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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 10, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on February 10, 2025 are accepted.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 1 recites in lines 3-4 “…to provide an ultrasonic image…without full waveform inversion (FWI) processing”. Claim 6 recites that “no inversion process is performed with said ultrasound image”. The terms that recite “without full FWI processing” and “no inversion process is performed” are negative limitations that require explicit disclosure support by the specification. The mere absence of a positive recitation is not basis for an exclusion. See MPEP 2173.05(i). “Any negative limitation or exclusionary provision must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977)”.
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 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claim 1 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: providing an indication of positioning of said wearable ultrasound device on the patient area of interest.
Examiner first notes that, the recited limitation of “adjusting a position of said wearable ultrasound device if needed” is currently rejected under 35 U.S.C. 112(b) and is interpreted as carrying no patentable weight (see p.7). This limitation hence is not analyzed in this rejection under 35 U.S.C. 101.
In claim 1, the above recited steps can be practically performed in the human mind, with the aid of a pen and paper. A person may observe the wearable ultrasound device and make a note as an indication with a pen and paper the position of the wearable ultrasound device. There is nothing recited in the claim to suggest an undue level of complexity in how the indication is provided. Therefore, a person would be able to perform the step of providing an indication mentally.
Prong Two: Claim 1 does not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claim recites additional steps of (1) assembling a garment comprising a wearable ultrasound device on a patient, and using said wearable ultrasound device to provide an ultrasonic image of a patient area of interest; and (2) sending full acquisition data acquired by said wearable ultrasound device for full 3D FWI processing.
The step in (1) represent merely data gathering or pre-solution activities. This data is not even used to perform the abstract idea.
The step in (2) represents merely further process the gathered data, and how the data is processed (i.e.,, for full 3D FWI processing) is recited at a high level of generality.
As a whole, the additional elements merely serve to gather information and to further process the gathered information in a high generality. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the indication is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claim recites additional steps of (1) assembling a garment comprising a wearable ultrasound device on a patient, and using said wearable ultrasound device to provide an ultrasonic image of a patient area of interest; and (2) sending full acquisition data acquired by said wearable ultrasound device for full 3D FWI processing. For similar reasons set forth in Step 2A, Prong Two above, the additional elements do not provide an inventive concept under Step 2B.
Dependent Claims
The dependent claims incorporate all the limitations of their respective independent claims. The following analysis focus on the limitations recited in the dependent claims to determine whether they merely recite further abstract idea, or whether or not they recite additional elements that may either amount to significantly more than the abstract idea in their respective independent claims, or may integrate the abstract idea in their respective independent claims to a practical application.
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons as stated in the analysis for their respective independent claims, hence are patent ineligible:
describing the ultrasound imaging modality being phased array imaging (claim 2);
describing where the data processing is performed, i.e., a cloud-based processor (claim 3);
describing that the collected ultrasonic image is used as an indication, i.e., data gathering and data feeding that is necessary for use of the recited judicial exception yet is recited at a high level of generality (claim 4);
describing further configuration of the garment (claim 5); and
describing a condition of the data processing (claim 6).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Based on the above consideration and analysis, claims 1-6 are patent ineligible, i.e., rejected under 35 U.S.C. 101.
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.
Claims1-6 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 pre-AIA the applicant regards as the invention.
Claim 1 recites in step c “adjusting a position of said wearable ultrasound device if needed” that renders the scope of the claim indefinite. It is unclear what condition is considered being “needed”. Further note that “if needed” is a conditional phrase. In the case when there is no need, step c. won’t be performed. For examination purpose, since the condition of “if needed” does not necessarily occur, step c. is determined to be an optional step that carries no patentable weight. Note that since this limitation is interpreted as carrying no patentable weight, it is not analyzed in the 101 rejection.
Claim 1 recites in step d “after correct positioning…” that renders the scope of the claim indefinite. There is no recitation prior to step d that the position is “corrected”. It is unclear whether it refers to “adjusting a position” recited in step c. Consistent claim language with proper antecedent basis is required. Further note that step C is determined to be an optional step that does not necessarily perform. Hence it is also unclear whether the full 3D FWI processing would perform if the position of the wearable ultrasound device is not adjusted. For examination purpose, since whether step d is performed depends on step c (only if the position is adjusted), step d. is determined to be also an optional step that carries no patentable weight.
Claim 1 recites in step d “full acquisition data acquired by said wearable ultrasound device” that renders the scope of the claim indefinite. It is unclear of the “full acquisition data” refers to the “ultrasound image” that is provided using the same wearable ultrasound device.
In the specification, the “full acquisition data” is discloses on pages 4-5 as being sent for full FWI processing. However, the specification does not disclose at all if the full acquisition data is different from the ultrasound image recited in line 4, i.e., acquired at different time points from the ultrasound image. Since the specification fails to disclose any ultrasound data being acquired after the position of the wearable ultrasound device is adjusted, for examination purpose, the full acquisition data is interpreted to be referring to the ultrasonic image recited in line 3. The ultrasound image without FWI processing in step a is sent for a full 3D FWI processing in step d.
Claim 1 recites “full waveform inversion (FWI) processing” in line 5 and “full 3D FWI processing” in line 11. It is unclear if they refer to the same. Note that FWI stands for “full waveform inversion”. Hence the word “full” before the word “3D” appears to be redundant. If the above identified two terms refer to the same, consistent claim language with proper antecedent basis is required.
Claim 5 recites in lien 2 “specific location” that renders the scope of the claim indefinite. The term “specific” is a relative term which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The dependent claims of the above rejected claims are rejected due to their dependency.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Baym et al., US 2017/0273664 A1, hereinafter Baym, in view of Backmann et al., US 2021/0080573 A1, hereinafter Backmann.
Claims 1, 4 and 6. Baym teaches a method of evaluating patient scan quality by a wearable ultrasound device ([0090]: the controller 106 can be programmed or configured to monitor signals from ultrasound elements 102 of the one or more arrays 104 that indicate the quality of their acoustic coupling with the body 200; and [0091]: the quality of acoustic coupling at least ultrasound element 102 is determined utilizing the ultrasound element 102 itself. For example, one or more ultrasonic signals applied or detected by the ultrasound element 102, either at the imaging frequency or at another frequency, can be used to determine the quality of acoustic coupling) – the coupling between the ultrasound element and the body affects the quality of the scan comprising:
a. assembling a garment comprising a wearable ultrasound device on a patient ([0080]: FIGS.5 and 6, the one or more ultrasound elements 102 or arrays 104 can be included in or coupled to a wearable garment 120), and using said wearable ultrasound device to provide an ultrasonic image of a patient area of interest without a mathematical analysis ([0081]: the one or more received ultrasonic signals can be processed to identify or image one or more portions 202 of fetus within the body 200; [0082]: the controller 106 can be programmed or configured to perform ultrasonography, shear wave imaging, or mathematical analysis with the one or more received electrical signals or digital values to identify or image one or more portions 202 of the fetus; [0091]: the quality of acoustic coupling at least ultrasound element is determined utilizing the ultrasound element; and [0092]: the controller can be programmed or configured to monitor acoustic coupling of the one or more ultrasound elements with the body, and can simply omit or discard image data received from an ultrasound element) – the determination/monitoring of the acoustic coupling is considered a mathematical analysis. Since this analysis is performed after the image data is acquired, it indicates that prior to the image acquisition, there is no mathematical analysis being performed;
b. providing an indication of positioning of said wearable ultrasound device on the patient area of interest ([0092]: all measured image data can be used to generate an ultrasound image, but pixels can be shaded in red in areas where contact with the body 200 is poor, and in green in areas where it is good. In some cases, an ultrasonic image may have “holes” in indicating that there was insufficient contact with the body in those areas);
c. following a review of said ultrasonic image, adjusting a position of said wearable ultrasound device if needed ([0134]: FIG.28, block 606 an include identifying at least one non-detected portion of the fetus based upon one or more detected portion of the fetus (block 624)…The non-detected portion can be imaged…by repositioning the same ultrasound element; and [0080]: The one or more support members can facilitate appropriate positioning or contact between the one or more ultrasound elements and the body…the one or more ultrasound elements are repositionable within the garment) – “based on the identification of non-detected portion of the fetus based upon one or more detected portion of the fetus” is considered “reviewing said ultrasonic image” as claimed.
In the above teaching to steps b and c, since the quality of the coupling is determined based on the image (i.e., “one or more ultrasonic signals applied or detected by the ultrasound element 102, either at the imaging frequency or at another frequency, can be used to determine the quality of acoustic coupling”), and the ultrasound element is repositioned to “facilitate appropriate positioning or contact between the one or more ultrasound elements and the body”, the quality of the coupling indicated in the image is considered “an indication of positioning of said wearable ultrasound device on the patient area of interest” as claimed.
In regard to step d., as indicated above in step a, Baym teaches in [0082] that the controller 106 can be programmed or configured to perform…mathematical analysis with the one or more received electrical signal or digital values; in [0096]: the remaining sensor data can be used to generate an ultrasound image; and in [0117]: the controller 106 can also be programmed or configured to identify one or more portions of the fetus based upon the images or based on an analysis of the data., hence, it teaches that the mathematical analysis occurs after the repositioning of the ultrasound elements.
Baym does not teach that the mathematical analysis is a full 3D FWI processing.
However, in an analogous ultrasound imaging data analysis field of endeavor, Bachmann teaches that the image data acquired by said wearable ultrasound device after the position of the ultrasound element is corrected with
full 3D FWI processing ([0007]: this disclosure provides a Full Waveform Inversion (FWI)-based method and system for producing ultrasound images. The method features an accurate wave propagation solver, which permits reconstruction of high-quality 2D and 3D computerized maps of mechanical parameters).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the mathematical analysis of the imaging data of Baym employ such a feature of being full 3D FWI processing, as taught in Bachmann for the advantage of “featuring an accurate wave propagation solver that permits reconstruction of high-quality 2D and 3D computerized maps of mechanical parameters”, as suggested in Bachmann, [0007].
Claim 2. Baym further teaches
providing said ultrasonic image of the patient area of interest is done by phased array imaging ([0099]: knowledge of the spatial profile of coupling quality for an array of ultrasound elements 102 can be used in operation of a phased array).
Claim 3. Bachmann further teaches that
the full 3D FWI processing is done by a cloud-based processor ([0075]: the present solution can take advantage of multiple CPU cores over a distributed network of computing devices in a cloud or cloud-like environment).
Claim 5. Baym further teaches that
said garment comprises transceivers located on specific locations on said garment ([0076]: Referring to FIGS.1-15, embodiments of a fetal imaging device 100 are shown to include at least one ultrasound element 102, such as an ultrasonic sensor, transceiver, transducer, or the like; and FIG.6: each element 102 occupies a specific location), and the method comprises
providing a reflection profile for each of said transceivers, each of said reflection profiles being translated to a presence of bone, air or soft tissue ([0081]: the one or more received ultrasonic signals can be processed to identify or image one or more portions of a fetus within the body…detected portions 202 of the fetus are identified as being portions of the fetus, and…the portions 202 are further identified as being or corresponding to particular features (e.g., bones, muscles, joints, etc) of the fetus…The one or more received ultrasonic signals can include a reflected portion (e.g., an echo) of the one or more applied ultrasonic signals), and
at least one of said reflection profiles is used as the indication of positioning of said wearable ultrasound device on the patient area of interest ([0095]: determining a quality of acoustic coupling at or in the immediate proximity of each ultrasound element 102 can include…determining the magnitude of an echo or reflection from an exterior surface of the body…a strong echo is typically associated with good coupling with the body 200).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal M Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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