DETAILED ACTION
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 .
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 under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-7 are directed to a method (i.e., a process), claims 8-13 are directed to a system (i.e., a machine), and claims 14-20 are directed to one or more non-transitory computer-readable media (i.e., a machine). Accordingly, claims 1-20 are all within at least one of the four statutory categories.
Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts.
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
1. A computer-implemented method, comprising: identifying a subset of target records from a set of records stored at a database associated with one or more hardware processors and with a medical records computer system; determining, based on the subset of target records, a longitudinal timeseries of a plurality of longitudinal timeseries, determining an entropy index that corresponds to one or both of the longitudinal timeseries and a cluster data element associated with the longitudinal timeseries and that represents a measure of disruption associated with the longitudinal timeseries; and electronically writing, via the one or more hardware processors, encoded data to an electronic digital memory at the medical records computer system, wherein the encoded data indicates a level of reliability (a) based on the entropy index and (b) associated with a recommendation or a prediction computed using the longitudinal timeseries.
The Examiner submits that the foregoing underlined limitations constitute “a mental process” because identifying a subset of target records from a set of records; determining, based on the subset of target records, a longitudinal timeseries of a plurality of longitudinal timeseries, determining an entropy index that corresponds to one or both of the longitudinal timeseries and a cluster data element associated with the longitudinal timeseries and that represents a measure of disruption associated with the longitudinal timeseries; and wherein the data indicates a level of reliability (a) based on the entropy index and (b) associated with a recommendation or a prediction computed using the longitudinal timeseries amount to observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind or via pen and paper.
Accordingly, the claim recites at least one abstract idea.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claims 1, 8, and 14, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting a database, one or more hardware processors, a records computer system, an electronic digital memory, and one or more non-transitory computer-readable media, nothing in the claim elements precludes the steps from practically being performed in the mind. 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 claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the database, one or more hardware processors, records computer system, electronic digital memory, and one or more non-transitory computer-readable media, are recited at a high-level of generality (i.e., as generic computer components performing generic computer functions of identifying data, determining data, and writing data) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05). Their collective functions merely provide conventional computer implementation.
Claims 2-7, 9-13, and 15-20 are ultimately dependent from Claim(s) 1, 8, and 14 and include all the limitations of Claim(s) 1, 8, and 14. Therefore, claim(s) 2-7, 9-13, and 15-20 recite the same abstract idea. Claims 2-7, 9-13, and 15-20 describe further limitations regarding determining a cluster distance metric that describes or relates to the presence of similarity between the candidate record and the data; wherein determining the cluster distance metric utilizes one or both of: a pair-wise matching algorithm that is based on a theoretical use case associated with one or more of the set of cluster data elements; and an evaluation algorithm that is based on entropies associated with one or more of the plurality of timeseries trajectories; determining an entropy index for each cluster data element of the set of cluster data elements; determining a match between the at least one cluster data element and the candidate record; generating, based on the match, one or both of (a) an indication of one or more clinical orders or future conditions associated with the candidate record and (b) at least one preventative intervention for a patient associated with the candidate record. These are all just further describing the abstract idea recited in claims 1, 8, and 14, without adding significantly more.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. In particular, the graphical user interface of a computing device and component are recited at a high-level of generality (i.e., as generic computer components performing generic computer functions of presenting data and determining data) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, independent claims 1, 8, and 14 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations directed to records stored at a database and electronically writing encoded data to an electronic digital memory, all of which the Examiner submits merely add insignificant extra-solution activity to the abstract idea or are claimed in a merely generic manner (e.g., at a high level of generality), the Examiner further submits that such steps are not unconventional as they merely consist of electronic recordkeeping and storing and retrieving information in memory. See MPEP 2106.05(d)(II).
The dependent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-20 are ineligible under 35 USC §101.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his 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.
The newly added recitation of “electronically writing, via the one or more hardware processors, encoded data to an electronic digital memory at the medical records computer system, wherein the encoded data indicates a level of reliability (a) based on the entropy index and (b) associated with a recommendation or a prediction computed using the longitudinal timeseries” within claim 1, 8, and 14 appear to constitute new matter. The newly added recitation of “wherein determining the cluster distance metric utilizes one or both of: a pair-wise matching algorithm that is based on a theoretical use case associated with one or more of the set of cluster data elements; and an evaluation algorithm that is based on entropies associated with one or more of the plurality of timeseries trajectories“ within claims 3, 10, and 16 also appear to constitute new matter.
In particular, Applicant does not point to, nor was the Examiner able to find support for this newly added language within the specification as originally filed. As such, Applicant is respectfully requested to clarify the above issues and to specifically point out support for the newly added limitations in the originally filed specification and claims.
Applicant is required to cancel the new matter in the reply to this Office Action.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3-5, 10-12, and 16-18 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.
Claims 3, 5, 10, 12, 16, and 18 recite the limitation "the set of cluster data elements" in line 3 of claim 3, line 3 of claim 5, line 3 of claim 10, line 3 of claim 12, lines 3-4 of claim 16, and line 4 of claim 18. There is insufficient antecedent basis for this limitation in the claims.
Claims 4, 11, and 17 recites the limitation "the set of entropy indexes" in line 2 of claim 4, line 2 of claim 11, and lines 2-3 of claim 17. There is insufficient antecedent basis for this limitation in the claims.
Claim Objections
Claims 2, 9, and 15 are objected to because of the following informalities: change “the presence” to “a presence” and “the candidate record” to “a candidate record.” In addition, Examiner requests clarifying if “the data” refers to the “encoded data” recited in the independent claims, or different data. Appropriate correction is required.
Claims 6, 13, and 19 are objected to because of the following informalities: change “the at least one cluster data element and the candidate record“ to “the a candidate record.“ Appropriate correction is required.
Claims 3, 10, and 16 are objected to because of the following informalities: change “the plurality of timeseries trajectories“ to “a plurality of timeseries trajectories.“ Appropriate correction is required.
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.
Claim(s) 1, 2, 6-9, 13-15, 19, and 20 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Michelson et al. (US 2009/0318775 A1) in view of Bosi et al. (US 2015/0216436 A1).
(A) Referring to claim 1, Michelson discloses A computer-implemented method, comprising (abstract & para. 18 of Michelson):
identifying a subset of target records from a set of records stored at a database associated with one or more hardware processors and with a medical records computer system (para. 171-174 of Michelson; A database is developed for a medical condition in which relevant clinical information is filtered or mined over a communication network (for example, the Internet) from one or more data sources, such as a public remote database, an internal remote database, and a local database. Data from a database can be filtered and classified according to specific cases or medical conditions or a group of diagnoses and conditions. For example, the classification within the database may follow the standard international code of diagnoses (ICD-9 coding system).);
determining, based on the subset of target records, a longitudinal timeseries of a plurality of longitudinal timeseries (para. 24, 104, & 285 of Michelson; obtaining longitudinal subject data corresponding to at least one biomarker in a set of biomarkers for a clinically relevant condition to obtain a trend of the subject data. As testing methods and devices, such as point-of-care microfluidic devices, become more reliable and accessible, data from the patient can be acquired and processed at multiple time points. The sequential structure of obtained data is often a time series or a set of longitudinal data. Applying a time series-based statistical methodology to the longitudinal (within an individual patient) protein profiles systematically accounts for the periodicity of a given dosing regimen within an individual patient and using that information to identify and characterize the emergence of any clinically relevant trends in the response. This knowledge can then be used to both monitor a therapeutic regimen in an individual patient and to design and manage the dynamics of an adaptive clinical trial.),
electronically writing, via the one or more hardware processors, encoded data to an electronic digital memory at the medical records computer system (para. 207, 213, 179, 187, and 189 of Michelson; The platform may read and write to and from a storage unit. The storage unit may be as magnetic random access, such as flexible or hard disk drive, magnetic sequential access, such as tape, optical random access such as CD, DVD or Magnetic Optical drive, and solid state memory, such as EPROM, MRAM and Flash. Also illustrated in FIG. 11 is transmitting information in real-time from the point-of-care device to a server or system that is capable of converting the information or data to a physiologically relevant context. This can be accomplished by transferring the information to a database or a plurality of databases. The databases can be on a server or a plurality of servers. In an embodiment, a centralized database repository is used to analyze the data and return the data to an end user in a physiologically relevant context.), wherein the encoded data indicates a level of reliability (b) associated with a recommendation or a prediction computed using the longitudinal timeseries (para. 66-68, 104-107, and 110 of Michelson; a method is provided herein for characterizing the probability of a clinical outcome of a subject. The method comprises the steps of (a) constructing a probability space defined by a set of discrete clinical outcomes, each of which is characterized by a statistical distribution of at least one biological marker; (b) obtaining subject data corresponding to the at least one biological marker; and (c) calculating the position of said subject data in said probability space, thereby characterizing the probability of the clinical outcome of said subject. As testing methods and devices, such as point-of-care microfluidic devices, become more reliable and accessible, data from the patient can be acquired and processed at multiple time points. The sequential structure of obtained data is often a time series or a set of longitudinal data, but may also be data that reflects changes that occur sequentially with no specific reference to time. The longitudinal data provides valuable insight into the progression of a medical condition or treatment.).
Michelson does not disclose determining an entropy index that corresponds to one or both of the longitudinal timeseries and a cluster data element associated with the longitudinal timeseries and that represents a measure of disruption associated with the longitudinal timeseries; and wherein the encoded data indicates a level of reliability (a) based on the entropy index.
Bosi discloses determining an entropy index that corresponds to one or both of the longitudinal timeseries and a cluster data element associated with the longitudinal timeseries and that represents a measure of disruption associated with the longitudinal timeseries (para. 58, 59, 61, & 64 of Bosi; A single measure of system complexity that can be computed from physiological time series is sample entropy. Although entropy measures have been used to characterize time signals for more than sixty years, the computation of entropy on multiple scales derived from a time series was only introduced recently. Multiscale entropy measures have been shown to be useful for detecting changes in physiological systems, including mental disorders such as Alzheimer's Disease, schizophrenia, the effect of antipsychotic drugs, normal aging, and autism.); and wherein the encoded data indicates a level of reliability (a) based on the entropy index (para. 6-9, 21, 56, & 138 of Bosi; analysis of electromagnetic data for the detection of reliable biomarkers for epilepsy. For example, some embodiments may be directed to a method of diagnosing a patient as having epilepsy, the method comprising: receiving electroencephalography (EEG) data recorded from the patient; applying, using at least one processor, a multiscale algorithm to the received EEG data to produce scaled EEG data; determining at least one nonlinear feature value for the received EEG data and/or the scaled EEG data; and diagnosing the patient as having epilepsy based, at least in part, on the at least nonlinear feature value. In some embodiments, determining at least one nonlinear feature value comprises determining an entropy value for the received EEG data and/or the scaled EEG data.).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Bosi within Michelson. The motivation for doing so would have been to improve diagnosis (para. 4 of Bosi).
(B) Referring to claim 2 and similar claims 9 & 15, Michelson discloses further comprising determining a cluster distance metric that describes or relates to the presence of similarity between the candidate record and the data (para. 89-91 of Michelson).
(C) Referring to claim 6 and similar claims 13 & 19, Michelson discloses further comprising determining a match between the at least one cluster data element and the candidate record (para. 89-91 of Michelson).
(D) Referring to claim 7 and similar claim 20, Michelson discloses further comprising generating, via the one or more hardware processors and based on the match, one or both of (a) an indication of one or more clinical orders or future conditions associated with the candidate record and (b) at least one preventative intervention for a patient associated with the candidate record (para. 19, 25, & 89-92 of Michelson).
(E) Claims 8 and 14 differ from claim 1 by reciting: “A system having one or more hardware processors configured to facilitate a plurality of operations, the operations comprising:” (para. 168 of Michelson) and “One or more non-transitory computer-readable media having instructions that, when executed by one or more hardware processors, cause the one or more hardware processors to facilitate a plurality of operations, the operations comprising:” (para. 202-208 of Michelson).
The remainder of claims 8 and 14 repeat the same limitations as claim 1, and are therefore rejected for the same reasons given above.
Claim(s) 3, 5, 10, 12, 16, and 18 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Michelson et al. (US 2009/0318775 A1) in view of Bosi et al. (US 2015/0216436 A1), and further in view of Geva et al. (US 2004/0230105 A1).
(A) Referring to claim 3 and similar claims 10 & 16, Michelson and Bosi do not disclose wherein determining the cluster distance metric utilizes one or both of: a pair-wise matching algorithm that is based on a theoretical use case associated with one or more of the set of cluster data elements; and an evaluation algorithm that is based on entropies associated with one or more of the plurality of timeseries trajectories.
Geva discloses wherein determining the cluster distance metric utilizes an evaluation algorithm that is based on entropies associated with one or more of the plurality of timeseries trajectories (para. 248, 249, 251, and 252 of Geva).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned feature of Geva within Michelson and Bosi. The motivation for doing so would have been to detect changes (para. 248 of Geva).
Insofar as the claim recites “one or both of,” it is immaterial whether or not the other element is disclosed.
(B) Referring to claim 5 and similar claims 12 & 18, Michelson and Bosi do not disclose further comprising determining, via an entropy index component associated with the one or more hardware processors, an entropy index for each cluster data element of the set of cluster data elements.
Geva discloses determining, via an entropy index component associated with the one or more hardware processors, an entropy index for each cluster data element of the set of cluster data elements (para. 248 & 481 of Geva).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned feature of Geva within Michelson and Bosi. The motivation for doing so would have been to detect changes (para. 248 of Geva).
Claim(s) 4, 11, and 17 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Michelson et al. (US 2009/0318775 A1) in view of Bosi et al. (US 2015/0216436 A1), and further in view of Melker et al. (US 2013/0172759 A1).
(A) Referring to claim 4 and similar claims 11 & 17, Michelson and Bosi do not disclose further comprising causing presentation of an entropy index of the set of entropy indexes on a graphical user interface of a computing device associated with a caregiver.
Melker discloses causing presentation of an entropy index of the set of entropy indexes on a graphical user interface of a computing device associated with a caregiver (Fig. 8, para. 164, 165, 167, 176, 118, and 316 of Melker).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned feature of Melker within Michelson and Bosi. The motivation for doing so would have been to provide the necessary support for the patient (para. 118 of Melker).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited but not applied prior art teaches modulation and analysis of cerebral perfusion in epilepsy and other neurological disorders (US 2006/0265022 A1); method and system for computing trajectories of chronic disease patients (WO 2007/097906 A2); methods for modeling neurological development and diagnosing neurological impairment of a patient (US 2013/0035579 A1); and method for diagnosing heart disease, predicting sudden death, and analyzing treatment response using multifractial analysis (US 2003/0163057 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENA NAJARIAN whose telephone number is (571)272-7072. The examiner can normally be reached Monday - Friday 9:30 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571)270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LENA NAJARIAN/Primary Examiner, Art Unit 3687
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