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 . 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 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.
Response to Amendment
This Office Action is responsive to the amendment filed 03/18/2026 (“Amendment”). Claims 33-40, 43, and 44 are currently under consideration. The Office acknowledges the amendments to claims 33-40 and 44.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Information Disclosure Statement
Applicant is reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this application.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 33-40, 43, and 44 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.
Regarding claim 33, there is no support for the electronics module including more than one processor, memory device, and transceiver.
Further regarding claims 33, 34, and 40, there is no support for the phrase “metabolic health risk score.” A risk score is only contemplated with respect to sepsis, not metabolic health generally. Likewise, there is no support for determining a risk score based on a tissue hydration level and predetermined correlations between lactate risk values and glucose risk values generally. This is especially true in the context of a metabolic health risk score that is separate from lactate and glucose risk values. The displaying and comparing of this score are not supported. Applicant is requested to point to specific support in the disclosure for all claim limitations.
Claims 34-40, 43, and 44 are rejected because they depend on rejected claims.
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 33-40, 43, and 44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 33-40, 43, and 44 are directed to a “method,” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 33 recites (“sets forth” or “describes”) the abstract idea of a mental process and mathematical concept, substantially as follows:
determining a lactate risk value by normalizing the lactate level; determining a glucose risk value by normalizing the glucose level; determining a tissue hydration level of the subcutaneous tissue based on the tissue impedance level; determining a metabolic health risk score based at least in part on the tissue hydration level and predetermined correlations between lactate risk values and glucose risk values, the metabolic health risk score being indicative of a disease state; comparing the metabolic health risk score to a predetermined threshold corresponding to the disease state, and automatically generating an alert signal responsive to the metabolic health risk score exceeding the predetermined threshold, the alert signal being configured to notify a user of the disease state.
The determining and comparing steps can be practically performed in the human mind, with the aid of a pen and paper, but for performance on a generic computer, in a computer environment, or merely using the computer as a tool to perform the steps. If a person were to see a printout of the measurements of the plurality of analytes, e.g. lactate and glucose, they would be able to normalize the values to obtain risk values, determine a metabolic conditions score by visually observing correlations/trends/etc. in the data, and monitor changes over time. There is nothing to suggest an undue level of complexity in the metabolic conditions scores or the monitoring. Therefore, a person would be able to perform the steps mentally or with pen and paper.
The determining and comparing steps also involve the mathematical concepts of calculation and comparison. These steps correspond to “[w]ords used in a claim operating on data to solve a problem [that] can serve the same purpose as a formula.” See MPEP 2106.04(a)(2)(I).
Prong Two: Claim 33 does not include additional elements that integrate the abstract idea into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. an electronics module having one or more processors, memory devices, and transceivers, and processing circuitry coupled to the electronics module), and
add insignificant extra-solution activity (the pre-solution activity of: inserting a sensor array and measuring lactate, glucose, and hydration levels, using generic data-gathering components (i.e., the sensor assembly, having a plurality of electrodes and coupled to an electronics module); the post-solution activity of: displaying the risk values and the metabolic health risk score, using generic data-outputting components (i.e., a mobile device)).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The alert signal is not actually outputted. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 33 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the abstract idea (e.g. determining a tissue oxygen risk value (claim 34), calculating a ratio or rate of change (claims 35 and 36), the health score including other data (claim 40), etc.),
further describe the extra-solution activity (or the structure used for such activity) (e.g. measuring tissue oxygen (claim 34), using particular intervals (claims 37-39), etc.), and
describe field of use context (e.g. the disease state being cancer or a metabolic condition (claims 43 and 44), etc.).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. Although data is outputted/displayed, there is nothing requiring the data to be seen or acted on. The alert signal is not outputted. The additional elements also do not add anything significantly more than the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Response to Arguments
Applicant’s arguments filed 03/18/2026 have been fully considered.
In response to the amendments and arguments regarding the rejections under 35 USC 101, they are not persuasive. The claims do not necessarily contemplate real-time monitoring. The real-time measurements, even if they provide real-time data, do not need to be processed in real-time. Further, even if they do, there is nothing preventing a user from seeing the data, being collected in real-time, and making determinations based thereon. Nothing requires the determinations to be e.g. for every data point, not based on trends, etc..
As noted above, the electrodes of the array are not part of the abstract idea. I.e., the Office agrees that the mind cannot obtain an invasive measurement. Instead, the electrodes merely serve to provide data to the abstract idea. They do not practically apply it.
An improvement to the technology is not evident, as the determined lactate and glucose risk values are only outputted and are otherwise not used for anything. It is unclear how recitation of “a specific technological environment” provides a practical application.
The Office did not rely on characterizing any elements as well-understood, routine, or conventional, and therefore does not need to establish this. It is unclear how recitation of “a specific technological implementation” provides an inventive concept.
In response to the amendments and arguments regarding the rejections under 35 USC 103, they are persuasive to the extent that the previous combination did not mention the concept of using hydration level to determine a metabolic health risk score. However, Applicant should note the new rejections under 35 USC 112(a), necessitated by amendment.
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 ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday - Friday 7 am - 3 pm.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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