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 .
Priority
The application claims the benefit of U.S. Provisional Patent Application No. 63/339,759 and has an effective priority date of 9 May 2022.
Claim Amendment
In the amended claims received 07 April 2026 the following occurred: claims 1,6,8-9,11-12,17,19-20,23,26, and 30-31 were amended and claims 5 and 16 were canceled.
Distinguishing Prior Art
In claim 1, the prior art of record fails to teach repeating the plotting under the condition when only sparse data is observed for a measure of a patient, strength from other measures and from the user defined disease cohort is borrowed…
The prior art of record fails to teach or suggest several of the specific visualized combination of features (lists of features that are being visualized).
For example:
Regarding Claim 11
The method of claim 1, further comprising: illustrating, by the visualization tool, data across multiple organ systems, the data including cardiac (left ventricular ejection fraction, right ventricular systolic pressure, and right heart catheterization data), pulmonary (percent predicted forced vital capacity and diffusing capacity), cutaneous (modified Rodnan skin score), gastrointestinal (Medsger GI severity scores and body mass index) peripheral vasculature (Medsger Raynaud’s scores capturing damage including digital pits, ulcerations and gangrene), muscle (proximal muscle strength on a 0-5 scale), laboratory measurements, and patient reported outcomes (HAQ-DI).
Commentary: the prior art failed to teach the specific combination of visualized features.
Regarding Claim 22
The system of claim 12, further comprising: plotting, by the visualization tool, critical events of the patient, the critical events including clinically significant interstitial lung disease, severe interstitial lung disease, cardiomyopathy, pulmonary hypertension, mean pulmonary arterial pressure, severe gastrointestinal dysmotility, myopathy, renal crises, and cancer diagnosis.
Commentary: the prior art failed to teach the specific combinations of visualized features collectively on one plot.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: visualization tool (at least in claims 1,11,12,22,23), analytics platform (at least in claims 2,6,8,9,12,13,17,19,20,31).
The structure for the visualization tool is processor connected to a memory.
The structure for the analytics platform interpreted to be the cloud because of Fig. 3.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-33 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 1,12 and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a method, system, non-transitory computer readable medium for providing an interactive patient level data visualization and analysis tool that illustrates a patient’s health trajectory across multiple organ systems, which are within a statutory category (or are interpreted to be within a statutory category for subject matter eligibility analysis purposes).
Step 2A1
The limitations of […] integrating data from an electronic medical record system and one or more research databases into a […] analytics platform; plotting, via a […] visualization tool the patient’s health trajectory, the plotting including determining and plotting of predictions for the patient; overlaying, by the [..] visualization tool, data from the entire user defined disease cohort as a reference group to visualize a disease course of the patient compared to courses of other patients, with a same disease, selected by a user; receiving new real-time data; updating the predictions for the patient upon receipt of the new real-time data; and repeating the plotting and overlaying after the updating, wherein: when only spare data is observed for a measure of a patient, strength from other measures and from the user-defined disease cohort is borrowed to produce more accurate and precise predictions for the patient as drafted, is a process that, under the broadest reasonable interpretation, covers performance of the limitation in the mind but for recitation of generic computer components. That is, other than reciting a system comprising a processor, a memory connected with the processor and a non-transitory computer readable medium nothing in the claim precludes the step from practically being performed in the mind. For example, but for these additional elements, this claim encompasses a person thinking integrating data from various sources into an analytics platform, plotting the patient’s health trajectory, overlaying data, receiving new real-time data, updating the predictions for the patient upon receipt of new real time data; repeating the plotting and overlaying the updating in the manner described in the identified abstract idea, supra. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
In addition, the process, as drafted, under broadest reasonable interpretation also covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is, other than reciting a system comprising a processor, a memory connected with the processor, a non-transitory computer readable medium the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the system comprising a processor, memory connected with the processor and non-transitory computer readable medium, this claim encompasses integrating data from various sources into an analytics platform, plotting the patient’s health trajectory, overlaying data, receiving new real-time data, updating the predictions for the patient upon receipt of new real time data; repeating the plotting and overlaying the updating and overlaying data from an entire user-defined disease cohort as a reference group to visualize a disease course of the patient compared to courses of other patients, with a same disease, selected by a user in the manner described in the identified abstract idea, supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The types of abstract ideas will be considered as a single abstract idea for analysis purposes.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional element of a system comprising a processor, a memory connected with the processor and a non-transitory computer readable medium that implements the identified abstract idea. These additional elements are not described by the applicant and are recited at a high-level of generality such that they amount to no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim further recites the additional element of an visualization tool an analytics platform. The visualization tool and analytics platform merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application.
Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a system comprising a processor, a memory connected with the processor and a non-transitory computer readable medium to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
The claim further recites the additional element of an visualization tool and analytics platform. The visualization tool and analytics platform merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application.
Claims 2,4,6,8-9,11,13-14,17,19-20,22-23,26 and 30-31 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 2 merely describe(s) the data integrated from the electronic medical record system and the one or more research databases into the analytics platform is real-time-data, and the real-time data is provided using a certain type of technology. Claim 4 merely describes performing calculations and processing of the data from the electronic medication system and the one or more research databases for each patient individually and for all reference patients collectively. Claim 6 merely describes receiving filters to compare the patient’s health trajectory to a user-specified subgroup based on demographic, clinical and biological characteristics. Claim 8 merely describes modeling, respective latent health states of disease patients based on using cardiopulmonary and cutaneous parameters. Claim 9 merely describes projecting the disease patient’s health trajectory into a future; calculating, by the analytics platform, respective probabilities that parameters of the disease patient will fall below or rise above clinically set boundaries; and presenting the respective probabilities with a corresponding visualization of the parameters. Claim 11 merely describes illustrating data across multiple organ systems. Claim 13 merely describes the data integrated from the electronic medical record system and the one or more research databases into the analytics platform is a certain type of data. Claim 14 merely describes wherein the real time data is provided using a certain data type. Claim 17 merely describe receiving filters to compare the patient’s health trajectory to a user-specified subgroup based on demographic, clinical and biological characteristics, wherein the demographic, the clinical and the biological characteristics include age at disease onset, race, sex, cutaneous subtype, and autoantibody status. Claim 19 merely describes modeling respective latent health states of disease patients based on using cardiopulmonary and cutaneous parameters. Claim 20 merely describes projecting the patient’s health trajectory into a future, calculating respective probabilities and parameters of the patient will fall below or rise above clinically set boundaries; and presenting the respective probabilities with a corresponding visualization of the parameters. Claim 22 merely describes plotting critical events of the patient, the critical events including clinically significant interstitial lung disease, severe interstitial lung disease, cardiomyopathy, pulmonary hypertension, mean pulmonary arterial pressure, severe gastrointestinal dysmotility, myopathy, renal crises, and cancer diagnosis. Claim 26 merely describes performing calculations and processing of the data from the electronic medical record system and the one or more research databases for each patient individually and for all reference patients collectively. Claim 30 modeling respective latent health states and disease patients based on using cardiopulmonary and cutaneous parameters. Claim 31 merely describes projecting the patient’s health trajectory into a future, calculating respective probabilities that parameters of the patient will fall below or rise above clinically set boundaries; and presenting the respective probabilities with a corresponding visualization of the parameters.
The dependent additional elements include an analytics platform, an electronic medical records system, research databases, a non-transitory computer readable medium, a visualization tool. The visualization too and analytics platform generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more. The remaining additional elements were analyzed as were the computer part(s) of the independent claims.
Response to Arguments
Applicant has amended the claim to indicate that the functions described are computer-implemented and claims that this is sufficient structure such that the claims should no longer be interpreted under 35 U.S.C. 112(f).
The Examiner disagrees. To claim a means for performing a specific computer-implemented function and then to disclose only a general purpose computer as the structure designed to perform that function amounts to pure functional claiming. Aristocrat, 521 F.3d 1328 at 1333, 86 USPQ2d at 1239. In this instance, the structure corresponding to a 35 U.S.C. 112(f) claim limitation for a computer-implemented function must include the algorithm needed to transform the general purpose computer or microprocessor disclosed in the specification. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239; Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008); WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999); Rain Computing, Inc. v. Samsung Electronics America Co., 989 F.3d 1002, 1007-8, 2021 USPQ2d 284 (Fed. Cir. 2021). Applicant may express the algorithm in any understandable terms including as a mathematical formula, in prose, in a flow chart, or "in any other manner that provides sufficient structure." Here the processing units of Fig.2 and Fig. 4 and Fig. 5 are considered the associated algorithms to provide the necessary structure to satisfy 35 U.S.C. 112(f). No additional rejection was necessary.
35 U.S.C. 101 Argument Responses:
Applicant argues that the claimed subject matter is not directed to certain methods of organizing human activity because the claim clearly is not focused on social activities, teaching, or following rules or instructions. Further, Applicant submits that amended claim 1 obviously is not directed to mathematical concepts or mental steps.
The abstract idea that is categorized as a mental process and a certain method of organizing human activity. The abstract ideas were considered as a single abstract idea for eligibility purposes.
Applicant argues that claim is integrated into a practical application. In a clinic, physicians use cognitive skills to integrate information across multiple parameters and organ systems, factoring in a patient’s prior health trajectory and baseline risk factors, to make estimates about a patient’s health state, risk for complications, and need for high-risk therapies. This process is informed by a physician’s prior experiences caring for patients with a similar expression of disease, and therefore is not generalizable across providers particularly in a rare disease. Aggregating this complex, longitudinal data for clinical use requires a tremendous time investment on the part of a treating provider. It is also challenging to clearly explain this information to patients during a routine clinical visit to facilitate shared decision making. See published specification of the present application at paragraph 0004. Claim 1 plots a patient’s health trajectory and determines and plots predictions for a patient . A visualization tool shows a disease course of a patient with respect to disease courses of other patients of a user-defined disease cohort with a same disease. Thus, the method of claim 1 provides information regarding the patient’s disease course with respect to other similar patients. For at least these reasons, Applicant submit that amended claim 1 is integrated into a practical application and respectfully requests that the rejection of claim 1 be withdrawn.
Saving a healthcare provider time is not a patentable consideration.
Applicant argues that the as amended claims do not teach the features of the amendments.
Line by line explanations have been given in the 35 U.S.C. 103 rejection above.
Conclusion
Tangentially related to the specification:
Crabb et al. Innovation in resuscitation: A novel clinical decision display system for advanced cardiac life support. The American Journal of Emergency Medicine, Volume 43, 2021, Pages 217-223. Crab teaches clinical decision display for advanced cardia life support.
US 20140236630 A1 teaches systems and method for collecting, sharing, and analyzing data of electronic medical records for improved health analysis.
THIS ACTION IS MADE FINAL. 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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/T.I.E./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683
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