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 § 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 January, 2019 (updated October 2019), the USPTO released new examination guidelines setting forth a two-step inquiry for determining whether a claim is directed to non-statutory subject matter. According to the guidelines, a claim is directed to non-statutory subject matter if:
STEP 1: the claim does not fall within one of the four statutory categories of invention (process, machine, manufacture or composition of matter), or
STEP 2: the claim recites a judicial exception, e.g., an abstract idea, without reciting additional elements that amount to significantly more than the judicial exception, as determined using the following analysis:
STEP 2A (PRONG 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Using the two-step inquiry, it is clear that the claims are directed toward non-statutory subject matter, as shown below:
STEP 1: Do the claims fall within one of the statutory categories? Yes. All claims fall within a statutory category under § 101.
Claim 1: Device.
Claims 13 and 14: Method and non-transitory computer-readable storage device/software program product.
STEP 2A (PRONG 1): Is the claim directed to a law of nature, a natural phenomenon or an abstract idea? Yes, the claims are directed to an abstract idea.
With regard to STEP 2A (PRONG 1), the guidelines provide three groupings of subject matter that are considered abstract ideas:
Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations;
Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
Mental processes – concepts that are practicably performed in the human mind (including an observation, evaluation, judgment, opinion).
Claim 1-14 are directed to the abstract idea of collecting, comparing, and manipulating data related to diagnostic accuracy metrics (e.g., indices of accuracy, predicted values from models, ROC curves) to select or combine models for analysis.
The core of the claimed invention is a process of:
Acquiring input data (set value of a first index, predicted values of a second index).
Performing calculations/comparisons on that data (using assumed values, based on correspondence information between indices).
Generating an output or making a decision (making an inference regarding a lesion based on the predicted value and models).
These steps relate to mathematical relationships, data comparison, and the organization of information for a decision-making process—activities considered abstract ideas. The claim uses generic computer components ("processor," "memory") to perform these functions, which does not remove the claim from the abstractness category
To distinguish ineligible claims that merely recite a judicial exception from eligible claims that require an implementation of judicial exception, the Supreme Court uses a two-step framework: Step One (Step 2A), determine whether the claims at issue are directed to one of those patent-ineligible concepts; and Step Two (Step 2B), if so, ask “what else is there in the claims?’ to determine whether the additional elements transform the nature of the claim into a patent eligible application.
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application? No, the claim does not recite additional elements that integrate the judicial exception into a practical application.
With regard to STEP 2A (prong 2), whether the claim recites additional elements that integrate the judicial exception into a practical application, the guidelines provide the following exemplary considerations that are indicative that an additional element (or combination of elements) may have integrated the judicial exception into a practical application:
an additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
While the guidelines further state that the exemplary considerations are not an exhaustive list and that there may be other examples of integrating the exception into a practical application, the guidelines also list examples in which a judicial exception has not been integrated into a practical application:
an additional element merely recites the words “apply it” (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea;
an additional element adds insignificant extra-solution activity to the judicial exception; and
an additional element does no more than generally link the use of a judicial exception to a particular technological environment or field of use.
The claim fails to demonstrate that the abstract idea is integrated into a practical application in a way that is specific and non-generic.
The claim attempts to anchor the idea by using an "image processing device," "processor," and "endoscopic image." However, these limitations do not demonstrate a sufficient practical application because:
The claims only describe the functions using generic computing components ("processor configured to execute instructions to...").
The application to "lesion analysis" is merely a field-of-use limitation (applying the abstract math to a specific type of medical data).
The claim does not recite any improvement to the functioning of the computer itself, nor does it describe a specific, unconventional physical process (e.g., an improved camera sensor, a novel image capture hardware technique).
Therefore, the claim is "directed to" the abstract idea.
Accordingly, none of the claims integrate the abstract idea into a practical application.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No, the claim does not recite additional elements that amount to significantly more than the judicial exception.
With regard to STEP 2B, whether the claims recite additional elements that provide significantly more than the recited judicial exception, the guidelines specify that the pre-guideline procedure is still in effect. Specifically, that examiners should continue to consider whether an additional element or combination of elements:
adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or
simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
The following computer functions have been recognized as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality): receiving or transmitting data over a network. See MPEP 2106.05(d)(II).
The additional elements in Claim 1 do not provide an "inventive concept" sufficient to transform the nature of the claim into patent-eligible subject matter. The additional elements are routine, conventional steps using generic technology:
Generic Computing Hardware: The "processor" and "memory" are conventional computer components used in a standard manner to execute instructions.
Conventional Activity: The steps of acquiring data, using "plural models" (a known AI technique), and making inferences based on accuracy metrics (using standard statistical tools like ROC curves as implied by dependent claims) are routine activities common in computer science and data analysis fields.
Lack of Unconventionality: There is nothing in Claim 1 that describes an unconventional technical solution or an improvement to the underlying technology that moves beyond simply implementing the abstract idea on a generic computer.
There is no indication that the claim elements, individually or in combination, perform any function beyond the ordinary use of a computer executing an algorithm. The claims do not provide any unconventional architecture, sensor arrangement, or computer operation that would transform the abstract idea into a patent-eligible application.
Accordingly, the claims do not recite any additional elements sufficient to amount to “significantly more” than the abstract idea itself. See Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018); SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161 (Fed. Cir. 2018).
Thus, since claims 1, 13, and 14 are: (a) directed toward an abstract idea, (b) does not recite additional elements that integrate the judicial exception into a practical application, and (c) does not recite additional elements that amount to significantly more than the judicial exception, it is clear that claims 1, 13, and 14 are directed towards non-statutory subject matter.
Further, dependent claims 2–12 further limit the abstract idea without integrating the abstract idea into practical application or adding significantly more. Each of the claimed limitations either expand upon or add either 1) new mathematical process, 2) a new additional element, 3) previously presented mathematical process, and/or 4) a previously presented additional element. As such, claim 2 is similarly rejected as being directed towards non-statutory subject matter.
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.
Claim(s) 1-4 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bonakdar Sakhi (20220138932, referred to as “Bon” herein) in view of Murthy (20180247107).
Regarding claim 1, Bon teaches an image processing device comprising: at least one memory configured to store instructions; and at least one processor configured to execute the instructions to (pars. 13-14):
acquire a set value of a first index indicating an accuracy relating to a lesion analysis (pars. 219-220, the index value is patient level sensitivity is set to 98 percent);
acquire, for each of plural models which make inference regarding a lesion, a predicted value of a second index, which is an index of the accuracy other than the first index, on an assumption that the set value of the first index is satisfied (pars 188-189 and 219-221, use the ROC data set to 98 percent and determine a second level of specificity. In other words, the first model is the accuracy metric and the second index is the second metric that is predicted based on the position of the ROC. This is also shown in figures 18a); and
make inference regarding the lesion included in an image of an examination target, based on the predicted value of the second index and the plural models (see pars. 210-212 and 218, classification).
Murthy teaches the medical image are endoscopic images in pars. 2-5.
It would have been obvious prior to the effective filing date of the invention to one of ordinary skill in the art to include in Bon the ability to work on endoscopic images as taught by Murthy. The reason is to classify lesion images.
Regarding claim 2, see pars. 188-189 and 219-221 of Bon, ROC curves data is used to find the correspondence between the two indexes.
Regarding claim 3, see pars. 188-189 of Bon.
Regarding claim 4, see figure 18a and pars. 188-189 and 219-221 of Bon.
Regarding claim 11, see pars. 10-12m 40-46 of Murthy for training.
Regarding claim 12, see par. 47 of Murthy.
Regarding claims 13 and 14, see the rejection of claim 1.
Claim(s) 5-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bonakdar Sakhi (20220138932, referred to as “Bon” herein) in view of Murthy (20180247107) in further view of Nozaki (11024031).
Regarding claim 5, par. 13 of Bon which teaches multiple models.
Nozaki teaches in col. 42 lines 20-65, selecting the best from a plurality of models.
It would have been obvious prior to the effective filing date of the invention to one of ordinary skill in the art to include in Bon and Murthy the ability to choose the best model from a group of models as taught by Nozaki. The reason is to improve the performance of the system.
Regarding claim 6, see col. 30 line 49 to col. 31 line 50 of Nozaki.
Regarding claim 10, see col. 42 lines 20-65, based on precision. And col. 30-31 of Nozaki teach updating the weighting.
Allowable Subject Matter
Claims 7-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The specifics of the mode selections are not found in the prior art.
The 101 rejection must be overcome first.
Conclusion
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/HADI AKHAVANNIK/Primary Examiner, Art Unit 2676