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 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 1-7 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. Regarding claim 1, instantly amended claim recites that “a frequency of the ultrasound stimulation is configured to match the heart rate frequency”, but no element is positively set forth as setting the frequency/matching the frequency or any equivalent function. The heart rate sensing unit positively recited is configured to detect the signal that corresponds to heart rate frequency, but recitation is lacking as to what controls the stimulation frequency. Claim 2 positively recites such a potential unit, but the recitation is lacking from claim 1.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4 and 7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fitzgerald (US 2025/0072759).
Regarding claims 1-4, Fitzgerald (‘759) discloses and teaches ultrasound signaling (0056-0061) via a support unit and stimulation unit for providing ultrasound stimulation, and a heart rate sensing unit which is capable of detecting heart rate signals and setting the transmission/stimulation frequency to a specific point in the heart cycle (frequency) as detected by the sensing unit (0056, 0063, 0072-0074, 0076-0078, 0113). Fitzgerald specifically denotes an annular band as the support unit (Fig 11a-b, 0115-0116), includes an array of transducer elements (0060), which includes at least groups of transducers (Fig 8, 9).
Regarding claim 7, Fitzgerald (‘759) discloses and teaches blood vessel monitoring (0001, Claim 6-7).
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.
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.
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.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald (US 2025/0072759) in view of Miskovic et al (US 2021/0373991, hereafter ‘991).
Fitzgerald discloses what is listed above, and additionally that the head may be a target for interrogation and signaling (Fig 11c, 0118, 0056, 0068), specifically teaching that a “headband” is a contemplated wearable device, but does not specify that the headband is for a cap body/band (for a skull), nor the pairwise control thereof.
Attention is hereby directed to Miskovic et al which expressly discloses a transcranial ultrasound stimulation with heart rate sensing (0064-0065, 0076-0077) for interrogation and stimulation of the skull of a patient (abs). Miskovic et al specifically disclose that heart rate and EEG sensors can be included in the cap of the device, including in various bands of the cap-like device (Fig 1, 3a, 3b). The insert elements which can include transducers and the litany of sensors listed above are capable of being included into the housing device which is tailored to the skull (0156-0161). Specific to claim 6, these sensors are specifically denoted as being controllable separately or in groups (like of 2 or more, 0116, 0040).
This customization enables and provides teaching to adjust the sensor elements to fit the patient (0156-0161). It would have been obvious to one of ordinary skill in the art at the time of the invention to have utilized the teachings of Miskovic et al for a cap-based wearable element, with the teachings of Fitzgerald for processing and guiding transcranial ultrasonic stimulation with HR feedback control (Abs, Miskovic et al, 0068 Fitzgerald).
Response to Arguments
Applicant’s arguments with respect to claim(s) 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL M. LAMPRECHT whose telephone number is (571)272-3250. The examiner can normally be reached Mon - Fri 9:00-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOEL LAMPRECHT/Primary Examiner, Art Unit 3798
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