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 .
Response to Arguments
Examiner notes that new 101 rejections are set forth in view of the amendments to the claims.
Regarding 35 U.S.C. 112
Examiner notes that the previously set forth 112(a) and 112(b) rejections are withdrawn in view of the amendments to the claims.
Regarding prior art
Applicant’s arguments with respect to claim 1 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.
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 and 22-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea without significantly more.
In a test for patent subject matter eligibility, the claims pass Step 1 (see 2019 Revised Patent Subject Matter Eligibility), as they are related to a process, machine, manufacture, or composition of matter.
When assessed under Step2A, Prong I, Independent claims 1 and 25 are found to recite a judicial exception (i.e. abstract idea). In this instance, claims 1 and 25 recite the limitations “detect/ing B-lines in the ultrasound image”. The cited limitation, under their broadest reasonable interpretation, encompass a mental process (i.e. abstract idea) of detecting B-lines which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a person could reasonably detect B-lines via observation/evaluation of an ultrasound image. Examiner notes that with the exception of generic computer-implemented steps (e.g. a processor/machine learning model recited in claim 1 and a machine learning model in claim 25), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the cited limitation(s) recites a judicial exception (MPEP 2106.04(a)) and the claim must be reviewed under Step 2A, Prong II to determine patent eligibility.
Step 2A, Prong II determines whether any claim recites an additional element that integrates the judicial exception into a practical application. Independent claims recites the following additional element(s):
An ultrasound probe (claim 1)
A portable device including a processor and a monitor (claim 1)
a machine learning model (claims 1 and 25)
generate/generating an ultrasound image based on an ultrasound echo signal received by the/an ultrasound probe (claims 1 and 25)
display/displaying, on the/a monitor, a plurality of lines corresponding to a region of the detected B-lines so as to overlap the ultrasound image, based on the detected B-lines wherein the plurality of lines include: two first lines extending in depth directions of the detected B-lines; and a second line connecting shallow side ends of the two first lines and extending along a direction intersecting the depth directions, and wherein deeps side ends of the two first lines are not connected to each other (claims 1 and 25)
The additional elements in the cited independent claims are not found to integrate the judicial exception into a practical application. In this case, the ultrasound probe and the portable device including a processor and a monitor of claim 1 are considered merely generic elements of an ultrasound system, the processor of claim 1 and the machine learning model of claims 1 and 25 are considered merely a generic computer for performing the judicial exception, generating an ultrasound image is considered merely insignificant pre-solution activity of data gathering/generic processing in the field of ultrasound, and displaying a plurality of lines corresponding to a region of the detected B-lines so as to overlap the ultrasound image is found to be merely generic display of B-lines where the first two lines and second lines are highly generically recited and amount to merely reciting display of lines on the detected B-lines or outer B-lines and connecting said lines with a third line. These elements are seen as adding insignificant extra-solution activity to the judicial exception. They do no more than link the judicial exception to a particular technological environment or field of use. Therefore, under step 2A Prong II the Judicial exception is not integrated into a practical application by additional elements of independent claims 1 and 25 and the claims must be reviewed under Step 2B to determine patent eligibility.
Step 2B determines where a claim amounts to significantly more.
The additional element(s) listed above do not amount to significantly more than the judicial exception. In this instance, as noted above the ultrasound probe, portable device, and machine-learning model are seen as merely generic components/computer of an ultrasound system and generating an ultrasound image is merely pre-solution activity of data gathering/generic processing. Displaying of the plurality of lines is recited with such high generality that it does not provide anything significantly more to the judicial exception. Additionally there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. Therefore, under Step 2B in a test for patent subject matter eligibility, the judicial exception of the independent claim(s) do not amount to significantly more and the independent claim(s) remain patent ineligible.
Dependent claims 22-24 and 26-28 further limit the abstract idea of independent claims 1 and 25. When analyzed as a whole, these claims are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed towards an abstract idea and do not sufficiently integrate the subject matter into a practical application or recite elements which constitute significantly more than the abstract ideas identified.
Under Step 2A, Prong II, dependent claims 22-24 and 26-28 present additional elements which only further narrow the judicial exceptions (e.g. claims 22 and 26 which merely further narrow the first lines such that they do not extend to a deeper side beyond a depth range of the detected B-lines, claims 23 and 27 which merely further narrow the plurality of lines without providing any specifics as to the contour line of a region of interest defining the region of the detected B-lines, and claims 24 and 28 which further narrow the case in which the plurality of lines is displayed) and provide no additional element which are found to integrate the judicial exception into a practical application.
These dependent claims include no additional claims that are sufficient to amount to significantly more than the judicial exception. Additionally, there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. As discussed above with respect to integration of the abstract idea into a practical application, the additional claims do not provide any additional elements that would amount to significantly more than the judicial exception. Under Step 2B, these claims are not patent eligible.
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.
Claims 1 and 22-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raju et al. (US 20200352547 A1), hereinafter Raju.
Regarding claims 1 and 25,
Raju discloses an ultrasound diagnostic apparatus (at least fig. 1 (100) and corresponding disclosure in at least [0020]) comprising:
An ultrasound probe (at least fig. 2 (210) and corresponding disclosure in at least [0023]); and
A portable device (at least fig. 2 (200) and corresponding disclosure in at least [0025]) including a processor (at least fig. 2 (228 and 232) and corresponding disclosure in at least [0023]) and a monitor ([0021] which discloses the ultrasound system may include a display or graphics processor, which is operable to arrange the ultrasound images and/or additional graphical information, which may include annotations, confidence metrics, user instructions, tissue information, patient information, indicators, and other graphical components, in a display window for display on a user interface of the ultrasound system),
Wherein the processor is configured to:
Generate an ultrasound image based on an ultrasound echo signal received by the ultrasound probe ([0024] which discloses the display processor 232 can be configured to generate ultrasound images 236 from the image frames 224, which can then be displayed in real time on the user interface 234 as an ultrasound scan is being performed. See also [0046]);
Detect B-lines in the ultrasound image using a machine-learned model (at least fig. 2 (228 and/or 230) and corresponding disclosure in at least [0023] and [0029]-[0030] which discloses the data processor 228 can be configured to identify B-lines and the data processor can determine the total number of B-lines present within the target region and/or the location of one or more B-lines. Examiner notes that 228 implementing neural network 230 is considered a machine-learned model trained in advance. Furthermore, since the neural network 230 is trained to assess B-line patterns ([0023]) B-lines are considered detected using the neural network 230);
And
Display, on the monitor, a plurality of lines (at least fig. 4 (450 and 458) and corresponding disclosure in at least [0039]. Alternatively see annotated fig. 4 below where the plurality of lines consist of the first lines and the pleural line 450) corresponding to a region of the detected B-lines so as to overlap the ultrasound image (see at least fig. 4), based on the detected B-lines,
Wherein the plurality of lines include:
Two first lines extending in depth directions of the detected B-lines (any two of 458 or in the alternative the first lines of annotated fig. 4 below); and
A second line (450) connecting shallow side ends of the first two lines and extending along a direction intersecting the depth directions (see at least fig. 4), and
Wherein deep side ends of the two first lines are not connected to each other (see at least fig. 4 in which the deeps side ends of any of the first lines 438 are not connected to each other).
Examiner notes that the system of Raju teaches the method of claim 25 having corresponding method steps.
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Annotated fig. 4
Regarding claims 22 and 26,
Raju teaches wherein the first lines do not extend to a deeper side beyond a depth range of the detected B-lines (see at least fig. 4 in which the first lines 458 do not extend to a deeper side beyond a depth range of the detected B-lines in that they extend only to the end of the detected B-lines).
Regarding claims 23 and 27,
Raju further discloses wherein the plurality of lines consist of only a part of a contour line of a region of interest defining the region of the detected B-lines (see annotated fig. 4 above in which the annotated first lines and pleural line 450 are considered to be part of a contour line of a region of interest defining the region of the detected B-lines in its broadest reasonable interpretation).
Regarding claims 24 and 28,
Raju further discloses wherein, in a case where a plurality of B-lines are detected at different positions, the processor is configured to display, on the monitor, the plurality of lines corresponding to the plurality of detected B-lines so as to overlap the ultrasound image (see at least fig. 4).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mehanian (US 20200054306 A1) teaches detecting B-lines in an ultrasound image using a machine learning model (Abstract and [0046])
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797