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 .
Response to Arguments
Applicant's arguments filed 04/27/2026 have been fully considered but they are not persuasive.
Applicant argues on page 4
“The difference between Patil and claim 1, as Applicant understands it, is
therefore fundamental. In claim 1, the recorded signals are used to generate a trajectory that did not previously exist. In Patil, the recorded signals are apparently used to identify a location within a set of trajectories that were fully defined before surgery from MRI data. These are different operations, and no combination of Younis and Patil changes that. In short, Patil does not teach that the spatially distinct trajectory is algorithmically derived from results of said functionally mapping, and therefore cannot supply what Younis lacks.”
Examiner respectfully disagrees. Firstly, applicant does not expressly claim what the algorithm in the claim term, “algorithmically derived” is. Hence examiner submits that any algorithm that provides an alternate /additional trajectory, as in Patil is sufficient to meet the claim limitation. Secondly, claim language does not exclude any algorithm that uses prestored trajectories. Selection of a trajectory (an algorithm) may be interpreted as deriving an additional trajectory algorithm as claimed, as long as there is no positive recitation in claim that, this method is not allowed. That is, claim language does not exclude this type of algorithm. Thirdly, “algorithmically derived” encompasses comparing stored trajectories in light of applicant spec. page 61 which recites
“Optionally, previously assigned tags are updated upon recording neurophysiological data from a current depth, for example by comparing the likelihoods of complete alternative state paths from the beginning of the mapping process to a current depth, and selecting the most likely state path.”
This means that specification supports storing and utilizing alternate paths during procedure for comparison and selection. That is, a selection of a path, is also an algorithm that is described in specification and hence may be interpreted as one that may be utilized.
Applicant’s arguments 1.3, on page 4 are similar to that above. Examiner notes that selection of a trajectory as in Patil is algorithmically deriving.
Applicant further argues on page 5
“As understood by Applicant, Patil apparently requires a pre-defined library of candidate trajectories derived from MRI images acquired before surgery. The claimed invention requires no such library and no pre-operative imaging whatsoever. A method that begins, as claim 1 does, with nothing more than signals recorded during lead insertion, and from those signals alone apparently derives a spatially distinct trajectory, would not appear to be what Patil describes, teaches, or suggests. There is therefore no apparent motivation for a person of ordinary skill in the art to look to Patil when designing the method of claim 1.”
Examiner respectfully disagrees. Claim recites “algorithmically derived from results” the arguments seem to suggest that the invention requires derivation only from results of functional mapping and nothing else may be used. There is no express recitation of derivation only from results of functional mapping. The claim does not recite this exclusivity, and hence can be interpreted to encompass interpretation using other information, for generating an alternate / additional trajectory.
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.
Claims 1-10, 13-18, 20-23 rejected under 35 U.S.C. 103 as being unpatentable over Younis [US 20040199235 A1] in view of Patil [US 20140081127 A1].
As per claim 1, Younis teaches a method for inferring at least one trajectory inside a brain tissue, comprising:
recording a plurality of signals from said brain tissue by electrodes positioned at different spatial locations inside the brain along an insertion trajectory of a lead (Younis Figs 2, 4, ¶0021 sensing using electrodes) during the insertion of said lead into brain tissue (Younis ¶0086 “one or more measurements are made during insertion to ensure that the expected trajectory is being followed”);
storing said recorded signals in a memory of a control system during the insertion of said lead (Younis ¶0094-¶0097, channels of signals displayed, ¶0155 “a memory for recording signals and/or signal characteristics of a plurality of leads”);
analyzing using a control circuitry of said control system said signals by functionally mapping brain tissue surrounding said insertion trajectory (Younis ¶0051-¶0056, determining brain functions at different locations, Younis ¶0023-¶0024, ¶0077, ¶0084, automatic algorithms using computer),
wherein said functionally mapping comprises assigning by said control circuitry a functional indication for a location along said insertion trajectory based on said signals (In view of applicant spec. page 57, functional indication relates to properties from electrophysical behavior as indication for location. Younis Fig 3B steps 356-358. Location assigned based on properties. ¶0098-¶0103, properties obtained from channel data) and
using at least one mapping algorithm stored in a memory of said control system (Younis ¶0023 “automatic recognition algorithm”, requires memory);
d. inferring by said control circuitry at least one spatially distinct trajectory or a segment thereof being spatially distinct from said insertion trajectory, at a distance from said insertion trajectory based on said functionally mapping (Younis "At 312 and 314, the axial (e.g., along the trajectory) and/or trans-axial (e.g., perpendicular to the trajectory) positioning of lead 206 are optionally adjusted, for example, to iteratively determine the position of location106 in a more exact manner". This implies that additional trajectories are inferred for the feedback loop, i.e. based on the functional mapping. Further any shift in axial position implies at least a segment is spatially distinct)
Younis does not expressly teach the at least one spatially distinct trajectory is algorithmically derived from results of said functionally mapping, and delivering by said control system an indication during or after said recording regarding said inferred at least one spatially distinct trajectory.
Patil, in a similar field of targeting electrode placement in the brain, teaches the at least one spatially distinct trajectory is algorithmically derived from results of said functionally mapping (Patil Fig 2 steps 206-220, or 228 algorithms form computing paths and alternate paths from virtual paths), and delivering by said control system an indication during or after said recording regarding said inferred at least one spatially distinct trajectory (Patil Fig 4A, l0031 “The virtual path shown in FIG. 3, along with several other nearby virtual paths 22 that were defined by the processor, are displayed in a two dimensional image plane shown in FIG. 4A.”, Figs 8-9).
Younis does not discuss any algorithmic determination at step 312 of Fig 3A. Patil discussed algorithm for determining physical paths and alternate paths from a plurality of defined virtual paths, and displaying of the information. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify method in Younis by integrating real-time neural targeting system as in Patil. The motivation would be to improve the ease and accuracy, and reduce surgical risks for brain procedures and like DBS (Patil ¶0005).
As per claim 2, Younis in view of Patil further teaches wherein said delivering comprises delivering said indication with a location of the at least one additional axis shifted trajectory (Patil Figs 8-9).
As per claim 3, Younis in view of Patil further teaches wherein said delivering comprises delivering an indication for a more effective alternative trajectory (Patil Fig 9, ¶0007, ¶0061).
As per claim 4, Younis in view of Patil further teaches wherein said functional mapping comprises calculating a series of functional tags based on the recorded plurality of signals (Younis ¶0108 “above steps use a database of neural traces and/or properties, for example from the same or from different patients”, Fig 7 step 704, ¶0104 “At 358, a location is assigned to each electrode, which associates an apparent functional behavior of the electrode”), and associating each functional tag of the series of functional tags to a depth position along the insertion trajectory (Younis ¶0051 “locating a position of a functional location in a brain”, ¶0116 “…the physical electrodes are grouped to define logical electrodes that have various effective depths of detection”).
As per claim 5, Younis in view of Patil further teaches wherein said inferring comprises calculating by said control circuitry, functional tags associated with said at least one additional axis shifted trajectory or said part of an additional trajectory (Younis Fig 3A steps 312, 314) using signals recorded from a specific combination of said electrodes of said lead (Younis Fig 4, multiple electrodes, ¶0110 “ In this and other electrode designs, smaller electrodes (e.g., of sizes of 25 microns) are optionally used for stimulation and/or sensing of micro-volumes (e.g. single or small numbers of cells) and larger electrodes are used for stimulation and/or sensing of macro-volumes (e.g., multiple cells and general activity)”).
As per claim 6, Younis in view of Patil further teaches wherein said at least one additional axis shifted trajectory comprises a plurality of additional axis shifted trajectories, each with different associated functional tags for a similar depth position (Younis Fig 3A, multiple recordings and feedback loop implies additional trajectories for fine tuning).
As per claim 7, Younis in view of Patil further teaches wherein said analyzing comprising separately analyzing by said control circuitry each of said plurality of signals, and wherein said inferring comprising inferring a plurality of axially-shifted trajectories in a distance of at least 0.5 mm from said lead (Younis ¶0015, “a placement error and/or a desired sensing volume, for example, a length, width and/or depth of 1, 2, 5, 10, 15, 20 mm, or any smaller, intermediate or larger dimension” placement and sensing at these distances require inferring trajectories at these distances).
As per claim 8, Younis in view of Patil further teaches updating by said control circuitry an insertion step size of said lead based on said functionally mapping of said brain tissue following said analyzing (Younis ¶0021 “locating a brain location using one or more composite sensing steps, … a plurality of measurements are analyzed to determine an exact or more exact (than in a previous estimation) location. Then, a lead used for the measurements is optionally moved to provide another set of measurements. In an exemplary embodiment of the invention, when the lead is inserted, it is inserted in one step to a location … Alternatively or additionally, the lead may be moved in large jumps…”).
As per claim 9, Younis in view of Patil further teaches wherein said recording comprising recording directional signals from sources located inside the brain in a distance of at least 0.2 mm from a measuring electrode on said lead (Younis ¶0015 “micro-electrodes is selected to match a placement error and/or a desired sensing volume, for example, a length, width and/or depth of 1, 2, 5, 10, 15, 20 mm, or any smaller, intermediate or larger dimension.”).
As per claim 10, Younis in view of Patil further teaches wherein said analyzing comprising analyzing by said control circuitry said plurality of signals in a single multi-channel model by a multi-channel algorithm (Younis ¶0095-¶0096, multichannel scanning and displaying, requires algorithm), and wherein inferring comprising inferring a single trajectory based on the results of said multi-channel algorithm (Younis Fig 3A, Step 312 after step 310, I a result of the multi-channel sensing).
As per claim 13, Younis in view of Patil further teaches wherein said plurality of signals comprises a plurality of directional signals (Younis ¶0116 “a plurality of electrodes are shorted together to define various directional active channels of lead 206.”), and wherein said recording comprises recording said plurality of directional signals by at least two micro-electrode contacts or at least two macro-electrode contacts, of said lead (Younis Fig 4).
As per claims 14-18, 20, they have limitations similar to claims 1-4, 7, 12 and are rejected for same reasons as above. Younis further teaches a brain navigation system, comprising: a lead having an elongated lead body with a distal end shaped to penetrate into brain tissue comprising at least two electrodes located at different circumferential angular positions on a circumference of said elongated lead body (Younis Figs 4A to 4E, ¶0119 “The electrodes may cover a large sector or a small sector, for example, 1o, 10o, 25o or 45o, or any smaller greater or intermediate angular size”), wherein said at least two electrodes are configured to record directional electrical signals from brain tissue surrounding said lead during navigation of said lead along an insertion trajectory (Younis ¶0116 “a plurality of electrodes are shorted together to define various directional active channels of lead 206.”);and a control system electrically connected to said lead (Younis ¶0046 “computing means for determining said location based on said correlation”).
As per claim 21, Younis in view of Patil further teaches wherein said functional indication comprises a functional tag assigned to said location using said at least one mapping algorithm (Younis ¶0104 “At 358, a location is assigned to each electrode, which associates an apparent functional behavior of the electrode”).
As per claim 22, Younis in view of Patil further teaches wherein said functional indication comprises a functional state assigned to said location using a mapping model which includes possible states and observations (Younis Fig 3B steps 356-358, ¶0104 “At 358, a location is assigned to each electrode, which associates an apparent functional behavior of the electrode”, This is based on model which uses properties as discussed in ¶0097-¶0103).
As per claim 23, it has limitations similar to claim 1, and is rejected for same reasons as above.
Claims 11-12, 19 rejected under 35 U.S.C. 103 as being unpatentable over , Younis in view of Patil as applied to claims 1, 14 above, and further in view of Molnar [US 20110264165 A1].
As per claims 11-12, 19, Younis in view of Patil teaches claims 1, 14 as discussed above. Younis in view of Patil further teaches wherein said recording comprises recording a plurality of directional signals by at least one micro-electrode contact (Younis Fig 4, ¶0116 “a plurality of electrodes are shorted together to define various directional active channels of lead 206”).
Younis in view of Patil does not expressly teach at least one macro-electrode contact of said electrodes of said lead.
Molnar teaches at least one macro-electrode contact of said electrodes of said lead (Molnar ¶0078 “leads 20 may include both macro electrodes (e.g., rings, segments adapted to sensing local field potentials and stimulation) and micro electrodes (e.g., adapted to sensing spike trains in the time domain) in any combination.”).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify method in Younis in view of Patil by integrating well known electrodes and combinations, as in Molnar for sensing and simulation. The motivation would be to provide leads of different shapes and electrode combinations capable of effectively treating patients (Molnar ¶0078).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/ Primary Examiner, Art Unit 3797
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