The 35 U.S.C. § 103 rejections for claims 1-14 are maintained.
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, 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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-3, 6, 12, and 14 are rejected under U.S.C 103 as being unpatentable over Osorio (US 7,551,951 B1) in view of Steinke (US PG Pub 2018/0280698 A1) and King (US PG Pub 2007/0208394 A1).
Regarding Claim 1, Osorio discloses a movement monitor sensor (Col 5, Lines 17-36 – three-dimensional localizations of signals to modulate brain stimulation), disposed in a human brain (Figure 6C, Col 8, Lines 25-29 – device placed in brain), suitable to connect a processor (Col 11, Lines 50-57 – control unit for determining stimulation), comprising:
• a body, having an axis and two axial ends along the axis and opposite to each other (Figure 6C, Col 10, Lines 28-49 - Shaft Portion 24 has two axial ends along a longitudinal axis);
• a conduction area, disposed at one of the two axial ends, connected with a conductive wire (Col 10, Lines 1-27 – the sensing and stimulation elements are connected to conductors contained within the shaft portion; Figures 6D-6E, Col 8, Lines 30-45 – a stimulating contact surface 36 is depicted at the distal end of the lead; Col 13, Col 4-17 – describes the use of wires connecting to the electrode contacts);
• at least one depth electrode set, each including a plurality of depth electrodes disposed on a surface of the body by surrounding the axis (Figure 6D, Col 8, Lines 30-36 – four depth electrodes 36 with contact surfaces wrapped around the longitudinal axis separated by three insulators 38 are depicted);
• a flat electrode set, including a substrate and a plurality of flat electrodes (Figure 6F – six flat electrodes depicted; Col 8, Lines 46-54 – multiple flat electrode contacts on the lower surface of disk 22’s substrate) the substrate having oppositely a first surface and a second surface (Figure 6F – disk 22 has top and bottom surfaces), the second surface being disposed at one of the two axial ends opposite to the conduction area (Figure 6F – the lower surface is disposed at the proximal end of shaft 24), each of the plurality of flat electrodes being disposed at the substrate by surrounding the axis to correspond individually to one of four directions (Figure 6F – provides an example of six contacts in a circular arrangement; Col 10, Lines 7-27 – describes one or more contacts can be used where a circular arrangement of four contact electrodes on the lower surface of disk 22 is a possible configuration), each of the plurality of flat electrodes being connected with a second wire (Figure 6F, Col 8, Lines 46-54 – independent conductors, wires 26, connect with each contact surface)
wherein the conductive wire, the first wires and the second wires are individually connected electrically with the conduction area, the depth electrodes and the flat electrodes (Col 10, Lines 1-27 – the sensing and stimulation elements are connected to conductors contained within the shaft portion).
However, Osorio does not disclose (1) a plurality of depth electrodes being distributed to a respective one of the four directions, each of the plurality of depth electrodes being connected with a first wire; and (2) wherein, when a movement of a human changes, the processor evaluates and compares impedance variations generated by two or more depth electrodes of the same at least one depth electrode set, the flat electrode set and/or the conduction area to determine a corresponding electrical stimulation control upon brain tissue of the human.
Steinke, in the same field of endeavor of neurostimulation using depth electrodes (Figures 3A-3D, [0053]), teaches a plurality of segmented electrode rings where a ring can be separated into four segmented electrodes disposed around the circumference of the lead ([0049]). Segmented electrodes are used to impart directionality of stimulation and sensing in a manner not achievable with ring electrodes ([0041]). The alignment of the four directions of the cortical contacts in Osorio and the four directions of the segmented deep brain electrodes in Steinke (as a modification of the ring electrodes in Osorio) would be seen as an obvious configuration given the benefits of directional stimulation described in Steinke ([0004]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Osorio’s deep brain stimulation depth electrodes by incorporating the segmented electrodes in Steinke. This would have been obvious because both Osorio and Steinke discuss deep brain stimulation using depth electrodes and Steinke provides a solution/improvement to create steerable and directional stimulation and sensing. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Osorio by incorporating the segmented depth electrodes in Steinke.
King, in the same field of endeavor of neurostimulation ([0002]), teaches the measurement of impedance between electrodes provides information about how electrical current flows through tissue, where stimulation amplitude can be adjusted based on changes to impedance ([0011]). This arrangement is used to modulate potentially painful variations in stimulation from “postural change,
lead array movement, or scar tissue maturation” which cause impedance changes ([0010]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Osorio’s deep brain stimulation electrodes by incorporating the impedance feedback system to account for electrode migration or movement in King. This would have been obvious because both Osorio and King discuss neurostimulation and King provides a solution/improvement to adjust stimulation in response to measured changes in electrical properties between electrodes to mitigate variations which may painful to the patient. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Osorio by incorporating the impedance feedback system to account for electrode migration or movement in King.
Therefore, Claim 1 is obvious over Osorio in view of Steinke and King.
Regarding Claim 2, the movement monitor sensor according to Claim 1 is obvious over Osorio in view of Steinke and King. Osorio further discloses wherein the substrate has a central through hole extending in parallel to the axis (Figure 6D – a hole containing conductors 26 along the longitudinal axis), and the plurality of flat electrodes surround the central through hole (Figure 6F – provides an example of six contacts in a circular arrangement around the hole; Col 10, Lines 7-27 – describes one or more contacts can be used where a circular arrangement of four contact electrodes on the lower surface of disk 22 is a possible configuration).
Therefore, Claim 2 is obvious over Osorio in view of Steinke and King.
Regarding Claim 3, the movement monitor sensor according to Claim 2 is obvious over Osorio in view of Steinke and King. Osorio further discloses wherein the first wires, the second wires and the conductive wire are individually extended from the body to an exterior via the central through hole of the substrate (Figure 6D – a hole in disk 22 containing conductors 26 along the longitudinal axis; Col 9, Lines 45-48 – conductors can be wires; Col 10, Lines 1-27 – the sensing and stimulation elements are connected to conductors contained within the shaft portion).
Therefore, Claim 3 is obvious over Osorio in view of Steinke and King.
Regarding Claim 6, the movement monitor sensor according to Claim 1 is obvious over Osorio in view of Steinke and King. Osorio discloses depth electrodes 36 with contact surfaces wrapped around the longitudinal axis separated by insulators 38 (Figure 6D, Col 8, Lines 30-36) and the lower surface of disk 22 contains electrode contacts (Col 10, Lines 22-27) to be positioned onto the cortical surface of the brain (Col 11, Lines 65-67 and Col 12, Lines 1-8). The disk contacts are circumferential distributed around the longitudinal axis (such as using four electrodes) and therefore given directionality (Figure 6F – provides an example of six contacts in a circular arrangement; Col 10, Lines 7-27 – describes one or more contacts can be used where a circular arrangement of four contact electrodes on the lower surface of disk 22 is a possible configuration). Osorio does not disclose:
• the four directions includes a first direction, a second direction, a third direction and a fourth direction;
• the first direction, the second direction, the third direction and the fourth direction are individually perpendicular to the axis, centered at the axis by equal angular spacing;
• the first direction and the third direction are located oppositely with respect to the axis, the second direction and the fourth direction are located oppositely with respect to the axis, and the first direction is located between the second direction and the fourth direction;
• the plurality of depth electrodes include a first depth electrode, a second depth electrode, a third depth electrode and a fourth depth electrode corresponding to the first direction, the second direction, the third direction and the fourth direction, respectively; and
• the plurality of flat electrodes include a first flat electrode, a second flat electrode, a third flat electrode and a fourth flat electrode facing the first direction, the second direction, the third direction and the fourth direction, respectively.
Steinke, in the same field of endeavor of neurostimulation using depth electrodes (Figures 3A-3D, [0053]), teaches any number of segmented electrode sets on a lead where a set can be four segmented electrodes disposed around the circumference of the lead ([0049]), i.e. facing outward and perpendicular to the longitudinal axis. Segmented electrodes are used to impart directionality of stimulation and sensing in a manner not achievable with ring electrodes ([0041]). Four segmented electrode sets can be divided in each set into four equal electrodes around the circumference of the lead ([0050]), thereby naturally being distributed into quadrants facing a different direction (similar to the distribution of three electrode segments in 120° arcs in Figures 3A-3H and 6). The alignment of the four directions of the cortical contacts in Osorio and the four directions of the segmented deep brain electrodes in Steinke (as a modification of the ring electrodes in Osorio) would be seen as an obvious configuration given the benefits of directional stimulation described in Steinke ([0004]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Osorio’s deep brain stimulation depth electrodes by incorporating the segmented electrodes in Steinke. This would have been obvious because both Osorio and Steinke discuss deep brain stimulation using depth electrodes and Steinke provides a solution/improvement to create steerable and directional stimulation and sensing. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Osorio by incorporating the segmented depth electrodes in Steinke.
Therefore, Claim 6 is obvious over Osorio in view of Steinke and King.
Regarding Claim 12, the movement monitor sensor according to Claim 1 is obvious over Osorio in view of Steinke and King, as indicated hereinabove. Osorio further discloses wherein the substrate is shaped to be a ring disc having a maximum diameter equal to or less than 10 mm (Col 10, Lines 29-49 – the disk can be less than or equal to 10 mm: “Generally, the disk portion 22 has a diameter between approximately 1-25 mm”). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
Therefore, Claim 12 is obvious over Osorio in view of Steinke and King.
Regarding Claim 14, the movement monitor sensor according to Claim 1 is obvious over Osorio in view of Steinke and King. Osorio discloses four depth electrodes 36 with contact surfaces wrapped around the longitudinal axis separated by three insulators 38, all arranged parallel to the longitudinal axis (Figure 6D, Col 8, Lines 30-36). However, Osorio does not disclose wherein the at least one depth electrode set includes four said depth electrode sets, the four depth electrode sets are disposed at the body in parallel to the axis, the four depth electrodes of each of the four depth electrode sets are corresponding to the four directions, part of the four depth electrode sets are served as stimulating electrodes for performing electrical stimulation upon the brain tissue of the human.
As stated in claim 1, the proposed combination with Steinke yields segmented depth electrodes arranged facing out toward multiple directions (Steinke, [0049-0050]), such as quadrants facing different directions (similar to the distribution of three electrode segments in 120° arcs in Steinke Figures 3A-3H and 6). The alignment of the four directions of the cortical contacts in Osorio and the four directions of the segmented deep brain electrodes in Steinke (as a modification of the ring electrodes in Osorio) would be seen as an obvious configuration given the benefits of directional stimulation described in Steinke ([0004]).
Therefore, Claim 14 is obvious over Osorio in view of Steinke and King.
Claims 4-5 are rejected under U.S.C 103 as being unpatentable over Osorio (US 7,551,951 B1) in view of Steinke (US PG Pub 2018/0280698 A1), King (US PG Pub 2007/0208394 A1), and Dayeh (US PG Pub 2017/0231518 A1).
Regarding Claim 4, the movement monitor sensor according to Claim 1 is obvious over Osorio in view of Steinke and King. Osorio discloses the lower surface of disk 22 contains electrode contacts (Col 10, Lines 22-27) positioned onto the cortical surface of the brain (Col 11, Lines 65-67 and Col 12, Lines 1-8). However, Osorio does not disclose wherein the second surface of the substrate is furnished with a micro structure.
Dayeh, in the same field of endeavor of cortical neurological measurements ([0002]), teaches electrode sensor array 10 facing the cortical surface of the brain contains a set of penetration electrodes 16 which protrude from the sensor array into the brain cortex ([0057]). Flat electrodes on the scalp provide poor resolution and an inability to measure below the topmost layers of the brain ([0003]), while penetrating electrodes mitigate these problems and conform to the brain surface ([0007], [0009]) and would be interpreted as a microstructure.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Osorio’s contacts on the bottom of disk 22 by incorporating the penetrating electrodes in Dayeh. This would have been obvious because both Osorio and Dayeh discuss cortical brain electrode sensing and Dayeh provides a solution/improvement to provide penetrating electrodes to attach to the cortex to increase resolution and depth of readings in the cortex. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Osorio by incorporating the penetrating electrodes in Dayeh.
Therefore, Claim 4 is obvious over Osorio in view of Steinke, King, and Dayeh.
Regarding Claim 5, the movement monitor sensor according to Claim 4 is obvious over Osorio in view of Steinke, King, and Dayeh, as indicated hereinabove. Osorio discloses the lower surface of disk 22 contains electrode contacts (Col 10, Lines 22-27) positioned onto the cortical surface of the brain (Col 11, Lines 65-67 and Col 12, Lines 1-8). However, Osorio does not disclose wherein the micro structure protrudes out of the substrate by a height equal to or greater than 50 µm.
As stated in claim 5, the proposed combination with Dayeh yields penetrating electrodes with a microstructure ([0007-0009], [0057]). Dayeh further teaches the electrodes protrude within a particular range of distance: “The semiconductor penetrating electrodes are preferably arranged in a square pattern. A height of said semiconductor micro electrodes is preferably ~0-120 μm, and most preferably ~70-100 μm” ([0032-0033]). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations where the ranges in Dayeh contain values equal to or above 50 μm.
Therefore, Claim 5 is obvious over Osorio in view of Steinke, King, and Dayeh.
Claims 7-9 are rejected under U.S.C 103 as being unpatentable over Osorio (US 7,551,951 B1) in view of Steinke (US PG Pub 2018/0280698 A1), King (US PG Pub 2007/0208394 A1), and Bradley (US PG Pub 2019/0269910 A1).
Regarding Claim 7, the movement monitor sensor according to Claim 6 is obvious over Osorio in view of Steinke and King, as indicated hereinabove. Osorio discloses depth electrodes 36 with contact surfaces wrapped around the longitudinal axis separated by insulators 38 (Figure 6D, Col 8, Lines 30-36) and the lower surface of disk 22 contains electrode contacts (Col 10, Lines 22-27) to be positioned onto the cortical surface of the brain (Col 11, Lines 65-67 and Col 12, Lines 1-8). The disk contacts are circumferential distributed around the longitudinal axis (such as using four electrodes) and therefore given directionality (Figure 6F – provides an example of six contacts in a circular arrangement; Col 10, Lines 7-27 – describes one or more contacts can be used where a circular arrangement of four contact electrodes on the lower surface of disk 22 is a possible configuration).
However, Osorio does not disclose wherein, when the human moves in the first direction or the third direction, a first impedance variation is generated between the first flat electrode and the first depth electrode of the depth electrode set, a third impedance variation is generated between the third flat electrode and the third depth electrode of the depth electrode set, and the processor compares the first impedance variation to the third impedance variation so as to determine the corresponding electrical stimulation control upon the brain tissue of the human.
As stated in claim 6, the proposed combination with Steinke yields segmented depth electrodes arranged facing out toward multiple directions (Steinke, [0049-0050]), such as quadrants facing different directions (similar to the distribution of three electrode segments in 120° arcs in Steinke Figures 3A-3H and 6). The alignment of the four directions of the cortical contacts in Osorio and the four directions of the segmented deep brain electrodes in Steinke (as a modification of the ring electrodes in Osorio) would be seen as an obvious configuration given the benefits of directional stimulation described in Steinke ([0004]).
Bradley, in the same field of endeavor of deep brain stimulation ([0030]), teaches a plurality of segmented electrode sets ([0010]) which use comparisons between pairs of electrodes to measure directional impedance ([0046] – pairs can be between electrodes in one lead, but the electrode pairs are not limited to combination along a single lead and can interact with electrodes on other leads, electrodes on the body, or conductive elements more proximal to the segmented depth electrodes such as the pulse generator casing). The directional system in Bradley can be used as part of deep brain or cortical stimulation ([0030]), suggesting the same principles exist between electrodes for both applications and that the same directional impedance analysis would be known as able to be applied between aligned electrode pairs (such as the cortical contacts in Osorio and segmented deep brain stimulation depth electrodes in Osorio in view of Steinke). This analysis is further described in Bradley as determining movement in lead position by comparing changes between impedances from electrode pairs oriented to face different directions ([0075] – the positional changes of the electrodes are used to change electrode stimulation settings).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Osorio’s deep brain stimulation depth electrodes by incorporating the directional impedance measurements between electrodes in Bradley. This would have been obvious because both Osorio and Bradley discuss deep brain stimulation and Bradley provides a solution/improvement to determining lead location changes using segmented electrodes that provide directionality to the impedance measures and alter stimulation to compensate for changes. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Osorio by incorporating the directional impedance measurements between electrodes in Bradley.
Therefore, Claim 7 is obvious over Osorio in view of Steinke, King, and Bradley.
Regarding Claim 8, the movement monitor sensor according to Claim 6 is obvious over Osorio in view of Steinke and King, as indicated hereinabove. Osorio discloses depth electrodes 36 with contact surfaces wrapped around the longitudinal axis separated by insulators 38 (Figure 6D, Col 8, Lines 30-36) and the lower surface of disk 22 contains electrode contacts (Col 10, Lines 22-27) to be positioned onto the cortical surface of the brain (Col 11, Lines 65-67 and Col 12, Lines 1-8). The disk contacts are circumferential distributed around the longitudinal axis (such as using four electrodes) and therefore given directionality (Figure 6F – provides an example of six contacts in a circular arrangement; Col 10, Lines 7-27 – describes one or more contacts can be used where a circular arrangement of four contact electrodes on the lower surface of disk 22 is a possible configuration).
However, Osorio does not disclose wherein, when the human moves in the second direction or the fourth direction, a second impedance variation is generated between the second flat electrode and the second depth electrode of the depth electrode set, a fourth impedance variation is generated between the fourth flat electrode and the fourth depth electrode of the depth electrode set, and the processor compares the second impedance variation to the fourth impedance variation so as to determine the corresponding electrical stimulation control upon the brain tissue of the human.
As stated in claim 6, the proposed combination with Steinke yields segmented depth electrodes arranged facing out toward multiple directions (Steinke, [0049-0050]), such as quadrants facing different directions (similar to the distribution of three electrode segments in 120° arcs in Steinke Figures 3A-3H and 6). The alignment of the four directions of the cortical contacts in Osorio and the four directions of the segmented deep brain electrodes in Steinke (as a modification of the ring electrodes in Osorio) would be seen as an obvious configuration given the benefits of directional stimulation described in Steinke ([0004]).
Bradley, in the same field of endeavor of deep brain stimulation ([0030]), teaches a plurality of segmented electrode sets ([0010]) which use comparisons between pairs of electrodes to measure directional impedance ([0046] – pairs can be between electrodes in one lead, but the electrode pairs are not limited to combination along a single lead and can interact with electrodes on other leads, electrodes on the body, or conductive elements more proximal to the segmented depth electrodes such as the pulse generator casing). The directional system in Bradley can be used as part of deep brain or cortical stimulation ([0030]), suggesting the same principles exist between electrodes for both applications and that the same directional impedance analysis would be known as able to be applied between aligned electrode pairs (such as the cortical contacts in Osorio and segmented deep brain stimulation depth electrodes in Osorio in view of Steinke). This analysis is further described in Bradley as determining movement in lead position by comparing changes between impedances from electrode pairs oriented to face different directions ([0075] – the positional changes of the electrodes are used to change electrode stimulation settings).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Osorio’s deep brain stimulation depth electrodes by incorporating the directional impedance measurements between electrodes in Bradley. This would have been obvious because both Osorio and Bradley discuss deep brain stimulation and Bradley provides a solution/improvement to determining lead location changes using segmented electrodes that provide directionality to the impedance measures and alter stimulation to compensate for changes. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Osorio by incorporating the directional impedance measurements between electrodes in Bradley.
Therefore, Claim 8 is obvious over Osorio in view of Steinke, King, and Bradley.
Regarding Claim 9, the movement monitor sensor according to Claim 6 is obvious over Osorio in view of Steinke and King, as indicated hereinabove. Osorio discloses depth electrodes 36 with contact surfaces wrapped around the longitudinal axis separated by insulators 38 (Figure 6D, Col 8, Lines 30-36 – the stimulating contact surface 36 is depicted at the distal end of the lead in the same position as the conduction area) and the lower surface of disk 22 contains electrode contacts (Col 10, Lines 22-27) to be positioned onto the cortical surface of the brain (Col 11, Lines 65-67 and Col 12, Lines 1-8). The disk contacts are circumferential distributed around the longitudinal axis (such as using four electrodes) and therefore given directionality (Figure 6F – provides an example of six contacts in a circular arrangement; Col 10, Lines 7-27 – describes one or more contacts can be used where a circular arrangement of four contact electrodes on the lower surface of disk 22 is a possible configuration).
However, Osorio does not disclose wherein, when the human moves in parallel to the axis, a fifth impedance variation is generated between each of the first flat electrode, the second flat electrode, the third flat electrode and the fourth flat electrode and corresponding one of the first depth electrode, the second depth electrode, the third depth electrode and the fourth depth electrode of the depth electrode set, respectively, a sixth impedance variation is generated between the conduction area and each of the first depth electrode, the second depth electrode, the third depth electrode and the fourth depth electrode of the depth electrode set, and the processor compares the fifth impedance variation to the sixth impedance variation so as to determine the corresponding electrical stimulation control upon the brain tissue of the human.
As stated in claim 6, the proposed combination with Steinke yields segmented depth electrodes arranged facing out toward multiple directions (Steinke, [0049-0050]), such as quadrants facing different directions (similar to the distribution of three electrode segments in 120° arcs in Steinke Figures 3A-3H and 6). The alignment of the four directions of the cortical contacts in Osorio and the four directions of the segmented deep brain electrodes in Steinke (as a modification of the ring electrodes in Osorio) would be seen as an obvious configuration given the benefits of directional stimulation described in Steinke ([0004]).
Bradley, in the same field of endeavor of deep brain stimulation ([0030]), teaches a plurality of segmented electrode sets ([0010]) which use comparisons between pairs of electrodes to measure directional impedance ([0046] – pairs can be between electrodes in one lead, but the electrode pairs are not limited to combination along a single lead and can interact with electrodes on other leads, electrodes on the body, or conductive elements more proximal to the segmented depth electrodes such as the pulse generator casing). The directional system in Bradley can be used as part of deep brain or cortical stimulation ([0030]), suggesting the same principles exist between electrodes for both applications and that the same directional impedance analysis would be known as able to be applied between aligned electrode pairs (such as the cortical contacts or conduction area in Osorio and segmented deep brain stimulation depth electrodes in Osorio in view of Steinke). This analysis is further described in Bradley as determining movement in lead position by comparing changes between impedances from electrode pairs oriented to face different directions ([0075] – the positional changes of the electrodes are used to change electrode stimulation settings).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Osorio’s deep brain stimulation depth electrodes by incorporating the directional impedance measurements between electrodes in Bradley. This would have been obvious because both Osorio and Bradley discuss deep brain stimulation and Bradley provides a solution/improvement to determining lead location changes using segmented electrodes that provide directionality to the impedance measures and alter stimulation to compensate for changes. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Osorio by incorporating the directional impedance measurements between electrodes in Bradley.
Therefore, Claim 9 is obvious over Osorio in view of Steinke, King, and Bradley.
Claims 10-11 are rejected under U.S.C 103 as being unpatentable over Osorio (US 7,551,951 B1) in view of Steinke (US PG Pub 2018/0280698 A1), King (US PG Pub 2007/0208394 A1), and Peterson (US PG Pub 2021/0205623 A1).
Regarding Claim 10, the movement monitor sensor according to Claim 1 is obvious over Osorio in view of Steinke and King. Osorio discloses the placement of the disk portion 22 on the cortical surface and the shaft portion 24 into the cortex (Col 9, Lines 38-60) where the device is placed through a hole in the skull (Col 15, Lines 4-9) with conductors 26 communicating with a controller (Col 11, Lines 42-47). Osorio discloses: “this approach is favored over others, such as anchoring the device to the dura mater or to the skull, because it increases the area of recording surfaces and minimizes tearing of the cortex and dura that may result from differential displacement of these structures associated with head movements of certain force/ acceleration 65 and direction” (Col 9, Lines 60-66). However, Osorio does not disclose wherein the first surface of the substrate is furnished with a fixing part configured to be disposed at a head bone of the human, wherein the brain tissue is located under the head bone of the human.
Peterson, in the same field of endeavor of deep brain stimulation ([0004]), teaches a burr hole cap placed in the skull which anchors the stimulation leads to the desired positions on the brain ([0057]). The burr hole apparatus is connected to and anchors cortical electrodes facing toward the brain as well as anchoring deep brain stimulation leads ([0061-0062]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter the disk portion 22 in Osorio by incorporating the burr hole cap apparatus which anchors the cortical and deep brain stimulation electrodes to the skull in Peterson. At the time, there would have been a recognized need for a conduit through the skull which properly positions device electrodes. Osorio discloses the selected solution as chosen from a set of options, explicitly mentioning an anchoring device to the dura mater or skull as one of those options. Peterson teaches an anchoring device in the skull which is used to maintain the position of brain stimulating electrodes and would be obvious to try. A person of ordinary skill in the art would have a reasonable expectation of successfully using the burr hole cap device in Peterson to anchor the electrodes in Osorio.
Therefore, Claim 10 is obvious over Osorio in view of Steinke, King, and Peterson.
Regarding Claim 11, the movement monitor sensor according to Claim 10 is obvious over Osorio in view of Steinke, King, and Peterson, as indicated hereinabove. Osorio discloses the placement of the disk portion 22 on the cortical surface and the shaft portion 24 into the cortex (Col 9, Lines 38-60) where the device is placed through a hole in the skull (Col 15, Lines 4-9) with conductors 26 communicating with a controller (Col 11, Lines 42-47). However, Osorio does not disclose wherein the fixing part has a channel for allowing the first wires, the second wires and the conductive wire to extend thereinside and to pass therethrough for further protruding out of the fixing part to exterior of the head bone.
As stated in claim 10, the proposed combination with Peterson yields a burr hole cap placed in the skull which anchors the stimulation leads to the desired positions on the brain ([0057]) for both cortical electrodes facing toward the brain as well as anchoring deep brain stimulation leads ([0061-0062]). Peterson further teaches a channel ([0005] – burr hole) through which wires from burr cap electrodes and the stimulation lead can pass through to the control unit outside the skull ([0061] – “Burr hole cap electrodes 150 could be molded into the plastic, or whatever material composing the base 122, with wires 115 running through the cover 124 to a common exit point. The wires 115 would exit, similar to lead”). Note wires connecting to electrodes placed on the surface of the cortex pass through the burr hole cap ([0051] – “Where electrodes are not available in the burr hole cap assembly, some techniques involved placing sensing electrodes, such as for cortical sensing, via a surgical procedure to place such sensing electrodes on the patient's cortex. In such cases, extended procedures or multiple procedures were required: a first procedure to implant leads 20A, 20B through one or more burr holes”).
Therefore, Claim 11 is obvious over Osorio in view of Steinke, King, and Peterson.
Claim 13 is rejected under U.S.C 103 as being unpatentable over Osorio (US 7,551,951 B1) in view of Steinke (US PG Pub 2018/0280698 A1), King (US PG Pub 2007/0208394 A1), and McLaughlin (US PG Pub 2018/0126155 A1).
Regarding Claim 13, the movement monitor sensor according to Claim 1 is obvious over Osorio in view of Steinke and King. Osorio discloses, with respect to the composition of disk 22, the electrodes 20 are “constructed of biocompatible materials, such as polyurethane covered as appropriate with thin sheets 25 or coatings of noble metals, such as platinum or other suitable material” (Col 11, Lines 24-27) and “insulating material between the various contact surfaces is constructed of biologically inert material, such as polyurethane or other suitable material, to prevent adjacent contacts from touching each other, which could otherwise create an undesirable ‘shunt’” (Col 11, Lines 38-42). However, Osorio does not disclose wherein the substrate is made of a silicone or a thermoplastic polyurethane (TPU).
McLaughlin, in the same field of endeavor of stimulation of nervous tissue such as the brain ([0030], [0032]), teaches an electrode array containing a seamless substrate containing the electrodes ([0040]). The electrode arrays can take a number of shapes such as a cylinder ([0031]). When discussing the material composition of the substrate, McLaughlin teaches: “Among other things, the unvulcanized material may include elastomers (e.g., silicone), polyurethanes (e.g., Pellethane, Tecothane) or other polymers. As an example, the unvulcanized material may include the first and second unvulcanized layers comprise thermoplastic polyurethane. When vulcanized (discussed below), the two layers together form a thermoplastic-polyurethane bond” ([0044]). The vulcanized material is noted to be flexible ([0011]), where polymer substrate materials in the past have been mechanically unstable ([0035-0036]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Osorio’s disk substrate by incorporating the flexible thermoplastic polyurethane substrate in McLaughlin. This would have been obvious because both Osorio and McLaughlin discuss brain stimulation using electrodes embedded in a substrate and McLaughlin provides a solution/improvement to reduce mechanical stress on the substrate by using the flexible thermoplastic polyurethane substrate. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Osorio by incorporating the flexible thermoplastic polyurethane substrate in McLaughlin.
Therefore, Claim 13 is obvious over Osorio in view of Steinke, King, and McLaughlin.
Conclusions
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.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights