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 .
Response to Arguments
Regarding the arguments against the rejection of claims under 35 USC 101, the Examiner respectfully disagrees. Applicant argues that the use of the partial common path detection unit and the common difference information provision unit provide an improvement to disease treatments or drug discovery related techniques and is regarded as integrating abstract concepts into a practical application of disease treatment or drug discovery. Examiner asserts that improvements such as understanding changes in pathways due to state changes of the disease recites an abstract concept. Generating the pathways to determine the change in pathways recites an abstract configuration of data to understand the temporal states changes as pathophysiological responses, as there is no indication of a particular configuration of computing components to carry out the abstract idea. The use of the units as claimed recite generic computing components as analyzed under Step 2A Prong 2 in the rejection below. Additionally, there is no indication in the claims of a specific generation of settings for optimal conditions for a cell stimulant for a response change. Analyzing the data in an abstract manner as described in the Step 2A Prong One analysis in order to improve disease treatments or drug discovery related techniques in a non-specific manner would not integrate the abstract concepts into a practical application. Examiner further asserts that the claims as analyzed below in the rejection were analyzed under broadest reasonable interpretation with consideration of the written description of the Applicant.
Regarding the arguments against the rejection of claims under 35 USC 102, Examiner agrees and therefore this rejection is withdrawn.
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.
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) 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: a partial common path detection unit and a common difference information provision unit in claims 1 and 8 and a disease/symptom common path detection unit and a second common difference information provision unit in claims 3 and 7.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), 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), applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
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 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more.
It is appropriate for the Examiner to determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance to the Subject Matter Eligibility Test as recited in the following Steps: 1, 2A, and 2B, see MPEP 2106(III.).
Patent Subject Matter Eligibility Test: Step 1:
First, the Examiner is to establish whether the claim falls within any statutory category including a process, a machine, manufacture, or composition of matter, see MPEP 2106.03(II.) and MPEP 2106.03(I).
Claims 1-4 and 7 are related to a system, and claim 5 is also related to a method (i.e., a process). Claim 6 is related to a program that is stored in a storage medium as described in [0065] of Applicant’s Specification. Claim 8 recites a system, claim 9 recites a method, and claim 10 recites the analysis program stored on a non-transitory computer readable medium. Accordingly, these claims are all within at least one of the four statutory categories.
Patent Subject Matter Eligibility Test: Step 2A- Prong One:
Step 2A of the Subject Matter Eligibility Test demonstrates whether a clam is directed to a judicial exception, see MPEP 2106.04(I.). Step 2A is a two-prong inquiry, where Prong One establishes the judicial exception. 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) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes, see MPEP 2106.04(II.)(A.)(1.) and 2106.04(a)(2).
Representative independent claim 1 includes limitations that recite at least one abstract idea as underlined in the following limitations. Specifically, independent claim 1 recites:
A pathway analysis apparatus characterized by comprising:
a partial common path detection unit configured to detect a common part exclusively in a portion between a start point and an end point of a path by using three or more disease pathways representing, as a route map, an intermolecular interaction of related molecules with respect to a disease for each of three or more diseases related to state changes or by using three or more symptom pathways representing, as a route map, an intermolecular interaction of related molecules with respect to a symptom for each of three or more symptoms related to state changes, between each combination of two of the pathways is an order of the states changes; and
a common difference information provision unit configured to provide information on a partial common path detected by the partial common path detection unit and a non-partial common path other than the partial common path in a mutually distinguishable state.
The Examiner submits that the foregoing underlined limitations constitute a “mental process”, as the following abstract limitations are related to observations and analysis that can be practically performed in the human mind:
“detect” a common part exclusively in a portion between a start point and an end point of a path by using three or more disease pathways representing, as a route map, an intermolecular interaction of related molecules with respect to a disease for each of three or more diseases related to state changes or by using three or more symptom pathways representing, as a route map, an intermolecular interaction of related molecules with respect to a symptom for each of three or more symptoms related to state changes, between each combination of two of the pathways is an order of the state changes, which are abstract limitations related to analysis of intermolecular interactions with respect to diseases, state changes from the diseases, and symptoms of the disease using an abstract model of pathways and a route map as claimed,
information on a partial common path “detected” by a non-partial common path other than the partial common path in a mutually distinguishable state, which is an abstract limitation of observation and analysis related to the abstraction of the common path for the analysis of the diseases.
Accordingly, the claim recites the steps for detecting and analysis of a path for disease pathways that can practically be performed in the human mind.
The abstract idea recited in claims 5 and 6 is similar to that of claim 1.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” (i.e., units) and will be discussed in further detail below.
Accordingly, the claim as a whole recites at least one abstract idea.
Furthermore, dependent claims further define the at least one abstract idea, and thus fails to make the abstract idea any less abstract as noted below:
Claim 2 recites further abstract limitations of dividing the pathway in an upstream, downstream and midstream sections to then “detect” a common path along the pathways in the sections, further describing the abstract idea. Claims 3 and 7 recites further abstract limitations of “detecting” a common path between the disease and symptom pathways represented as a route map and consideration of intermolecular interactions of related molecules with respect to symptom with the disease and information on common path “detected” by the common path, further describing the abstract idea. Claim 4 recites further abstract limitations of “detecting” a common path between the partial common path detected by the non-partial common path for the disease and symptom pathways, further describing the abstract idea.
Claim 8 further recites:
A pathway analysis apparatus characterized by comprising:
a partial common path detection unit configured to detect a common part exclusively in a portion between a start point and an end point of a path among a plurality of disease pathways representing, as a route map, an intermolecular interaction of related molecules with respect to a disease for each of a plurality of diseases related to state changes or among a plurality of symptom pathways representing, as a route map, an intermolecular interaction of related molecules with respect to a symptom for each of a plurality of symptoms related to state changes; and
a common difference information provision unit configured to provide information on the plurality of disease pathways or the plurality of symptom pathways in a state where a partial common path detected by the partial common path detection unit and a non-partial common path other than the partial common path are mutually distinguishable and in a state where the plurality of disease pathways or the plurality of symptom pathways can be compared to each other.
The Examiner submits that the foregoing underlined limitations constitute a “mental process”, as the following abstract limitations are related to observations and analysis that can be practically performed in the human mind:
“detect” aa common part exclusively in a portion between a start point and an end point of a path among a plurality of disease pathways representing, as a route map, an intermolecular interaction of related molecules with respect to a disease for each of a plurality of diseases related to state changes or among a plurality of symptom pathways representing, as a route map, an intermolecular interaction of related molecules with respect to a symptom for each of a plurality of symptoms related to state changes, which are abstract limitations related to analysis of intermolecular interactions with respect to diseases, state changes from the diseases, and symptoms of the disease using an abstract model of pathways and a route map,
information on the plurality of disease pathways or the plurality of symptom pathways in a state where a partial common path “detected” and a non-partial common path other than the partial common path are mutually distinguishable and in a state where the plurality of disease pathways or the plurality of symptom pathways can be “compared” to each other, which are abstract limitations of observation and analysis related to the abstraction of the common path for the analysis of the diseases and where there is further analysis of comparison of the symptom pathways.
Accordingly, the claim recites the steps for detecting a path for disease pathways and analysis of the symptom pathways that can practically be performed in the human mind.
The abstract idea recited in claims 9 and 10 is similar to that of claim 8.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” (i.e., units) and will be discussed in further detail below.
Accordingly, the claim as a whole recites at least one abstract idea.
Patent Subject Matter Eligibility Test: 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 integrates 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 exceptions into a “practical application,” see MPEP 2106.04(II.)(A.)(2.) and 2106.04(d)(I.).
In the present case, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A pathway analysis apparatus characterized by comprising (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)):
a partial common path detection unit configured to (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)) detect a common part exclusively in a portion between a start point and an end point of a path among a plurality of disease pathways representing, as a route map, an intermolecular interaction of related molecules with respect to a disease for each of a plurality of diseases related to state changes or among a plurality of symptom pathways representing, as a route map, an intermolecular interaction of related molecules with respect to a symptom for each of a plurality of symptoms related to state changes; and
a common difference information provision unit configured to (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)) provide information on a partial common path detected by the partial common path detection unit and (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)) a non-partial common path other than the partial common path in a mutually distinguishable state.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitation of the overall pathway analysis apparatus, a partial common path detection unit, and a common difference information provision unit, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f)). [0014] of the Applicant’s Specification recites the overall generic computing system to perform the steps. [0064, 0065] recites the configuration of the “units” that are used as generic computing components to carry out the steps. The additional elements recite the use of generic computing components with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer. Claim 8 recites similar additional elements. Claim 6 and 10 further recite additional elements of the pathway analysis program being stored on a generic non-transitory computer readable medium as further described in [0014], however this also amounts to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components.
Taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional 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 analyze pathways, 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 2106.04(d), 2106.05(a), 2106.05(b).
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set below:
Claims 3 and 7 recite additional elements of a disease/symptom common path detection unit and a second common difference information provision unit to perform the steps of the abstract idea, however these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components.
Thus, taken alone and in ordered combination, the additional elements do not integrate the at least one abstract idea into a practical application.
Patent Subject Matter Eligibility Test: Step 2B:
Regarding Step 2B of the Subject Matter Eligibility Test, the independent 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 claim does not integrate the abstract idea into a practical application, see MPEP 2106.05(II.). Further, it may need to be established, when determining whether a claim recites significantly more than a judicial exception, that the additional elements recite well understood, routine, and conventional activities, see MPEP 2106.05(d).
Regarding the additional limitation of the overall pathway analysis apparatus, a partial common path detection unit, and a common difference information provision unit, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f) and 2106.05(d)(II), specifically “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”). [0014] of the Applicant’s Specification recites the overall generic computing system to perform the steps. [0064, 0065] recites the configuration of the “units” that are used as generic computing components to carry out the steps. The additional elements recite the use of generic computing components with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer and does not recite significantly more than the judicial exception. Claim 8 recites similar additional elements. Claim 6 and 10 further recite additional elements of the pathway analysis program being stored on a generic non-transitory computer readable medium as further described in [0014], however this also amounts to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components. Use of the units by retrieving them from generic memory and computing components recites well understood, routine, and conventional activities.
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 exceptions 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.
For the reasons stated, the claims fail the Subject Matter Eligibility Test and therefore claims 1-10 are rejected under 35 USC 101 as being directed to non-statutory subject matter.
The previously recited references have been considered, however have not been used in the above rejections:
US 2025/0182844 A1 to Kain et al. teaches of a processing system for determining shared biological pathways and shared nucleotide polymorphisms (NPs) associated with a first disease, NP clusters of a first disease having causal effect on the second disease and where the clustering happens according to biological pathways.
WO-2024102200-A1 to Owen Katherine et al. teaches of using genetic pathways to track disease states.
NPL “Symptom-based network classification identifies distinct clinical subgroups of liver diseases with common molecular pathways” to Shu et al. teaches of the use of molecular pathways to generate a comorbidity network.
These references do not teach aspects of the invention including but not limited to: “detect a common part exclusively in a portion between a start point and an end point of a path among a plurality of disease pathways representing, as a route map, an intermolecular interaction of related molecules with respect to a disease for each of a plurality of diseases related to state changes or among a plurality of symptom pathways representing, as a route map, an intermolecular interaction of related molecules with respect to a symptom for each of a plurality of symptoms related to state changes”
Conclusion
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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/CONSTANTINE SIOZOPOULOS/
Examiner
Art Unit 3686