DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant filed a response dated 9/19/2025 in which claims 1-42, 44-45, and 54 have been canceled, claims 43, 53, and 55 have been amended. Thus, the claims 43, 46-53, and 55-62 are pending in the application.
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 43, 46-53, and 55-62 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of providing remote medical diagnosis without significantly more.
Claim 43 is directed to a system, which is one of the statutory categories of invention (Step 1: YES).
The claim 43 is directed to a system comprising: a remote server; and a test device comprising: a sensor position to detect physical indicia on a lateral flow assay test strip following application of a sample to the lateral flow assay test strip; at least one processor; and at least one memory device storing a plurality of instructions which, when executed by the at least one processor, cause the at least one processor to: determine a first result of a diagnostic test based on data from the sensor, the first result indicating at least the presence or absence of a condition, store the first result locally in association with additional information associated with the diagnostic test; establish a connection with a network; and transmit the first result and the additional information to the remote server via the network, wherein the additional information indicates a lack of functionality of the test device; and a plurality of additional test devices in communication with the remote server, wherein the remote server is configured to: cause, at the remote server or at one or more of the plurality of additional test devices in response to the additional information, generation of a second result based at least in part on the first result, the additional information, and an aggregation of data from a plurality of diagnostic test results generated at a plurality of test devices and stored at the remote server, wherein the second result comprises a characteristic of the condition, and wherein the lack of functionality of the test device is associated with determination of the characteristic; and transmit the second result to the test device via the network. These limitations (with the exception of italicized limitations), under their broadest reasonable interpretation, describe the abstract idea of providing remote medical diagnosis which may correspond to a Certain Methods of Organizing Human Activity. The additional elements of a remote server, test device(s), a sensor, test strip, one memory device, one processor, and a network do not necessarily restrict the claim from reciting an abstract idea. Thus, the claim 43 recites an abstract idea (Step 2A-Prong 1: YES).
This judicial exception is not integrated into a practical application because the additional elements of a remote server, one memory device, one processor, and a network result in no more than simply applying the abstract idea using generic computer elements. The additional elements of a remote server, one memory device, one processor, and a network are recited at a high level of generality and under their broadest reasonable interpretation comprises a generic computing device. The presence of a generic computing device does nothing more than to implement the claimed invention (MPEP 2106.05(f)). The additional elements of a remote server, one memory device, one processor, and a network are no more than mere instructions to apply the exception using a generic computer element. The additional elements of test device(s), a sensor, test strip are also recited at a high level of generality in that it amount to an insignificant extra-solution activity (i.e., data gathering step) and do not transform the abstract idea into a practical application. Therefore, the recitation of additional elements of a remote server, test device(s), a sensor, test strip, one memory device, one processor, and a network do not meaningfully apply the abstract idea and hence do not integrate the abstract idea into a practical application. Thus, the claim 43 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claim 43 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of a remote server, one memory device, one processor, and a network are recited at a high level of generality in that it results in no more than simply applying the abstract idea using generic computer elements. The additional elements of test device(s), a sensor, test strip are also recited at a high level of generality in that it amount to an insignificant extra-solution activity (i.e., data gathering step) and do not transform the abstract idea into a practical application. The additional elements when considered separately and as an ordered combination do not amount to add significantly more as these elements provide nothing more than to simply apply the exception in a generic computer environment (Step 2B: NO). Thus, the claim 43 is not patent-eligible.
Similar arguments can be extended to other independent claim 53 and hence rejected on similar grounds as claim 43.
Dependent claims 46-52 and 55-62 further define the abstract idea that is present in their respective independent claims 43 and 53 and hence corresponds to Certain Methods of Organizing Human Activity and hence are abstract in nature for the reasons presented above. Dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the claims 46-52 and 55-62 are directed to an abstract idea. Thus, the claims 43, 46-53, and 55-62 are not patent-eligible.
Response to Arguments
Examiner withdraws 35 U.S.C. 103 rejection of claims 43, 46-53, and 55-62 in view of the amendment/argument.
Applicant's arguments filed dated 9/19/2025 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claims 43, 46-53, and 55-62 under 35 U.S.C. 101, Applicant states that the claimed systems, taken as a whole, integrate any alleged judicial exception to improve the field of electronically reported remote diagnostic testing, and applies that improvement to the practical application of improving the function of malfunctioning remotely operated IVD devices.
Examiner respectfully disagrees and notes that the claim does not recite any improvement to a function of malfunctioning remotely operated IVD devices. In this case, when a IVD lacks certain functionality (a malfunction device), the obtained test results from the malfunction IVD is analyzed by additional IVD devices that are remotely located. The results are then sent back to the malfunction device so that it can continue to process the test results. In this case, another IVD is used to analyze the data which was not possible by the malfunction IVD due to the lack of functionality of one of its components. There is no restoration of functionality of the malfunction component of the IVD. The invention makes use of remotely located IVD which can process the data that is otherwise not possible with the malfunction components of the IVD. As such, the malfunctioning component of the IVD has not been restored. Thus, these arguments are not persuasive.
With respect to the claims amounting to significantly more than the identified judicial exception, Examiner notes that since there is no technical solution to a technical problem, the additional elements simply applies the abstract idea and do not amount to add significantly more.
With respect to the double patent rejection of claims 43, 45-53, and 55-62, Examiner notes that Applicant will consider filing a terminal disclaimer in the event that the claims are found to be otherwise in condition for allowance.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJESH KHATTAR whose telephone number is (571)272-7981. The examiner can normally be reached M-F 8AM-5PM.
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RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684