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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/15/26 has been entered.
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”, “input device” 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 § 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 (see Ahn’s paragraph [0117] and [0113]; provide optimal treatment plan to avoid harm/danger to the patient).
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).
Allowable Subject Matter
Claims 4-5 allowed.
Response to Arguments
Applicant's arguments filed 06/15/26 have been fully considered but they are not persuasive. Applicant argues Konofagou does not teach pre-calculated subject-specific beam profiles for a plurality of scalp locations. Applicant’s argument is not persuasive because examiner does not rely on Konofagou to disclose this limitation. Applicant argues Ahn is directed to an entirely different field of high- intensity focused ultrasound (HIFU) irradiation planning for tumor ablation. Applicant argues combine Konofagou with Ahn produce undesirable outcome that would lead one of ordinary skill in the art to not consider either combination of the references. Applicant’s argument is not persuasive because applicant make a conclusory statement without providing evidences. They are both in related ultrasound field. There no reason why one can not incorporate a certain element of different ultrasound treatment into a different ultrasound treatment to improve the system. Improve ultrasound treatment and focus is universal in every ultrasound treatment. KSR rationales: (C) Use of known technique to improve similar devices (methods, or products) in the same way; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. Examiner provided motivation reason to combine and pointed out the benefit provided by Ahn. Applicant argues Ahn does not account for acoustic propagation effects through the subject skull. Applicant’s argument is not persuasive because examiner does not relies on Ahn to disclose acoustic propagation effects through the subject skull. Further, when Ahn avoids bones obstacle that is implicitly take into account of acoustic propagation. Applicant argues the system models the skull’s effects on the ultrasound beam rather than simply avoiding the skull. Applicant’s argument is not persuasive because the main reference discloses models the skull’s effects on the ultrasound beam. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant argues Hynynen's transducers are physically fixed in pre-selected positions on a manufactured headset frame. Applicant’s argument is not persuasive because examiner only relies on Hynynen to disclose “beam profiles for a plurality of locations around the scalp of the subject”. It is irrelevant that Hynynen’s transducers are fix or movable. Applicant argues Hynynen does not generate a visualization of an acoustic beam for the current position of a transducer as it moves around the scalp. Applicant’s argument is not persuasive because examiner does not rely on Hynynen to disclose this limitation. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant argues examiner make conclusory statement does not satisfy the requirement of KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), which requires that an examiner articulate a reason with rational underpinning for why a person of ordinary skill in the art would have combined the cited references. Applicant’s argument is not persuasive because KRS (C) rationales allow for combine of references when the known technique improve similar devices. Examiner also provided motivation reason provided in the prior art as suggested in KSR (G). KSR rationales: (C) Use of known technique to improve similar devices (methods, or products) in the same way; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. Applicant argues the claimed real-time feedback loop, where the system generates a visualization of the acoustic beam at the current position of the physical transducer based on pre-calculated beam profiles, is entirely absent from the combination of Konofagou, Ahn, and Hynynen. Applicant’s argument is not persuasive because Konofagou in view of Ahn and Hynynen disclose the claim limitation. Applicant argues the reference individually while the claims are rejection as a combination of references.
Regarding 112(f) interpretation applicant argues the term “input device” is a well-recognized structural term. Examiner place a 112(f) interpretation for term “input device” and “input” to interpret the claim according to what applicant present in the specification as applicant pointed out these terms connote definite structure, for example, a data port, a communication interface, or a peripheral device and this is consistent with the description and Fig. 9 of the present application. Applicant argues each module is a software component executed on a hardware processor. Examiner place a 112(f) interpretation for term “module” to interpret the claim according to what applicant present in the specification.
Applicant’s argument regarding 101 rejection is persuasive therefore examiner withdraw 101 rejection.
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).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HIEN NGOC NGUYEN whose telephone number is (571)270-7031. The examiner can normally be reached Monday-Thursday 8:30am-6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne 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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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
Prosecution Insights