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 .
DETAILED ACTION
Status of the Application
Claims 1-20 are currently pending in this case and have been examined and addressed below. This communication is a Non-Final Rejection in response to the Preliminary Amendments to the Claims filed on 03/14/2025.
Claim 1 is currently amended.
Claims 2-20 are newly added.
Claim Rejections - 35 USC § 112
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 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 8, and 14 recite receiving supplemental information associated with the target patient and the set of conditions, the supplemental information corresponding to at least one clinical concept in a non-coded clinical format data element. However, there is not sufficient support in the specification for the concept of receiving information associated with the target patient and set of conditions which corresponds to a clinical concept in a non-coded clinical format. The specification describes coded concepts in the patient’s health record and unstructured data such as studies and literature, patient provided information, raw patient data from sensors, etc. ([0054]), but these are not described as associated with the target patient and the set of conditions. Additionally, the specification describes unstructured content but this is described as being codified ([0095]) and again this is not specifically associated with the target patient and set of conditions. The specification describes patient data in a first nomenclature and a second nomenclature ([0128-0130]), but this data is coded as it is either coded in the first or second nomenclature, which is not the same as non-coded data.
Claims 1, 8, and 14 also recite converting the supplemental information and/or the non-coded clinical format data element to the coded clinical format. However, there is not sufficient support in the specification for the concept of converting a non-coded data element to the coded clinical format. The specification discusses converting clinical concepts from a first nomenclature to a second nomenclature and also converting information/concepts from the second nomenclature to the first nomenclature ([00122], [00128]), but these are both coded clinical data elements, one in a first nomenclature/code and the other in a second nomenclature/code.
Claims 1, 8, and 14 recite a particular treatment procedure is administered to the target patient in association with treating the particular condition based at least partially on the second set of risk factors corresponding to the set of conditions. However, there is not sufficient support in the specification for the concept of administering any treatment procedure to the target patient. The specification does not include any teaching of administering a treatment procedure. The specification describes determining a recommended treatment ([0017], [0054], [0066], [0073], [0152], [0195]) and determine specific actions to take based on recommended treatments ([0055]). The specification also describes determining a score reflecting an average of treatments administered ([00144]). None of these concepts described in the specification is the same as a particular treatment procedure being administered to a target patient, as there is nothing in the specification related to an administration of a treatment or a procedure.
As per Claims 2-7, 9-13, and 15-20, the claims depend on Claims 1, 8, and 14 and do not remedy the written description requirement issues of Claims 1, 8, and 14. As dependent claims inherit the deficiencies of the claims they depend on, they are also rejected.
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 6, 13, and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “relatively frequently occurring” in claims 6, 13, and 19 is a relative term which renders the claim indefinite. The term “relatively frequently occurring” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what magnitude of occurrences of indications of concepts are required to be relatively frequently occurring. Therefore, the claim is indefinite.
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 1-20 are rejected because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-7 fall within the statutory category of an apparatus or system. Claims 8-13 fall within the statutory category of an article of manufacture as a computer-readable medium. Claims 14-20 fall within the statutory category of a process.
Step 2A, Prong One
As per Claims 1, 8, and 14, the limitations of determining, based on a condition care program associated with the clinical decision support event, a set of conditions associated with the clinical decision support event; converting the supplemental information and/or the non-coded clinical format data element to the coded clinical format; and dynamically updating, based on the supplemental information and/or the non-coded clinical format data element in the coded clinical format, the first set of risk factors with a second set of risk factors corresponding to the set of conditions, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. The steps of determining a set of conditions associated with the clinical decision support event, converting the supplemental information to the coded clinical format, and dynamically updating the first set of risk factors with a second set of risk factors corresponding to the set of conditions are concepts performed including observation, evaluation, judgement and opinion in the human mind. The determining, converting, and updating steps are recited broadly such that they can be performed in any manner and such can be performed as a mental process. If a claim limitation, under its broadest reasonable interpretation, covers the 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 claims recite an abstract idea.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application because the additional elements and combination of additional elements do not impose meaningful limits on the judicial exception. In particular, the claims recite the additional elements:
system having hardware processors (claim 1), where the hardware processors are recited at a high-level of generality, such that it amounts to no more than mere instructions to apply the exception using a generic computer component.
non-transitory media having computer-readable instructions executed by hardware processors (claim 8), where the non-transitory media having computer-readable instructions are recited at a high-level of generality, such that it amounts to no more than mere instructions to apply the exception using a generic computer component.
storing a set of clinical information in a coded clinical format relating to a particular condition of a target patient in one or more network-based storage devices having a collection of medical records stored thereon, wherein the set of clinical information includes (a) an initial preliminary likelihood associated with a clinical decision support 4vent and (b) first set of risk factors associated with the clinical decision support event, which amounts to mere instructions to apply the exception because the use of a general purpose computer, i.e. the processor, in its ordinary capacity for tasks such as receiving, storing, transmitting data does not integrate the abstract idea into a practical application, as per MPEP 2106.05(f)(2). The description of the clinical information is not function but merely description and does not integrate the abstract idea into a practical application.
wherein a particular treatment procedure is administered to the target patient in association with treating the particular condition based at least partially on the second set of risk factors corresponding to the set of conditions. There is no particular treatment or prophylaxis recited, as the use of the word “particular” does not result in the recitation of a particular prophylaxis or treatment, as is described in MPEP 2106.04(d)(2). This administration step is not particular and is instead merely instructions to “apply” the exception in a generic way and therefore does not integrate the mental analysis into a practical application, analogous to MPEP 2106.05(d)(2)a.
receiving supplemental information associated with the target patient and the set of conditions, the supplemental information corresponding to at least one clinical concept in a non-coded clinical format data element which amounts to insignificant extra-solution activity, as in MPEP 2106.05(g), because the steps of receiving supplemental information associated with the target patient and the set of conditions is mere data gathering in conjunction with the abstract idea where the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output).
Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. As discussed above with the respect to integration of the abstract idea into a practical application, the additional element of a system having hardware processors and non-transitory media having computer-readable instructions executed by hardware processors to perform the method of the invention amounts to no more than mere instructions to apply the exception using a generic computing component. The hardware processors and non-transitory media are recited at a high level of generality and are not specified beyond the high-level computing components recited in the claims, which do not add meaningful limitations to the abstract idea beyond mere instructions to apply an exception. The claims also recite the additional element of storing a set of clinical information in a coded clinical format relating to a particular condition of a target patient in one or more network-based storage devices having a collection of medical records stored thereon, which is well-understood, routine and conventional computer functions in the field of data management because they are claimed at a high level of generality and include storing and retrieving information from memory, which has been found to be well-understood, routine and conventional computer functions by the Court (MPEP 2106.05(d)(II)(iv) Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93). The claims recite the additional element of wherein a particular treatment procedure is administered to the target patient in association with treating the particular condition which is found to be mere instructions to apply the exception. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims also include the additional element of receiving supplemental information associated with the target patient and the set of conditions which is well-understood, routine and conventional computer functions in the field of data management because they are claimed at a high level of generality and include receiving or transmitting data as well, which have been found to be well-understood, routine and conventional computer functions by the Court (MPEP 2106.05(d)(II)(i) Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of the computer or improves another technology. The claims do not amount to significantly more than the underlying abstract idea.
Dependent Claims
Dependent Claims 2-7, 9-13, and 15-20 add further limitations which are also directed to an abstract idea. For example, Claims 2, 9, and 15 include automatically generating an updated preliminary likelihood of the clinical decision support event which is directed to a mental process for the same reasons as the independent claims. Claims 3, 10, and 16 include transmitting an electronic encoded signal to a clinician interface of a clinician device which amounts to transmitting data which is mere instructions to apply the exception, and also display the updated likelihood which is mere data outputting that is insignificant extra-solution activity which is well-understood, routine, and conventional similar to presenting offers. Claims 4, 11, and 17 include directing a message to a clinician which amounts to transmitting data which is mere instructions to apply the exception. Claims 5, 12, and 18 include electronically writing content corresponding to the non-coded clinical format data element in the collection of medical records in the coded clinical format which is storing data in a database, which as per MPEP 2106.05(f)(2) is mere instructions to apply the exception. Claims 6-7, 13, and 19-20 include a description of data which is not a functional step and is therefore directed to the same abstract idea as the independent claims. Because the additional elements do not impose meaningful limitations on the judicial exception and the additional elements are well-understood, routine and conventional functionalities in the art, the claims are directed to an abstract idea and are not patent eligible.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Stang (US 2006/0206359 A1), hereinafter Stang, in view of Boone et al. (US 2004/0243545 A1), hereinafter Boone, in view of Schmidt et al. (US 2011/0184250 A1), hereinafter Schmidt.
As per Claims 1, 8, and 14, Stang discloses a system having one or more hardware processors ([0026]) and a non-transitory media having computer-readable instructions that, when executed by one or more hardware processors, cause the one or more hardware processors to facilitate a plurality of operations ([0029]), the operations comprising:
wherein the set of clinical information includes (a) an initial preliminary likelihood associated with a clinical decision support event ([0038] predictive indicator section includes the likelihood a patient has a particular medical condition, i.e. clinical decision support event) and (b) first set of risk factors associated with the clinical decision support event ([0035] patient risk factors section including parameters related to the patient, [0038] the risk factors are those associated with the likelihood of having a particular medical condition);
determining, via the one or more hardware processors and based on a condition care program associated with the clinical decision support event, a set of conditions associated with the clinical decision support event ([0050] determine output data which is determined by the predictive indicator based on plurality of parameters for the patient, the conditions related to the patient event and associated risk for each, see Fig. 3 and 4);
receiving supplemental information associated with the target patient and the set of conditions ([0052] second set of input data received for the patient, which is related to the parameters which are associated with the conditions), and
dynamically updating, via the one or more hardware processors and based on the supplemental information and/or the non-coded clinical format data element in the coded clinical format, the first set of risk factors with a second set of risk factors corresponding to the set of conditions ([0052-0053] second input data is received and includes values for the patient risk factors and compared with the first input data, [0044-0045] health changes information also input as second data and used to update the patient data which is used to update the patient risk information).
However, Stang may not explicitly disclose the following which is taught by Boone: storing a set of clinical information in a coded clinical format relating to a particular condition of a target patient in one or more network-based storage devices having a collection of medical records stored thereon ([0011] generation of summarized electronic medical record for a patient, [0012-0013] storage means for the electronic documents in an electronic record);
the supplemental information corresponding to at least one clinical concept in a non-coded clinical format data element ([0048] patient information received/transmitted as medical data in descriptive or natural language medical information in electronic form, where Examiner interprets natural language form to be non-coded format);
converting the supplemental information and/or the non-coded clinical format data element to the coded clinical format ([0047] the medical report text is normalized by associating standard, predetermined medical terms/elements, i.e. coded format, to the extracted elements, [0071-0072] medical facts are extracted from the text of the medical data and subjected to a normalization process to apply standard nomenclature data using a standard to the data fields).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of a patient medical record with patient data in a coded format, receiving supplemental information and converting to the coded format from Boone with the clinical decision support system which predicts a preliminary and updated risk factors and conditions associated with a clinical decision support event from Stang in order to increase the reliability, consistency, and efficiency of coding patient data for data analysis of a large amount of data (Boone [0005]).
wherein a particular treatment procedure is administered to the target patient in association with treating the particular condition based at least partially on the second set of risk factors corresponding to the set of conditions (see Fig. 9 where treatment procedures are administered to the patient via a digital recommendation to treat patient condition, such as messages to take Claritin and take 2 inhaler puffs, etc., [0009] proactively transmit corrective action to the patient based on predicted event, [0032-0034] determining and presenting corrective actions to the patient based on predicted event for the patient, the alert action plan is regularly updated based on current measures, i.e. updated risk factors).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of administering a treatment to the patient from Schmidt with the clinical decision support system which predicts a preliminary and updated risk factors and conditions associated with a clinical decision support event from Stang and Boone in order to help mitigate the occurrence of catastrophic health situations and prevent the need for emergency care (Schmidt [0007]).
As per Claims 2, 9, and 15, Stang, Boone, and Schmidt discloses the limitations of Claims 1, 8, and 14. Stang also teaches automatically generating an updated preliminary likelihood of the clinical decision support event based at least in part on the set of clinical information and on the non-coded clinical format data element ([0052-0053] second input data is received and includes values for the patient risk factors and compared with the first input data, [0044-0045] health changes information also input as second data and used to update the patient data which is used to update the patient risk information).
As per Claims 3, 10, and 16, Stang, Boone, and Schmidt discloses the limitations of Claims 1, 8, and 14. Stang also teaches transmitting an electronic encoded signal to a clinician interface of a clinician device to display the updated preliminary likelihood ([0013] graphical user interface for displaying information, see Fig. 3 and 4, [0029] signals received by the communications interface to allows transfer of data, [0043] GUI screen presents predictive indicator based on the changed in parameters, i.e. the updated preliminary likelihood).
As per Claims 4, 11, and 17, Stang, Boone, and Schmidt discloses the limitations of Claims 1, 8, and 14. Stang also teaches directing a message corresponding to the electronic encoded signal to a clinician based on an association of a role of the clinician to the at least one clinical concept ([0033] user terminal which is connected to the server including processor and data repository, [0047] system initiates communication with specialist).
As per Claims 5, 12, and 18, Stang, Boone, and Schmidt discloses the limitations of Claims 1, 8, and 14. Boone also teaches electronically writing content corresponding to the non-coded clinical format data element in the collection of medical records in the coded clinical format ([0067]/[0072] the extracted and normalized data, i.e. converted to coded format, is stored in the database of patient data).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of storing a patient medical record with patient data in a coded format from Boone with the clinical decision support system which predicts a preliminary and updated risk factors and conditions associated with a clinical decision support event from Stang in order to increase the reliability, consistency, and efficiency of coding patient data for data analysis of a large amount of data (Boone [0005]).
As per Claims 6, 13, and 19, Stang, Boone, and Schmidt discloses the limitations of Claims 1, 8, and 14. Schmidt also teaches the collection of medical records includes indications of concepts determined, via the one or more hardware processors, as relatively frequently occurring in association with the particular condition ([0040] collection of patient data includes frequency of risk factors such as cough frequency as a predictor for a particular condition of disease event, see fig. 2 which includes collecting of patient data including how often/relatively frequently the risk factor occurs).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of the medical record for a patient includes frequently occurring factors from Schmidt with the clinical decision support system which predicts a preliminary and updated risk factors and conditions associated with a clinical decision support event from Stang and Boone in order to help mitigate the occurrence of catastrophic health situations and prevent the need for emergency care (Schmidt [0007]).
As per Claims 7 and 20, Stang, Boone, and Schmidt discloses the limitations of Claims 1, 8, and 14. Boone also teaches utilizing the supplemental information and the non-coded clinical format data element with one or both of the condition care program and the first set of risk factors after the converting, wherein the non-coded clinical format data element corresponds to a natural language utterance ([0048] natural language is entered to produce medical information in electronic form as a medical report for the patient).
Therefore, it would have been obvious to a person of ordinary skill in the art before the filing of the present invention to combine the known concept of a patient medical record with patient data in a coded format, receiving supplemental information and converting to the coded format from Boone with the clinical decision support system which predicts a preliminary and updated risk factors and conditions associated with a clinical decision support event from Stang in order to increase the reliability, consistency, and efficiency of coding patient data for data analysis of a large amount of data (Boone [0005]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen et al. (US 2013/0304510 A1) teaches a health information exchange system which exchanges data between systems of different formats and converting data from one format to another.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evangeline Barr whose telephone number is (571)272-0369. The examiner can normally be reached Monday to Friday 8:00 am to 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682