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 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 12 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 as follows:
In this instance the originally filed disclosure simply does not provide any substantive disclosure of the learned model. It is in every meaningful way absent from the original claims and specification and therefore there is an incredibly strong prima facie case that one of ordinary skill in the art would not be appraised even what it was that the applicant had in their possession at the time of filing. For compact prosecution purposes the examiner further elaborates that one of ordinary skill in the art would also not be appraised to how make/use a learned model of a sort commensurate with the claims because there is likewise not enough disclosure to allow one of ordinary skill in the art to make a model in accordance with the applicant’s disclosure. That is the learned model is mentioned in the applicant’s specification (citing paragraph numbers from PGPUB US 20260060656 A1; hereafter merely the specification) at [0037]-[0038] and [0119]-[0123] and in these sections there is not so much of a mention of what generic type of model this learned model is nor is there mention of how to validate the model nor is there mention of what sorts of data sets would be required to construct the model etc. For example, in these and all other sections of the specification there is no mention of: artificial neural networks nor generative AI nor whether this is supervised or unsupervised nor where this uses regression nor whether learning is reinforced or static nor any other salient feature of the sort required to reconstruct a learned model. As such the subject matter of claim 12 is not adequately disclosed in the originally filed disclosure to allow one of ordinary skill in the art to understand what sort of learned model the applicant possessed at time of filing nor is there adequate disclosure to allow one of ordinary skill in the art make or use an invention commensurate with the scope of the claim.
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 1-14 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, the applicant recites four steps of detecting, acquiring, determining, and updating which are required to be sequential as they each proceed from the former as best understood. However, the claim also recites “wherein the processing circuitry detects the lesion based on the updated detection threshold”, which is logically impossible to perform given that the same threshold must be used in the claim in order to obtain the updated threshold calling into question how or even if the claimed steps could be enacted. While the examiner cannot read in limitations from the specification the examiner notes that the specification regards this as a desideratum about how subsequent frames will be processed. As such this terminal wherein clause will be treated as a desiderata holding no patentable weight for examination purposes. The examiner recommends either simply cancelling the wherein clause of the independent claims or otherwise recommends cancelling claim 2 and drafting its subject matter into the independent claims to distinguish which frame(s) are subject to the updated threshold. Claims 13 and 14 are each directly affected by their similar drafting and claims 2-12 are each similarly affected, at least by virtue of dependency.
Regarding claim 1, the claim recites “detects a lesion based on a detection threshold … each of a plurality of imaged frames” and then additionally iterates “acquires detection results of the lesion in the plurality of frames”. The fact that the latter’s scope entirely overlaps with the former scopes’ limitation calls into question whether or not any acquisition step is intended or limiting which renders the scope of the claim unclear. More specifically, the examiner notes that if the applicant meant that the latter step of merely acquiring was required then it appears that the former step of determining must necessarily be optional/unused (i.e. if the detection result is required from elsewhere than it was at best extra-solution to determine it) and if the applicant meant that the former step of determining was required than the latter step of acquiring would necessarily be either an unused/optional step and e.g. would also seeming necessarily contradict the former and broaden the scope. Regardless and as a related issue, it can be seed that a direct reading of these two steps existing in the same claim is necessarily a narrow limitation (the determination via a threshold) and a broad limitation (simply acquiring by any means) in the same claim – which is a separate but related issue that falls under MPEP § 2173.05(c)). For examination purposes the examiner will presume that a proper rejection of either limitation covers both limitations; however, clarification and redrafting of the claim is required as it is fundamentally unclear how these two steps could co-exist as they are currently drafted. Claims 13 and 14 are each directly affected by their similar drafting and claims 2-12 are each similarly affected, at least by virtue of dependency.
Regarding claim 1, the claim recites “determine a lesion type based on … appearance frequency of the lesion type” which, if given its ordinary meaning, required that one determine what lesions are present in the image by already known what lesions are present in the image which is prima facie confusing and seemingly impossible. For compact prosecution purposes if the applicant meant for “appearance frequency” to be specifically defined contrary to its ordinary meaning (e.g. the BRI of the term might cover “commonality” or “prevalence within the general patient population”, and thus the applicant may have meant for this measure to cover such an assumption based on a priori knowledge) than the applicant is urged to expressly recite such definition and clarify where in the specification such a definition exists. To compact prosecution the examiner notes that merely differentiating between frames does not remedy the issue (i.e. including claim 2’s scope does not fix this) as it is still fundamentally unclear how the appearance frequency itself is being used and also how this would work for the first frame/when the frequency is 0, which would still be at least a gap in the elements under MPEP § 2172.01. Given that the specification did not provide any clear guidance as to how to determine lesion type by appearance frequency in this context, in this instance and for examination purposes the examiner will treat any metric that can be used to determine a lesion type (including e.g. any morphometric measure such as appearance, border irregularity, size, shape, etc., which are all old and well known in the art and the most commonly used metrics in the art of cancer detection. See MPEP 2104.03 as this constitutes official notice) as reading on the claimed limitation. Claims 13 and 14 are each directly affected by their similar drafting and claims 2-12 are each similarly affected, at least by virtue of dependency.
Regarding claim 1, the claim recites “An ultrasound diagnostic apparatus”; however apart from the single statement that apparatus the has “processing circuitry” the entirety of the body of the claim is drafted in method format as it expressly sets for actions being formed and all but the first of these actions is entirely removed from any structure for performing the acts, e.g. “determines a lesion type” is both a step/action as drafted and not required to be done using any structure as drafted. This calls into question the scope of the claim and even its statutory category as it is unclear whether or not the applicant is reciting a method which utilizes a processor for performing one step and the remainder, with the remaining steps being expressly performed in one’s head or by hand as they do not require structure, or otherwise if the applicant is laying claim to an apparatus but has miss-drafted all limitations as steps and has not properly linked such limitations to structures. For compact prosecution purposes the examiner recommends doing one of the following: 1) move the “processing circuitry” into the preamble and change the word “apparatus” to “method”; or alternatively 2) replace each iteration of an step/action in this and all claims addressed below with the appropriate functional limitation (e.g. using “configured to determine” or the like instead of “determines”) and link each of these functions to the processing circuitry or to any other (e.g. currently omitted/non-examined) structure for performing the function. Claim 13 is directly affected by their similar drafting and claims 2-12 are each also directly affected as they each expressly recite steps instead of functions yet each purport to be apparatus claims via their preambles.
Claims 3, 4, 6, and 10 each recite a confidence metric. This presents two issues of indefiniteness. First the use of e.g. “the confidence” without previously declaring this metric lacks proper antecedence. Secondly, the use of a confidence metric in comparisons (claims 3, 4, and 6) or display (claim 10) without first calculating or determining or receiving from an outside source any data about confidence values in this or any other claim is prima facie confusing. For compact prosecution the use of confidence values will be examined below as best understood and claims 5 and 7 are both similarly rejected, at least by virtue of dependency.
Regarding claim 12, the claim is prima facie indefinite. As an initial matter the claim directly contradicts parent claim 1 and requires the incompatible limitations that this is “according to claim 1” yet also the body of the claim sets forth that the detection threshold be set/updated by an entirely different process instead of the process of parent claim 1. As such the claim will be examined below as best understood, but given the related 112(a) and 112(d) issues it will be assumed for examination purposes that updating the detection threshold based on either of the method steps of claim 1 or the method steps of claim 12 will equally rejection the claim. As a secondary issue the claim purports to be dependent from claim 1 but also uses terminology that lacks antecedence therefrom such as “the current frame” and “the previous frames” and which also calls into question whether what sort of data the claim is processing and if this relates to the frame data used in claim 1. As a tertiary issue, in addition to directly contradicting the step of updating the detection threshold the scope of claim 12 would also make every other limitation of parent claim 1 at least option and at least explicitly extraneous to the solution of claim 1, as the steps of claim 1 would no longer relate to or affect the terminal step/end result which likewise renders the scope fundamentally unclear as it calls into question whether or not any step that is “according to claim 1” is required by or utilized in claim 12 despite this preamble limitation.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4 and 6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this instance parent claim 1 requires that the detection threshold be changed based on “at least one of continuity and appearance frequency”; however, claims 4 and 6 both broaden this to be based on “at least one of continuity and the appearance frequency, and the confidence” This fails to further limit/broadens how the threshold is changed. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 5 and 7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this instance claims 5 and 7 recite the same scope as parent claims 4 and 6 respectively without providing a narrowing limitation if read by their ordinary meaning. For compact prosecution purposes the examiner notes that if the applicant meant for claims 5 and 7 to define that there are thresholds beyond which the step of updating does not occur than this would be a separate issue under 112(d) as it seemingly would make optional/broaden a parent claimed step. Alternatively, if the applicant meant to require that further steps are conducted to more narrowly update the detection threshold than they are welcome and invented to add such steps into the claims but they are not currently presented and thus not currently under examination as the current claim drafting of 5 and 7 does not establish any proactive step. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this instance claim 12 appears to both broaden the scope of and fail to require the steps of parent claim 1 in its entirety. See the related 112(b) rejection incorporated herein by reference to fully flesh out the issues. In summary, claim 12 would/lack replace the updating step of parent claim 1 with a different step and also, as best understood, renders all other steps of parent claim 1 to be optional since they would no longer affect the end result/terminal step. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
In more detail and initially regarding only independent claim 1, the examiner will evaluate the claims in accordance with and with reference to the Subject Matter Eligibility Test for Products and Processes found in MPEP 206(III).
Regarding step 1, the claim is directed to either a product or processes and therefore step 1 is YES.
Regarding step 2A prong 1 the claim is directed to an abstract idea and thus contains a judicial exception. In more detail it can be seen that the claim recites between three and four steps, see 112(b) rejections above, and that each of these is abstract.
The claim recites “detect a lesion based on a detection threshold”. This definitively falls under mathematical concepts (e.g. a mathematical relationship or calculation) as set forth to be an abstract idea in MPEP 2106.04(a) and additionally can be considered a mere mental process (e.g. evaluation, judgment). This step is intended to be performed by a processing circuit which is addressed below in the step 2B analysis.
The claim also recites “acquire detection results”. As best understood, this is the same scope as the foregoing and may not be a required step of the invention, but for 101 analysis purposes the examiner also notes that it is expressly data gathering under MPEP 2106.05(g) and thus plays no further part in the analysis. In this instance there is also a prima facie case that this step is abstract to the point that it can be practiced in one’s head or by hand (e.g. looking at the results or being handed a print out of them) because it is not linked to any structure.
The claim also recites “determine a lesion type based on at least one of continuity and appearance frequency”. This squarely falls within mental processes set forth in MPEP 2106.04(a), particularly evaluation or judgement regardless of the particular implementation of the determination; however and for compact prosecution purposes the examiner notes that many of the ways in which continuity and appearance frequency are likely to be implement (e.g. based on the specification) are also clearly mathematical concepts, particularly calculations. In this instance there is also a prima facie case that this step is abstract to the point that it can be practiced in one’s head or by hand because it is not linked to any structure.
Lastly the claim recites “update the detection threshold” this could again be a rote mental activity (remembering or writing out the new value) but is also so broad that it appears to overlap with the “certain methods of organizing human activity” category of abstract ideas as set forth in MPEP 2106.04(a) since it merely involves memory or (if we account for the wherein clause which is not a step unto itself) involves planning for the future. In this instance there is also a prima facie case that this step is abstract to the point that it can be practiced in one’s head or by hand because it is not linked to any structure.
Given that each of these is abstract for the foregoing reasons, step 2A prong 1 is YES.
Turning to step 2A prong 2, the examiner notes that the claimed invention has no output whatsoever. There is no capability for the abstract idea to have any affect on the real world and therefore there is no analysis to conduct under step 2A prong 2 at this juncture. Thus, step 2a Prong 2 is NO. For compact prosecution purposes the examine notes that claims 8-11 are separately addressed below.
Turning to step 2B, the only structure required by any claim is the “processing circuitry”. This structure is not currently drafted to do anything other than the detection of the lesion based on the detection threshold and there is no physical limitation on the structure whatsoever in any claim. This renders crystal clear that there is no particular machine under 2106.05(b). Likewise, it may compact prosecution to note that any of the three examples of MPEP 2106.04(a)(2)(III)(C) would seemingly apply in this instance given the lack of specificity of how the computer is structured or applied to the otherwise abstract steps. Therefore, step 2B is NO.
Given the foregoing analysis it is clear that claim 1 is not patent eligible. Furthermore, claim 13 is identical in scope and verbatim recites the same limitations in the body of the claim with respect to claim 1 and therefore is ineligible for exactly the same reasons. Further still, claim 14 is also identical in scope to claim 1 as while claim 14 is drafted as a process instead of a product the examiner notes (see 112(b) above) that this was also true of claim 1 and that the minor differences in wording do not materially impact the foregoing analysis in any way. Therefore, independent claims 13 and 14 are equally held to be patent ineligible for the same reasons.
Turning to the dependent claims, the examiner notes the following:
Claim 2 does not add any additional steps for the examiner to consider, it merely iterates that the plurality of frames is split into previous frames and a current frame. As such this does not materially impact the examiner’s analysis and claim 2 is held to be ineligible for the same reasons as its parent.
Claim 3 does not add any further step for the examiner to consider. It does indicate that the step of determining the lesion type include confidence data, but no steps of generating nor applying additional data are recited nor would these steps (arguendo, if later added) cause the step of determining the lesion type to be something other than a mental process, particularly judgement or evaluation. As such this does not materially impact the examiner’s analysis and claim 3 is held to be ineligible for the same reasons as its parent.
Claims 4-7 address that the update to the detection threshold is a decrease (claims 4-5) or an increase (claims 6-7) but do not add any further step for the examiner to consider. As such this does not materially impact the examiner’s analysis and claims 4-7 are held to be ineligible for the same reasons as their parents.
Claims 8-11 introduce an intent to provide an output. The examiner notes that the only declared structure in the claims is processing circuitry and that the mention of the display only exists within a clause describing the function of the processing circuitry. As such this prima facie does not add anything for the examiner to further consider in the 101 analyses as currently drafted.
For compact prosecution purposes the examiner notes that if (i.e. arguendo, in a later amendment) the claims had the structure to provide an output and positively recited that this output was required per se, than this would still not render the claims patent eligible. For claims 8 and 11 this can be simply worded as a prima facie case as there is no diagnostically useful data provided to the user that is not inherent or at least ordinary in being in the field of “ultrasound imaging”. That is, claim 8 merely displays the frame, but does not incorporate any data that would appraise the user of particulars therein and instead relies on their judgment to determine whether or not the frame selection actually provides meaningful data. This is a rote application of a mere output under MPEP 2106.05(g) and does not require further consideration. Similarly, information that the threshold was updated from claim 11 does not appraise the user of anything clinically or diagnostically relevant to the actual images/to the patient’s condition and therefore is again a rote output of data divorced from meaningful application that can be regarded under MPEP 2106.05(g) without further consideration. Claims 9-10 are more nuanced and cannot be dismissed solely by reference to MPEP 2106.05(g) because they provide diagnostic data in a usable format, specifically both the image data itself and at least one piece of data about how the processing steps relate to that data (i.e. the false coloration of claim 9 and the confidence data for claim 10, which relate the base frame data to the steps being performed). However, in this instance the analysis is still exceedingly clear. See MPEP 2106.04(d)(2). That is, diagnostic presentation of data, even if useful and intended to provide a user/doctor with data that will change the course of treatment, is not unto itself something which can integrate abstract steps into a practical application. This is actually given as an example and it is worth noting:
“Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.”
Claim 12 cannot be fully evaluated at this time given the 112(a), 112(b), and 112(d) issues with the claim. In this instance and noting that the claim is being interpreted due to the 112(b) rejection one potential reading of the claim is that this is an option for determining the updated threshold but that it can be determined according to claim 1 above, as such this is as best understood not patent eligible for the reasons given above in regards to claim 1. If that interpretation is incorrect, then the examiner notes for compact prosecution purposes that while they cannot reasonably evaluate the limitations of an undisclosed model they can at least note that, without more, it appears that merely applying processing circuitry to the problem of determining the updated threshold value would fall under the guidance of MPEP 2106.05(f) and/or merely using the processing circuitry to run a model/calculation under MPEP 2106.04(a)(2)(III)(C) which would also cause the claim to remain considered as ineligible at the current time.
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.
Claim(s) 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20210366120 A1 by Ito et al. (hereafter Ito).
Regarding claim 1, Ito teaches: 1. An ultrasound diagnosis apparatus (see Ito’s Abstract and Figs. 1, 10, and 19-20 which generally describe a US diagnostic apparatus, show an overview of the physical structure of the apparatus being comprised of an imaging device and processing unit, and show the steps as a flow chart including the use and updating of the thresholds respectively) comprising:
processing circuitry (see Ito’s Fig. 1 noting that part 200 is the data processing unit that performs the steps discussed hereinafter, at least through the various subcomponents therein (e.g. image processing unit 210 is a component of 200 as seen in Fig. 1 and this itself comprises various other units such as the detection unit 410 shown as a subcomponent thereof in Fig. 4 etc. as the processing circuitry performs all functions through its various units) and/or see Ito’s [0037] which explains that the invention at large is implemented on a computer) that detects a lesion based on a detection threshold for detecting a lesion corresponding to a lesion type in each of a plurality of imaged frames (this can be seen visually in Ito’s Fig. 10 wherein a threshold separates 1003 (non-lesion) and 1004 (lesion) to detect the lesion, where (relevant to one interpretation of dependents 5 and 7) this is also subject to additional maximum/upper threshold 1002 and minimum/lower threshold 1001. Additionally, the use of these threshold can be seen in the larger context of the system via Ito’s Figs. 19-20 which flow chart out their use. While Ito’s invention is for processing a time series of images and thus a stream of frames, the examiner notes that the “in each of a plurality of frames” can be seen from [0082]-[0085] which, in describing flow chart 19, iterate that the detection unit 410 holds therein a plurality of detection results, for example, data detected for each frame, data detected immediately before, and the like which is also relevant to claim 2 below),
acquires detection results of the lesion in the plurality of frames (as best understood the detecting is the acquisition and therefore this is taught in the foregoing. For compact prosecution purposes the examiner notes that Ito’s Fig. 19 step S531 is a step of receiving candidate lesion from the detection unit, presumably to another unit of the processor which may alternatively teach this), and
determines a lesion type based on at least one of continuity and appearance frequency of the lesion type in the detection results of the plurality of frames (see Ito’s Figs. 19-20 and [0082]-[0085] noting that the lesion detection uses data about whether or not the lesion appears in the previous image (i.e. appearance frequency) as well as the position information between the current potential lesion and detected lesion in the former frames (i.e. continuity) as well as a certainty value (i.e. confidence metric, see broadening dependents below) to determine if the tissue type is lesion or not), and
updates the detection threshold according to the determined lesion type (see Ito’s Figs. 19-20 and [0082]-[0085] noting in particular the two threshold update steps S555 and S556 or the keep same threshold step S557 (via S553 YES path) and how they each lead to S51 (take next frame, where this threshold will then be applied as the current threshold)),
wherein the processing circuitry detects the lesion based on the updated detection threshold (as best understood this is inherent or holds no patentable weight. For compact prosecution purposes the examiner notes that the foregoing update step covers what, as best understood, the applicant appears to be attempting to claim i.e. the updated threshold being sequentially applied to the next frame).
Regarding claim 2, Ito further teaches: 2. The ultrasound diagnosis apparatus according to claim 1, wherein the processing circuitry acquires detection results of the lesion in a plurality of previous frames before a current frame, determines the lesion type in the current frame based on at least one of continuity and appearance frequency of the lesion type in the detection results of the plurality of previous frames, and updates the detection threshold according to the determined lesion type in the current frame, and detects the lesion in the current frame based on the updated detection threshold (the rejection of claim 1 above was expressly drafted so as to cover this. See above. Alternatively see Ito’s Figs. 19-20 in light of [0082]-[0085] as further explained above in claim 1).
Regarding claim 3, Ito further teaches: 3. The ultrasound diagnosis apparatus according to claim 2, wherein the processing circuitry further determines the lesion type in the current frame based on the confidence of the lesion type in the detection results of the previous frames (also expressly covered in the rejection of claim 1 above, noting that the certainty factor is a probability score representing the confidence and/or see It’s Figs. 19-20 in light of [0082]-[0085]).
Regarding claims 4 and 6, Ito further teaches: 4. The ultrasound diagnosis apparatus according to claim 3, wherein the processing circuitry updates the detection threshold so as to lower the detection threshold in a case where at least one of the continuity and the appearance frequency, and the confidence satisfy a preset condition. 6. The ultrasound diagnosis apparatus according to claim 3, wherein the processing circuitry updates the detection threshold so as to raise the detection threshold in a case where at least one of the continuity and the appearance frequency, and the confidence satisfy a preset condition (regarding these together, see Ito’s Fig. 20 noting the use of the certainty factor and noting the threshold adjustments S555 and S556. In this instance S555 alone teaches this (i.e. it can be an adjustment up or down) but just to be abundantly clear that both can happen per se it is noted that S556 occurs when S555 has proceeded in the same direction multiple sequential times, to that end [0085] gives an example wherein after lowering the threshold twice via S555 the threshold is raised via S556 to prevent erroneous detection showing both occurring due to the lesion threshold going too low, which is in an explicit textual example of both occurring).
Regarding claims 5 and 7, Ito further teaches: 5. The ultrasound diagnosis apparatus according to claim 4, wherein the processing circuitry sets a lower limit to the updated detection threshold. 7. The ultrasound diagnosis apparatus according to claim 6, wherein the processing circuitry sets an upper limit to the updated detection threshold (regarding these together the examiner notes that from one perspective this is shown via Ito’s Fig. 10 noting the min and max thresholds 1001 and 1002; however, from a second perspective this is taught above in parent claims 4 and 6, noting that the lower limit is the threshold after lowering and the upper limit is the threshold after raising in the process of adjusting the threshold shown in Ito’s Fig. 20, either of which would teach the claimed limitation given the breadth of the claim drafting).
Regarding claims 8-11, Ito teaches: 8. The ultrasound diagnosis apparatus according to claim 1, wherein the processing circuitry causes a display to display (in this instance a display is not a required structure at the current juncture, but it may compact prosecution to see Ito’s [0036] which describes the structure of the display) a detection frame indicating the detected lesion in a case where the lesion is detected based on the updated detection threshold. 9. The ultrasound diagnosis apparatus according to claim 8, wherein the processing circuitry causes the display to display the detection frame so as to change a color of the detection frame according to the detected lesion type. 10. The ultrasound diagnosis apparatus according to claim 8, wherein the processing circuitry causes the display to display the detection frame together with confidence of each of the detected lesion type. 11. The ultrasound diagnosis apparatus according to claim 8, wherein the processing circuitry causes the display to display information on the update in a case where the detection threshold is updated (regarding each of these display functions, see Ito’s Fig. 11 in light of [0054] where frames containing the detected lesion are displayed in each instance and where this also covers false color (e.g. the superimposed marker 1101 being the clearest example but surrounding shapes such as 1103 would still qualify) as well as detection confidence (e.g. 1104 or 1107) and while Ito does not display the current threshold value this is not required by the claim, rather ‘information on’ the update is displayed. This is therefore inherent in any of the foregoing as the threshold updates determine whether or not something is determined to be lesion or not in the first place but see also Fig. 12 and [0055] which covers displaying further information related to the updated threshold values).
Regarding claim 12, Ito further teaches: 12. The ultrasound diagnosis apparatus according to claim 1, wherein the processing circuitry updates the detection threshold in the current frame using a detection threshold output from a learned model by inputting the detection results in the previous frames to the learned model learned so as to output the detection threshold in the current frame based on the detection results in the previous frames (as best understood, this is simply inherent in or taught by any proper rejection of claim 1. See 112(b) rejection above. For compact prosecution purposes the examiner notes that Ito can additionally or alternatively employ learning algorithms/models per se. For example see Ito’s [0039] where a CNN or SVM or adaboost can be used. Ito does not expressly discuss the training data for these systems; however it is inherent that they must be trained in advance on previous data and also implicitly taught that this will involve the previous frames as Ito’s process is a continuous process with each frame being taken and then processed in real time, see Ito’s Abstract and Figs. 19-20 describing this as a real time process and showing the flow of this process and how the processing steps relate to and interact with new/current frames).
Regarding claim 13, Ito teaches: 13. A lesion detection apparatus (see Ito’s Abstract and Figs. 1, 10, and 19-20 which generally describe a US diagnostic apparatus, show an overview of the physical structure of the apparatus being comprised of an imaging device and processing unit, and show the steps as a flow chart including the use and updating of the thresholds respectively) comprising:
processing circuitry (see Ito’s Fig. 1 noting that part 200 is the data processing unit that performs the steps discussed hereinafter, at least through the various subcomponents therein (e.g. image processing unit 210 is a component of 200 as seen in Fig. 1 and this itself comprises various other units such as the detection unit 410 shown as a subcomponent thereof in Fig. 4 etc. as the processing circuitry performs all functions through its various units) and/or see Ito’s [0037] which explains that the invention at large is implemented on a computer) that detects a lesion based on a detection threshold for detecting a lesion corresponding to a lesion type in each of a plurality of imaged frames (this can be seen visually in Ito’s Fig. 10 wherein a threshold separates 1003 (non-lesion) and 1004 (lesion) to detect the lesion, where (relevant to one interpretation of dependents 5 and 7) this is also subject to additional maximum/upper threshold 1002 and minimum/lower threshold 1001. Additionally, the use of these threshold can be seen in the larger context of the system via Ito’s Figs. 19-20 which flow chart out their use. While Ito’s invention is for processing a time series of images and thus a stream of frames, the examiner notes that the “in each of a plurality of frames” can be seen from [0082]-[0085] which, in describing flow chart 19, iterate that the detection unit 410 holds therein a plurality of detection results, for example, data detected for each frame, data detected immediately before, and the like which is also relevant to claim 2 below),
acquires detection results of the lesion in the plurality of frames (as best understood the detecting is the acquisition and therefore this is taught in the foregoing. For compact prosecution purposes the examiner notes that Ito’s Fig. 19 step S531 is a step of receiving candidate lesion from the detection unit, presumably to another unit of the processor which may alternatively teach this), and
determines a lesion type based on at least one of continuity and appearance frequency of the lesion type in the detection results of the plurality of frames (see Ito’s Figs. 19-20 and [0082]-[0085] noting that the lesion detection uses data about whether or not the lesion appears in the previous image (i.e. appearance frequency) as well as the position information between the current potential lesion and detected lesion in the former frames (i.e. continuity) as well as a certainty value (i.e. confidence metric, see broadening dependents below) to determine if the tissue type is lesion or not), and
updates the detection threshold according to the determined lesion type (see Ito’s Figs. 19-20 and [0082]-[0085] noting in particular the two threshold update steps S555 and S556 or the keep same threshold step S557 (via S553 YES path) and how they each lead to S51 (take next frame, where this threshold will then be applied as the current threshold)),
wherein the processing circuitry detects the lesion based on the updated detection threshold (as best understood this is inherent or holds no patentable weight. For compact prosecution purposes the examiner notes that the foregoing update step covers what, as best understood, the applicant appears to be attempting to claim i.e. the updated threshold being sequentially applied to the next frame).
Regarding claim 14, Ito teaches: 14. A lesion detection method (see Ito’s Abstract and Figs. 1, 10, and 19-20 which generally describe a US diagnostic apparatus, show an overview of the physical structure of the apparatus being comprised of an imaging device and processing unit, and show the steps as a flow chart including the use and updating of the thresholds respectively) comprising:
a lesion detection step of detecting a lesion based on a detection threshold for detecting a lesion corresponding to a lesion type in each of a plurality of imaged frames (this can be seen visually in Ito’s Fig. 10 wherein a threshold separates 1003 (non-lesion) and 1004 (lesion) to detect the lesion, where (relevant to one interpretation of dependents 5 and 7) this is also subject to additional maximum/upper threshold 1002 and minimum/lower threshold 1001. Additionally, the use of these threshold can be seen in the larger context of the system via Ito’s Figs. 19-20 which flow chart out their use. While Ito’s invention is for processing a time series of images and thus a stream of frames, the examiner notes that the “in each of a plurality of frames” can be seen from [0082]-[0085] which, in describing flow chart 19, iterate that the detection unit 410 holds therein a plurality of detection results, for example, data detected for each frame, data detected immediately before),;
a frame result acquisition step of acquiring detection results of the lesion in the plurality of frames (as best understood the detecting is the acquisition and therefore this is taught in the foregoing. For compact prosecution purposes the examiner notes that Ito’s Fig. 19 step S531 is a step of receiving candidate lesion from the detection unit, presumably to another unit of the processor which may alternatively teach this); and
a threshold update step of determining a lesion type based on at least one of continuity and appearance frequency of the lesion type in the detection results of the plurality of frames (see Ito’s Figs. 19-20 and [0082]-[0085] noting that the lesion detection uses data about whether or not the lesion appears in the previous image (i.e. appearance frequency) as well as the position information between the current potential lesion and detected lesion in the former frames (i.e. continuity) as well as a certainty value (i.e. confidence metric, see broadening dependents below) to determine if the tissue type is lesion or not), and
updating the detection threshold according to the determined lesion type (see Ito’s Figs. 19-20 and [0082]-[0085] noting in particular the two threshold update steps S555 and S556 or the keep same threshold step S557 (via S553 YES path) and how they each lead to S51 (take next frame, where this threshold will then be applied as the current threshold)),
wherein the lesion is detected based on the updated detection threshold in the lesion detection step (as best understood this is inherent or holds no patentable weight. For compact prosecution purposes the examiner notes that the foregoing update step covers what, as best understood, the applicant appears to be attempting to claim i.e. the updated threshold being sequentially applied to the next frame).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael S Kellogg whose telephone number is (571)270-7278. The examiner can normally be reached M-F 9am-1pm.
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/MICHAEL S KELLOGG/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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