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 Amendment
Claims 1-9, 24, and 25 are currently pending. Claim 10 has been cancelled. Claim 25 has been added. The cancellation of claim 10 has rendered the 35 U.S.C. 112(b) rejection set forth in the Non-Final Office Action mailed on 26 March 2026 moot.
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 1-9, 11, 24, and 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including providing a system. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
providing a system comprising a temperature measurement device configured to be positioned in a body orifice, and
an analyzing tool configured to analyze a continuous series of body core temperature data points
the analyzing tool determining a series of representative temperature values for the plurality of first time intervals;
the analyzing tool subtracting the series of representative temperature values from the continuous series of body core temperature data points relating to the body temperature to obtain a series of temperature fluctuations;
the analyzing tool determining, in the series of temperature fluctuations, for the plurality of first time intervals, a difference between a temperature maximum of the series of temperature fluctuations data and a temperature minimum of the series of temperature fluctuations data to obtain a plurality of temperature amplitudes;
the analyzing tool determining a series of temperature amplitudes from the plurality of temperature amplitudes; and
the analyzing tool determining if a first portion of the series of temperature amplitudes varies from a second portion of the series of temperature amplitudes indicating a change in the biomarker status
set forth a judicial exception. The providing step describes a concept of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The determining and subtracting steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to Organizing Human Activity and a Mental Process, which is an Abstract Idea. It is noted that the subtracting step and determining a difference step describes mathematical relationships, mathematical formulas or equations, mathematical calculations, which is a Mathematical Concept, which is also an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites the analyzing tool determining if a first portion of the series of temperature amplitudes varies from a second portion of the series of temperature amplitudes indicating a change in the biomarker status, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The determining of variation does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the determined variation, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional step of the temperature measurement device positioned in the body orifice measuring, for a plurality of first time intervals, the continuous series of body core temperature data points relating to body temperature, wherein the measuring is continuously performed all day for at least 10 days. The measuring step is well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the measurement step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the method is performed by a temperature measurement device and an analyzing tool. However, these devices are generic components configured to perform the Abstract Idea. The temperature measurement device is a generic sensor configured to perform pre-solutional data gathering activity and the analyzing tool is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims.
Claims 2-4, 6, 7, and 9 recite additional details of the data, which does not add anything significantly more to the Abstract Idea. Claims 5, 8, 11, and 25 recite steps that would add to the Abstract Idea as each step in the claims recite steps that could be performed mentally or by hand. Claim 24 recites that the temperature measurement device is positioned in a vaginal cavity, which is not significantly more than the abstract idea as it is well-understood, routine, and conventional, as supported by Pardey et al. '630. The comparing and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Response to Arguments
Applicant argues that providing and operating a temperature measurement device is not organizing human activity. Examiner respectfully disagrees as a user could be instructed to obtain a temperature measurement device and position the temperature measurement device on a person. Applicant also argues that the determining and subtracting steps are not mental processes. Examiner respectfully disagrees, as this could be merely be a user reviewing the temperature data points and subtracting the temperature values from body core temperature data points. Applicant also argues that the processing is continuous and done over multiple days. However, it is noted that claim 1 only mentions that the measurement of the temperature data is done continuously for at least 10 days, which is seen as pre-solutional activity of data gathering (see pages 5-6 of Remarks).
Applicant argues that the continuous measurement of body core temperature for at least 10 days, subtracting a series of representative temperature values from the continuous data, and determining interval-specific amplitudes from maxima and minima in those fluctuations, and comparing the portions of the resulting amplitude series to identify a biomarker-status change is the technical solution. However, it is noted that section 2106.05(a) II. of the MPEP states that “…it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology.” Applicant mentions that the subtraction removes shifts in absolute temperature that results in more precise variations and more reliable amplitude determinations. However, the subtracting step is seen as an Abstract Idea. There is no improvement as a result to the subtracting step. Examiner suggests to add more detail to the subtracting step to clearly recite how this step improves/transforms that system to potentially overcome the 35 U.S.C. 101 rejection (see pages 6-7 of Remarks).
Applicant argues that the all-day body orifice measurement as recited in claim 1 is not WURC. Examiner respectfully disagrees, as the structural components are recited at high generality. Claim 1 merely recites a temperature measurement device and an analyzing tool, which is WURC, as supported by [0308] of Dugan ‘822 (US Pub No. 2015/0289822) (see page 7 of Remarks).
Applicant argues that new claim 25 confines the method to a specific interval-matched processing architecture. However, claim 25 also recites determining and subtracting steps that add to the Abstract Idea. Regarding the 24-hour intervals, these are just additional elements that are not significantly more (see pages 7-8 of Remarks). As such, Applicant’s arguments are not persuasive and the 35 U.S.C. 101 rejection has been maintained.
Applicant’s arguments, see pages 8-14, have been fully considered and are persuasive. Thus, the 35 U.S.C. 102(a)(1) and 103 rejections of claims 1-9, 11 and 24 have been withdrawn.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
