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 .
DETAILED ACTION
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: “input” and “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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 10 and 13 recites a planning method and system real-time navigation for transcranial focused ultrasound stimulation (Step 1: Yes). In this case, the judicial exception relied upon by the instantly claimed invention is an abstract idea (Step 2A: Yes), and the limitation(s) that set(s) forth or describe(s) the abstract idea(s) is/are: “generate/pre-calculate a subject-specific set of acoustic beam profile”, “generate an acoustic intensity scalp map” and “generate real-time 3D visualization”. The reason(s) that the limitation(s) are considered an abstract idea is because they are directed to functionally-described algorithmic processes that require performing mathematical calculations, and the Supreme Court has explicitly characterized mathematical relationships/formulas as abstract ideas (Federal Register, Vol. 79, No. 241, December 16, 2014 at 74622, column 2). The claims are just claiming calculation and processing data to generate scalp map, 3D visualization. The instantly claimed invention is also similar to claims already found to be directed to an abstract idea and patent ineligible. See at least the following court decisions:
• SmartGene, Inc. v Advanced Biological Labs., 555 Fed. Appx. 950 (Fed. Cir. 2014), directed to systems, methods and computer program products for guiding the selection of therapeutic treatment regimens (ineligible)
• TLI Communications LLC v. A. V. Automotive, LLC (Fed. Cir. May 17, 2016) directed to generalized steps for recording, administration and archiving of digital images, and classifying and storing digital images in an organized manner (ineligible)
• Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015)., directed to a method of non-invasive prenatal diagnosis (ineligible)
• Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709 (Fed. Cir. 2014), directed to methods of payment of intellectual property royalties by interposed sponsor over a telecommunications network (ineligible)
• Digitech Image Techs., LLC v Electronics for Imaging, Inc., 758 F.3d 1344 (Fed. Cir. 2014), drawn to device profiles for use in a digital image processing system (ineligible)
The claims do not include additional elements that are sufficient to amount to
significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The claim recites the additional limitations of an “input” for receiving image and a “display” to display images and simulation. The additional elements are recited at a high level of generality and are recited as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. Thus, taken alone, these additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. The input is well-known and generic to the computer field. For prong 1 of Step 2A the claim is an abstract idea as stated above. For prong 2 of Step 2A, the claims do not integrate into practical application because the claims do not claim any particular medical treatment or condition. It is merely obtain images, process signal/data and generate data/simulation/visualization from the obtain images and data using a computer.
With regards to the instantly rejected dependent claim(s), these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. For example, claims 2-9, 11-12 and 14-16 are merely claiming obtain certain type of images, process images and generate data/visualization. The dependent claims do not claim any particular medical treatment or condition to be considered practical application. Thus, claims 1-16 as a whole do not amount to significantly more than the exception itself (Step 2B: No).
Applicant is reminded that additional steps/elements may be enough to qualify as “significantly more” if they meaningfully limit the judicial exception, improve the technology or technical field, improve the functioning of a computer itself, or add a specific limitation other than what is well-understood, routine, conventional activity in the field or unconventional steps that confine the claim to a particular useful application.
For additional guidance, applicant is directed generally to MPEP 2106 and to the USPTO's Guidance on Subject Matter Eligibility (October 2019 Update). This information can be found at: http://www.uspto.gov/patent/laws-and-regulations/examination-policy/2014-interim-guidance-subject-matter-eligibility-0.
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 1-3, 6-8 and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Konofagou (WO 2021/081373 (provided in the IDS)), in view of Ahn et al. (US 2013/0144194) and further in view of Hynynen (US 2019/0021666).
Addressing claim 1, Konofagou discloses a system for planning and real-time navigation for transcranial focused ultrasound stimulation (t(FUS) comprises:
an input for receiving an image of a head of a subject (see pg. 14, lines 25-26);
an acoustic beam profile simulation module coupled to the input and configured to generate a subject-specific set of acoustic beam profiles based on the image of the head of the subject, wherein the subject-specific set of acoustic beam profiles is configured to account for acoustic propagation effects through the subject's skull (see pg 12, lines 12-16, lines 26-28; Fig. 2, pg. 20, line 31-page 21, line 1 and page 22, lines 31-32; use CT or MRI image to simulate to obtain treatment parameters (acoustic beam profile); the simulate provide information regarding beam attenuation through the skull (acoustic propagation effects through the subject's skull));
a planning module coupled to the acoustic beam profile simulation module and configured to generate an acoustic intensity scalp map for a target region based on the subject- specific set of acoustic beam profiles and to generate a three-dimensional (3D) visualization of a selected beam profile from the subject-specific set of acoustic beam profiles (see pg. 11, lines 6-10, pg. 12, lines 12-16, pg. 13, lines 27-29; Fig. 2 and pg. 20, line 31-page 21, line 1; simulate to get subject-specific set of acoustic beam profile (treatment parameters) and produce 3D skin scalp and brain resconstructions; planned and achieved trajectory can be visualized in real-time; Fig. 2 shows real-time 3D simulation of ultrasound)
a real-time navigation module coupled to the acoustic beam profile simulation module and configured to generate a real-time 3D visualization of an acoustic beam for tFUS for a current position of a transducer around the head of the subject based on current position data and the subject-specific set of acoustic beam profiles (see Fig. 2, pg. 11, lines 6-15, pg 12, lines 12-16, lines 26-28 and pg. 20, line 31-page 21, line 1).
Konogagou does not disclose beam profiles for a plurality of locations around the scalp of the subject and generate a graphical user interface to select beam profile of one of the plurality of locations around the scalp of the subject for 3D visualization by movement of a virtual transducer around a 3D scalp representation of the subject. Anh discloses generate a graphical user interface to select beam profile of one of the plurality of locations around the subject for 3D visualization by movement of a virtual transducer around a 3D representation of the subject (see abstract, [0010-0011], [0031-0032], [0065], [0067], [0078] and claims 4-5; moving virtual transducer to many locations and select treatment parameters for virtual transducer at the location and perform virtual irradiation is generate a graphical user interface to select beam profile of one of the plurality of locations around the subject for 3D visualization by movement of a virtual transducer around a 3D representation of the subject). Hynynen discloses beam profiles for a plurality of locations around the scalp of the subject (see [0058], [0078-0079] and Fig. 4; determine transducer location and determine beamforming parameters for that transducer is the beam profile for that transducer; many beam profiles for many transducers locate around the scalp of the subject). Konofagou and Hynynen disclose transcranial ultrasound treatment therefore Konofagou and Hynynen in view of Ahn could moving virtual transducer and perform virtual irradiation at the scalp of the subject. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Konofagou to have beam profiles for a plurality of locations around the scalp of the subject and generate a graphical user interface to select beam profile of one of the plurality of locations around the subject for 3D visualization by movement of a virtual transducer around a 3D representation of the subject as taught by Ahn and Hynynen because this improve treatment by providing better ultrasound irradiation and focus.
Addressing claims 2-3 and 6-8, Konofagou discloses:
addressing claim 2, further comprising a display configured to display one or more of the images of the head of the subject, the scalp map, the 3D visualization of a selected beam profile from the subject-specific set of acoustic beam profiles, and the real-time 3D visualization of an acoustic beam for tFUS for a current position of a transducer around the head of the subject (see Figs. 1-2 and pg. 20, line 31-pg. 21, line 1; display 110).
addressing claim 3, wherein the image of the head of the subject is a magnetic resonance (MR) image (see pg. 12, line 27).
addressing claim 6, wherein the acoustic beam profile simulation module is configured to generate the subject-specific set of acoustic beam profiles for a plurality of transducer locations around the head of the subject (see Fig. 2 and pg. 20, line 31-pg. 21, line 1).
addressing claim 7, wherein the acoustic beam profile simulation module is configured to generate a basis set of ultrasound excitations and decompose the subject-specific set of acoustic beam profiles on the basis set of ultrasound excitations (see Fig. 2 and pg. 20, lines 31-pg 21, line 13; emitting pulses of variable length; pressure profile).
addressing claim 8, wherein the current position data for the transducer is received from a neuronavigation system configured to track the position of the transducer (see Fig. 1, pg. 11, lines 11-15).
Addressing claims 10-11 and 13-15, the system in claims 1, 3 and 8 performs the method in claims 10-11 and 13-15, therefore claims 10-11 and 13-15 are being rejected for the same reason as claims 1, 3 and 8.
Addressing claim 12, the target region is a region of a brain of the subject (see page 3, lines 1-2).
Claims 9 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Konofagou (WO 2021/081373 (provided in the IDS)), in view of Ahn et al. (US 2013/0144194), further in view of Hynynen (US 2019/0021666) and Allen et al. (WO 2021/055889 (provided in the IDS)).
Addressing claims 9 and 16, Konofagou does not disclose registering the head of the subject to the MR image of the head of the subject. In the same field of endeavor, Allen discloses registering the head of the subject to the MR image of the head of the subject (see pg. 61, lines 5-7 and abstract; register head model to intraoperative image; intraoperative image is MRI image of subject head). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Konofagou to register the head of the subject to the MR image of the head of the subject as taught by Allen because this would minimize patient exposure to ionizing radiation (see page 60, lines 31-33).
No art rejection for claims 4-5.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argued regarding 101 rejections that there is technical advancement over the prior art therefore 101 rejections should be withdrawn. Applicant’s argument is not persuasive because the prior art teaches the technical features therefore there is no technical advancement.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2021/0346726; US 2019/0362522; US 2019/0318474; US 2019/0184204 (see [0235]; determine transducer location on the skull and based on this information calculate treatment parameters/beam profile) and US 2017/0291044 (see claim 3 and [0140]; adjust/place transducer and sound source; simulate and determine treatment parameter/beam profile).
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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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797