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 .
Drawings
The drawings are objected to because several are of poor image quality. Specifically, Fig. 5 are not legible. Increase the text and drawing size such that the image(s) when scanned becomes legible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Examiners Notes
It should be noted that Claims 1-20, though rejected under 35 U.S.C. § 112(a), & 35 U.S.C. § 112(b) are not rejected under the prior arts. The following unsupported features of claim 1, 11, & 20: “processing circuitry configured for operative communication with a conformable grid, a user interface, and a memory, wherein the conformable grid comprises a plurality of modular grid elements having a plurality of electrodes configured for implantation in a cerebrum of a patient, and wherein the processing circuitry is configured to execute instructions stored in the memory to: model brain tissue to define inter-contact and intra-contact distances along the conformable grid and each of the plurality of electrodes; determine the spacing between the plurality of modular grid elements of the conformable grid;”, are not disclosed or taught in the references or record for rejections or the cited pertinent arts, individually or combined.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 3: line 2, “three-dimensional (3D)”.
Claim 10: line 2, “[[a]]the sub-region”.
line 4, “[[a]]the depth”.
Claim 13: line 2, “three-dimensional (3D)”.
Claim 19: line 2, “[[a]]the sub-region”.
line 4, “[[a]]the depth”.
Appropriate correction is needed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites: “
wherein the processing circuitry is configured to execute instructions stored in the memory to:
model brain tissue to define inter-contact and intra-contact distances along the conformable grid and each of the plurality of electrodes;
determine the spacing between the plurality of modular grid elements of the conformable grid;
[...]
a depth of each electrode of the plurality of electrodes in the cerebrum within the sub-region of the cerebrum.”
The rejection to claim 1 applies to claim 11 and claim 20 for substantially identical claim limitations recited in the claim.
Claim 2 recites:
“wherein the processing circuitry is configured to define the inter-contact and intra-contact distances along the conformable grid by at least running a finite element model (FEM) stimulation within the model brain tissue.”
The rejection to claim 2 applies to claim 12 for substantially identical claim limitations recited in the claim.
Claim 4 recites:
“wherein the processing circuitry is configured to manipulate the segmented 3D mesh to determine the spacing”
The rejection to claim 4 applies to claim 14 for substantially identical claim limitations recited in the claim.
Claim 5 recites:
“wherein the processing circuitry is configured to determine, based on the distances and spacing, a number of electrodes of the conformable grid for implantation in the cerebrum.”
The rejection to claim 5 applies to claim 15 for substantially identical claim limitations recited in the claim.
Claim 6 recites:
“wherein the processing circuitry is configured to determine, based on the distances and spacing, a location of each electrode of the plurality of electrodes within the cerebrum.”
The rejection to claim 6 applies to claim 16 for substantially identical claim limitations recited in the claim.
The claim is rejected under 35 USC § 112(a) for a lack of written description. Proper written description cannot be identified in the specification, claims, and drawings directed the full scope of the steps, specifically, the specification provides a generalized level of inputs and desired outputs, effectively treating the internal calculations of the above highlighted limitations as being tantamount to a black box. It lacks detailed algorithmic disclosures, mathematical equations, weights, or computational flowcharts for how these steps are implemented using a computing device.
An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may "express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008) (internal citation omitted). This can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015), see MPEP § 2161(I).
These limitations are computer/processor-implemented functional claim limitation as it is directed to a processor-controlled algorithm configured to determine measurements. Yet the specification does not disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed functions in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. It is not enough to disclose that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015). As the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, these claims are rejected for lack of written description. For more information regarding the written description requirement, see MPEP §§ 2161, 2162-2163.07(b).
Regarding the determination of distances, spacing and depth via FEM stimulations, the specification repeatedly asserts that inter-contact distances, intra-contact distances, depth and modular grid spacing “will be determined by the FEM simulation”, ¶0036, ¶¶0041-0053. The specification teaches that the inputs for these stimulations (i.e., from the medical literation of Michael E. et al. Electrical Conductivity and Permittivity Maps of the Brain Tissue Derived from Water Content Based on T1-Weighted Acquisition. Magnetic Resonance in Medicine 2017. 77:1094-1103 – FIG. 5 of the Applicants Drawings correspond to Michael E. et al’s Table 2). However, it does not disclose or provide mathematical formulas, algorithmic code, or flow-charts, step-step algorithmic flow of the simulations for the determination of these measurements, or computational weights that the FEM uses.
Regarding the segmented 3D mesh, the specification states, “This 3D mesh can then be manipulated by the system in a FEM environment with various electrodes to elucidate the adequate number and precise location of each electrode and contact based on a target zone.”, ¶0035. Proper written description is not provided in the specification for how the computer implementation manipulates the 3D mesh to determine the spacing. There are no programmatic operations or step-by-step logic detailing how the computer manipulates the mesh.
Regarding the determining of the number and location of electrodes, the specification generalizes its discussion and merely asserts, “The system may also determine, based on inter-contact and intra-contact distances along a confirmable grid and each of the plurality of electrodes of the grid and based on spacing between modular grid elements of the confirmable grid, the number of electrodes of a conformable grid for implantation and/or the location of implantation for the conformable grid and/or each of the electrodes of the conformable grid.”, ¶0035. The specification does not explain the algorithmic translation or logic operations used to convert distances into discrete electrode counts or precise spatial locations. In addition, it doesn’t provide any internal logic, rules, thresholds, or parameters the software uses to decide the number and location of electrodes.
While the specification describes hardware of the computing system while listing standard computer components, it does not provide flowcharts or weights for the computer implementation’s internal operations. Regarding FIG. 19, it’s a clinical decision marking tree, rather than a step-by-step algorithmic flowchart of computer internal logic operations. FIG. 5 as previously discussed, entirely omits any algorithmic parameters that the processing circuitry would apply to those biological variables during the simulation.
In addition, an assertion that could be derived using simulations or test (i.e., prophetic examples) does not demonstrate that the inventors actual did so or had possession of the specific functional relationships and constraints to obviate the lack of written description requirement.
Consequently, one of ordinary skill in the art would not deem the instant specification having sufficient detail so that they could understand how the inventor intended to achieve the aforementioned above identified features of the claims. Since the instant specification fails to provide a finite sequence of steps how the aforementioned above identified features of the claims, the aforementioned claim fails to meet the written description requirement under 35 U.S.C. 112(a).
Dependent claims are rejected by virtue of their dependency to abovementioned claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 1:
line 9, “the spacing”. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes a spacing. Accordingly, proper antecedent basis is required. The above rejections to claim 1 apply to claim 11 and claim 20 for substantially identical claim limitations recited in the claim. Appropriate correction is required.
line 14-15, “a depth of each electrode of the plurality of electrodes in the cerebrum within the sub-region of the cerebrum.” in view of the following limitations “[...] a plurality of modular grid elements having a plurality of electrodes configured for implantation in a cerebrum of a patient, [...] each of the plurality of electrodes; [...] a depth of each electrode of the plurality of electrodes in the cerebrum within the sub-region of the cerebrum.”, renders the claim indefinite. Upon review of the specification the modular grid elements comprises two types of electrodes, ¶0037, the surface and depth electrodes. It is unclear if the claim is directed to depth electrodes only, or any of the two types of electrodes. For examination purposes, the Examiner assumes the electrodes claimed refer only to the depth electrodes. Appropriate correction is required. The above rejections to claim 5 apply to claim 11 and claim 20 for substantially identical claim limitations recited in the claim. Appropriate correction is required.
Claim 5:
line 2, “a number of electrodes”. It is unclear if these electrodes refer to or is separate from “the plurality of electrodes” (i.e., the electrodes defined in claim 1). For examination purposes, the Examiner assumes a number of the plurality of electrodes. Appropriate correction is required. The above rejections to claim 5 applies to claim 15 for substantially identical claim limitations recited in the claim. Appropriate correction is required.
The dependent claims of the above rejected claims are rejected due to their dependency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Slutzky et al. Optimal spacing of surface electrode arrays for brain-machine interface applications. J Neural Eng. 2010 Apr, discloses modeling brain tissue utilizing FEM based on MR images and determining electrode spacing.
Zhang et al. A cortical potential imaging study from simultaneous extra- and intracranial electrical recordings by means of the finite element method. Neuroimage. 2006 Jul 15;31(4):1513-24. doi: 10.1016/j.neuroimage.2006.02.027. Epub 2006 May 2 discloses, using a comfortable gride with modular grid elements implanted in the cerebrum.
Lanfer et al. Influence of a silastic ECoG grid on EEG/ECoG based source analysis. Brain Topogr. 2013 Apr;26(2):212-28. discloses, modeling brain tissue with grids.
Yang et al. Localization of dense intracranial electrode arrays using magnetic resonance imaging. Neuroimage. 2012 Oct 15. discloses, a grid composition of brain tissue with localized grids in 3D MRI space.
Xiang et al. A flexible three-dimensional electrode mesh: An enabling technology for wireless brain–computer interface prostheses. Microsyst Nanoeng 2, 16012 (2016). discloses, a comfortable gride with electrodes for implantation in the cerebrum.
Taimouri et al. Electrode localization for planning surgical resection of the epileptogenic zone in pediatric epilepsy. Int J Comput Assist Radiol Surg. 2014 Jan discloses, localization of electrodes for planning in surgeries.
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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