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 .
Applicants Amendment
Applicants’ amendment filed 8/14/2025 has been received and entered. The specification has been amended. Claims 1, 7 and 10 have been amended, claims 11-18 have been cancelled.
Claims 1-10 are pending.
Election/Restriction
Applicant’s election without traverse of Group I in the reply filed on 2/19/2025 was acknowledged. The requirement for an election of species was withdrawn in the prior action because there did not appear to be an undue burden to examine the claims, specifically the ‘types’ that result from the analysis are dependent on the data that is being analyzed and not unique to the method steps themselves.
Non-elected claims 11-18 previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions have been cancelled.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 1-10, drawn to a method of estimating a probability of a population based on reoccurrence of types are currently under examination.
Priority
This application filed 6/29/2020 is a continuation of 14/246100 filed 4/6/2014, now Abandoned, which claims benefit to foreign application MK:P/2013/126 filed 4/8/2013.
No comments regarding the priority summary were made in Applicants response.
Specification
The disclosure objected to because the status of application 14/246,100 was left an empty place holder is withdrawn.
The amendment to the specification has addressed the basis of the objection.
Information Disclosure Statement
In review of the specification, it was noted that the listing of references in the specification is not a proper information disclosure statement. See for example [0009].
Applicants state that they have reviewed the citations and that they are not material to the patentability of the claimed subject matter.
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 1-10 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. Specifically, the claims have been amended to require ‘performing Big Data operations’ which appears to be a new limitation not supported by the specification. Review of the specification does provide for ‘operations’ however does not provide the basis or the metes and bounds of what Big Data operations are to know what is in or outside the scope of the claims.
Dependent claims fail to clarify what is encompassed or what is performed as part of Big Data operations and are included in the basis of the rejection because they require practicing the method of claim 1
More clearly providing for the specific operations to be practiced in the analysis of the array data would address the basis of the rejection.
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.
Claims 1-10 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 claims have been amended to require ‘performing Big Data operations’ which appears to be a new limitation not supported by the specification. Review of the specification does provide for ‘operations’ however does not provide the basis or the metes and bounds of what Big Data operations are to know what is in or outside the scope of the claims. It is unclear if only searching and determining as specifically set forth in the claims is required, or other ‘operations’ are necessary to meet the limitation of ‘Big Data operations’.
For purposes of examination, the claims will be interpreted for what they specifically define or include as steps considered operations to analyze the array data.
Claims 1-10 stand 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.
Response to Applicants arguments
Applicants summarize the basis of the rejections and point to support in the specification for the definition of Big Data and support for ‘array of items’, ‘average recurrence distance’, and argue that one of ordinary skill in the art would understand without any ambiguity the requirements of the claims given the disclosure.
In response, the claims have been amended, but still comprise the limitation of ‘Big Data’. Applicants’ citation of [0166] is acknowledged, and is provided in its entirety for clarity of the record.
[0166]"Big Data", as used herein includes datasets that are so large or complex that traditional data processing applications are inadequate. As a result, Big Data works with specialized computers and computing devices, in order to provide the analysis, capture, data curation, search, sharing, storage, transfer, visualization, querying and information privacy, associated with "Big Data.""Big Data", as used herein additionally refers to the use of predictive analytics, user behavior analytics, or certain other advanced data analytics methods that extract value from data, and seldom to a particultr size of data set. By performing a big data analysis, the method of the present invention is performed on computer processors in real time, and is employed with processes such as streaming Big Data. By performing the disclosed processes in real time, on Big Data, the a computer processor is the only way in which such large amounts of data can be handled, in any reasonable amount of time, such that should there be a need to issue an alert based on the result, the alert can be issued in real time, contemporaneous with the "Big Data" analysis., but simply requires that it ‘
Importantly, it is important that the claims set forth big data ‘includes’ but this does not define but rather sets forth one possible type of data or data source. For the purposes of 112 and the metes and bounds encompassed by the claims, it must be clear what is encompassed and what is not in evaluating the claims. Further, the guidance suggests that ‘traditional data processing applications are inadequate’, however fail to teach what those are. Moreover, the claims only appear to require processing steps generically and broadly set forth for ‘searching’ and ‘determining’ which appear inconsistent with any complexity or size being clearly required, or any requirement to clearly set forth what the scope of the claims encompass. Finally, given the examples throughout the specification for associating genotypes with phenotypes for example (see [0005] for example) appears to suggest that the data array of the big data does not have to be large or complex, but could be provided as data points or as a table of information about multiple patients.
As noted previously for claim 1, the metes and bounds of “Big Data” are vague and undefined, and appear relevant to what one would consider an ‘amount sufficient’ as set forth in the claim. While big data is recognized term, there does not appear to be an art accepted appreciation for what the size or complexity of a data source would be to be considered big data as required of the claims. Additionally, the claim requires that ‘the database including an array of items’ and it is unclear to what the array is or what format it comprises, and if the database comprises an array and other forms of data structures as well. Further, the claims require calculating ‘average reoccurrence distance’ but it is unclear what this is without any data defined or any structure to an array that would provide the ability to perform such calculations. Dependent claims fail to clarify the basis of the rejection and generically indicate that the data is directed to populations or are related to words, traits,… (claim 3) or ‘members’ (claims 4-5) or ‘types’ of information, without giving any of the necessary function or structure to the database itself.
More clearly providing the nature of the ‘dig data’ and the structure sufficiently such that one could perform ‘operations’ or calculating averages of ‘distance’ would address the basis of the rejection.
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 1-10 stand 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.
Claim analysis
Claim 1 has been amended and still is generally directed to a method of estimating a probability of at least one event in a population. Specifically, the claims have been amended to indicate that Big Data is processed by ‘performing Big Data operations’ which include analyzing an array for ‘distances of the set of types’ to provide an average of reoccurrences (if they exist in the data) such that it defines the probability of a frequence of what is identified. In view of the specification an and occurrence or an even’ provided in the specification is exemplified in [0002] “The present invention, in some embodiments thereof, relates to bioinformatics and, more particularly, but not exclusively, to a method and system for predicting a disease by computational analysis of a DNA sequence.” which specifically provides for a correlation between a DNA variation with the likelihood of developing a gene related disease. As amended, the claims still recite broadly and encompass any type of event, and that the information from the database includes ‘Big Data’ which for correlations of gene variations and diseases can be an average reoccurrence distance between adjacent occurrences of gene sequences including at least an oncogene or a tumor suppressor. The are no physical steps required in obtaining data and the final step requires recording a value of a calculation.
For step 1 of the 101 analysis, the claims are found to be directed to a statutory category of a method.
For step 2A of the 101 analysis, the judicial exception of the claims are the steps of accessing big data for correlations based on occurrences. The judicial exception is a set of instructions for analysis of data and appears to fall into the category of a Mental Processes, that is concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Here there is no definition of big data or what the array comprises, but the specification and drawings provide for a limited amount of information that can be visually assessed (see for example Fig 5). Also, to the extent the claims encompass and require calculations of ‘probability’ it is also falls into the category of Mathematical Concepts, that is mathematical relationships or mathematical calculations that could applied broadly to any of the data types provided in the data.
Recent guidance from the office requires that the judicial exception be evaluated under a second prong to determine whether the judicial exception is practically applied. In the instant case, the claims do not have an additional element to which the analysis is applied. Again, the judicial exception requires steps recited at high level of generality and are dependent on the data being analyzed. In view of the specification, it is noted that the process of analysis or data can be performed using a computer, however it is found that the instructions for the judicial exception are only stored or implemented with a computer as a tool, and is not found to be a practical application of the judicial exception as broadly set forth.
For step 2B of the 101 analysis, the claims have no additional elements and are found to be the steps of analyzing data. As such, the claims do not provide for any additional element to consider under step 2B as a practical application. Further, in view of the specification if implemented using a computer to analyze data, there is no evidence that a special computer is required or that the method as generically recited affects the function of the computer itself. It is noted that in explaining the Alice framework, the Court wrote that "[i]n cases involving software innovations, [the step one] inquiry often turns on whether the claims focus on the specific asserted improvement in computer capabilities or, instead, on a process that qualifies as an abstract idea for which computers are invoked merely as a tool." The Court further noted that "[s]ince Alice, we have found software inventions to be patent-eligible where they have made non-abstract improvements to existing technological processes and computer technology." Moreover, these improvements must be specific -- "[a]n improved result, without more stated in the claim, is not enough to confer eligibility to an otherwise abstract idea . . . [t]o be patent-eligible, the claims must recite a specific means or method that solves a problem in an existing technological process." As indicated in the summary of the judicial exception above and in view of the teachings of the specification, the steps are drawn to analysis of data, and while the instruction could be stored on a medium and could be implemented on a computer, together the steps do not appear to result in significantly more than a means to compare sequences. The judicial exception of the method as claimed can be performed by hand and in light of the previous claims to a computer medium and in light of the teaching of the specification on a computer. In review of the instant specification the methods do not appear to require a special type of processor and can be performed on a general purpose computer.
Dependent claims have been analyzed and appear to set forth additional steps which are more specifically define the considerations and steps of calculating, and comparing, and do not add additional elements which result in significantly more to the claimed method for the analysis.
Response to Applicants arguments
Applicants provide a summary of the 101 analysis set forth in the basis of the rejection and argue under step 2A prong 1, the recitation and requirement of analyzing Big Data underscores that the invention cannot be performed mentally or by observation.
In response, limitations not required of the claim are not read into any requirement of the claims. As discussed in the basis of the 112 above and in light of the specification Big Data has multiple aspects to which the specification suggest as ‘used herein’ and in part are in contrast where the data is so big it cannot be processed but in the same paragraph states refers to ‘seldom to a particular size of data set’. Here it is acknowledged that claim recites Big Data, but requires an undefined ‘array of items for the population’ and does not point to any complexity and broadly can be any array of information. Importantly, in the 101 assessment the steps of analysis are the critical element to evaluate, and here it appears the it simply requires looking/searching at the array for ‘types’ for identification of possible occurrences, and then in view of the specification how often they occur as a ‘distance’, which appear to be simple tasks that can be done by observation. It is unclear what size and/or complexity makes identifying ‘occurance’ and how often it occurs a task that can not be done by observation. Even very large data sets, for example set forth in a table as an array can be scanned and specific ‘types’ of things listed can be identified. That is, what is being analyzed for 101 is what has to be performed, not to what the method is applied.
It is noted that the claims have been amended to require ‘performing Big Data operations’ which is not defined in the specification as any specific requirement, and does not appear to import any complexity or requirement. Further, given the evidence of record for no specific operations that are required, they can simply be ‘searching’ the array and ‘determining’ occurrences as specifically set forth in the method steps of the claim and which is ‘included’ as part of the Big Data operation as amended.
For Step 2A prong 2 Applicants argue that method is integrated in a practical application of estimating even probabilities in a population, relying on the fact pattern of Electric Power Group v. Alstom.
In response, Applicants summary and arguments appear to support the conclusion in the basis of the rejection that the method is directed to mathematical analysis of data for ‘estimating probabilities in a population’. Providing a statistical analysis, even to large data sets, is still steps directed to applying math to data, and providing as an outcome a summary of the analysis. Again, the steps are generic and broad, and can be applied to any array of data (aka Big Data) and it is unclear how providing a statistical analysis of data provides a practical application as provided in the amended claims, and it appears consistent with the fact pattern of Electric Power that was found not to be patent eligible.
For Step 2B, Applicants argue that the claims provide for significantly more and transform the abstract idea into an improvement.
In response, 2B analyzes additional elements, which beyond practicing the steps using a general purpose computer, the method steps for analysis are all found to be part of the judicial exception. The evidence of record does not appear to support that the data required is so complex that observing events is inefficient or infeasible as argued by Applicants. For example, the specification teaches that “All these operations are well-known to those skilled in the art of computer systems.” see [0073], which appears to support that there is no or unique operations provided in the specification
As noted previously, one way to overcome a rejection for non-patent-eligible subject matter is to persuasively argue that the claimed subject matter is not directed to a judicial exception. Another way for the applicants to overcome the rejection is to persuasively argue that the claims contain elements in addition to the judicial exception that either individually or as an ordered combination are not well understood, routine, or conventional. Another way for the applicants to overcome the rejection is to persuasively argue that the claims as a whole result in an improvement to a technology. Persuasive evidence for an improvement to a technology could be a comparison of results of the claimed subject matter with results of the prior art, or arguments based on scientific reasoning that the claimed subject matter inherently results an improvement over the prior art. The applicants should show why the claims require the improvement in all embodiments.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
In prosecution, the art of record evidences that the analysis of big data comprising genomic information can be informative relative to finding correlations of alleles or variants and diseases, there is no guidance on establishing ‘reoccurrence distance’ as required of the claims. For example, Zhao et al. teach detection of subchromosomal abnormalities cfDNA which involves the analysis of read sequences and assessment of cfDNA sequence relative to a reference genome, but this comprises analysis of an occurrence, not a reoccurrence. More generally, ‘reoccurrence’ does not appear to be an inherent or implicit feature of data that is contemplated by the present specification, nor does the specification appear to provide for an array which would provide the ability to assess a reoccurrence as set forth in the instant claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph T Woitach whose telephone number is (571)272-0739. The examiner can normally be reached Mon-Fri; 8:00-4:00.
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/Joseph Woitach/Primary Examiner, Art Unit 1687