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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 17 February 2026 has been entered.
Response to Amendment
Claims 1-11 and 24 are currently pending. Claims 1, 5, 8-11, and 24 have been amended. Claim 9 has been amended to overcome the claim objection set forth in the Final Office Action mailed on 15 September 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “significant” in claim 10 is a relative term which renders the claim indefinite. The term “significant” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what it means for a change to be “significant.” It is noted that although [0060], [0062], [0076], Figs. 6c, 6e, and 11 of the PGPUB mentions a “significant decrease/variation,” there is no clear definition as to what a “significant decrease/variation” is. Although Figs. 6c, 6e, and 11 show a “significant decrease/variation,” it is unclear the different between a “regular” decrease/variation and a “significant” decrease/variation. Clarification is requested.
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 1-11 and 24 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, 10, and 11 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 (see 35 U.S.C. 102(a)(1) rejection below). 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.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pardey et al. ‘630 (US Pub N. 2016/0143630 – previously cited).
Regarding claim 1, Pardey et al. ‘630 teaches a method for determining a status of a biomarker in a human being or mammal ([0094]) comprising:
providing a system comprising a temperature measurement device configured to be positioned in a body orifice (Fig. 1 indwelling unit 2 and [0224]), and an analyzing tool configured to analyze a continuous series of body core temperature data points (Fig. 1 processor 11 and [0231]);
the temperature measurement device positioned in the body orifice measuring (Fig. 1 indwelling unit 2 and [0224]), for a plurality of first time intervals ([0224]; “regular time intervals”), the continuous series of body core temperature data points relating to body temperature ([0224]; “multiple temperature readings at regular time intervals during the overnight period”), wherein the measuring is continuously performed all day for at least 10 days (Fig. 3 and [0332]; “…temperature readings taken every 5 minutes from an indwelling temperature recording device (“personal sensor”) placed intravaginally in a woman from day 9 to day 26 of her cycle.”;
the analyzing tool determining a series of representative temperature values for the plurality of first time intervals ([0033], [0224]);
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 ([0033]; “determining a representative temperature value”);
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 and a temperature minimum of the series of temperature fluctuations data to obtain a plurality of temperature amplitudes ([0328]);
the analyzing tool determining a series of temperature amplitudes from the plurality of temperature amplitudes ([0184]-[0190], [0328]); 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 ([0185], [0328]).
Regarding claim 2, Pardey et al. ‘630 teaches wherein the first portion of the series of temperature amplitudes varies from the second portion of the series of temperature amplitudes due to a decrease in the second portion of the series of temperature amplitudes relative to the first portion of the series of temperature amplitudes, and wherein the decrease indicates a higher biomarker level (Fig. 4 and [0339]; “pre-ovulatory temperature dip which is associated with a rise in oestradiol levels”).
Regarding claim 3, Pardey et al. ‘630 teaches wherein the biomarker is a progesterone response of the human being or mammal ([0185], [0328]).
Regarding claim 4, Pardey et al. ‘630 teaches wherein the series of representative temperature values is a series of Nadir values of the body core temperature data, a series of average temperature values of the body core temperature data ([0060], [0366]), or a combination thereof.
Regarding claim 5, Pardey et al. ‘630 teaches the analyzing tool determining a change in rate of the temperature amplitudes ([0057]-[0058], [0188], [0328]).
Regarding claim 6, Pardey et al. ‘630 teaches wherein the variation between the first portion of the series of temperature amplitudes and the second portion of the series of temperature amplitudes is a variation in the average amplitude of the temperature amplitudes ([0060], [0366]), a variation in the change in rate of the temperature amplitudes ([0057]-[0058], [0188], [0328]), an increase in the temperature amplitudes ([0061]), a decrease in the temperature amplitudes ([0339]), or a combination thereof.
Regarding claim 24, Pardey et al. ‘630 teaches wherein the body orifice is in a vaginal cavity ([0224]; “The indwelling device is worn in the vagina every night from the first night following the end of menstruation until such time as the next menstrual period starts.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Pardey et al. ‘630 in view of Barton-Sweeney ‘311 (International Pub No. WO 2016/183311 – previously cited).
Regarding claim 7, Pardey et al. ‘630 teaches all of the elements of the current invention as mentioned above except for wherein the first portion of the series of temperature amplitudes varies from the second portion of the series of temperature amplitudes due to a decrease in the second portion of the series of temperature amplitudes relative to the first portion of the series of temperature amplitudes, and wherein the decrease indicates a higher level of progesterone as the biomarker.
Barton-Sweeney ‘311 teaches wherein the first portion of the series of temperature amplitudes varies from the second portion of the series of temperature amplitudes due to a decrease in the second portion of the series of temperature amplitudes relative to the first portion of the series of temperature amplitudes, and wherein the decrease indicates a higher level of progesterone as the biomarker ([0055]; “The predetermined prediction equation can further comprise temperature changes in thermogenic processes, such as the thermogenic properties of progesterone…” It is noted that [0029] teaches that the predetermined prediction equation can predict when ovulation will occur or has occurred, and at what point a woman is in her menstrual cycle. One of ordinary skill would understand that progesterone, a biomarker, is at higher levels when ovulation has occurred. [0029] also teaches that mesor of the temperature values increases and amplitude is lowered during the post-ovulatory/luteal phase.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biomerker of Pardey et al. ‘630 to include indicating a higher level of progesterone as Barton-Sweeney ‘311 teaches that this will aid in determining when ovulation will occur or has occurred and at what point a woman is in her menstrual cycle.
Regarding claim 8, Pardey et al. ‘630 in view of Barton-Sweeney ‘311 teaches all of the elements of the current invention as mentioned above except for the analyzing tool determining the length of the second portion of the series of the temperature amplitudes and characterizing a female cycle based on the length of the second portion of series of temperature amplitudes.
Barton-Sweeney ‘311 teaches determining the length of the second portion of the series of the temperature amplitudes and characterizing a female cycle based on the length of the second portion of series of temperature amplitudes ([0029]; “changes in the amplitude of the temperature values…comprising at least one of the foregoing over time…can be used in the predetermined prediction equation…and the predetermined prediction equation can predict when ovulation will occur or has occurred, and at what point a woman is in her menstrual cycle.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analyzing tool of Pardey et al. ‘630 to include determining the length of the second portion of the series of the temperature amplitudes and characterizing a female cycle based on the length of the second portion of series of temperature amplitudes as Barton-Sweeney ‘311 teaches that this will aid in predicting when ovulation will occur or has occurred and at what point a woman is in her menstrual cycle.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Pardey et al. ‘630 in view of Barton-Sweeney ‘311 further in view of Park et al. ‘990 (US Pub No. 2018/0274990 – previously cited).
Regarding claim 9, Pardey et al. ‘630 in view of Barton-Sweeney ‘311 teaches all of the elements of the current invention as mentioned above except for wherein the first portion of the series of temperature amplitudes varies from a second portion of the series of temperature amplitude due to the decrease in the second portion of the series of temperature amplitudes relative to the first portion of the series of temperature amplitudes and wherein the second period lasts for at least 17 days, indicating a beginning of pregnancy.
Park et al. ‘990 teaches if the basal body temperature is maintained at a high temperature for 18 days or more after the ovulation day, it is considered that there is a possibility of pregnancy. If the high temperature is increased without being maintained, it is considered that the menstruation starts ([0124]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Pardey et al. ‘630 in view of Barton-Sweeney ‘311 to include wherein the first portion of the series of temperature amplitudes varies from a second portion of the series of temperature amplitude due to the decrease in the second portion of the series of temperature amplitudes relative to the first portion of the series of temperature amplitudes and wherein the second period lasts for at least 17 days, indicating a beginning of pregnancy as Park et al. ‘990 teaches that the change in basal body temperature would indicate which stage a woman is in the menstruation cycle or if the woman is pregnant.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Pardey et al. ‘630 in view of Sano ‘184 (US Pub No. 2017/0319184 – previously cited).
Regarding claim 10, Pardey et al. ‘630 teaches all of the elements of the current invention as mentioned above except for the analyzing tool determining the duration of a significant change by determining a number of first time intervals, for which the representative temperature value changes.
Sano ‘184 teaches an analysis unit calculates and records values of the user's temperature difference, menstrual cycle, predicted ovulation date, and the like and calculates amounts of time series changes in these items to determine the tendency ([0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analzying tool of Pardey et al. ‘630 to include determining the duration of a significant change by determining a number of first time intervals, for which the representative temperature value changes as Sano ‘184 teaches that this will aid in determining the tendency.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Pardey et al. ‘630 in view of Cantor et al. ‘879 (US Pub No. 2014/0073879 – previously cited).
Regarding claim 11, Pardey et al. ‘630 teaches all of the elements of the current invention as mentioned above except for the analyzing tool identifying a variation in measured pH-values, and the analzying tool correlating the variation in the measured pH-values with the variation between the first portion of the series of temperature amplitude and the second portion of the series of temperature amplitude.
Cantor et al. ‘879 teaches it will be understood that monitoring of the physiological parameters of a pregnancy requires that body temperature and pH may also be monitored and recorded. The various embodiments of the sensing devices described herein are provided with the appropriate sensors for detecting body temperature and pH. These sensing devices are well understood in the art and do not per se form a part of this invention ([0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analyzing tool of Pardey et al. ‘630 to include identifying a variation in measured pH-values and correlating the variation in the measured pH-values with the variation between the first portion of the series of temperature amplitude and the second portion of the series of temperature amplitude as Cantor et al. ‘879 teaches that it is known in the art to monitor body temperature and pH to monitor pregnancy.
Response to Arguments
Applicant argues that the term “significant” is definite and that the disclosure provides examples of a significant decrease/variation. It is noted that although [0060], [0062], [0076], Figs. 6c, 6e, and 11 of the PGPUB mentions a “significant decrease/variation,” there is no clear definition as to what a “significant decrease/variation” is. Although Figs. 6c, 6e, and 11 show a “significant decrease/variation,” it is unclear the different between a “regular” decrease/variation and a “significant” decrease/variation. As such, the 35 U.S.C. 112(b) rejection has been maintained.
Applicant argues that claim 1 is not drawn to a mental process because the steps are performed by the temperature measurement device and an analyzing tool. However, these structural components are generic computer components. The disclosure does not provide further details as to what the temperature measurement device and analyzing tool are. Thus, the Examiner is interpreting as a generic temperature measurement device and analyzing tool that are known in the art. 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. As such, the 35 U.S.C. 101 rejection has been maintained.
Applicant argues that Pardey et al. ‘630 does not teach measuring temperature continuously for at least 10 days. Examiner respectfully disagrees, as Fig. 3 and [0332] teaches taking temperature readings every 5 minutes from an indwelling temperature recording device placed intravaginally in a woman from day 9 to day 26 of her cycle, or 17 days. Applicant also argues that Pardey et al. ‘630 does not teach “determining…a difference between the temperature maximum…and temperature minimum…” Examiner respectfully disagrees, as [0328] of Pardey et al. ‘630 teaches determining the change in temperature. One of ordinary skill would understand that a change in temperature requires subtracting a minimum temperature from a maximum temperature to determine the change. As such, Applicant’s arguments are not persuasive and the 35 U.S.C. 102(a)(1) and 35 U.S.C. 103 rejections have been maintained.
Conclusion
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