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 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 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more. The claim(s) recite(s) a predicting step which is directed to an abstract idea of collecting data and then outputting via a mental process a predicted outcome based on statistical models or mathematical formulas. This judicial exception is not integrated into a practical application because the claim recites limitations that are based on or involve a mathematical concept that is carried out in the mind (predicting based upon collected data). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because data is being applied to an abstract idea and predicting is being performed in the mind based upon a statistical model.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/146043 (herein after WO 043) in view of WO 2019/213520 (herein after WO 520).
Regarding claim 15, WO 043 teaches method for predicting ovulation in a subject using a device for measuring one or more analytes in a sample of interstitial fluid, blood or both, where the device comprises at least one electrochemical aptamer-based (EAB) (sensor 120, 150, is an EAB comprising an attached redox couple that measures at least one analyte, para 50, fig. 1a) The EAB of WO 043 is structurally capable of measuring an analyte in an interstitial fluid) positioned ex-vivo (para 50 states, EAB is ex-vivo, also seen in fig. 1a, 100 is positioned outside of the body.); and
the method comprising: determining a baseline luteinizing hormone level in the subject prior to ovulation by continuous monitoring average luteinizing hormone levels over an initial time period of at least 10 minutes (analyte levels are monitored over time, see fig. 2-3).
WO 043 does not teach wherein the initial time period is cycle start date until 18 days before the next expected cycle start date; and confirming ovulation when progesterone levels, or levels of metabolites thereof: a) increase at least 2-fold over the baseline of progesterone level, or a level of metabolites thereof, and/or b) reach an absolute progesterone level, or level of metabolites thereof, of greater than 5 ng/ml progesterone or a metabolite thereof.
WO 520 teaches an EAB sensor having an attached redox couple (para 19,29-30) that measures the amount of estrogen within the interstitial fluid (para 29-30).
It would have been obvious to one having an ordinary skill in the art at the time of the invention to modify WO 043 to employ the device to measure estrogen as taught by WO 520 in order to monitor ovulation within women (WO 520, para 29). WO 043 measures continuous concentration (see fig 2-3).
Regarding claim 16, the method of claim 15, wherein ovulation is predicted when the luteinizing hormone levels increase 2-fold or 3-fold over the baseline luteinizing hormone level. The modified WO 045 measures analyte levels at 2 fold, see fig. 2-3)
Regarding claim 17, WO 045 teaches a method of confirming ovulation in a subject using a device for measuring one or more analytes in a sample of interstitial fluid, blood or both, where the device comprises at least one electrochemical aptamer-based (EAB) (sensor 120, 150, is an EAB comprising an attached redox couple that measures at least one analyte, para 50, fig. 1a) The EAB of WO 043 is structurally capable of measuring an analyte in an interstitial fluid) positioned ex-vivo (para 50 states, EAB is ex-vivo, also seen in fig. 1a, 100 is positioned outside of the body.);
the method comprising: determining a baseline of progesterone level, or a level of metabolites thereof (analyte levels, para 50), in the subject prior to ovulation by continuous monitoring average progesterone levels, or average levels of metabolites thereof (para 50), over an initial time period of at least 10 minutes (fig. 2-3).
WO 043 does not teach wherein the initial time period is cycle start date until 18 days before the next expected cycle start date; and confirming ovulation when progesterone levels, or levels of metabolites thereof: a) increase at least 2-fold over the baseline of progesterone level, or a level of metabolites thereof, and/or b) reach an absolute progesterone level, or level of metabolites thereof, of greater than 5 ng/ml progesterone or a metabolite thereof.
WO 520 teaches an EAB sensor having an attached redox couple (para 19,29-30) that measures the amount of estrogen within the interstitial fluid (para 29-30).
It would have been obvious to one having an ordinary skill in the art at the time of the invention to modify WO 043 to employ the device to measure estrogen as taught by WO 520 in order to monitor ovulation within women (WO 520, para 29). WO 043 measures continuous concentration (see fig 2-3).
Regarding claim 18, the method of claim 17, wherein ovulation is predicted when the progesterone levels, or levels of metabolites thereof, increase 2-fold (see fig. 2-3) or 3-fold over the baseline progesterone level, or level of metabolites thereof.
Regarding claim 19, the method of claim 17, wherein the metabolite of progesterone is pregnanediol. WO 520 teaches an EAB sensor having an attached redox couple (para 19,29-30) that measures the amount of estrogen within the interstitial fluid (para 29-30).
It would have been obvious to one having an ordinary skill in the art at the time of the invention to modify WO 043 to employ the device to measure estrogen as taught by WO 520 in order to monitor ovulation within women (WO 520, para 29). WO 043 measures continuous concentration (see fig 2-3).
Regarding claim 20, the method of claim 15, wherein the initial time period is at least 2 hours, or about 2 hours (see fig 2-3).
Response to Arguments
Applicant's arguments filed 3/25/26 have been fully considered but they are not persuasive. Applicant argues, “However, WO 043 does not teach the claimed hormone-specific ovulation prediction/confirmation methods, including baseline determination, threshold-based prediction, and dual-hormone monitoring. The mere mention of estrogen as an analyte that can be measured using the device in WO 043 would not lead one of ordinary skill in the art to the claimed methods. Independent claim 15 directed to a method for predicting ovulation requires (1) "determining a baseline luteinizing hormone level in the subject prior to ovulation" and (2) "continuous monitoring average luteinizing hormone levels over an initial time period of at least 10 minutes", and then (3) "predicting ovulation when the luteinizing hormone levels: a) increase at least 2-fold over the baseline luteinizing hormone level; and/or b) reach an absolute luteinizing hormone level of greater than 20 mUI/ml". WO 043 does not provide any guidance to arrive at such steps in the method for predicting ovulation.” The modified WO 043 teaches detecting estrogen cycles at are determined from a baseline and then used to detect/predict future outcome.
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.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758
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