DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 2 and 5 are objected to because of the following informalities:
In claim 2, line 2: “electric field neural network” should apparently read --electric field simulation neural network--.
In claim 5, line 2: “electric field neural network” should apparently read --electric field simulation neural network--.
In claim 5, line 3: “network configured” should apparently read --network are configured--.
Appropriate correction is required.
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: a neuronavigation system in claims 1 and 14; a graphical rendering module in claims 2 and 14; and an optimization module in claims 5 and 18. Paragraph 0005 of the present specification notes that neuronavigation systems can include an infrared camera, and paragraph 0023 teaches that the neuronavigation system “may be any known neuronavigation system in the art.” The graphical rendering module is taught to be, for example, a graphics processing unit of a computer system. No structure is taught for the optimization module.
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.
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 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 1-13 and 18-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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 recites the limitation “a coil position and orientation” in lines 6-7. It is not clear if this is intended to refer to the previously recited electromagnetic coil or to a separate coil.
Claim 11 recites the limitation “a head and brain of a subject” in line 2. It is not clear if this is intended to refer to the previously recited subject and brain or to a separate head/brain/subject.
Claims 2-13 are rejected by virtue of their dependence upon claim 1.
Claim 18 recites the limitation “a position and orientation of an electromagnetic coil” in line 4. It is not clear if this is intended to refer to the previously recited position and orientation and electromagnetic coil or to a separate position/orientation/coil.
Claim 18 also recites the limitation “an optimization module” in line 13. As detailed supra, this claim limitation invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no description of any structural component of this module. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 19-21 are rejected by virtue of their dependence upon claim 18.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10 and 13-21 are rejected under 35 U.S.C. 103 as being unpatentable over Saitoh et al. (U.S. Pub. No. 2017/0049387 A1; hereinafter known as “Saitoh”), in view of Yokota et al., “Real-Time Estimation of Electric Fields Induced by Transcranial Magnetic Stimulation with Deep Neural Networks,” Brain Stimulation, vol. 12, issue 6, Nov.-Dec. 2019, p. 1500-1507 (cited in the IDS filed 17 May 2024; hereinafter known as “Yokota”).
Regarding claim 1, Saitoh discloses a system for integrated electric field simulation and neuronavigation (Abstract; Fig. 16), the system comprising; a neuronavigation system 19/20/43 configured to track an electromagnetic coil 8 used for neuromodulation of a brain of a subject ([0123]; [0125]; [0130]-[0131]); an electric field simulator coupled to the neuronavigation system and configured to generate a simulated electric field for a region of interest based at least on a coil position and orientation, a magnetic field profile of the electromagnetic coil, and multimodal neuroimaging data associated with the subject ([0014]-[0016]; [0032]; [0040]-[0042]; [0066]-[0084]; [0135]-[0137]); and a display 21 coupled to the electric field simulator and configured to display the simulated electric field ([0072]; [0079]; [0127]; [0130]-[0131]; [0136]-[0137]). Saitoh fails to disclose that the electric field simulator is an electric field simulation neural network. Yokota discloses a similar system (Fig. 1) that comprises an electric field simulation neural network in order to provide rapid electric field simulation and allow calculations to be performed in real-time during navigated TMS (Introduction). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Saitoh with the neural network taught by Yokota in order to provide rapid simulation and allow calculations to be performed in real-time during navigated TMS.
Regarding claim 2, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Saitoh further discloses a graphical rendering module coupled to the electric field neural network and configured to generate a graphical rendering of the simulated electric field ([0072]; [0079]; [0127]; [0130]-[0131]; [0136]-[0137]).
Regarding claim 3, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Saitoh further discloses that the neuronavigation system is configured to detect the coil position and orientation and to provide the coil position and orientation to the electric field simulation neural network ([0123]; [0125]; [0130]-[0131]; [0136]).
Regarding claim 4, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Saitoh further discloses that the display is configured to display the graphical rendering of the simulated electric field ([0072]; [0079]; [0127]; [0130]-[0131]; [0136]-[0137]).
Regarding claim 5, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Saitoh further discloses an optimization module coupled to the electric field neural network, wherein the optimization module and the electric field simulation neural network configured to determine an optimized coil position and orientation for a brain target ([0016]; [0056]; [0134]; Yokota also teaches optimizing the electric field distribution).
Regarding claim 6, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Saitoh further discloses that the optimized coil position and orientation is provided to the neuronavigation system ([0056]; [0134]).
Regarding claim 7, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Saitoh further discloses that the region of interest is the brain of the subject ([0121]-[0122]).
Regarding claim 8, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Saitoh further discloses that the region of interest is a region of the brain of the subject ([0045]; [0064]; [0068]).
Regarding claim 9, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Yokota further discloses that the electric field simulation neural network is a convolutional neural network (Introduction, final paragraph).
Regarding claim 10, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Yokota further discloses that the electric field simulation neural network is configured to generate the simulated electric field in less than one second (Introduction, final paragraph; 0.01-0.03 seconds).
Regarding claim 13, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Saitoh further discloses that the electromagnetic coil is a transcranial magnetic stimulation (TMS) coil ([0121]-[0123]).
Regarding claim 14, Saitoh discloses a method for generating a graphical rendering of a simulated electric field using a system for integrated electric field simulation and neuronavigation (Abstract; Fig. 16), the method comprising: detecting, using a neuronavigation system 19/20/43, a position and orientation of an electromagnetic coil 8 used for neuromodulation of a brain of a subject ([0123]; [0125]; [0130]-[0131]); providing the position and orientation of the electromagnetic coil, a magnetic field profile of the electromagnetic coil and multimodal neuroimaging data associated with the subject to an electric field simulator ([0014]-[0016]; [0032]; [0040]-[0042]; [0066]-[0084]; [0135]-[0137]); generating, using the electric field simulator, a simulated electric field for a region of interest based at least on the position and orientation of the electromagnetic coil, the magnetic field profile of the electromagnetic coil, and the multimodal neuroimaging data associated with the subject, generating, using a graphical rendering module, a graphical rendering of the simulated electric field, and displaying the graphical rendering on a display 21 ([0072]; [0079]; [0127]; [0130]-[0131]; [0136]-[0137]). Saitoh fails to disclose that the electric field simulator is an electric field simulation neural network. Yokota discloses a similar method (Fig. 1) that uses an electric field simulation neural network in order to provide rapid electric field simulation and allow calculations to be performed in real-time during navigated TMS (Introduction). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Saitoh with the neural network taught by Yokota in order to provide rapid simulation and allow calculations to be performed in real-time during navigated TMS.
Regarding claim 15, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Saitoh further discloses that the region of interest is the brain of the subject ([0121]-[0122]).
Regarding claim 16, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Saitoh further discloses that the electromagnetic coil is a transcranial magnetic stimulation (TMS) coil ([0121]-[0123]).
Regarding claim 17, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Yokota further discloses that the electric field simulation neural network is a convolutional neural network (Introduction, final paragraph).
Regarding claim 18, Saitoh discloses a method for optimizing a position and orientation of an electromagnetic coil of a neuromodulation system using a system for integrated electric field simulation and neuronavigation (Abstract; Fig. 16), the method comprising: providing a position and orientation of an electromagnetic coil 8, a magnetic field profile of the electromagnetic coil and multimodal neuroimaging data associated with a subject to an electric field simulator, wherein the electromagnetic coil is used for neuromodulation of a brain of the subject; generating, using the electric field simulator, a simulated electric field for a region of interest based at least on the position and orientation of the electromagnetic coil, the magnetic field profile of the electromagnetic coil, and the multimodal neuroimaging data associated with the subject; receiving a reference target in the region of interest; comparing, using an optimization module, the simulated electric field to the reference target to determine if the position and orientation of the electromagnetic coil maximizes an electric field at the reference target in the region of interest; and providing the position and orientation of the electromagnetic coil to a neuronavigation system 19/20/43 if the position and orientation of the electromagnetic coil maximizes an electric field at the reference target in the region of interest ([0014]-[0016]; [0032]; [0040]-[0042]; [0066]-[0084]; [0123]; [0125]; [0130]-[0131]; [0135]-[0137]). Saitoh fails to disclose that the electric field simulator is an electric field simulation neural network. Yokota discloses a similar method (Fig. 1) that uses an electric field simulation neural network in order to provide rapid electric field simulation and allow calculations to be performed in real-time during navigated TMS (Introduction; Yokota also teaches calculating a maximum electric field and optimizing an electric field distribution on the brain, in Discussion and conclusion). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Saitoh with the neural network taught by Yokota in order to provide rapid simulation and allow calculations to be performed in real-time during navigated TMS.
Regarding claim 19, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Saitoh further discloses that the region of interest is the brain of the subject ([0121]-[0122]).
Regarding claim 20, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Yokota further discloses that the electric field simulation neural network is a convolutional neural network (Introduction, final paragraph).
Regarding claim 21, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, and Saitoh further discloses that the electromagnetic coil is a transcranial magnetic stimulation (TMS) coil ([0121]-[0123]).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Saitoh and Yokota as applied to claim 1 above, and further in view of Weisand (U.S. Pub. No. 2017/0087367 A1).
Regarding claim 11, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, but fails to disclose that the multimodal neuroimaging data includes neuroimaging data of a head and brain of a subject acquired using a plurality of different modalities; though Saitoh does teach different modalities as possibilities ([0125]). Weisand discloses a similar system for applying TMS (Abstract; [0012]; [0122]; [0144]) that acquires multimodal neuroimaging data of a head and brain of a subject using a plurality of different modalities in order to provide both functional and structural data ([0035]; [0040]-[0041]; [0116]; [0120]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Saitoh and Yokota by using a plurality of different modalities, as taught by Weisand, in order to provide both functional and structural data.
Regarding claim 12, the combination of Saitoh and Yokota discloses the invention as claimed, see rejection supra, but fails to disclose that the multimodal neuroimaging data includes anisotropic conductivity of brain tissue of the subject. Weisand discloses a similar system for applying TMS (Abstract; [0012]; [0122]; [0144]) that acquires multimodal neuroimaging data that can include both MRI/PET (as in Saitoh) and DTI (which includes anisotropic conductivity) in order to provide both functional and structural data ([0035]; [0040]-[0041]; [0116]; [0120]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Saitoh and Yokota by using anisotropic conductivity of brain tissue of the subject via DTI, as taught by Weisand, in order to provide both functional and structural data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791