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 .
Status of the Claims
The status of the claims as of the response filed 12/23/2025 is as follows:
Claims 1 and 4-10 are pending.
Claims 2 and 3 are canceled.
Claims 1, 4 and 9-10 were amended.
All pending claims have been considered below.
Applicant Argument Response:
The applicant pending claims 1, 4-10 filled on 12/23/25, and applicant arguments in relation to Subject Matter Eligibility 35 U.S.C 101 analysis in pages 6-10 were considered, and found not persuasive, and therefore 35 U.S.C 101 is sustained by the reasons below.
The applicant argue that Claim 1 is not properly rejected under 35 U.S.C. § 101 because its recited GUI features and interactive operations constitute a specific technological improvement that integrates the alleged abstract idea into a practical application, warranting eligibility when the claim is considered as a whole under the Step 2A, Prong Two and Step 2B analyses.
The Examiner respectfully disagrees, because under the broadest reasonable interpretation, Claim 1’s features simply facilitate alternative timeline presentations and visual representations of patient information, which improve human review but do not constitute a technological improvement to computer functionality. The asserted GUI structure and interactive operations are deemed abstract information-display arrangements implemented with generic computing components, and the added claim details do not alter this conclusion. As a result, the rejection under 35 U.S.C. § 101 is maintained.
The applicant pending claims 1, 4-10 filled on 12/23/25, and applicant arguments in relation to 35 U.S.C 103 analysis in pages 10-13 were considered, and found not persuasive, and therefore 35 U.S.C 103 is submitted by adding Tsimberidou NPL-refer to PTO-892-U for the reasons below.
Applicant argues that Claim 1, “switch between a first screen in which the time axis represents a date and a second screen in which the time axis represents a time period from the event, according to a user's selection; and display a degree of response indicating a treatment effect for each patient on the screen, wherein, on the screen, the state of the disease is displayed as a rectangular portion representing a time period during which a degree of progression of cancer of the patient is at a constant degree of progression” is not properly rejected because Lake allegedly does not teach multiple patients on an event-based relative time axis or a rectangular portion for a constant cancer-progression period, and Pellini allegedly does not teach an interface for switching between absolute and relative time axes or the claimed rectangular stage-period display.
The Examiner respectfully disagrees with the applicant, because obviousness is based on the combined teachings of the references, not whether any single reference discloses all features, and the current rejection relies on Tsimberidou to cure gaps from Lake and Pellini. While Lake and Pellini alone do not fully disclose the amended features, the present rejection is supported by the combined references, and thus the rejection under 35 U.S.C. 103 is maintained.
Claim Rejections - 35 USC § 112
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.
Claim 5 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. Because “Claim 5.
The treatment-method selection assistance apparatus according to claim 2” depends on a canceled claim 2. 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.
Rejection Under 35 U.S.C. § 101
Claims 1, 4-10 are rejected under 35 U.S.C. § 101 because the claimed subject matter is directed to a judicial exception (an abstract idea) without reciting elements that integrate the exception into a practical application or provide an inventive concept amounting to significantly more than the exception itself.
Step 1: Statutory Categories Analysis
The claims are directed to statutory subject matter, encompassing the following statutory categories:
Machine (Claims 1, 4-8): The language reciting "A treatment-method selection assistance apparatus comprising: at least one memory storing instructions and at least one processor configured to execute the instructions..." (Claim 1) describes a concrete thing consisting of parts (memory and processor
Process (Claim 9): The language reciting "A treatment-method selection assistance method comprising by a computer..." defines a series of acts or steps.
Manufacture (Claim 10): The language reciting "A non-transitory computer-readable medium storing a program..." describes a tangible article (the medium) given a new form (encoded with instructions).
Having confirmed the claims are directed to statutory subject matter, the analysis proceeds to Step 2A.
Step 2A, Prong One: Judicial Exception Analysis
The claims 1, 4-10 are directed to a judicial exception because, under the Broadest Reasonable Interpretation (MPEP § 2111), they recite a mental process: collecting, organizing, and displaying patient medication histories and disease states on a time axis (including switching between date-based and event-relative views) i.e., organizing and presenting information., which can be carried out mentally or with pen and paper and therefore constitutes an abstract idea.
Independent Claims Analysis
Claim 1: A treatment-method selection assistance apparatus comprising: at least one memory storing instructions and at least one processor configured to execute the instructions to: acquire a history of administering a medicine to each patient as a medication history; acquire a state of a disease of each patient; cause a display apparatus to display a screen on which the medication histories and states of the disease of a plurality of patients are displayed along a time axis;
cause the screen to display an event in which a date is determined for each patient; switch between a first screen in which the time axis represents a date and a second screen in which the time axis represents a time period from the event, according to a user's selection; and display a degree of response indicating a treatment effect for each patient on the screen, wherein, on the screen, the state of the disease is displayed as a rectangular portion representing a time period during which a degree of progression of cancer of the patient is at a constant degree of progression.
Note: The bolded portions represent additional elements evaluated in Prong Two and Step 2B. The non-bolded portions represent the abstract idea. References to US20250191784A1 for applicant language
Claim Classification & Mapping
Under the broadest reasonable functional interpretation, this claim “acquire a history,” “acquire a state,” “display … along a time axis,” “display an event,” “switch between” two timeline views, and “display a degree of response”: gathers patient treatment and disease information, arranges that information on a timeline with dated events, changes the temporal viewpoint between calendar-date and event-relative displays based on user choice, and presents treatment response and stable disease-progression periods in visual form for comparison. Functionally stated, the claim is directed to collecting medical information, organizing that information into alternative timeline views, and displaying the organized information so that a clinician can review patient treatment courses and outcomes. The acquiring limitations recite obtaining patient data, the timeline, event, switching, and rectangular-portion limitations recite organizing and re-organizing that information into alternative visual formats, and the response-display limitation recites presenting the information for human evaluation; together, these are observations, evaluations, and judgments of the type MPEP 2106 groups as mental processes.
Human Example that mirror Claims 1, 9 and 10:
A medical records clerk reviews each patient’s chart and records the patient’s medication history, disease state, treatment response, and dated clinical events.
The clerk prepares a first paper timeline sheet for the patients, arranging the medication histories, disease states, and dated events along a calendar-date time axis.
On that sheet, the clerk marks each patient’s treatment response and draws rectangular blocks spanning periods during which the patient’s cancer progression remained at the same degree.
The clerk also prepares a second paper timeline sheet that contains the same patient information, but arranged on a time axis measured from a selected event rather than by calendar date.
The physician switches between the first and second paper sheets to compare the patients’ treatment courses and responses and then makes a treatment judgment.
Dependent Claims Analysis
The dependent claims 2-8 are also directed to an abstract idea.
(Claims 4, 5): These claims recite displaying the event type such as "starting or ending of administration" or "holding of an expert panel" (Claim 4), or an event related to a "degree of response" (Claim 5). Under BRI (MPEP 2111), this is selecting specific additional data points (e.g., dates of events or evaluations like CR/PR [0023]) and organizing them on the display. This is a Mental Process (MPEP § 2106.04(a)(2)(III)) of selecting and organizing specific information for analysis.
(Claims 6, 8): These claims recite displaying additional information such as "a time period during which the medicine is not approved" (Claim 6) or "medical history" or "gene mutation information" (Claim 8). Under BRI (MPEP 2111), this is gathering and organizing additional specific data points [0027], [0029]. This is a Mental Process (MPEP § 2106.04(a)(2)(III)).
(Claim 7): This claim specifies the "state of the disease" (e.g., cancer progression [0019]). Under BRI (MPEP 2111), this merely narrows the type of data being collected and organized, remaining a Mental Process (MPEP § 2106.04(a)(2)(III)).
The dependent claims merely specify the types of data being handled or the manner of organization. They inherit the abstract idea of the independent claims and do not eliminate the abstract categorization (MPEP 2106.04).
Step 2A, Prong Two: Integration into a Practical Application
The claims fail to integrate the abstract idea into a practical application because the additional elements merely provide a generic technological environment.
Evaluation of Additional Elements
(Generic Hardware Components): The recitation of "at least one memory," "at least one processor" (Claim 1), "computer" (Claims 9, 10), "non-transitory computer-readable medium" (Claim 10), and "display apparatus" (Claims 1, 9, 10) fails to integrate the abstract idea because these elements represent generic components performing generic functions.
(MPEP § 2106.05(f) - Mere Instructions): MPEP § 2106.05(f) explains that additional elements that amount to mere instructions to implement an abstract idea on a computer, or merely using a computer as a tool, are insufficient to integrate the exception. Under BRI (MPEP 2111), the claims merely instruct a generic computer system to "apply" the abstract idea of organizing and displaying medical data. The hardware is recited generically ("processor," "memory," "computer") or functionally ("processor configured to execute the instructions to: acquire... acquire... and cause a display"), covering any generic computing device used as a tool for these basic data handling tasks.
(MPEP § 2106.05(a) - No Tech Improvement): MPEP § 2106.05(a) explains that an improvement to the functioning of a computer or other technology may integrate an exception. Under BRI (MPEP 2111), the claims do not improve computer functionality or any other technology. The specification does not describe any technical problem with existing data visualization systems; rather, it focuses on the cognitive benefit to the physician (Spec., para. [0005], [0020]). The claims merely automate the manual process of organizing records without reciting any specific implementation that improves how the computer operates.
(MPEP § 2106.05(g) - Insignificant Activity): MPEP § 2106.05(g) explains that adding insignificant extra-solution activity to the judicial exception is insufficient to integrate the exception. Under BRI (MPEP 2111), the steps of "acquiring" data are mere data gathering (insignificant pre-solution activity) necessary to perform the abstract idea of organizing that data. The step of "causing a display apparatus to display" the organized data is insignificant post-solution activity, merely presenting the result of the abstract organization.
(MPEP § 2106.05(h) - Linking to Environment): MPEP § 2106.05(h) explains that generally linking the use of a judicial exception to a particular technological environment is insufficient to integrate the exception. Under BRI (MPEP 2111), the claims merely link the abstract idea of organizing medical information to a general computing environment (processor, memory, display). This does not impose a meaningful limitation on the abstract idea.
Combination Analysis
When viewed as a whole, the combination of these elements does not integrate the abstract idea. The claims describe a generic computer arrangement performing the abstract organization and display of information. This does not transform the abstract idea into an eligible application; it merely uses a computer as a tool to perform the abstract idea.
Dependent Claims Analysis
The dependent claims add only minor limitations that fail to provide the necessary integration.
(Claims 4-8): These claims add the acquisition or display of specific data types (events, response degrees, approval status, medical history, specific disease states). Under BRI (MPEP 2111), this is insignificant pre-solution activity (g) (gathering additional specific data) or insignificant post-solution activity (g) (displaying additional organized data). Merely specifying which data to include in the abstract organization does not integrate the abstract idea.
(Claim 3): This claim adds switching the time axis reference (absolute vs. relative time). Under BRI (MPEP 2111), this merely specifies the format of the abstract data organization and presentation. It fails to improve computer functionality (a) and is a mere instruction (f) to organize the data in different abstract ways based on user preference.
Conclusion: Because the claims are directed to an abstract idea without integrating it into a practical application, the analysis proceeds to Step 2B.
Step 2B: Inventive Concept Analysis
The claims lack an inventive concept because the additional elements are well-understood, routine, conventional activities that do not amount to significantly more than the judicial exception itself.
Evaluation of Additional Elements
(Generic Hardware Components): The "memory," "processor," "computer," "CRM," and "display apparatus" do not provide an inventive concept.
(MPEP § 2106.05(d) - Well-understood, Routine, Conventional (WURC)): MPEP § 2106.05(d) explains that simply appending WURC activities, specified at a high level of generality, to the judicial exception does not provide an inventive concept. Under BRI (MPEP 2111), the recited components are generic hardware performing their basic functions. The specification confirms this, noting the apparatus includes a standard "processor, a memory, and a storage device" and implementation via standard programming (Spec., para. [0030]). Acquiring data, processing it, and displaying it on a screen are WURC activities for a computer.
(MPEP § 2106.05(f) - Mere Instructions): MPEP § 2106.05(f) explains that mere instructions to implement an abstract idea on a computer do not amount to significantly more. Under BRI (MPEP 2111), the elements are mere instructions to apply the abstract idea using generic computing devices. The specification describes the implementation using standard computing hardware and software (Spec., para. [0030]), failing to add significantly more to the abstract idea.
(MPEP § 2106.05(a) - No Tech Improvement): MPEP § 2106.05(a) explains that improvements to technology may provide an inventive concept. Under BRI (MPEP 2111), the claims do not result in an improvement to computer functionality or other technology. As analyzed in Step 2A, Prong 2, the specification identifies no technical problem or solution (Spec., para. [0020]), and the claims merely use conventional computer technology to automate a mental process.
(MPEP § 2106.05(g) - Insignificant Activity): MPEP § 2106.05(g) explains that insignificant extra-solution activity does not amount to significantly more. Under BRI (MPEP 2111), the acquisition and display steps are insignificant pre- and post-solution activity. As analyzed in Step 2A, Prong 2, these are mere data gathering and presentation surrounding the abstract idea.
(MPEP § 2106.05(h) - Linking to Environment): MPEP § 2106.05(h) explains that generally linking the use of a judicial exception to a particular technological environment is insufficient. Under BRI (MPEP 2111), the elements merely link the abstract idea to a generic technological environment. The use of generic hardware (Spec., para. [0030]) is insufficient to confer eligibility.
Combination Analysis
The elements, taken in combination, do no more than recite the abstract idea of organizing and displaying medical data performed on a generic computer system. The combination of generic components performing generic functions (data acquisition, processing, timeline display) in a conventional manner does not amount to significantly more than the abstract idea itself.
Dependent Claims Analysis
(Claims 4-8): These claims add the gathering and display of specific data types. Under BRI (MPEP 2111), gathering and displaying specific medical data fields (e.g., events [0021], expert panels [0022], response degrees [0023]) in the field of medical informatics and constitutes insignificant extra-solution activity (g).
(Claim 3): This claim adds switching the time axis format (e.g., normalizing based on an event start date [0025]). Under BRI (MPEP 2111), reorganizing data based on different reference points (data normalization or re-formatting) and allowing a user to switch views which does not present any additional elements just describe more the abstract idea.
Combination Analysis (Dependent Claims)
Even considering the specific data types and organizational formats recited in the dependent claims, the claims as a whole merely recite the abstract idea of organizing and presenting information for analysis implemented using conventional computer functions and visualization techniques. The combination does not provide an inventive concept.
Conclusion
The additional elements, individually and in combination, do not provide an inventive concept that amounts to significantly more than the abstract idea. The claims are directed to an abstract idea and lack an inventive concept. Therefore, Claims 1-10 are rejected under 35 U.S.C. § 101.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1,9 and 10, 2-5 and 7- 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US-20160246943-Lake in view of US-20140337052-A1- Pellini and in further view of Tsimberidou, refer to pto-892-U.
Lake teaches Claim 1.
A treatment-method selection assistance apparatus comprising: (Lake, par. 0010, 0018-0020, 0024, 0026, 0066, fig. 6)
at least one memory storing instructions and at least one processor configured to execute the instructions to: (Lake, par. 0159, 0256-0258)
acquire a history of administering a medicine to each patient as a medication history; (Lake, par. 0017-0018, fig. 6)
acquire a state of a disease of each patient; (Lake, par. 0018, 0024, 0026,0071-0072)
and cause a display apparatus to display a screen on which the medication histories and states of the disease of a . (Lake, par. 0010, 0018-0020, 0024, 0026, 0066, fig. 6)
Lake invention has a graphical representation in a time scale to compare treatment regimen and physiological state of the patient that contain drug administration history and patient health report to improve medication and therapy for disease management.
cause the screen to display an event in which a date is determined for each patient;
“the UID display unit is operable to display the processed first data and second data … Alternatively, the processed first data and second data can be displayed in the form of a calendar, such as a daily, weekly or monthly calendar”; “Calendar software component 32g may also issue reminders of an event to patient or HCP”; “The patient visit 32b … helps to track the EDSS score, relapses and the hospitalization period of the patient since last visit”; “the fourth data comprises a date and time of an appointment with a care giver”; Lake, pars. 0130-0131, 0246, 0244, 0121.
switch between a first screen in which the time axis represents a date and (Lake, par. 0018, par. 0024, par. 0079 “…plotted on a graph having a time axis…; Fig. 6, par. 0131 “…daily, weekly or monthly calendar…”, par. 0044-0047 “…the first and second time scale are aligned and displayed simultaneously…”, “..first and second time scale are displaced in relation to each other…”, “…the time scale may display…”)
Lake discloses a date-based screen because the data “can be displayed in the form of a calendar” and also discloses an alternative time-scale presentation in which reports are shown on “a first time scale” and “a second time scale,” including scales that are “displaced in relation to each other” to account for delay and allow comparison over time.
and display a degree of response indicating a treatment effect for each patient on the screen, wherein, (Lake, pars. 0018, 0043-0047, 0064-0065.)
Lake discloses displaying a patient outcome report on the screen and using it to evaluate treatment effect, for example “patient outcome reports to facilitate evaluation of the effects” and “a measurable or perceived outcome effect of the patient,” which reads on displaying a degree of response indicating treatment effect.
Obvious Rationales:
Lake disclosed all limitations explained limitations above, except for the limitations that are strikethrough.
However, Lake invention it is focus in a patient filtering criteria as can be observed in figure 6 “all patients” not to show a plurality of patient at the same time.
But Pellini describe in par. Fig. 1, 0009, 0013-0015, 0021 a generation in real-time treatment and outcome time line displays and identify similar patients based on information related to affected gene identified in a cancer.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to combine the teachings of Lake with Pellini because both references share the goal to help professional into decision making to facilitate diagnosis and therapy Lake par. 0010, Pellini par. 0004.
A person of ordinary skill in the art would have been motivated to integrate the plurality of patients from Pellini into the system of Lake to achieve the benefit of to capture a large portion of outcome through the similar patients and therefore improve treatments decisions, as Pellini (para. [0003, 0013-0015]).
Furthermore, the proposed combination is obvious because it represents Combining prior art elements according to known methods to yield predictable results. The integration of plurality patients option into the Lake inventions single-patient timeline to display multiple patient timelines on a common axis, to comparing similar patient data (pellini) it is obvious to obtain the know benefit of comparing similar patient data and demonstrates no unexpected synergy.
A PHOSITA would have had a reasonable expectation of success in combining the references because the modification required only ordinary skill and routine experimentation.
However, Lake does not teach the missing feature that the second screen time axis is expressly measured as a time period from an event rather than another chronological or offset scale.
Tsimberidou teaches that missing feature, as shown by “Cycle 1, day 1 was chosen as baseline time 0, page 559, figure 1/figure 2” and “The horizontal x axis shows time … as weeks from baseline page 559, figure 1/figure 2” for the swimmer plot, which reads on a second screen in which the time axis represents a time period from the event because the event is the baseline reference point and the axis shows elapsed time from that event.
A person of ordinary skill in the art would have combined Lake with the Tsimberidou to improve Lake’s patient timeline interface so clinicians could view treatment information either by calendar date or normalized to an event baseline, because Lake already seeks to compare patient reports over time through “first and second time scale[s]” and the Tsimberidou shows that using “baseline time 0” and “weeks from baseline” makes treatment response and clinical events easier to compare over a treatment course. Doing so would have predictably yielded a user-selectable absolute-time/event-relative-time display for improved comparison of treatment effects.
However, Lake does not teach the missing feature that the disease state is shown as a rectangular portion representing a time period during which the patient’s cancer progression remains at a constant degree.
Tsimberidou teaches that missing feature, as shown by “Figure 2. Clinical events in 12 patients … Swimmer plot illustrates clinical responses in relationship to duration of treatment … Bar length indicates duration of stability or response. Symbols along and at the end of each bar represent relevant clinical events, which include stable disease … progressive disease …, page 559, figure 2” and “The best RECIST response was stable disease, which lasted for 10.9 months, 5.5 months, and 4.5 months”. This reads on a rectangular portion representing a time period of constant progression because each patient’s bar is a rectangular time-span and the disclosed stable disease over stated durations corresponds to an unchanged disease state during that interval.
A person of ordinary skill in the art would have combined Lake with Tsimberidou to improve Lake’s patient-outcome display so clinicians could not only view treatment-effect information on screen, but also visualize per-patient cancer status over sustained intervals in a clinically familiar oncology timeline format, because Lake already seeks to compare and/or correlate treatment adherence with patient outcome over time and Tsimberidou shows that “clinical responses in relationship to duration of treatment” can be effectively conveyed by bars whose “length indicates duration of stability or response”. By modifying Lake’s outcome display to use Tsimberidou’s swimmer-plot rectangular duration bars for each patient’s response state, the combination would have predictably yielded an on-screen per-patient treatment-effect display in which a rectangular portion represents a time period of constant cancer progression/response state.
Note: Claims 9-10 are rejected with claim 1 for being very similar.
Lake in combination with Pellini and Tsimberidou, teaches 4.
The treatment-method selection assistance apparatus according to claim 1, wherein. (Lake, fig. 6, par. 0012, 0017-0018, 0041, 0075, 0109-0110, 0120)
Lake invention, describe the comparison of drug administration in a selected time stamped, therefore the user can select start to ending administration to develop comparison treatment analysis.
Lake in combination with Pellini and Tsimberidou, teaches Claim 5.
The treatment-method selection assistance apparatus according to claim 2, wherein the event is related to a degree of response indicating a treatment effect for each patient, and the at least one processor is further configured to execute the instructions to:
display the degree of response on the screen. (Lake, fig. 6, par. 0018, 0042-0044,0059, 0066, 0115)
Lake invention it is for by comparison determine efficacy of a treatment using in this case a score by a questionnaire that it is display in fig. 6 (Outcome Score).
Lake in combination with Pellini and Tsimberidou, teaches Claim 7.
The treatment-method selection assistance apparatus according to claim l, wherein the state of the disease is any one of .
Lake teaches displaying patient outcome/physiological state data on a common time scale and generating composite reports combining drug administration history with patient outcome reports, describing a system that generating in the computing system a report comprising a first graphical representation of the adherence to a treatment regimen and a second graphical representation of the patient reported outcome, said first and second graphical representations comprising a common time scale. (Lake, paras. 0064–0065).
However, Lake fails to disclose state of the disease is any one of cancer progression, malignancy, class classification, and prognostic factors, i.e., Lake does not provide the claimed oncology outcome taxonomy and explicitly labeled disease-state categories recited in the limitation; Lake instead refers generically to “patient outcome reports” or “physiological state.”
Pellini teaches the Missing Element state of the disease is any one of cancer progression, malignancy, class classification, and prognostic factors, describing a timeline outcome taxonomy that includes discrete oncology outcome classes and timeline display of those classes: "FIG. 26 shows four categories describing outcome information: 2604 progressive disease, 2606 stable disease, 2608 partial response, and 2610 complete response are shown with respect to a period of time shown at horizontal display bar 2612." (Pellini, paras. 0124–0125, 0038, 0026).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to combine the teachings of Lake with Pellini because both references address the shared purpose of providing computerized systems to monitor patient treatment outcomes for chronic diseases to assist healthcare decisions. Lake provides a system for monitoring patients suffering a chronic condition (Lake, para. 0001) to improve patient treatment monitoring (Lake, para. 0010). Pellini provides a system specific to cancer, a chronic condition, where users utilize the information to facilitate diagnosis and therapy decisions (Pellini, Abstract). A person of ordinary skill in the art seeking to adapt Lake's general patient monitoring framework for use in the specific field of oncology would be motivated to utilize the disease-specific outcome metrics recognized in that field, such as those taught by Pellini, to ensure the system accurately reflects the status of cancer patients.
A person of ordinary skill in the art would have been motivated to utilize the cancer-specific state of the disease metrics from Pellini when adapting the system of Lake for oncology to achieve the benefit of providing clinically relevant, actionable information tailored to cancer treatment. Pellini teaches this benefit, stating the need for systems that provide "actionable information that a physician can apply in daily practice or, in another example, use to inform the physician's decision on potential treatment options" (Pellini, para. 0003).
Furthermore, the proposed combination is obvious KSR because it represents Simple substitution of one known element for another to obtain predictable results. The modification involves substituting the disease state metrics utilized by Lake (e.g., EDSS Score, FIG. 6) with the disease state metrics taught by Pellini (e.g., cancer progression, tumor type, para. 0011, Abstract). A PHOSITA would recognize these elements as interchangeable depending on the specific chronic disease being monitored—using MS metrics for MS patients and cancer metrics for cancer patients—for the purpose of tracking the state of the disease. The substitution yields the predictable result of a patient monitoring system that tracks recognized oncology metrics when used for cancer patients.
A PHOSITA would have had a reasonable expectation of success in combining the references because the modification required only ordinary skill and routine experimentation. The technical integration is straightforward, involving the configuration of the software (Lake, para. 0018) to utilize different standardized clinical metrics (Pellini, para. 0011) depending on the disease application, which is a routine task in developing patient management software.
The integration is technically straightforward because both systems time-stamp and align treatment and outcome data and Pellini’s outcome classes are a representational layer (visual labels/vertical bars) that can be implemented as an output mapping in Lake’s reports timeline component to Lake’s data capture or core processing; Lake already contemplates time stamping and alignment of outcome data "such that an operator can compare the adherence to the treatment regimen and the physiological state of the patient." (Lake, para. 0044).
Lake in combination with Pellini and Tsimberidou, teaches Claim 8
The treatment-method selection assistance apparatus according to claim 1, wherein the at least one processor is further configured to execute the instructions to:
display, on the screen, at least one of a medical history of each patient, a medical history of a family of each patient, and gene mutation information regarding each patient. (Lake, par. 0041, 0192, 0204-0212)
Lake invention display history overview and injection that describe medical history.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US-20160246943-Lake in view of US-20140337052-A1-Pellini in combination with Tsimberidou-NPL, refer to PTO-992-U and further view of US-20120215554- Yurkovich.
Lake in combination with Pellini and Tsimberidou, teaches Claim 6.
The treatment-method selection assistance apparatus according to claim l, wherein the at least one processor is further configured to execute the instructions to:
display on the screen, (Lake, par. 0046, Pellini, par. )
Lake comparing a patient's medication adherence report with their outcome report by displaying them on adjustable time scales, allowing an operator to correlate medication timing with health effects, especially when there's a delay between treatment and observable outcomes.
However, Lake fails to disclose the screen displays a time period during which the medicine is not approved (i.e., an on-screen pre-approval interval derived from an authoritative approval date).
Yurkovich teaches the missing element displaying a product-level approval date that can be used to determine the pre-approval period, describing that “the system of the present invention rolls up the NDCs to the product level and takes the minimum approval date… to display FDA information at the product level,” par.0090 and that “the listing includes … the first date the product was approved.” Par. 0107.
It would have been obvious to one of ordinary skill in the art to combine Lake with Yurkovich because both references address temporally indexed pharmaceutical information for analysis: Lake provides clinician-facing patient timelines for evaluating efficacy while Yurkovich provides authoritative regulatory approval dates tied to the same drug/product identifiers that are displayed to users. Yurkovich’s explicit product-level approval date supplies the exact boundary datum that Lake’s timeline requires to render a not-approved interval, and integrating that datum into Lake’s existing time-axis visualization predictably enables on-screen shading or a mark that denotes the pre-approval period.
A person of ordinary skill in the art would have been motivated to integrate the approval-date overlay from Yurkovich into Lake’s timeline to gain the benefit of immediate regulatory context for clinical decision-making: seeing whether a treatment’s observed effect occurred before or after authorization. Yurkovich teaches that the approval date is displayed and used in product-level analysis (“the listing includes … the first date the product was approved”), which gives a POSITA a reasonable expectation of success in shading or marking the pre-approval interval on Lake’s time axis using that date.
Furthermore, this proposed combination is obvious under KSR (combining prior-art elements according to known methods to yield predictable results). The integration involves taking an already-disclosed date field (Yurkovich approval date) and rendering it on a time axis (Lake’s existing UI); each element performs its established function (dates demarcate; the axis displays time), and the resulting pre-approval shading/marking is the predictable outcome of displaying a known boundary on a time-series chart.
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.
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/JOSHUA DAMIAN RUIZ/Examiner, Art Unit 3684
/KAREN A HRANEK/Primary Examiner, Art Unit 3684
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