DETAILED ACTION
Applicant’s response, filed 02 Sept. 2025 has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 Claims
Claims 1-30 are pending.
Claims 1-30 are rejected.
Claims 1 and 18 are objected to.
Priority
Applicant’s claim for the benefit of a prior-filed application, U.S. Non-Provisional App. No. 17/461,995 filed 30 Aug. 2021, 16/732,168 filed 31 Dec. 2019, and Provisional App. No. 62/786,739 filed 31 Dec. 2018, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/732,168 filed 31 Dec. 2019 and U.S. Provisional App. No. 62/786,739 filed 31 Dec. 2018, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Instant claim 1 recites displaying a second region presenting “for each subgroup, a time on treatment indicator comprising a graphical representation of a distribution of an amount of time…and an indicator representing a median duration time on the treatment regimen for that subgroup”, and similarly “a third region…presenting the time on treatment indicator… and patient-specific information in one or more patient-specific subregions”. The parent App. No. ‘739 and ‘168 do not appear to disclose an interface presenting multiple distributions of time on treatment information (one for each subgroup) and including an indicator representing a median duration. The parent App. No. ‘739 and ‘168 also do not disclose, in the third region, patient-specific information in patient specific regions. In contrast, parent App. ‘995 and the instant application appear to provide support for the recited time on treatment indicators at FIG. 55-57 and 60-61. However, no corresponding drawings and/or disclosure is present in the parent App. No. ‘739 and ‘168.
Therefore, the effective filing date of claims 1-30 is 30 Aug. 2021.
Drawings
The drawings replacement drawing sheets filed 02 Sept. 2025 have been entered.
The previous objection to the drawings filed 03 May 2022 has been withdrawn in view of the replacement drawing sheets filed 02 Sept. 2025 and Applicant’s remarks filed 02 Sept. 2025 at pg. 12, para. 4 noting that FIG. 27 does not include 3753, which is correct as FIG. 37 includes 3758, which is in the specification.
Therefore, the drawings filed 03 May 2022 and the placement drawing sheets filed 02 Sept. 2025 are accepted.
Claim Objections
Claims 1 and 18 are objected to because of the following informalities. This objection is newly recited and necessitated by claim amendment.
Claim 1 recites “…generating, for each subgroup, the time on treatment indicator along the width relative to the anchor event”. To increase clarity and use consistent language, claim 1 should be amended to recite “…along the time on treatment indicator width relative to the anchor event…”.
Claim 18 recites “…displaying, withing a fourth region…”, which is a typographical error and should read “displaying, within[[g]] a fourth region…”.
Appropriate correction is required.
Claim Interpretation
Claim 1 recites “…displaying, concurrently with the first region and within a second region of the computer screen, time on treatment information…in response to receiving further selections for one or more of the plurality of user-selectable inputs…” in the second limitation of the claim. Claim 1 previously recites “…displaying, within a first region…a plurality of user-selectable inputs”, but does not require receiving selections for one or more user selectable inputs. Therefore, the step of “displaying, concurrently with the first region and within a second region of the computer screen, time on treatment information…., the second region dividing the first cohort of patients into a plurality of subgroups according to a corresponding plurality of treatment regimens…, wherein the time on treatment information comprises…a time one treatment indicator…” is not required under the broadest reasonable interpretation of the claims because the condition precedent has not been met. See MPEP 2111.04 II.
Claim 1 further recites “…wherein displaying the time on treatment indicator for each subgroup comprises: identifying….; associating…; generating…; and generating…”, which further limits the step of displaying time on treatment information that is not required under the broadest reasonable interpretation of the claims as discussed above. Therefore, these steps are also not required for the same reasons. See MPEP 2111.04 II.
Claim 1 recites “…displaying, within a third region of the computer screen that replaces the second region and in response to receiving a further selection of one of the plurality of subgroups in the second region, the time on treatment indicator…”. Because claim 1 does not require that the condition precedent of receiving a further selection of one of the plurality of subgroups in the second region is met, the limitation of displaying, within a third region, the time on treatment indicator, as claimed, is not required by the claims. See MPEP 2111.04 II.
Claim 1 recites “…displaying a third region that replaces the second region in response…”. Given the interface is claimed to be dynamic, and comprises a third region that replaces the second region, the second and third regions of the dynamic user interface are interpreted to not be required to be simultaneously presented on the user interface. That is, sequential display of the second region, and then the third region is considered to read on the claims given there is no requirement the second and third regions are simultaneously displayed.
Claim 15 recites “…wherein data used to generate each of treatment indicators for each subgroup is normalized to a treatment regimen-dictated level of granularity”. The limitation is interpreted to recite a product by process limitation which only defines the process in which data used to create each of the visual time on treatment indicators was previously generated. However, the claim does not require normalizing the data used to generate the indicators. See MPEP 2113, which states [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.
Examiner comment:
To avoid the above claim interpretations regarding the broadest reasonable interpretation of contingent limitations for method claims, Applicant may consider amending the claims to recite a system with a processor configured to carry out the method of displaying. In such systems, the broadest reasonable interpretation of the claims still requires the system is programmed to perform the recited function. See MPEP 2111.04 II, explaining the broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur. The system claim interpretation differs from a method claim interpretation because the claimed structure must be present in the system regardless of whether the condition is met and the function is actually performed.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-30 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention. This rejection is newly recited and necessitated by claim amendment.
Claim 1, and claims dependent therefrom, recite “associating, for each subgroup, the first display screen width position with an anchor event common to the first cohort of patients”. Applicant’s specification does not disclose associating a display screen width position with an anchor point.
Applicant’s specification at para. [0010], [0185], [0236] discloses identifying a common anchor point from a set of anchor points associated with each of the group of patients, and aligning, for each patient of the group of patients, a timeline associated with each patient of the group of patients to the common anchor point. Applicant’s specification at para. [0142] discloses selecting a starting event as an anchor point. However, these paragraphs simply describe identifying an anchor point at which to align the timelines of each patient. Applicant’s remarks at pg. 15, para. 2 discloses the above limitation is supported by para. [0471] and FIG. 55-60 of the specification and its discussion of “occupying the same amount of non-overlapping area on the display, e.g. all being displayed in [a] region of equal width” and the system scaling each graphical representation. However, this is referring to scaling a display area #5520 for each subgroup to have equal widths and then scaling the time on treatment indicator distribution #5532 to each have the same width within the area #5520. While it is acknowledged each treatment indicator has the distribution aligned to a particular anchor event, the first display screen width is not associated with the anchor point within the treatment indicator in the process of displaying. At best, it is implied that the anchor point is associated with the time on treatment indicator width, given the starting positions are aligned.
For the reasons discussed above, the specification does not provide a sufficient disclosure of the limitation above of claim 1, and dependent claims 2-30, to demonstrate to one of ordinary skill in the art that the inventor possessed the invention at the time the application was filed. For more information regarding the written description requirement, see MPEP §2161.01- §2163.07(b).
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1-15 and 21-29 in the Office action mailed 30 April 2025 has been withdrawn in view of claim amendments received 02 Sept. 2025.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-30 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Any newly recited portion is necessitated by claim amendment.
Claim 1, and claims dependent therefrom, are indefinite for recitation of “…identifying a first display screen width position…”. The metes and bounds of a “width position” for a display screen are not clear. It is unclear if a “width position” is simply referring to a width of the display, if a “width position” is referring to some position related to the display screen, or if the term has some other meaning. A “width position” is not a term of art, nor does Applicant’s specification mention a “width position” or serve to clarify the metes and bounds of the term. Clarification is requested via claim amendment. It is noted that Applicant’s remarks at pg. 15, para. 2 point to para. [0471] and FIG. 55-60 ([0462] in the published specification) as apparently providing support for the limitation, describing that the interface may include discrete regions, and the graphical representation may occupy the same amount of non-overlapping area on the display, e.g. all being displayed in a region of equal width, and the system may scale each graphical representation. Therefore, the limitation will be interpreted to mean identifying a first display screen width, rather than a “width position” (a width position is interpreted to mean a width).
Claim 1, and claims dependent therefrom, are indefinite for recitation of “…generating, for each subgroup, the time on treatment indicator in a region defined by the first display screen width position and the time on treatment indicator width; and generating, for each subgroup, the time on treatment indicator along the width relative to the anchor event”. It is unclear if claim 1 intends to require generating two time on treatment indicators for each subgroup, given there are two generating steps, or if the second generating step is intending to further limit the first generating step to also require the time on treatment indicator is generated along the width relative to the anchor event. For purpose of examination, the claim will be interpreted to mean “generating, for each subgroup, the time on treatment indicator in a region defined by the first display screen width position and the time on treatment indicator width, wherein the time on treatment indicator is generated along the time on treatment indicator width relative to the anchor event” (and the second generating step is removed).
Claim 15 is indefinite for recitation of “the treatment indicators for each subgroup”. Claim 1, from which claim 16 depends, recites “for each subgroup, a time on treatment indicator…and an indicator representing a median duration time on the treatment regimen”. It is unclear if “the treatment indicators” of claim 15 intend to refer to the “time on treatment indicators”, the “indicator representing a median duration time on the treatment regimen”, or both the time on treatment indicator and the indicator representing the median duration. If Applicant intends for the treatment indicators to refer to the time on treatment indicators or the indicator, then there is further not sufficient antecedent basis for multiple time on treatment indicators for each subgroup, or multiple indicators representing the median for each subgroup, given claim 1 only recites a single of each indicator per subgroup. Clarification is requested via claim amendment. For purpose of examination, claim 15 is interpreted to refer to the time on treatment indicator and/or the indicator representing the median duration for each subgroup.
Claim 16, and claims dependent therefrom, are indefinite for recitation of “…presentation of the time on treatment indicators in the patient-specific subregions”. Claim 1, from which claim 16 depends, recites “…displaying, within a third region… the time on treatment indicator for the selected one of the plurality of subgroups and patient-specific information in one or more patient-specific subregions…”. First, there is insufficient antecedent basis for “the time on treatment indicators in the patient-specific subregions” because claim 1 only previously recites “the time on treatment indicator for the selected one of the plurality of subgroups”. Furthermore, it is unclear if the third region is required to simply present the time on treatment indicator for the one subgroup (i.e. a distribution of an amount of time) and only the patient-specific information is in the patient-specific subregions, or if the time on treatment indicator is also required to be presented in the patient-specific subregions even though the time on treatment indicator corresponds to a selected one subgroup of patients (i.e. the time on treatment indicator is not patient-specific). If Applicant intends for the time on treatment indicator, which represents a distribution of an amount of time each patient in the subgroup was on the treatment (i.e. a distribution corresponding to multiple patients), to be included in one or more patient-specific subregions, it is further unclear in what way the distribution representing multiple patients is included in a patient-specific subregion. Clarification is requested. For purpose of examination, claim 16 is interpreted to mean the presentation of the visual time on treatment indicator in the third region is normalized relative to a common event, in light of FIG. 61 which discloses the time on treatment indicator in a top region and then multiple patient-specific regions underneath. It is noted that FIG. 61 does include separate time on treatment indicators for each patient in the patient-specific subregions, but these are not the same indicators as the indicator for the distribution of an amount of time each patient was on the treatment recited earlier in claim 1.
Claim 18, and claims dependent therefrom, are indefinite for recitation of “…one of the time on treatment indicators in one of the patient-specific subregions”. There is insufficient antecedent basis for “the time on treatment indicators in one of the patient-specific subregions” because claim 1, from which claim 18 depends, recites “the time on treatment indicator for the selected one of the plurality of subgroups…in one or more patient-specific subregions”, but does not recite multiple time on treatment indicators or multiple patient-specific subregions. Furthermore, for the same reasons discussed above for claim 16, it is not clear if the time on treatment indicator for a subgroup is intended to be in the third region, or specifically within a patient-specific subregion. Therefore, the metes and bounds of the claims are unclear. For purpose of examination, claim 18 is interpreted to mean treatment-specific information is presented upon interaction with the visual time on treatment indicator in the third region.
Claim 21 is indefinite for recitation of “The method of claim 1, further comprising: a fourth region that presents…”. Given claim 1 recites a method, it is unclear in what way Applicant intends a method to further comprise a fourth region that presents information, given this is not a step. Accordingly, the metes and bounds of the claims are unclear because it is not clear what step is intended to performed with respect to a fourth region presenting information (e.g. displaying, analyzing?) Clarification is requested via claim amendment specifying a further step of the method of claim 1. For purpose of examination, the limitation will be interpreted to mean displaying, within a fourth region, patient-specific information upon receiving the user interaction.
Claim 30 is indefinite for recitation of “…a list of potentially actionable variants”. The term “potentially actionable” is a subjective term that requires the exercise of subjective judgement to determine whether a particular variant is potentially “actionable”, and Applicant’s specification does not provide an objective standard for measuring the scope of the term potentially actionable. Instead, Applicant’s specification at para. [00251] merely states features may be “actionable”, such that they may include things a given patient could to do possibly change their prognosis, which does not provide an objective standard for ascertaining whether a variant is potentially actionable. A claim term that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). For purpose of examination, the term will be interpreted to mean actionable variants.
Response to Arguments
Applicant's arguments filed 02 Sept. 2025 regarding 35 U.S.C. 112(b) have been fully considered but they are not persuasive.
Applicant remarks that claim 16 is amended to remove the word “visual”, so claim 16 recites “…the time on treatment indicators in the patient-specific subregions…”, while claim 1 recites “…displaying the time on treatment indicator for the selected on of the plurality of subgroups…in one or more patient-specific subregions”, and that the inclusion of one “or more” subregions provides antecedent basis for “the patient-specific subregions” (Applicant’s remarks at pg. 13, para. 2). Applicant remarks that claim 18 was rejected for a similar reason as claim 16, and Applicant’ traverses this rejection on the same basis (Applicant’s remarks at pg. 13, para. 3).
This argument is not persuasive. First, it is noted that claim 1 does not clearly require the time on treatment indicator for the selected one of the plurality of subgroups is presented in the one or more patient-specific subregions. As presently written, claim 1 may only require the patient-specific information is in the one or more patient-specific subregions. This is appears to be the case in light of Applicant’s own specification (see FIG. 61 as discussed above), and given the time on treatment indicator is not patient-specific information. Applicant’s specification does not appear to disclose presenting the time on treatment indicator representing a distribution of patients in patient-specific subregions, and thus the ambiguous language in claim 16 was interpreted in light of Applicant’s specification and consistent with claim 1 only reciting “patient-specific information in…patient-specific subregions”. Therefore, the regardless of the switch of “one or more patient-specific subregions” in claim 1 to “the patient-specific subregions” in claim 16, claim 16 does not provide antecedent basis for the time on treatment indicator (representing a distribution of multiple patients) presented in one or more patient-specific subregions. Claim 1 only requires patient-specific information in the one or more patient-specific subregions. The rejection of claim 18 is maintained for the same reasons.
Furthermore, it is noted that “one or more patient-specific subregions” in claim 1 does not provide antecedent basis for “the patient-specific subregions” (i.e. multiple subregions). In embodiments in which claim 1 only requires one patient-specific subregion, it is unclear what “subregions” claim 16 would be referring to. Does claim 16 require multiple patient-specific subregions, or are the patient-specific subregions referring to the one or more patient-specific subregions. As presently claimed, it is unclear. If Applicant intends to require there are multiple subregions, claim 16 can recite “…wherein the one or more patient-specific subregions comprise a plurality of patient-specific subregions” to properly further limit the one or more regions to comprise multiple regions. Otherwise, claim 16 should be amended to refer to “the one or more patient-specific subregions”.
Applicant remarks, regarding claim 30, that Applicant’s specification at para. [00251] discloses “[c]ertain molecular features may or may not be considered actionable, based on whether the molecular information that is obtained is associated with a subsequent action or step”, and further provides examples of what those subsequent actions or steps may be, including “prescribe a medication or combination of medications; prescribe a particular treatment…”, and thus this is not a case where the claim “requires the exercise of subjective judgement without restriction” and the claim is not indefinite (Applicant’s remarks at pg. 13, para. 4).
This argument is not persuasive. As explained in the previous rejection and above, Applicant’s specification states features may be “actionable”. However, claim 30 recites “…potentially actionable variants”, and thus does not even require the variants are actionable. Applicant’s specification does not provide an objective standard for discerning whether a variant potentially actionable, versus actionable or non-actionable. It is agreed that if claim 30 is amended to recite “a list of actionable variants…”, the rejection would be withdrawn.
Claim Rejections - 35 USC § 112(d)
The rejection of claim 13 under 35 U.S.C. 112(d) in the Office action mailed 30 April 2025 has been withdrawn in view of Applicant’s remarks filed 02 Sept. 2025 at pg. 14, para. 1-2. Claim 13 is interpreted to require that the visual time on treatment indicator for the common treatment regimen is visually distinct from the time on treatment indicators representing the other treatment regimens (e.g. different colors, shapes, line types, etc.).
Claim Rejections - 35 USC § 101
The rejection of claims 1-30 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter in the Office action mailed 30 April 2025 has been withdrawn in view of claim amendments received 02 Sept. 2025.
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 1-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Any newly recited portion is necessitated by claim amendment.
The Supreme Court has established a two-step framework for this analysis, wherein a claim does not satisfy § 101 if (1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea, and (2), if so, the particular elements of the claim, considered “both individually and as an ordered combination,” do not add enough to “transform the nature of the claim into a patent-eligible application.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (quoting Alice, 134 S. Ct. at 2355). Applicant is also directed to MPEP 2106.
Step 1: The instantly claimed invention is directed to a method (claim 1 being representative). [Step 1: Yes]
Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Step 2A, Prong 1: Under the MPEP § 2106.04, the Step 2A (Prong 1) analysis requires determining whether a claim recites an abstract idea, law of nature, or natural phenomenon.
Claim 1 recites the following steps which fall under the mathematical concepts and/or mental processes groupings of abstract ideas:
filter a plurality of patients into a first cohort of patients, the first cohort of patients having each of the selections in common;
displaying…within a second region… time on treatment information from the first cohort of patients derived from the patient cohort information…the second region dividing the first cohort of patients into a plurality of subgroups according to a corresponding plurality of treatment regimens, wherein each patient within a subgroup has undertaken or is undertaking the same treatment regimen as every other patient within that subgroup, and wherein the time on treatment information comprises, for each subgroup, a time on treatment indicator comprising a graphical representation of a distribution of an amount of time each patient within the subgroup was on the corresponding treatment regimen and an indicator representing a median duration time on the treatment regimen for that subgroup, and wherein displaying the time on treatment indicator for each subgroup comprises:
identifying a first display screen width position and a time on treatment indicator width;
associating, for each subgroup, the first display screen width position with an anchor event common to the first cohort of patients;
generating, for each subgroup, the time on treatment indicator in a region defined by the first display screen width position and the time on treatment indicator width; and
generating, for each subgroup, the time on treatment indicator along the width relative to the anchor event;
displaying, within a third region… the time on treatment indicator for the selected one of the plurality of subgroups and patient-specific information in one or more patient-specific subregions.
The identified claim limitations falls into one of the groups of abstract ideas of mathematical concepts and/or mental processes for the following reasons. The claims recite performing an analysis of a plurality of patients to identify patients sharing selected inputs in common, organizing time on treatment information for the identified cohort of patients divided into subgroups, and displaying the result. Furthermore, the specific steps for displaying the time on treatment indicator for each subgroup involves identifying/determining a length on the screen the time on treatment indicator requires (e.g. a length of time), identifying a common start time for a group of patients (i.e. the anchor event) along the length of time, and then generating the time on treatment distribution along the identified screen and indicator width aligned to the anchor event. These steps involve simply organizing the time on treatment information on an appropriately sized graph, aligned to a common start time, which can be practically performed in the mind aided with pen and paper. The claims further display/organize the time on treatment information for another selection of subgroups. Overall, these limitations are analogous to the mental process of "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016). See MPEP 2106.04(a)(2) III. That is, other than reciting these steps are carried out on a computer and displayed on a computer screen, nothing in the claims precludes the steps from being practically performed in the mind aided with pen and paper. See MPEP 2106.04(a)(2) III.
Furthermore, the limitations pertaining to displaying time on treatment information by representing a distribution of an amount of time each patient was on the treatment with an indicator representing a median duration time further recites a mathematical concept of a mathematical relationship, similar to the mathematical relationship of organizing information and manipulating information through mathematical correlations in Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014).
Dependent claims 2-7 and 11-30 further recite an abstract idea and/or further limit the abstract idea of claim 1 above. Claims 2-5 only serve to further limit the inputs used to filter the patients, and thus are part of the abstract idea of claim 1. Dependent claims 6-7 further limit the mental process and mathematical concept of organizing information identified above for claim 1. Dependent claim 11 further recites the mental process of removing patient subgroups from a region that do not include a particular treatment modifier. Dependent claims 12-14 further limit the abstract idea of presenting the time on treatment information of claim 1. Dependent claim 15 further limits the data used to generate the time on treatment indicators, and thus is part of the abstract idea of claim 1. Dependent claims 16-17 further recites a mathematical concept of normalizing the time on treatment indicators. Dependent claims 18-20 further recites a mental process of presenting treatment-specific information. Dependent claims 21-30 further recites the mental process of presenting different types of patient-specific information. Therefore, claims 1-30 recite an abstract idea. [Step 2A, Prong 1: YES]
Step 2A: Prong 2: Under the MPEP § 2106.04, the Step 2A, Prong 2 analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. This judicial exception is not integrated into a practical application for the following reasons.
Claims 6-7, 9, 12-17, 20, and 22-30 do not recite elements in addition to the judicial exception, and thus are part of the judicial exception.
The additional elements of claim 1 and 2-5 include:
displaying, within…the computer screen;
a plurality of user-selectable inputs;
claims 2-5 further limit these inputs;
in response to receiving further selections for one or more of the plurality of user-selectable inputs…; and
in response to receiving a further selection of one of the plurality of subgroups;
The additional elements of dependent claims 8, 10-11, 18, and 21 include:
an interactive treatment modifier for filtering (claim 8);
wherein the interactive treatment modifier comprises a regimen modifier (claim 10);
receiving a user selection of a particular treatment modifier (claim 11);
receiving a user interaction with one of the visual time on treatment indicators (claim 18); and
receiving a user interaction with one of the patient-specific subregions (claim 21).
The additional elements identified above include receiving information, such as by user-selectable inputs (claim 1), by a modifier for filtering (e.g. a drop menu) (claims 8 and 10), or by user selections (claims 1, 11, 18, 21). First, the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application. See MPEP 2106.05(f).
Furthermore, the above receiving limitations only serve to collect the required inputs used for the abstract idea of analyzing information and displaying the result of the analysis identified above, which amounts to insignificant extra-solution activity. While the claims recite some of these receiving steps as being performed on an interactive user interface (e.g. by selecting inputs or an interaction), this only serves to generally link the abstract idea to a particular technological environment of a graphical user interface. See MPEP 2106.05(h).
Last, it is not apparent that the claims reflect an improvement to computer technology or any other technology, and instead the claims appear directed to an improvement in an abstract idea (i.e. an analysis/organization of data), rather than a technology. After a review of the specification, the specification at para. [0003]-[0006] discloses there is a dearth of meaningful ways to compile and analyze data quickly, and the system facilitates the discovery of insights of therapeutic significance through analysis of response data, which describes an improvement in an abstract idea.
Therefore, the additionally recited elements generally serve to the link the abstract idea to a particular technological environment and/or amount to insignificant extra-solution activity and, as such, the claims as a whole do no integrate the abstract idea into practical application. Thus, claims 1-30 are directed to an abstract idea. [Step 2A, Prong 2: NO]
Step 2B: In the second step it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. See MPEP § 2106.05.
The claims do not include any additional steps appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception for the following reasons. The additional elements of the claims are identified above under Step 2A, Prong 2.
The additional elements relating to presenting information in response to receiving data encompasses the interface performing a conventional computer function. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit).
The additional elements of the claims further include interface elements of “user-selectable inputs” that are selectable and receiving a user interaction with various elements of the display (e. g. the time on treatment indicator, interactive treatment modifier), which are well-understood, routine and conventional. This position is supported by Horsky et al. (Interface design principles for usable decision support: A targeted review of best practices for clinical prescribing interventions, 2012, 45(6), pg. 1202-1216; previously cited) and Zahabi et al. (Usability and Safety in Electronic Medical Records Interface Design: A Review of Recent Literature and Guideline Formulation, 2015, Human Factors, pg. 1-30; previously cited). Horsky reviews clinical interfaces for clinical decision support systems (Abstract), and discloses that health care professionals have been migrating to using clinical decision support systems that use human interfaces (pg. 1203, col. 1, para. 1-2), including selectable elements such as selectable links, drop-down menus (i.e. interactive modifiers), scrolling tables, and selection menus/lists that guide clinicians and are populated with appropriate fields (pg. 1204, col. 1, para. 1; pg. 1209, col. 2, para. 3; pg. 1211, col. 1, para. 3). Zahabi similarly reviews the usability of electronic medical interface design (Abstract) and discloses that paper-based medical records have been replaced with electronic health records and systems (pg. 1, col. 2, para. 1-2). Zahabi discloses various interface design concepts, including receiving user inputs by free text, choosing from options, or a drop-down menu list to allow a natural work flow, and various references that have implemented various aspects (pg. 25, col. 2, para. 2; Table 5)
Therefore, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself. [Step 2B: NO]
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. For additional guidance, applicant is directed generally to applicant is directed generally to the MPEP § 2106.
Response to Arguments
Applicant's arguments filed 02 Sept. 2025 regarding 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant remarks that while the distribution of an amount of time each patient within a subgroup was on a corresponding treatment regimen and a median duration time on treatment may involve a determination using mathematical concepts, such concepts are not recited in claim 1, and claim 1 does not recite determining this distribution or median duration time but instead displaying, time on treatment information that includes these features (Applicant’s remarks at pg. 15, para. 1).
This argument is not persuasive. First, it is noted that claim 1 does recite “…generating, for each subgroup, the time on treatment indicator in a region defined by the first display screen…”. Thus, the claim does require generating the recited distribution of times, which is a mathematical concept as identified above. In other words, the displaying of the information also requires generating/determining the information. Furthermore, while the claims recite the information is being displayed, the displaying still recites the organization of information via mathematical concepts. LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea). See MPEP 2106.04(a)(2) I.
Applicant remarks the claims do not recite a mental process because amended claim 1 recites displaying the time on treatment indicator by identifying a first display screen width position and a time on treatment indicator width, associating the first display screen width position with an anchor event common to the first cohort of patients, generating the time on treatment indicator in a region defined by the widths, and generating the time on treatment indicator along with the width relative to the anchor event, and these limitations can be practically performed in the human mind (Applicant’s remarks at pg. 15, para. 2). Applicant remarks the Kim Memo instructs that mental processes include “observations, evaluations, judgements, and opinions”, and these newly added limitations reflect the generation of the claimed time on treatment indicators relative to the display screen which are none of an observation, evaluation, judgement, or opinion (Applicant’s remarks at pg. 15, para. 3 to pg. 16, para. 1).
This argument is not persuasive. MPEP 2106.04(a)(2) III. A. states claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions. These are simply examples of mental processes, but are not limiting. Regardless, identifying a display screen width position and time on treatment indicator with does recite a mental evaluation, involving simply evaluating a desired width of the displayed plot and a length of a computer screen to identify the appropriate size and/or position of the plot on a screen. Similarly associating (i.e. observations and evaluations) simply assigns an anchor time to the width position for each subgroup, and generating the time on treatment indicator (i.e. a distribution) involves mentally evaluating the duration of times for each patient to determine and generate a corresponding distribution. Therefore, it is not persuasive these limitations do not recite a mental process.
Applicant remarks the claims integrate the alleged mental process into a practical application of an improvement to user interfaces, similar to Example 37, because the display of each time on treatment indicator is tied to aspects of the underlying computer system, namely a first display screen width position and a width of the time on treatment indicator (Applicant’s remarks at pg. 16, para. 2). Applicant further states the Kim Memo compels the conclusion that these limitations reflect the integration of a practical application, citing MPEP 2106.05(a), and states the recited limitations indeed recite more than merely saying “apply it” to any alleged abstract idea, but recite “a particular solution to a problem or a particular way to achieve a desired outcome”, and thus the rejections should be withdrawn (Applicant’s remarks at pg. 16, para. 3 to pg. 17, para. 2).
This argument is not persuasive. Claim 1 of Example 37 was found to be patent eligible because the claimed recited the additional element of moving selectable user icons on a position of a graphical user interface closest to the start icon of the computer system, thus improving user interfaces of electronic devices. It is not clear how simply identifying particular screen and plot widths (e.g. a width of the time on treatment indicator and a screen width position) improves graphical user interfaces, nor has applicant explained how graphical user interfaces are improved other than stating “the display of each time on treatment indicator is tied to aspects of the underlying computer system, namely a first display screen width position”. Furthermore, it is noted that the limitations relating to generating the display, including identifying the width position and indicator width are part of the abstract idea and cannot provide the improvement to technology alone. See MPEP 2106.05(a).
Instead, the instant claims are more similar to those in Trading Technologies v. IBG LLC, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), where the courts found arranging transactional information on a graphical user interface in a manner that assists traders in processing information more quickly is not sufficient to show an improvement in computer-functionality. As discussed in the above rejection, it is not apparent that the claims reflect an improvement to computer technology or any other technology, and instead the claims appear directed to an improvement in an abstract idea (i.e. an analysis/organization of data), rather than a technology. After a review of the specification, the specification at para. [0003]-[0006] discloses there is a dearth of meaningful ways to compile and analyze data quickly, and the system facilitates the discovery of insights of therapeutic significance through analysis of response data, which describes an improvement in an abstract idea. Therefore, similar to the claims in Trading Technologies v. IBG LLC, the instant claims arrange information on a graphical user interface that assists users in analyzing information quickly, which is not an improvement to computer technology.
Last, while Applicant alleges the recited limitations recite the “a particular solution to a problem or a particular way to achieve a desired outcome”, Applicant has not explained what the problem is and/or what the particular solution to the problem is. Instead, Applicant broadly alleges the claims improve graphical user interfaces without explaining what problem with user interfaces the claims attempt to solve. Furthermore, as discussed above, it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. See MPEP 2106.05(a) II. Thus, an improvement in how information is arranged on a screen that simply allows users to analyze information quickly is an improvement in the abstract idea, rather than technology.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-30 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lefkofksy (2020). This rejection is newly recited and necessitated by claim amendment.
Cited reference: Lefkofsky et al., US 2020/0211716 A1; filed 31 Dec. 2019; Pub. Date: 02 July 2020; cited in IDS filed 19 Jan. 2023 (previously cited).
Regarding claim 1, Lefkofksy discloses a method of displaying information on a user interface for analyzing treatment responses for a cohort of patients ([0001]-[0004]), wherein the method comprises the following:
Lefkofsky discloses displaying within a first region of a computer screen, a plurality of user-selectable inputs, wherein selection of particular user inputs filters the patients into a cohort of patients that match the selected criteria (FIG. 2-9, e.g. see filtered patients having each specified criteria; [0082], .e.g. display screen; [0089-[0091]; FIG. 34) (i.e. the user selectable inputs are configured to cause the user interface to filter a plurality of patients into a first cohort of patients, the first cohort of patients having each of the selections in common).
Regarding the step of “displaying, concurrently with the first region and within a second region of the computer screen, time on treatment information…in response to receiving further selections for one or more of the plurality of user-selectable inputs…, wherein displaying the time on treatment indicator…comprises….” (including the full limitation), this step is not required under the broadest reasonable interpretatio