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 § 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 6-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 6 follows.
Regarding claim 6, the claim recites a series of steps or acts, including diagnosing whether the result sheet corresponds to the lower urinary tract symptoms by analyzing a correlation between the feature points and the lower urinary tract symptoms by the character trained model and the graph trained model. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of including diagnosing whether the result sheet corresponds to the lower urinary tract symptoms by analyzing a correlation between the feature points and the lower urinary tract symptoms by the character trained model and the graph trained model sets forth a judicial exception. This step describes a concept that can be practically performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The diagnosis of the lower urinary tract symptoms does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the diagnosed lower urinary tract symptoms, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. The claim, also includes mathematical concepts in the form of using deep learning to perform the steps of extracting character data from a result sheet obtained through a simple urine flow test; extracting graph data from a result sheet obtained through a simple urine flow test. As well as receiving a simple urine flow test result sheet to be diagnosed by a lower urinary tract symptom diagnosis system; automatically extracting the character data and the graph data from the result sheet; extracting a plurality of feature points having a correlation with a cause of lower urinary tract symptoms from the character data and the graph data; generating a character trained model using the character data as learning data to extract feature points having a correlation with a cause of lower urinary tract symptoms from the character data and generating a graph trained model using the graph data as learning data to extract feature points having a correlation with a cause of lower urinary tract symptoms from the graph data; and diagnosing whether the data reported on the result sheet document corresponds to the lower urinary tract symptoms by analyzing a correlation between the feature points and the lower urinary tract symptoms by the character trained model and the graph trained model. The steps of “automatically extracting” as described in the claims is merely feeding data into a computer to carry out an abstract idea in the form of a mathematical concept. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. Besides the Abstract Ideas, the claim recites additional step of receiving a result sheet document reporting data obtained through a simple non-invasive urine flow test. Receiving data to extract is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the receiving an extracting steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 11, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The non-transitory computer-readable recording medium having recorded thereon a program is conf configured to perform the Abstract Idea and presolution activity. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to the type of feature points. The extraction steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
Claims 6-8, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Belotserkovsky US 20160113562 A1 in view of Sobol US 20190209022 A1 in view of
Meger (JP 2012502671 A- English Translation).
In regards to claim 6, Belotserkovsky teaches a method comprising
receiving a result sheet document reporting data obtained through a simple non-invasive urine flow test ([0030] “The present invention can also be implemented as a standalone application which uses saved data files or printouts of previously conducted tests by digitizing their images. The files can be in .TXT, .DAT, .XLS, .CSV or of other format, which can be downloaded or imported from an external or internal database” [0032] “A reference database of such normal parameters obtained from clinical uroflowmetry tests from healthy individual can be generated” [0034] Reference database inherently contains simple urine flow test values);
automatically extracting character data from a result sheet obtained through a simple urine flow test ([0012] Primary parameters [0030] “Alternatively, the files can be generated by taking an image of a urine flow graph derived from an uroflowmetry test” [0034] Reference database inherently contains simple urine flow test values, processor inherently performs extraction automatically);
and generating a model using the character data as learning data, and extracting feature points having a correlation with a cause of lower urinary tract symptoms from the character data ([0031-0034] model trained using reference database of parameters to analyze the patient's primary and secondary urine flow dynamic parameters and generates an assessment or prediction of the patient's urological condition, application calculates primary and secondary parameters);
automatically extracting graph data from a result sheet obtained through a simple urine flow test ([0027] secondary parameters [0030] “Alternatively, the files can be generated by taking an image of a urine flow graph derived from an uroflowmetry test” [0034] Reference database inherently contains graph data);
and generating a model using the graph data as learning data, and extracting feature points having a correlation with a cause of lower urinary tract symptoms from the graph data ([0031-0034] model trained using reference database of parameters to analyze the patient's primary and secondary urine flow dynamic parameters and generates an assessment or prediction of the patient's urological condition, application calculates primary and secondary parameters);
receiving a simple urine flow test result sheet to be diagnosed by a lower urinary tract symptom diagnosis system ([0031] Fig 4 step 12);
automatically extracting the character data and the graph data from the result sheet ([0031] Fig 4 steps 15-16.);
extracting a plurality of feature points having a correlation with a cause of lower urinary tract symptoms from the character data and the graph data, respectively ([0033]);
and diagnosing whether the result sheet corresponds to the lower urinary tract symptoms by analyzing a correlation between the feature points and the lower urinary tract symptoms by the character trained model and the graph trained model ([0029] LUTS, OAB or other urological condition).
Belotserkovsky fails to what kind of model is used for extracting feature points. Sobol teaches a deep learning model that extracts features and identity patterns ([0316] [0320]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the mathematical model of Belotserkovsky to be a deep learning machine learning model that perform the feature extraction of the secondary references like the model of Sobol as well as and generating an assessment or prediction of the patient's urological condition. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of automating the extraction of features by using a deep learning model which would
Belotserkovsky in view of Sobol does not teach what happens during the final data processing step (Belotserkovsky [0029] “Both primary and secondary dynamic parameters calculations along with patient medical history including, for sample, gender, age, weight, height and blood pressure are taken into consideration during final data processing and parameters calculation in step”). Belotserkovsky in view of Sobol fails to teach integrating the feature points from the character data and the graph data by at least one of applying a concatenate function or by performing element-wise addition. Merger teaches a pattern analysis module that concatenates parameter data generated from one or more analysis modules to consolidate data to predict clinical signs (English Translation pattern Page 7, Paragraph 5). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the final data processing and parameters calculation of Belotserkovsky in view of Sobol to integrate the primary and secondary reference into a cohesive representation using the concatenation metho of Merger before generating an assessment of the patient's urological condition. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of assessing a user’s condition based on multiple combined features which would allow for a more thorough assessment of the user.
In regards to claim 7, modified Belotserkovsky teaches the method of claim 6, wherein the character data comprises at least one of a point (Qmax) having a maximum urine flow rate during urination, a voiding time, post-void residual (PVR), and a bladder filling volume (BFV) (Belotserkovsky [0012] Primary parameters include maximum urine flow rate (Qmax) and void time).
In regards to claim 8, modified Belotserkovsky teaches the method of claim 6, wherein the graph data comprises a voided volume over time or a voided rate over time (Belotserkovsky [0027] void time/total time).
In regards to claim 11, modified Belotserkovsky teaches a non-transitory computer-readable recording medium having recorded thereon a program for executing the method of claim 6 (Belotserkovsky [0037]).
In regards to claim 12, modified Belotserkovsky teaches the method of claim 6, wherein the lower urinary tract symptoms include symptoms related to a storage or excretion of urine including at least one of difficulty in starting, residual urine, frequent urination, thin urination, tension during urination, nocturia, urgency to urinate, or intermittent urination ([0029] “Diagnostic results 7 indicate the likelihood of whether the patient has a urological disorder and if so the probability of whether the condition is LUTS, OAB or other urological condition” OAB is frequent and urgent urination).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Belotserkovsky US 20160113562 A1 in view of Sobol US 20190209022 A1 in view of
Meger (JP 2012502671 A- English Translation) as applied to claim 6, in view of Laing (US 20240108265 A1).
In regards to claim 9, modified Belotserkovsky teaches the method of claim 6, including extracting a start and end point of urination and inputting a section of a graph including a start and end point into a graph trained model (Fig. 2 graph 2 contains a start and end point of urine flow, [0012] total time (time period from when the patient initiates urination to when urination stop)). Modified Belotserkovsky fails to teach pre-processing of the graph data by extracting a section from the starting point to the ending point. Laing teaches analyzing the plurality of outputs of a urine fluid level sensor over a time interval defined by the beginning and end time of the fluid flow ([0008] “analyzing the plurality of outputs of the fluid level sensor over a time interval defined by the beginning and end time of the fluid flow”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Belotserkovsky to include a step of only analyzing the data within a time interval defined by the beginning and end time of the fluid flow like the device of Laing. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of removing irrelevant data from the beginning and end of the graph which would increase accuracy of the results.
Claims 10, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belotserkovsky US 20160113562 A1 in view of Sobol US 20190209022 A1 in view of Meger (JP 2012502671 A- English Translation) as applied to claim 6, further in view of Persidsky (US 20150342518 A1)
In regards to claim 10, modified Belotserkovsky teaches the method of claim 6, including indicating the likelihood of whether the patient has a urological disorder and if so the probability of whether the condition is LUTS, OAB or other urological condition ([Belotserkovsky 0029]). Modified Belotserkovsky fails to teach as expressing the diagnosed lower urinary tract symptoms results as a binary or quaternary output. Persidsky teaches outputting a red negative or green positive indication to a user in order to clearly indicate an evaluation to a user ([0342]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Belotserkovsky to include a step of indicating if a patent has LUTS, OAB or other urological condition using a green indication or does not have a urological disorder using a red indication on a display like the device of Persidsky. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of clearly indicating to the user if they have a urological disorder.
In regards to claim 13, modified Belotserkovsky teaches the method of claim 10, wherein the binary output includes at least one of normal versus abnormal (Persidsky [0342] See claim 10 rejection, light is a binary output of either normal or symptomatic)
In regards to claim 14, modified Belotserkovsky teaches the method of claim 10, wherein the quaternary output includes at least one of normal versus bladder output obstruction (BOO) versus detrusor underactivity (DUA) versus BOO and DUA. Claim 14 is conditional on the output of claim 10 being quaternary. Modified Belotserkovsky teaches a binary output not quaternary (see claim 10 rejection).
Response to Arguments
Applicant’s arguments, see remarks, filed 01/29/2026, with respect to the 35 U.S.C. 112b rejections of claims 5, and 9-10 have been fully considered and are persuasive. The 35 U.S.C. 112b rejections of claims 5, and 9-10 have been withdrawn.
Applicant's arguments filed 01/29/2026, with respect to the 35 U.S.C. 101 rejections of claims 1-11 have been fully considered but they are not persuasive. Regarding the applicant’s arguments regarding the step 2A, prong 1 analysis, the claims are still drawn to abstract ideas, merely using a processor to automate the abstract idea is not enough to integrate the abstract ideas into a practical application. The steps of “automatically extracting” as described in the claims is merely feeding data into a computer to carry out an abstract idea in the form of a mathematical concept. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. Regarding the applicant’s arguments regarding the step 2A, prong 2A, “diagnosing whether the data reported on the result sheet document corresponds to the lower urinary tract symptoms by analyzing a correlation between the feature points and the lower urinary tract symptoms by the character trained model and the graph trained model” is merely an abstract idea. The method does not output the results of the diagnoses in a way that doesn’t amount to insignificant post-solution activity. Regarding the applicant’s arguments regarding the step 2A, prong 2B the applicant fails to provide evidence of improvement. The examiner recommends that the applicant submit proof of improvement in comparison to other simple urine flow test result methods within the art.
Applicant’s arguments, see remarks, filed 01/29/2026, with respect to the rejection(s) of claim(s) 1-11 under 35 U.S.C. 103 have been fully considered and are persuasive. The prior art of claim 6 fails to teach integrating the feature points from the character data and the graph data by at least one of applying a concatenate function or by performing element-wise addition. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection for claims 6-14 is made in view of Belotserkovsky US 20160113562 A1 in view of Sobol US 20190209022 A1 in view of Meger (JP 2012502671 A- English Translation). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In response to applicant's argument that the examiner’s rejection contains statements in the prior art taken wholly out of context, the Applicant fails to point out which statements they believe to have been taken out of context. The examiner contends that the 103 rejections in regards to claims 6-14 are within the context of medical diagnostics.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY EPPERT/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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