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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/28/26 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.
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: “mobile device” in claim 6 with support in published [0037]; and neuro-navigation system in claims 1, 9, and 14 with support at [0030].
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 Objections
Claims 3, 13, and 15 are objected to because of the following informalities:
In claim 3, line 7, it appears ‘a’ should be ‘the’ as the term is previously set forth.
In claim 3, lines 5 and 10, ‘user interface’ is included in the claim, but had been deleted in the prior claim set.
In claim 13, line 4, the typo ‘stimulation signals’ should be ‘neuromodulation beam’.
In claim 15, line 3, it appears both instances of ‘a’ should be ‘the’.
Appropriate correction is required.
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 is 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. In claim 1, there is no support of optical or acoustic measurements are from an MRI database. Rather it appears an MRI database only includes MR scans.
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.
Claim 3 is 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.
In claim 3, it is unclear whether the limitations regarding the functions of the computing device are required because claim 1 only requires “one or more” of (i) to (vi). For example, it appears the limitations of a fuel gauge in claim 3 would not be required because that only further limits (ii) in claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ebbini (US Pub 2019/0308036 -previously cited).
Re claim 1: Ebbini discloses a transcranial ultrasound treatment system comprising:
an ultrasound transducer comprising a 1.75D probe configured to focus a neuromodulation beam through a patient's skull into a brain region, wherein the 1.75D probe comprises an array of discrete rectangular bulk piezoelectric transducer elements arranged along an azimuth dimension and an elevation dimension, wherein each transducer element has an elevation dimension greater than an azimuth dimension such that the 1.75D probe has lower steering capability in the elevation dimension than in the azimuth dimension, wherein the 1.75D probe is configured to electronically steer and focus the neuromodulation beam in the azimuth dimension and to correct skull-induced aberration of the neuromodulation beam in both the azimuth dimension and the elevation dimension [0029, 0045, 0069, 0093, Fig 5; see the transducer that is a probe for transcranial FUS to transmit stimulation signals (i.e. a neuromodulation beam) and to produce neuromodulation and guidance with skull aberration correction wherein the elements 302 (the sampling elements are transducer elements [0036]) are discrete rectangular bulk piezoelectric elements as the element material is piezoelectric PVDF which is considered as a bulk piezo material, with a dimension larger in elevation relative to azimuth or that there are asymmetric element dimensions, thereby configuring the probe to steer and focus the beam in azimuth and to correct skull-induced aberration in azimuth and elevation further];
wherein the transcranial ultrasound treatment system is configured to adapt 3D anatomical guidance data to a specific patient 3D anatomy using one or more of: (i) optical or acoustic measurements from an MRI database; (ii) a fuel gauge to adapt probe data previously recorded by a volume capable matrix probe; (iii) a mechanical fixture configured to be mounted on a patient head to rotate the probe and acquire conical volume data, and supplementing the conical data by using data retrieved using CBIR form an atlas of human anatomical scans; (iv) similarity lookup employing blood vessel data obtained using the probe; (v) ventricles that provide fiducial marks; or (vi) contextual data provided by a neuro navigation system [0118, 0128, 0155, figure 12; 3D image data of the target skull/brain is obtained for accurate DMUA positioning for the treatment and this provides contextual data relative to the 3D anatomy of the specific patient].
Re claim 2: The probe comprises a rotatable mechanical structure (figures 1, 2; see the structure which is capable of being rotated relative the patient).
Re claims 11, 12: The probe further comprises an optical feature comprising visual markings for identification by a camera or a LIDAR device, where content-based image retrieval is employed to find a specific brain MRI in a database of brain MRIs, wherein the specific brain MRI is used to provide volume guidance for steering the neuromodulation beam (0069, figure 1; see the features/structure of the probe which are visible by a camera or LIDAR device and see the MR-compatibility indicating MR imaging).
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 3-9 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ebbini in view of Alzaga et al (US Pub 2021/0085398 -previously cited).
Re claim 3: Ebbini discloses the system comprising: acquisition hardware coupled to the probe, the acquisition hardware comprising a receiver that receives input from the probe; and a computing device coupled to the acquisition hardware, the computing device generating a fuel gauge user interface based upon input from the probe, the fuel gauge user interface indicating suitability of a current position or a current orientation of the probe for providing neuromodulation to the patient skull using the probe [0057, 0118, figures 2, 8, Abstract; see the Rx circuitry that receives probe input and see the computer and processing hardware wherein received information of surface/obstacle data indicates position suitability]. Ebbini does not disclose that the computing device performs a similarity lookup with a MRI database based on a volume data set from slice imaging of rotating the probe, and guiding the beam based on the lookup, wherein the suitability is based on proximity of the current pose to a position based on the lookup. However, Alzaga teaches a similarity lookup with a MRI database based on a volume data set from slice imaging of rotating the probe, and guiding the beam based on the lookup, wherein the suitability is based on proximity of the current pose to a position based on the lookup [0024, 0034; see the ultrasound data set is rotated and compared with MR data to generate a similarity]. It would have been obvious to the skilled artisan to modify Ebbini, to use the similarity as taught by Alzaga, in order to improve a desired treatment outcome.
Re claims 8, 9: Ebbini discloses guidance information associated with placement of the probe is obtained by the acquisition hardware acoustically measuring an inner surface of the skull on an opposing side of the patient skull from where the probe is positioned, wherein the information is received from a pre-procedure MRI and a Neuro-Navigation system (figure 8, 0069; see the surface/obstacle information which is guidance information for probe placement and see the MR-compatibility which indicates MR is performed).
Re claims 4-7: Ebbini discloses all features except for at least one of a camera or a LIDAR device integrated into a mobile device separate from the computing device and configured to obtain the current position or the current orientation of the probe relative to the patient skull, wherein the mobile device is movable about the patient skull to obtain optical feedback associated with the current position or the current orientation, and wherein the optical feature indicates a position or an orientation of the probe relative to the patient skull. However, Alzaga teaches of a system for supporting medical personnel including at least one of a camera or a LIDAR device integrated into a mobile device separate from the computing device and configured to obtain the current position or the current orientation of the probe relative to the patient skull, wherein the mobile device is movable about the patient skull to obtain optical feedback associated with the current position or the current orientation, and wherein the optical feature indicates a position or an orientation of the probe relative to the patient skull [0069, 0085, Figure 3; see the camera 12 to track position of ultrasound probe 10 relative to a patient wherein the camera is mobile as it can be moved and is used to obtain optical feedback for the probe]. It would have been obvious to the skilled artisan to modify Ebbini, to use the camera as taught by Alzaga, in order to facilitate probe positioning and making probe placement more accurate.
Re claims 13-15: Ebbini discloses all features including MR imaging for a pre-procedure MR wherein the pre-procedure MRI is replaced with an approximate 3D MRI obtained using a 1.75D probe and a similarity lookup into a database of 3D MRI scans [0069; see the MR-compatibility which indicates MR is performed] but does not disclose that the computing device generates a simulated prediction of an ultrasound neuromodulation beam output by the probe that is overlaid on an image of a brain associated with the patient skull for steering the neuromodulation beam, wherein the simulated prediction is based on input from a pre-procedure MRI and from a navigation system. However, Alzaga teaches of generation of a simulated prediction of an ultrasound neuromodulation beam output by the probe that is overlaid on an image of a brain associated with the patient skull for steering the neuromodulation beam, wherein the simulated prediction is based on input from a pre-procedure MRI and from a navigation system [0020, see the simulation of deformations of the examination object based on taking into account the imaged surface]. It would have been obvious to the skilled artisan to modify Ebbini, to use the simulation as taught by Alzaga, in order to provide for a plan to obtain a desired treatment outcome.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ebbini/Alzaga in view of Law et al (US Pub 2017/0080255 -previously cited).
Re claim 10: Ebbini/Alzaga discloses all features except that the computing device determines the guidance information from an average brain MRI customized to the patient skull using at least one of camera data, LIDAR data, or acoustic data relating to an inner surface of the patient skull. However, Law teaches of an ultrasound device wearable on the subject’s head, wherein guidance information from an average brain MRI customized to the patient skull using at least one of camera data, LIDAR data, or acoustic data relating to an inner surface of the patient skull [0170; see the averaged anatomical brain maps from MRI]. It would have been obvious to the skilled artisan to modify Ebbini/Alzaga, to use the averaged maps as taught by Law, in order to improve positioning of the transducer making treatment more accurate.
Response to Arguments
Applicant's arguments filed 5/28/26 have been fully considered but they are not persuasive. Regarding Ebbini, Applicant argues that there is no disclosure a 1.75D probe that meets the limitations of claim 1. Respectfully, the Examiner disagrees and finds that the limitations are met. The Examiner maintains that Ebbini discloses a 1.75D probe even though “1.75D” is not explicitly used. A 1.75D array is merely an array with elements having a dimension larger in elevation relative to azimuth or that there are asymmetric element dimensions. Ebbini meets this because the elements 302 are rectangular and this means that the elements are larger in elevation than azimuth or that there are asymmetric element dimensions. That the elements are made of PVDF films further does not preclude the rectangular elements meeting the definition of a 1.75D array. Applicant correctly points out that [0093] describes ‘fine sampling elements’, but incorrectly asserts that these are not physical elements. [0036] explicitly states that a “transducer element” is also referred to “sampling element”. Therefore, the elements 302 that are rectangular are transducer elements.
Claim 1 sets forth other functional limitations including that the probe has lower steering capability in elevation and that the beam is steered and focused in azimuth and aberrations are corrected in both azimuth and elevation. These functional limitations are met because Ebbini discloses a 1.75D probe. Applicant refers to these capabilities in the specification [see 0017] wherein the focusing and steering is a functional capability resulting from the element dimensions of the 1.75D probe. Since Ebbini discloses a 1.75D probe, then the functional capabilities are met. If these limitations are somehow met by a particular probe arrangement that is different from a typical 1.75D probe, this does not appear to be described in the specification.
The 112f interpretation is maintained, as previously described. The claim objections are withdrawn except for those not addressed. The 112a rejections are withdrawn except for one in claim 1 not addressed. The 112b rejections are withdrawn except for one in claim 3 not addressed.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
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