DETAILED ACTION
This Office action is responsive to communications filed on 06/10/2026. Claims 1, 8, & 15 have been amended. Presently, Claims 1-20 remain pending and are hereinafter examined on the merits.
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
The Applicant’s arguments with respect to rejections under 35 USC § 112(a) have been fully, considered, but are not persuasive.
The Applicant’s argument’s have been considered but are not persuasive. The Applicant’s remarks identifies portions of the specification that generally refer to voltage-current relationships, derivatives of current, electrode positions, PCA, gradient decent, x-y-z flux coordinates. However, identifying these general concepts does not explain how the Specification reasonably conveys procession of the claimed determination step.
The claim requires, determining, based on the change in current measured at each electrode, one or more flux measurements associated with each electrode. Applicant’s arguments does not identify disclosure explaining how the measured current change for each electrodes is processed to produce the claimed electrode specific flux measurements, how the data is used in that determination, or how the PCA and gradient decent discussion results in the specification results in the claimed flux measurements. At most the specification provides the desired result and general mathematical concepts that may be used.
The Applicant’s arguments merely asserts that the Specification teaches the limitation with proper written description because it mentions the relevant physical variables and mathematical tools. But naming the physical concepts, conceptual physics and alleged known techniques is not the same as disclosing the computational logic or operative sequence by which the claimed flux measurements are determined itself.
The Applicant’s statement regarding that the source code is not required is correct, but this does not resolve the issue. The issue is not that the Specification fails to provide source code or a textbook like explanation of PCA. The issue is whether the Specification reasonably conveys possession of the claimed flux determination process. Ultimately, the specification describes the idea of determining flux measurements by leaning on naming conceptual physics used & assuming the use of known techniques, and treating complex software as functional; however, at its core, it stops short of reasonably providing proper written description of how the computing device actually performs the determining steps of the flux measurements. The specification relies on functional descriptions and known techniques, rather than “actually” explaining or demonstrating how the computing device actually computes this determination itself.
The 35 USC § 112(a) is therefore maintained.
Previous 35 USC § 101 is withdrawn. The claimed step of "converting the MRI data and the voltage data into first image data; generating, based on the one or more flux measurements and from the first image data, corrected image data;" is considered to integrate the judicial exception into practical application; because the First image data (source image) FIG. 7A and the Corrected image data (Target image) FIG. 7B [Drawings filed on 03/02/2026], are not mere mathematical graphed images. This image transformation is the shifted correction of the determinization of the one or more flux measurements.
Examiners Notes
Claims 1-20, though rejected under 35 USC § 112(a) are not rejected under the prior arts in view of the change in scope of the claim amendment filed on 06/10/2026. The claims are statutorily ineligible for indication of allowable subject matter. Note; a change in scope in view of the requested corrections will require further search and consideration.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are: “computing device” for receiving the MRI data and voltage data is configured to deliver a controlled dose” in claim 8-9, 11, and 13 invoked 35 U.S.C. 112(f).
The term “device” is a non-structural generic placeholder that does not include any specific structure for performing the accompany functions. See MPEP 2181.I.A: The following is a list of non-structural generic placeholders that may invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, paragraph 6: "mechanism for," "module for," "device for," "unit for," "component for," "element for," "member for," "apparatus for," "machine for," or "system for." Welker Bearing Co., v. PHD, Inc., 550 F.3d 1090, 1096, 89 USPQ2d 1289, 1293-94 (Fed. Cir. 2008); Massachusetts Inst. of Tech. v. Abacus Software, 462 F.3d 1344, 1354, 80 USPQ2d 1225, 1228 (Fed. Cir. 2006); Personalized Media, 161 F.3d at 704, 48 USPQ2d at 1886–87; Mas-Hamilton Group v. LaGard, Inc., 156 F.3d 1206, 1214-1215, 48 USPQ2d 1010, 1017 (Fed. Cir. 1998).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“computing device” refers to a generic smart phone, tablet, a laptop, a desktop computer, a server or combinations thereof for receiving MRI data and Voltage data in specification ¶0014.
¶0014, ‘The computing device 101 may comprise for example, a smart phone, a tablet, a laptop, a desktop computer, a server, combinations thereof, and the like. The computing device 101 may send and receive data to/from the EEG device102 and/or the MRI device 103’
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 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, 8, & 15: recites:
“[computing device] [...] determining, based on the change in the current measured at each electrode of the plurality of electrodes one or more flux measurements wherein each flux measurement of the one or more flux measurements is associated with an electrode of the plurality of electrodes;”
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).
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 to determining, based on the change in the current measured at each electrode of the plurality of electrodes one or more flux measurements wherein each flux measurement of the one or more flux measurements is associated with an electrode of the plurality of electrodes. The written description requirement is not satisfied. Specifically, the specification defines mathematical tools and physical variables to be used, ¶0070. The specification provides little operational information on how the system actually executes these steps. Rather than detailing a concrete implementation, the specification presents a theoretical framework that lies on generalizations, conceptual physics, and black-box processing. There is a lack of clarity, regarding how the determining steps of the flux measurements are practically performed. There is no explanation of intermediate steps. There is no information on how the computing device structures this digitized data to execute the calculations.
Ultimately, the specification describes the idea of determining flux measurements by leaning on naming conceptual physics used & assuming the use of known techniques, and treating complex software as functional; however, at its core, it stops short of providing proper written description of how the computing device actually performs the determining steps of the flux measurements. There are multiple reasonable ways to perform this determination, yet the specification relies on functional descriptions and known techniques, rather than “actually” explaining or demonstrating how the computing device actually computes this determination. Naming physical concepts and/or conceptual physics is not the same as disclosing an algorithm and/or computational logic. The explanations regarding the PCA and gradient decent are discussed, but the algorithmic synthesis of computational logic is completely undisclosed. PCA and gradient decent are multi-stage data processes that require specific approaches to formatting, the specification provides no implementation details amounting to nothing more than “naming the process”. One of ordinary skill in the art would not be able to implement the described process without disclosure of a particular implementation. The specification merely declares that the physical relationships between the current and flux exist, and only defines the goal/result; but it fundamentally fails to disclose the step-by-step algorithmic logic required to execute the claimed limitation.
Accordingly, the specification and drawings are directed to mere examples of methods tantamount to a black box, rather than showing procession of a particular implementation. One of ordinary skill in the art would not be able to implement the described process without disclosure of a particular implementation. 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 step. Since the instant specification fails to provide a finite sequence of steps for performing the determination of the flux measurements, the aforementioned claims fail 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.
Conclusion
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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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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