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 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.
Claims 47 and 49-71 are 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. Limitation “train a machine learning model based on the generated features to optimize ultrasound therapy parameters using unsupervised or supervised machine learning methods, wherein the ultrasound therapy parameters are optimized to increase a likelihood of achieving a shockwave therapeutic effect comprising angiogenesis and neovascularization” is not sufficiently disclose in the specification. The specification does not sufficiently disclose what features are extracted and how using these features would optimized ultrasound therapy parameters to increase a likelihood of achieving a shockwave therapeutic effect comprising angiogenesis and neovascularization. For example, does one need to increase pulsing frequency to increase a likelihood of achieving a shockwave therapeutic effect comprising angiogenesis and neovascularization? How much to increase the frequency? What parameter need to optimized and by how much? How does one determine which parameter to optimizer? There no explanation on what features is extracted. There also no explanation or example on what parameter need to optimize and base on what reason is optimize that parameter would result in an increase of a likelihood of achieving a shockwave therapeutic effect comprising angiogenesis and neovascularization? The specification only provides a vague description of using machine learning with data such as a cardiac function, quality of life and angiogenesis, patient information data comprising demographic and medical history data of patients and ultrasound therapy parameter data comprising one or more of pulsing frequency, pulse train frequency, number of treated spots, duration and treatment zone area to optimize ultrasound therapy parameters using unsupervised or supervised machine learning methods.
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 47, 49-56 and 58-71 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. Limitation “wherein the ultrasound therapy parameters are optimized to increase a likelihood of achieving a shockwave therapeutic effect comprising angiogenesis and neovascularization” is unclear because applicant does not provide a mete and bound for ultrasound therapy parameters. Ultrasound therapy parameters could be a lot of things such as treatment duration, amplitude, intensity, frequency, duty cycle, etc. The claim discloses ultrasound therapy parameter data comprising one or more of pulsing frequency, pulse train frequency, number of treated spots, duration and treatment zone area. It is unclear if ultrasound therapy parameters and ultrasound therapy parameter data are the same and ultrasound therapy parameters are limit to pulsing frequency, pulse train frequency, number of treated spots, duration and treatment zone area.
No art rejection
The closest prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 12,119,102; US 2023/0343434; US 2023/0317283; US 2023/0298709; US 2023/0200811; US 2023/0100912; US 2021/0074432; US 2020/0269073; US 2019/0027252 and US 2017/0312165.
Conclusion
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
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