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 Objections
Claim 19 objected to because of the following informalities: Claim recites “The method according to claim 15” however it should be “The device according to claim 15”. Appropriate correction is required.
Response to Arguments
Regarding the arguments against the rejection of claims under 35 USC 101, the Examiner respectfully disagrees. Applicant argues that the claims do not represent or constitute an abstract judicial exception. Examiner asserts that the analysis of the radiology image and molecular sequencing data is claimed in a non-specific manner, and under broadest reasonable interpretation, these data inputs can be analyzed in the human mind. “Determining” a specific cancer diagnosis recites the abstract idea and there is no indication of an improvement to diagnostic medical imaging and sequencing technology. Further, the use of the aggregation network for the embeddings recites the use of generic computing components to perform the abstract idea.
Applicant further argues that the claims are integrated into a practical application of transforming molecular sequencing and imaging data from biological samples into a form that improves clinical interpretation and decision making. Examiner asserts that the use of the generic computing components to perform the abstract idea and to then improve interpretations and decision making recites an improvement to the abstract idea, not a technology improvement, see MPEP 2106.05(a)II, particularly “Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.” Further, Applicant argues that the claims are neither anticipated nor obvious in view of any cited art, much less routine or conventional features or combinations of features. Examiner further asserts that under Step 2B of the SME analysis, prior art is not necessary to establish significantly more subject matter. See MPEP 2106.05(d)(I), specifically “Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018). However, this does not mean that a prior art search is necessary to resolve this inquiry. Instead, examiners should rely on what the courts have recognized, or those in the art would recognize, as elements that are well-understood, routine, conventional activity in the relevant field when making the required determination.” Due to the amendments, rejection under 35 USC 101 has been updated as shown below.
Regarding the rejection of claims under 35 USC 102, Examiner agrees and therefore this rejection is withdrawn.
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 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 15-20 are related to a system, and claims 1-14 are also related to a method (i.e., a process). 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 15 includes limitations that recite at least one abstract idea as underlined in the following limitations. Specifically, independent claim 15 recites:
A clinical prediction device comprising at least one processing device having at least one communication interface
configured for retrieving input data, wherein the input data comprises multiple different modalities of characterizing a patient, the medical data modalities comprising pathology and/or radiology image data, and clinical status data,
wherein the processing device is configured for processing the input data, wherein the processing comprises generating embedding modality representations respective to the different modalities from the input data by using at least one trainable data embedder, wherein the embedding modality representations comprise sections or data points of the pathology and/or radiology image data, gene expressions of the molecular sequencing data, and a tumor or tissue type of the clinical status data, wherein the processing comprises combining the embedding modality representations using at least one aggregation network thereby generating the clinical prediction, wherein the aggregation network comprises at least one attention layer and/or at least one transformer layer,
wherein the processing device is configured for generating an output of a clinical prediction for cancer treatment or diagnosis.
The Examiner submits that the foregoing underlined limitations constitute a “mental process”, as the following abstract limitations are related to observations, evaluations and judgments that can be practically performed in the human mind:
“processing” the input data, wherein the processing comprises “generating” embedding modality representations respective to the different modalities from the input data, and wherein the embedding modality representations comprise sections or data points of the pathology and/or radiology image data, gene expressions of the molecular sequencing data, and a tumor or tissue type of the clinical status data, which are abstract limitations of analysis of the input data to generate abstract representations of the modalities of the data
Processing further comprises “combining” the embedding modality representations, which are abstract limitations of analysis and determinations for combining the abstract representations of the modalities,
“generating” the clinical prediction for cancer treatment or diagnosis, which is an abstract limitation of analysis and determination of the modality representations for cancer treatments.
Accordingly, the claim recites the steps for generating a clinical prediction that can practically be performed in the human mind.
The abstract idea recited in claim 1 is similar to that of claim 15.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” (i.e., device) 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 further describing the clinical prediction, further describing the abstract idea. Claim 6 recites further abstract limitations of the aggregation of the modality information, thus further describing the abstract idea. Claim 16 recites further abstract limitations describing the modality representations specific for a patient, further describing the abstract idea. Claim 17 recites further abstract limitations describing the clinical prediction comprising a specific therapy recommendation for the patient, further describing the abstract idea. Claim 18 recites further abstract limitations of the output of the embedder as comprising multiple instance embeddings for each modality, further describing the abstract idea. Claim 19 recites further the data that is used to create the embedding modality representations, further describing the 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 clinical prediction device comprising at least one processing device having at least one communication interface (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f))
configured for retrieving input data, wherein the input data comprises multiple different modalities of characterizing a patient, the medical data modalities comprising pathology and/or radiology image data, and clinical status data (merely data gathering steps as noted below, see MPEP 2106.05(g) and Symantec),
wherein the processing device is configured for (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)) processing the input data, wherein the processing comprises generating embedding modality representations respective to the different modalities from the input data by using at least one trainable data embedder (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)), wherein the embedding modality representations comprise sections or data points of the pathology and/or radiology image data, gene expressions of the molecular sequencing data, and a tumor or tissue type of the clinical status data, wherein the processing comprises combining the embedding modality representations using at least one aggregation network thereby (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)) generating the clinical prediction, wherein the aggregation network comprises at least one attention layer and/or at least one transformer layer (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)),
wherein the processing device is configured for generating an output of a clinical prediction (merely post solution activity as noted below, see MPEP 2106.05(g) and Symantec) for cancer treatment or diagnosis.
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 limitations of:
the overall clinical prediction device which comprises a processing device,
the use of at least one trainable data embedder,
use of at least one aggregation network, and
where the aggregation network comprises at least one attention layer,
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)). [Page 5 lines 1-20] of the Applicant’s Specification recites the use of the overall generic computing system with the processing device. [Page 7 lines 10-21] recites the trainable data embedder as a generically trained machine learning model, however there is no specific configuration of the embedder beyond the use as recited in the disclosure. [Page 7 lines 35-38 -Page 8 lines 1-10] recites the use of the aggregation network as a generically recited deep neural network, however there is no specific configuration beyond the generic configuration as recited in the disclosure. [Page 8 lines 16-23] recites the use of the attention layer, however there is no specific configuration of the layer of the neural network beyond the generic configuration as recited in the disclosure. 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.
Regarding the additional limitation of at least one communication interface configured for retrieving input data, wherein the input data comprises multiple different modalities of characterizing a patient, the medical data modalities comprising pathology and/or radiology image data, and clinical status data, this is merely pre-solution activity. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)). [Page 5 lines 21-36] of the Applicant’s Specification reciting the use of the communication interface that transmits data for the receiving of input data which is further described in [Page 14 lines 29-31]. The use of the communication interface to retrieve data are used to perform actions for the system including data gathering for the abstract idea, and thus recites insignificant pre-solution activities.
Regarding the additional limitation of wherein the processing device is configured for generating an output of the clinical prediction, these are merely post-solution activity. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of insignificant application to the at least one abstract idea in a manner that does not meaningfully limit the at least on abstract idea (see MPEP § 2106.05(g)). [Page 22 lines 1-7] of Applicant’s specification recites the use of the processing device for merely generating an output of the abstract idea using a display, and therefore recites impractical application.
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 generate a clinical prediction, 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:
Claim 3 recites insignificant post solution activity of using the interface to merely output the abstract idea. Claim 4 recites further detail of the insignificant pre-solution activity of receiving the modalities of data. Claim 5-14 recites details of the aggregation network and description of the layers of the models that are used when representing the modality data, however this detail amounts to merely “apply it”, as there is no specific configuration of the layers and processing network as to the integration with the abstract idea, and that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components. Claim 16 recites further the additional elements for data gathering by describing the input data from the insignificant pre-solution activity. Claim 20 recites additional elements related to the attention layer comprising ML through back propagation, 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 limitations of:
the overall clinical prediction device which comprises a processing device,
the use of at least one trainable data embedder,
use of at least one aggregation network, and
where the aggregation network comprises at least one attention layer,
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)). [Page 5 lines 1-20] of the Applicant’s Specification recites the use of the overall generic computing system with the processing device. [Page 7 lines 10-21] recites the trainable data embedder as a generically trained machine learning model, however there is no specific configuration of the embedder beyond the use as recited in the disclosure. [Page 7 lines 35-38 -Page 8 lines 1-10] recites the use of the aggregation network as a generically recited deep neural network, however there is no specific configuration beyond the generic configuration as recited in the disclosure. [Page 8 lines 16-23] recites the use of the attention layer, however there is no specific configuration of the layer of the neural network beyond the generic configuration as recited in the disclosure. 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.
Regarding the additional limitation of at least one communication interface configured for retrieving input data, wherein the input data comprises multiple different modalities of characterizing a patient, the medical data modalities comprising pathology and/or radiology image data, and clinical status data, this is merely pre-solution activity. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g) and MPEP § 2106.05(d)(II), specifically “Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information)”). [Page 5 lines 21-36] of the Applicant’s Specification reciting the use of the communication interface that transmits data for the receiving of input data which is further described in [Page 14 lines 29-31]. The use of the communication interface to retrieve data are used to perform actions for the system including data gathering for the abstract idea, and thus recites insignificant pre-solution activities and does not recite significantly more than the judicial exception. The use of the communication interfaces is for the transmission of information from one device to another as described in [Page 5 lines 21-36] for insignificant extra solution activity, and thus recites well understood, routine, and conventional activity.
Regarding the additional limitation of wherein the processing device is configured for generating an output of the clinical prediction, these are merely post-solution activity. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of insignificant application to the at least one abstract idea in a manner that does not meaningfully limit the at least on abstract idea (see MPEP § 2106.05(g) and MPEP § 2106.05(d)(II), specifically “Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information)”). [Page 22 lines 1-7] of Applicant’s specification recites the use of the processing device for merely generating an output of the abstract idea using a display, and therefore recites impractical application and does not recite significantly more than the judicial exception. The transmission of the output to another device such as a display for the insignificant post solution activity recites well understood, routine, and conventional activity.
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 1-20 are rejected under 35 USC 101 as being directed to non-statutory subject matter.
The following references have been considered as relevant, however have not been used in the above rejections:
US-20230410483-A1 to Chen et al. teaches of the use of multiple modalities of medical data to be used for medical image analysis.
NPL “MAIN: multimodal attention-based fusion networks for diagnosis prediction” to An et la. teaches of the analysis of HER data using a multimodal attention fusion model for predicting a diagnosis.
NPL “Multi-task prediction of clinical outcomes in the intensive care unit using flexible multimodal transformers” to Shickel et al. teaches the use of transformer models to make determinations of clinical outcomes.
Additionally, US 20220292674 A1 to Braman et al. teaches of a system for identifying a multimodal biomarker for deep learning to be used for unimodal embedding predictions.
These references do not teach aspects of the current invention including but not limited to: “wherein the embedding modality representations comprise sections or data points of the pathology and/or radiology image data, gene expressions of the molecular sequencing data, and a tumor or tissue type of the clinical status data, wherein the processing comprises combining the embedding modality representations using at least one aggregation network thereby generating the clinical prediction, wherein the aggregation network comprises at least one attention layer and/or at least one transformer layer”
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
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