CTFR 18/904,572 CTFR 89565 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Notice to Applicant This communication is in response to the amendment filed 2/10/2026. Claims 1, 5-7, 11, and 15-17 have been amended. Claim 21 has been added. Claims 1-21 remain pending and have been examined. Response to Arguments A. Applicant's arguments with respect to the rejection of claims 1-21 under 35 USC 101 have been fully considered but they are not persuasive. Applicant argues starting on page 2 that claims 1 and 11 are directed to eligible subject matter under Step 2A Prong 2 because “the claim as a whole is directed to an improved practical application of performing a facile and repeatable assessment of clinical events with improved outcome.” Examiner respectfully disagrees. Applicant asserts that “the assessment yields whether a clinical event is related to a clinical trial,” that “to yield this assessment, a computational processing system receives one or more patient reports, generates features from the reports, and utilizes a predictive model to determine whether the evaluation,” and that “the computational steps achieve superior assessment as compared to a Clinical Events Committee.” However, a general assertion that the claimed process is more accurate than a human being rendering judgement does not establish that the claims recite additional elements which integrate the abstract idea into a practical application. As set out below, claim 1 recites elements of generating features from at least one report associated with a patient within a clinical trial that has undergone a clinical event, wherein the features comprise a time period between a clinical trial procedure and clinical event; and entering the features into a predictive computational model to yield an evaluation of the clinical event, wherein the evaluation is whether the clinical event is related to the clinical trial. Using a computing system to execute these functions as recited in claim 1 only amounts to mere instructions to implement the abstract idea. Applicant further argues that the claims are directed to eligible subject matter under Step 2B on the basis that they recite elements which are not well-understood routine and conventional activities. Examiner respectfully disagrees. Applicant asserts that “claims 1 and 11 generate features from the at least one report and enter the features into a predictive computational model, wherein the features comprise a time period between a clinical trial procedure and clinical event,” and that “[u]se of a predictive computational model, especially with this feature, is unconventional in assessments of clinical events.” However, as noted with in Step 2A Prong 1, the element reciting a “predictive computational model” does not constitute an additional element within the claims, and Applicant does not offer any arguments in support of the assertion that use of a “predictive computational model” in to analyze a time period between a clinical trial procedure and clinical event amounts to significantly more than the recited abstract idea. As noted above, the additional elements such as use of a computational processing system only constitute instructions to implement functions within the abstract idea using computers. The rejection under 35 USC 101 is maintained. B. Applicant’s arguments with respect to the rejection of claims 1 and 11 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 USC 103 in view of Seltzer et al, Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium (hereinafter Seltzer). Claim Objections The previous objection to claims 6, 7, 16, and 17 is withdrawn based on the amendments filed 2/10/2026. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-10 and 21 are drawn to a method, while claims 11-20 are drawn to a system, each of which is within the four statutory categories. Step 2A(1) Independent claim 1 recites, in part, performing the steps of: generating features from at least one report associated with a patient within a clinical trial that has undergone a clinical event, wherein the features comprise a time period between a clinical trial procedure and clinical event; and entering the features into a predictive computational model to yield an evaluation of the clinical event, wherein the evaluation is whether the clinical event is related to the clinical trial. These steps amount to concepts performed in the human mind and therefore fall within the scope of an abstract idea. Determining features, including a time period between a clinical trial procedure and a clinical event, from at least one report associated with a clinical trial patient who has undergone a clinical event and entering the features into a computational model to evaluate whether the clinical event is related to the clinical trial constitute forms of evaluation, judgement, and opinion performable by a person mentally and/or with a calculation aid such as a pen and paper. Examiner notes that a “predictive computational model” is not limited to models requiring computer hardware, and encompasses predictive modeling techniques where the computations may be performed mentally or by hand. Independent claim 11 recites similar limitations and also recites an abstract idea under the same analysis. Step 2A(2) This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to: A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f) Claim 1 recites the additional element of a computational processing system used to perform the data processing functions of receiving the report, generating the features, and entering the features. Claim 11 recites the additional elements of a) a processor system recited as performing the subsequently recited data processing steps of receiving the report, generating the features, and entering the features, and b) a memory system recited as comprising one or more applications to control the processor. Paragraph 85 describes a computational processing system as including a processor system and a memory system, and further states that the processor system and memory system “can be implemented using any of a variety of components appropriate to the requirements of specific applications including (but not limited to) CPUs, GPUs, ISPs, DSPs, …, volatile memory (e.g., DRAM) and/or non-volatile memory (e.g., SRAM, and/or NAND Flash).” Paragraph 88 further states that “computational processes and/or other processes utilized in the provision of clinical event evaluation can be implemented on any of a variety of processing devices including combinations of processing devices,” and that “computational devices should be understood as not limited to specific monitoring systems, computational processing systems, and/or specific applications and models.” The computational processing system, processor system, and memory system are construed accordingly as encompassing generic computing elements. The above elements, considered individually and in combination, amount to mere instructions to implement the abstract idea using computing elements as tools. Specifically, each of the computational processing system, processor system, and memory system are recited at a high level of generality and are likewise disclosed broadly as encompassing any of a plurality of possible generic computing components. These elements are therefore not sufficient to integrate the abstract idea into a practical application. B. Insignificant Extra-Solution Activity. MPEP 2106.05(g) Claims 1 and 11 each further recite the additional element of receiving the at least one report. However, this element only constitutes a form of necessary data gathering for use during performance of the abstract idea, and therefore amounts to insignificant extra-solution activity. The above claims, as a whole, are therefore directed to an abstract idea. Step 2B The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of: A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f) As explained above, claims 1 and 11 only recite the computational processing system, processor system, and memory system as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f) B. Insignificant Extra-Solution Activity. MPEP 2106.05(g) Likewise, the recitation in claims 1 and 11 of receiving the at least one report only constitutes a form of necessary data gathering for use during performance of the abstract idea, and therefore amounts to insignificant extra-solution activity as set out above. C. Well-Understood, Routine and Conventional Activities. MPEP 2106.05(d) In addition to amounting to insignificant extra-solution activity, the element of receiving the at least one report recited in claims 1 and 11 only amounts to well-understood routine and conventional activity in the form of receiving or transmitting data over a network and/or storing and retrieving information in memory. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Depending Claims Claims 2 and 12 recite wherein the clinical event is one of: an adverse event, a serious adverse event, an adverse reaction, or a suspected unexpected serious adverse event. These limitations fall within the scope of the abstract idea as set out above. Claims 3 and 13 recite wherein the clinical event comprises: hospitalization or rehospitalization, disability, congenital anomaly, required intervention, allergic reaction, blood dyscrasias, seizures or convulsions, development of drug dependence or drug abuse, death, or a cardiovascular related event. These limitations fall within the scope of the abstract idea as set out above. Claims 4 and 14 recite wherein the cardiovascular related event is one of: transient ischemic attack (TIA), bleeding, myocardial infarction, arrythmia or conduction disturbances, structural valve deterioration, endocarditis, prosthetic valve dysfunction, thrombosis, and coronary obstruction. These limitations fall within the scope of the abstract idea as set out above. Claims 5 and 15 recite wherein the clinical trial is assessing: a clinical procedure performed, a medical device utilized during a treatment, a prosthetic device, a system for performing clinical procedure, or a medicinal product; wherein the evaluation is whether the clinical event is related to the medical device utilized during the treatment, the prosthetic device, the system for performing clinical procedure, or the medicinal product. These limitations fall within the scope of the abstract idea as set out above. Claims 6 and 16 recite wherein the at least one received report is a case report form, and wherein the features generated from the case report form comprise a categorical feature derived from a data entry, wherein the categorical feature is a Medical Dictionary for Regulatory Activity preferred term or a Medical Dictionary for Regulatory Activity system organ class. These limitations fall within the scope of the abstract idea as set out above. Claims 7 and 17 recite wherein the at least one received report is a narrative or a source document, and wherein the features generated from the narrative or the source document comprise a categorical feature or a numerical value feature. These limitations fall within the scope of the abstract idea as set out above. Claims 7 and 17 further recite the additional element of natural language processing as used to “yield” the categorical feature or numerical value feature. Paragraphs 66 and 82 describe the use of natural language processing in terms of its recited function of yielding or extracting a categorical feature or a numerical value from narrative or source documents. No further disclosure is provided of the natural language processing itself. The recited natural language processing is construed accordingly as encompassing any natural language processing technique. The recited natural language processing, considered individually and in combination, amounts to mere instructions to implement the abstract idea using computing elements as tools. Specifically, the natural language processing is only recited at a high level of generality as “yielding” the features, and is likewise disclosed broadly in terms of this functionality. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea. Claims 8 and 18 recite wherein the predictive computational model is a regression-based model or a classification-based model. These limitations fall within the scope of the abstract idea as set out above. Examiner notes that a “regression-based model” or “classification-based model” is not limited to models requiring computer hardware, and encompass regression or classification techniques which may be performed mentally or by hand. Claims 9 and 19 recite wherein the evaluation of the clinical event is yielded in lieu of an adjudication by a clinical event committee. These limitations fall within the scope of the abstract idea as set out above. Claims 10 and 20 recite wherein the evaluation of the clinical event is yielded to assess an adjudication by a clinical event committee. These limitations fall within the scope of the abstract idea as set out above. Claim 21 recites wherein the clinical trial comprises a cardiac valve replacement procedure, the clinical event is rehospitalization, and the evaluation comprises: whether the rehospitalization is cardiovascular or non-cardiovascular; whether the rehospitalization is related to a prosthetic cardiac valve; whether the rehospitalization is related to heart failure; or whether the rehospitalization is related to the cardiac valve replacement procedure. These limitations fall within the scope of the abstract idea as set out above. Claims 1-21 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim s 1-5, 7-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Khan et al (US Patent Application Publication 2024/0105289) in view of Seltzer et al, Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium (hereinafter Seltzer) . With respect to claim 1 , Khan discloses the claimed computational method for evaluating a clinical event, comprising: receiving, using a computational processing system (Figure 24 and [238], [239], and [244]-[246] describe a computing system used to implement the disclosed functions) , at least one report associated with a patient within a clinical trial that has undergone a clinical event (Figures 5, 11, 12, 15, and 18, and [182], [186], and [198] describe receiving patient reports from various sources) ; generating, using the computational processing system, features from the at least one received report (Figures 15, 16, and 18, and [183], [187], [192], and [206] describe extracting features from the received data using relevant feature sets, NLP, and various other techniques; Figures 20 and 21 show example model features) ; and entering, using the computational processing system, the features into a predictive computational model to yield an evaluation of the clinical event (Figures 15, 16, 18, and 19, and [85], [86], [170], [189], [206, and [207] describe supplying the extracted features to a trained model to evaluate the event) ; but does not expressly disclose: wherein the features comprise a time period between a clinical trial procedure and clinical event, and wherein the evaluation is whether the clinical event is related to the clinical trial. However, Seltzer teaches that it was old and well known in the art of clinical trial monitoring before the effective filing date of the claimed invention to evaluate whether a clinical event is related to a clinical trial using information including a time period between a clinical trial procedure and the clinical event (Abstract, Figure 1, P.80 Col.2 ¶3 - P.81 Col.1 ¶4 describe clinical trial endpoint adjudication including a determination of whether an event is causally linked to a medical procedure based in part on the temporal proximity of the adverse event to the procedure) . Therefore it would have been obvious to one of ordinary skill in the art of clinical trial monitoring before the effective filing date of the claimed invention to modify the system of Khan to evaluate whether a clinical event is related to a clinical trial using information including a time period between a clinical trial procedure and the clinical event as taught by Seltzer since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Khan already discloses clinical endpoint adjudication of adverse events, and including an analysis of whether the clinical event is related to the clinical trial using information including a time period between a clinical trial procedure and the clinical event as taught by Seltzer would serve that same function in Khan, making the results predictable to one of ordinary skill in the art (MPEP 2143). With respect to claim 2 , Khan/Seltzer teaches the computational method of claim 1. Khan further discloses: wherein the clinical event is one of: an adverse event, a serious adverse event, an adverse reaction (Figures 6 and 9, [22], [119], [154], [176], [179], and [207] describe various adverse events, serious adverse events, and adverse reactions such as physiological data events, death, hospitalization, cardiac events, and others) , or a suspected unexpected serious adverse event. With respect to claim 3 , Khan/Seltzer teaches the computational method of claim 1. Khan further discloses: wherein the clinical event comprises: hospitalization or rehospitalization (Figure 8, [88], [176], and [179] describe events as including hospitalization) , disability, congenital anomaly, required intervention, allergic reaction, blood dyscrasias, seizures or convulsions, development of drug dependence or drug abuse, death (Figures 19 and 23, [22], and [176] describe the events as including death) , or a cardiovascular related event (Figures 19 and 23, [22], [74], [176], and [179] describe events including myocardial infarction and other cardiovascular events) . With respect to claim 4 , Khan/Seltzer teaches the computational method of claim 3. Khan further discloses: wherein the cardiovascular related event is one of: transient ischemic attack (TIA), bleeding, myocardial infarction ([22], [74], and [176] describe events including myocardial infarction) , arrythmia or conduction disturbances, structural valve deterioration, endocarditis, prosthetic valve dysfunction, thrombosis, and coronary obstruction. With respect to claim 5 , Khan/Seltzer teaches the computational method of any claim 1. Khan further discloses: wherein the clinical trial is assessing: a clinical procedure performed, a medical device utilized during a treatment, a prosthetic device, a system for performing clinical procedure, or a medicinal product (Figure 13, [3], and [172] provide examples of clinical drug trials) , but does not expressly disclose: wherein the evaluation is whether the clinical event is related to the medical device utilized during the treatment, the prosthetic device, the system for performing clinical procedure, or the medicinal product. However, Seltzer teaches that it was old and well known in the art of clinical trial monitoring before the effective filing date of the claimed invention to evaluate whether a clinical event is related to a clinical trial using information including a time period between a clinical trial procedure and the clinical event (Abstract, Figure 1, P.80 Col.2 ¶3 - P.81 Col.1 ¶4 describe clinical trial endpoint adjudication including a determination of whether an event is causally linked to a medical device procedure based in part on the temporal proximity of the adverse event to the procedure) . Therefore it would have been obvious to one of ordinary skill in the art of clinical trial monitoring before the effective filing date of the claimed invention to modify the combination of Khan and Seltzer to evaluate whether a clinical event is related to a clinical trial using information including a time period between a clinical trial procedure and the clinical event as taught by Seltzer since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Khan and Seltzer already teaches clinical endpoint adjudication of adverse events, and including an analysis of whether the clinical event is related to the clinical trial using information including a time period between a clinical trial procedure and the clinical event as taught by Seltzer would serve that same function in Khan and Seltzer, making the results predictable to one of ordinary skill in the art (MPEP 2143). With respect to claim 7 , Khan/Seltzer teaches the computational method of claim 1. Khan further discloses: wherein the at least one received report is a narrative or a source document (Figures 11 and 12, [161], [182], and [187] describe the information being collected from unstructured narrative documents and source documents) , and wherein the features generated from the narrative or the source document comprise a categorical feature or a numerical value feature yielded from natural language processing (Figures 11, 12, and 15, and [182], [187] and [192] describe features as extracted using OCR and natural language processing, as well as including categorical features such as sex and cause of death and numerical features such as age) . With respect to claim 8 , Khan/Seltzer teaches the computational method of claim 1. Khan further discloses: wherein the predictive computational model is a regression-based model or a classification-based model (Figure 22, [189], and [190] describe models as including Random Forrest and Support Vector Machines; [223] and [231] describe a neural network having a classifier as its final layer) . With respect to claim 9 , Khan/Seltzer teaches the computational method of claim 1. Khan further discloses: wherein the evaluation of the clinical event is yielded in lieu of an adjudication by a clinical event committee ([220] describes the automated clinical adjudication process replacing clinician adjudication; Figure 2 shows the adjudication algorithm directly producing the adjudication outcome, vs Figure 1, [74], and [76] which describe the typical practice of an adjudication committee) . With respect to claim 10 , Khan/Seltzer teaches the computational method of claim 1. Khan further discloses: wherein the evaluation of the clinical event is yielded to assess an adjudication by a clinical event committee ([180] and [220] describe the automated adjudication process as augmenting or acting as quality assurance for an adjudication committee; Figure 2 shows the co-involvement of a committee in certain circumstances. Examiner notes however, that the recitation of the evaluation being yielded “to assess an adjudication by a clinical event committee” only amounts to non-functional descriptive material because the claim does not positively recite or require performing an assessment, and only recites it as an intended purpose or motivation for performing the evaluation) . With respect to claim 11 , Khan discloses the claimed computational processing system for evaluating a clinical event, the system comprising: a processor system and a memory system comprising one or more applications (Figure 24 and [238], [239], and [244]-[246] describe a computing system including a processor and memory used to implement the disclosed functions) that can direct the processor system to: receive at least one report associated with a patient within a clinical trial that has undergone a clinical event (Figures 5, 11, 12, 15, and 18, and [182], [186], and [198] describe receiving patient reports from various sources) ; generate features from the at least one received report (Figures 15, 16, and 18, and [183], [187], [192], and [206] describe extracting features from the received data using relevant feature sets, NLP, and various other techniques; Figures 20 and 21 show example model features) ; and enter the features into a predictive computational model to yield an evaluation of the clinical event (Figures 15, 16, 18, and 19, and [85], [86], [170], [189], [206, and [207] describe supplying the extracted features to a trained model to evaluate the event) ; but does not expressly disclose: wherein the features comprise a time period between a clinical trial procedure and clinical event, and wherein the evaluation is whether the clinical event is related to the clinical trial. However, Seltzer teaches that it was old and well known in the art of clinical trial monitoring before the effective filing date of the claimed invention to evaluate whether a clinical event is related to a clinical trial using information including a time period between a clinical trial procedure and the clinical event (Abstract, Figure 1, P.80 Col.2 ¶3 - P.81 Col.1 ¶4 describe clinical trial endpoint adjudication including a determination of whether an event is causally linked to a medical procedure based in part on the temporal proximity of the adverse event to the procedure) . Therefore it would have been obvious to one of ordinary skill in the art of clinical trial monitoring before the effective filing date of the claimed invention to modify the system of Khan to evaluate whether a clinical event is related to a clinical trial using information including a time period between a clinical trial procedure and the clinical event as taught by Seltzer since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Khan already discloses clinical endpoint adjudication of adverse events, and including an analysis of whether the clinical event is related to the clinical trial using information including a time period between a clinical trial procedure and the clinical event as taught by Seltzer would serve that same function in Khan, making the results predictable to one of ordinary skill in the art (MPEP 2143). Claim 12 recites limitations similar to those recited in claim 2, and is rejected on the same grounds set out above with respect to claim 2. Claim 13 recites limitations similar to those recited in claim 3, and is rejected on the same grounds set out above with respect to claim 3. Claim 14 recites limitations similar to those recited in claim 4, and is rejected on the same grounds set out above with respect to claim 4. Claim 15 recites limitations similar to those recited in claim 5, and is rejected on the same grounds set out above with respect to claim 5. Claim 17 recites limitations similar to those recited in claim 7, and is rejected on the same grounds set out above with respect to claim 7. Claim 18 recites limitations similar to those recited in claim 8, and is rejected on the same grounds set out above with respect to claim 8. Claim 19 recites limitations similar to those recited in claim 9, and is rejected on the same grounds set out above with respect to claim 9. Claim 20 recites limitations similar to those recited in claim 10, and is rejected on the same grounds set out above with respect to claim 10. With respect to claim 21 , Khan/Seltzer teaches the computational method of claim 1. Khan does not expressly disclose wherein the clinical trial comprises a cardiac valve replacement procedure, the clinical event is rehospitalization, and the evaluation comprises: whether the rehospitalization is cardiovascular or non-cardiovascular; whether the rehospitalization is related to a prosthetic cardiac valve; whether the rehospitalization is related to heart failure; or whether the rehospitalization is related to the cardiac valve replacement procedure. However, Seltzer teaches that it was old and well known in the art of clinical trial monitoring before the effective filing date of the claimed invention to evaluate whether a rehospitalization event is cardiovascular and related to a cardiac valve replacement procedure and trial (Abstract, Figure 1, P.80 Col.2 ¶3 - P.81 Col.1 ¶4, and P.82 Col.1 ¶4 – Col.2 ¶1 describe clinical trial endpoint adjudication including a determination of whether a valve surgery patient’s hospitalization is related to cardiovascular issues such as heart failure) . Therefore it would have been obvious to one of ordinary skill in the art of clinical trial monitoring before the effective filing date of the claimed invention to modify the combination of Khan and Seltzer to evaluate whether a rehospitalization event is cardiovascular and related to a cardiac valve replacement procedure and trial as taught by Seltzer since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Khan and Seltzer already teaches clinical endpoint adjudication of adverse events, and including an analysis of whether a rehospitalization event is cardiovascular and related to a cardiac valve replacement procedure and trial as taught by Seltzer would serve that same function in Khan and Seltzer, making the results predictable to one of ordinary skill in the art (MPEP 2143). While Examiner has applied the above cited art in the interest of expediting prosecution, Examiner notes that the clinical trial comprising a cardiac valve replacement procedure only constitute non-functional descriptive material. The recitation of the clinical trial comprising a cardiac valve replacement procedure does not have a functional relationship with the claimed system because it does not affect or change a required function of the method. The above limitations therefore do not serve to further limit the claimed method in view of the prior art . 07-22-aia AIA Claim s 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Khan et al (US Patent Application Publication 2024/0105289) in view of Seltzer et al, Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium (hereinafter Seltzer) as applied to claim s 1 and 11 above, and further in view of Liu et al (US Patent Application Publication 2022/0172805) . With respect to claim 6 , Khan/Seltzer teaches the computational method of any claim 1. Khan further discloses: wherein the features generated from the received report comprise a categorical feature derived from a data entry (Figures 11, 12, 15, and 16, and [101], and [161] describe features as extracted from structured documents and using electronic data capture, as well as including categorical features such as sex and cause of death) ; but does not expressly disclose: wherein the at least one received report is a case report form, and wherein the categorical feature is a Medical Dictionary for Regulatory Activity preferred term or a Medical Dictionary for Regulatory Activity system organ class. However, Liu teaches that it was old and well known in the art of clinical trial monitoring before the effective filing date of the claimed invention to receive data from a case report form (Figure 4A, [31], [63], and [66] describe receiving adverse event data from a case report form) , and to have categorical features include a Medical Dictionary for Regulatory Activity preferred term ([24], [37], and [42] describe model features including MedDRA preferred terms) . Therefore it would have been obvious to one of ordinary skill in the art of clinical trial monitoring before the effective filing date of the claimed invention to modify the combination of Khan and Seltzer to receive data from a case report form and to have categorical features include a Medical Dictionary for Regulatory Activity preferred term as taught by Liu since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Khan and Seltzer already teach the received reports including structured patient report data, and having the reports include case report forms and the categorical features including a Medical Dictionary for Regulatory Activity preferred term as taught by Liu would serve that same function in Khan and Seltzer, making the results predictable to one of ordinary skill in the art (MPEP 2143). Claim 16 recites limitations similar to those recited in claim 6, and is rejected on the same grounds set out above with respect to claim 6 . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bao et al (US Patent Application Publication 2019/0057191); Schmider et al, Innovation in Pharmacovigilance: Use of Artificial Intelligence in Adverse Event Case Processing ; National Institute on Aging, NIA Adverse Event and Serious Adverse Event Guidelines . 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 WILLIAM G LULTSCHIK whose telephone number is (571)272-3780. The examiner can normally be reached 9am - 5pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Gregory Lultschik/Examiner, Art Unit 3682 Application/Control Number: 18/904,572 Page 2 Art Unit: 3682 Application/Control Number: 18/904,572 Page 3 Art Unit: 3682 Application/Control Number: 18/904,572 Page 4 Art Unit: 3682 Application/Control Number: 18/904,572 Page 5 Art Unit: 3682 Application/Control Number: 18/904,572 Page 6 Art Unit: 3682 Application/Control Number: 18/904,572 Page 7 Art Unit: 3682 Application/Control Number: 18/904,572 Page 8 Art Unit: 3682 Application/Control Number: 18/904,572 Page 9 Art Unit: 3682 Application/Control Number: 18/904,572 Page 10 Art Unit: 3682 Application/Control Number: 18/904,572 Page 11 Art Unit: 3682 Application/Control Number: 18/904,572 Page 12 Art Unit: 3682 Application/Control Number: 18/904,572 Page 13 Art Unit: 3682 Application/Control Number: 18/904,572 Page 14 Art Unit: 3682 Application/Control Number: 18/904,572 Page 15 Art Unit: 3682 Application/Control Number: 18/904,572 Page 16 Art Unit: 3682 Application/Control Number: 18/904,572 Page 17 Art Unit: 3682 Application/Control Number: 18/904,572 Page 19 Art Unit: 3682 Application/Control Number: 18/904,572 Page 20 Art Unit: 3682 Application/Control Number: 18/904,572 Page 21 Art Unit: 3682 Application/Control Number: 18/904,572 Page 22 Art Unit: 3682 Application/Control Number: 18/904,572 Page 23 Art Unit: 3682 Application/Control Number: 18/904,572 Page 24 Art Unit: 3682
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