CTNF 17/636,755 CTNF 99357 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 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. Election/Restrictions 08-25-01 AIA Applicant’s election without traverse of the species of "following a result of the presence of PdG at a threshold, an interpretation comprising an indication that the subject woman may engage in sexual intercourse with a low risk of conceiving until the onset of menstruation in the subsequent menstrual cycle" (claim 54), "Snack bar comprising pumpkin seeds and flax seeds" (claim 70), and type of seed consumption of "Pumpkin seeds and Flax seeds" (claims 70 and 82) in the reply filed on 10/20/2025 is acknowledged. Priority Acknowledgment is made of the present application as a proper National Stage (371) entry of PCT Application No. PCT/US2020/040600, filed 7/2/2020, which claims benefit under 35 U.S.C. 119(e) to provisional application No. 62/720,953, filed 08/22/2018, to provisional application No. 62/611,467, filed 12/28/2017, to provisional application No. 62/503,223, filed 05/08/2017, and to provisional application No. 62/460,307, filed 02/17/2017. 02-09 AIA Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows: 02-10 The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application Nos. 62/720,953, 62/611,467, 62/503,223 and 62/460,307, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, claims 61, 67-68, 70-76 and 82-85 are not disclosed in the provisional applications and therefore receive no priority benefit. Claims 53-60, 62-66, 69 and 77-81 have an effective filing date of 2/17/2017, which is the filing date of Provisional Application No. 62/460,307. Claims 61, 67-68, 70-76 and 82-85 have an effective filing date of 7/2/2020, which is the filing date of the PCT application No. PCT/US2020/040600. Information Disclosure Statement The information disclosure statement filed 8/18/2022 and the information disclosure statement filed 10/20/2025 are being considered by the examiner. Claim Objections 07-29-01 AIA Claim s 54-55, 57 and 76 are objected to because of the following informalities: In claim 54 page 5 line 28 (Applicant’s elected species), Applicant uses the abbreviation “PdG” it is recommended that abbreviations be accompanied by their full meaning at least at first instance that the abbreviation is used in order to improved clarity and avoid confusion. In claim 55 line 4, Applicant uses the abbreviation "FSH, E3G, LH, hCG and PdG" it is recommended that abbreviations be accompanied by their full meaning at least at first instance that the abbreviation is used in order to improved clarity and avoid confusion. In claim 57 line 4, Applicant uses the abbreviation "ePHI" it is recommended that abbreviations be accompanied by their full meaning at least at first instance that the abbreviation is used in order to improved clarity and avoid confusion. In claim 57 lines 3-4, “a ePHI", appears to be a typographical error, namely it is suggested that “a ePHI" read as “ an ePHI" (emphasis added). In claim 76, “the progesterone supplement” in lines 1-2 should read “the plurality of progesterone supplement doses” as in claim 75 line 2 . Appropriate correction is required. 07-30-03-h AIA Claim Interpretation 07-30-03 AIA The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 07-30-05 The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a diagnostic test configured to detect for the presence or absence of pregnanediol glucuronide at a threshold” in claim 56. "telemedicine system configured to facilitate the scheduling and conduct of telemedicine appointment" in claim 60; “a seed consumption system, configured to prompt a user to consume specified seeds” in claim 61; “predicting fertile window system configured to provide a notification that the fertile period has begun… and configured to provide a notification that the fertile period has ended” in claim 62; “diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide…luteinizing hormone” in claim 64; “diagnostic tests configured to evaluate for the presence of FSH in urine” in claim 65. “diagnostic tests configured to evaluate for the presence of E3G in urine” in claim 66. “diagnostic tests each configured to evaluate for the presence of FSH…E3G…LH…PdG” in claim 67. “diagnostic test configured to evaluate an applied fluid for at least the presence or absence of pregnanediol glucuronide… luteinizing hormone” in claim 77. “diagnostic test configured to additionally evaluate for the concentration of FSH” in claim 79. “diagnostic test configured to additionally evaluate for the concentration of E3G” in claim 80. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The "telemedicine system configured to facilitate the scheduling and conduct of telemedicine appointment" in claim 60 is interpreted as the computer application described in paragraph 86 of the specification (“The Healthcare Professional-Facing Application incorporates a telemedicine block scheduling feature to facilitate the designation of certain time periods of the healthcare professional user as available periods to conduct a telemedicine appointment with a patient”) and equivalents thereof. The “seed consumption system, configured to prompt a user to consume specified seeds” in claim 61 is interpreted as “[a]n application and/or a digital reader configured to evaluate the diagnostic tests and generate one or more unique messages related to the interpretations of the diagnostic tests” (specification paragraph 21), and equivalents thereof. The “predicting fertile window system configured to provide a notification that the fertile period has begun… and configured to provide a notification that the fertile period has ended” in claim 62 is interpreted as via the graphical user interface as disclosed in paragraph 236 (“In one example, the system is configured to provide prompts via the graphical user interface not only signaling that a certain hormone is present or absent in a sample evaluated with a diagnostic test as described herein, but also an interpretation of the relevance of that hormone or analyte to the certain user”), and equivalents thereof. The diagnostic tests configured to evaluate for the presence or absence of pregnanediol glucuronide/luteinizing hormone of claims 56, 64, 67 and 77 is interpreted as “lateral flow assay test described elsewhere herein comprising testing zones and corresponding result indication lines” (para. 233). Therefore it is interpreted as the lateral flow devices using anti-PdG-gold conjugate with PdG-BGG capture reagent and anti-LH gold conjugate with anti-LH as capturing reagent as disclosed in paragraphs 61 and 63-64 of the specification (“during the manufacture of the diagnostic test 100, its conjugate pad 190 is at least sprayed at 2-6ul/cm with a Potassium Phosphate buffer including 0.5% BSA, 0.1 % surfactant, 5-15 OD anti-PdG gold (at a concentration selected from the range of 2ug/ml - 8ug/ml) to form a testing zone, optionally the first testing zone. In such embodiment, the membrane 193 is separately and additionally applied with a conjugate of PdG-BGG in an amount of 0.5 mg/ml, placed in a line across substantially the entire width of the membrane 193, which provides a configuration able to display an indication ( optionally an optical signal) in the form of a result indication line for the presence or absence of PdG at threshold amount of 5 µg/mL in an applied fluid” para. 61, “5-15 OD anti-LH gold conjugate of concentration selected from the range inclusive of 6 ug/ml -8 ug/ml. In the example, an anti-LH antibody at a concentration of 1 mg/ml is sprayed in a line across substantially the entire width of the membrane 193 to form a result indication line, optionally the second result indication line 108” para. 63), and equivalents thereof. The diagnostic tests configured to evaluate for the presence or absence of FSH of claims 65, 67 and 79 is interpreted as the lateral flow device using “anti-FSH gold (conc. 3-8ug/ml) … 1 mg/ml anti-FSH antibody test line” (para. 66) and equivalents thereof. The diagnostic tests configured to evaluate for the presence/concentration of E3G of claims, 66-67 and 80 is interpreted as being drawn to “a similar manner to the testing zone configured to facilitate evaluation of an applied fluid for PdG as described herein” (para. 66). However, it is noted that there is no sufficient structure disclosed to this limitation (see 112b rejection below) and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 53-85 are 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. Independent claims 53, 63-64 and 77 recite “a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL”. Independent claim 64 further recites “a quantity selected from the range inclusive of 4-15…7-25”. Independent claim 77 further recites “quantity selected from the range inclusive of 10-25”. Independent claims 64 and 77 further recite “…a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL”. Dependent claims 65-66 recite “a quantity selected from the range inclusive of 7-25”. Dependent claim 82 recites “an amount selected from the range inclusive of 6.5 grams-16 grams and flax seeds in an amount selected from the range inclusive of 6.5 grams-16 grams, and at least one single consumable food item comprising sesame seeds in an amount selected from the range inclusive of 6.5 grams-16 grams and sunflower seeds in an amount selected from the range inclusive of 6.5 grams-16 grams”. However, it is not clear what threshold/quantity/day/amount is being claimed. The language “the range inclusive of…” is considered vague because there are no actual end points to the claimed range. Therefore, a person having ordinary skill in the art would not recognized the metes and bounds of the claimed invention. Claims 66-67 and 80 recite diagnostic tests configured to evaluate for the presence/concentration of E3G, which invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (see above). However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Similarly, claim 55 requires diagnostic tests configured to evaluate for the presence or absence of E3G (note that claim 55 does not invoke 112(f) given that no generic placeholder is used). However, the instant specification discloses that detecting E3G involves “a similar manner to the testing zone configured to facilitate evaluation of an applied fluid for PdG as described herein” (para. 66), which suggests that it would involve an antibody-gold conjugate sprayed in the conjugate pad and analyte-carrier protein sprayed in the result indication line (as disclosed in paragraph 61 of the specification). However, the specification then discloses examples involving antibody-gold conjugates and antibodies sprayed on the test line (para. 66). Therefore, it is not clear what is being claimed by “configured to evaluate for the presence/concentration of E3G”. Does it involve the use of carrier proteins sprayed on the test line as done for PdG detection (para. 61) or antibodies against the target analyte as done for FSH detection (para. 66)? Claim 56 recites the limitation "the patient-facing information" in line 5. There is insufficient antecedent basis for this limitation in the claim. It is not clear what is being referred to by “the patient-facing information” because “patient-facing information” is not recited in claim 53. Claim 54 recites Applicant’s elected species “following a result of the presence of PdG at a threshold…”. Claim 56 further recites “to detect the presence or absence of pregnanediol glucuronide at a threshold”. Claim 62 recites “an indication on a diagnostic test performed during the menstrual cycle that LH is present at a threshold or an indication on a diagnostic test performed during the menstrual cycle that FSH and/or E3G is present at a threshold, …a diagnostic test performed during the menstrual cycle that PdG is present at a threshold”. Claim 67 recites “diagnostic tests each configured to evaluate for the presence or absence of LH at a threshold… diagnostic tests each configured to evaluate for the presence of PdG at a threshold”. Claim 70 recites “the presence of LH at a threshold”. Claim 76 recites “the absence of PdG at a threshold”. Claim 82 recites “the presence of LH at a threshold”. However, no threshold value is recited, which renders the claim indefinite. A person having ordinary skill in the art would question what is encompassed by the claim, i.e. the metes and bounds of the claim. Claim 71 recites the limitation "the" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is not clear what “the graphical user interface” refers to because “graphical user interface” is not recited in claims 70 or 64. Claim 75 recites the limitation "the plurality of progesterone supplement doses" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is not clear what “the plurality of progesterone supplement doses” refers to because “plurality of progesterone supplement doses” is not recited in claim 64. Claim 79 recites “each diagnostic test configured to additionally evaluate for the concentration of FSH in a testing zone”. Claim 80 recites “each diagnostic test configured to additionally evaluate for the concentration of E3G in a testing zone”. However, it is not clear what testing zone is being referred to. Does Applicant refer to a third testing zone? Claims 57-61, 68-69, 72-74, 78, 81 and 83-85 are included because they depend from rejected claims 53, 64, 67, 70, 77 and 82 but fail to clarify the scope of patent protection sought. For these reasons, the claims are indefinite. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 53-60 and 62-63 are rejected under 35 U.S.C. 103 as being unpatentable over Gilmour et al. (US 20100312137 A1)-Cite No. 7 of IDS 8/18/2022 (“Gilmour”) . Regarding claim 53, Gilmour suggests a menstrual cycle tracking system (“Ovulation Cycle and Management” Title, “Methods of monitoring the ovulation cycle of an animal by detecting specific analytes in body fluids, computer program products, devices, data processing systems, and kits for monitoring the ovulation cycle and determining the fertility of female mammals” Abstract), comprising: one diagnostic test or a plurality of diagnostic tests (“the analyte detector utilize a lateral flow assay format” para. 26) each configured to evaluate a sample of bodily fluid from a subject woman (“the fertility of a mammal (including a human) is measured or evaluated by detecting specific analytes in body fluids” para. 20) collected on a daily basis (“one or more hormone metabolites is/are measured for one or more days, or on a daily basis for a desired period of time or times” para. 40) during a menstrual cycle (“Example 12 PdG Standard Curve and PdG Menstrual Cycle Excretion Rates…PdG daily excretion rates over days 7-26 of a 26 day menstrual cycle were measured from urine samples provided by a 33 year old woman” para. 243), at least one of the one diagnostic test or a plurality of diagnostic tests comprising at least one testing zone and corresponding result indication line configured to detect for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL (“The standard curve was performed by adding 140 μL of standard to the application well of the cassette and reading the control and test line MAR values after 15 minutes with a Magna BioSciences magnetic assay reader…TABLE 4… PdG MAR Standard Curve…[PdG] ng/mL…1.38…4.14…13.80…41.40…137.90…413.70…1379.00…4137.00…13800.00…69000.00” Table 4, para. 242, “The time-diluted urine samples were then each diluted a further ½ before addition of 140 μL to the PdG cassette. The MAR results were expressed as T/C and the PdG excretion rate (nmol/24 hr) calculated from the corresponding standard curve” para. 243); and a computing device configured to collect one result or a plurality of results indicated by the one diagnostic test or the plurality of diagnostic tests and evaluate the one result or plurality of results to generate one interpretation or a plurality of interpretations following a result (“In one data processing system, a central data processing system is configured to communicate with and receive data from one or more subject monitoring systems. Each subject monitoring system is capable of one or more of receiving, storing, and/or analyzing subject data. An example of a method of monitoring a subject can be performed by the following steps…determining the status of the subject based on the analysis performed by said computer program” para. 43, “These computer program instructions may be loaded onto a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, which may be combined with the analyte detection system into a single device” para. 139, “The data is read from the strips by the paramagnetic reader and stored in the reader. The reader compares the band intensity of the strip with a standard or calibration curve which relates band intensities to the corresponding ElG or PdG concentration. The standard curve is stored in the reader and applies to the batch identification of the strips being used. A range of standard curves is typically applied” para. 205), the computing device further configured to store the one interpretation or a plurality of interpretations (para. 43, “The readout from the strips is stored in the CPU of the reader and is stored as an array with the cycle day or the date as shown below for some PdG half strips (Table 1 )” para. 205) and display the one interpretation or plurality of interpretations based on the one result or plurality of results to a graphical user interface (“An example of a method of monitoring a subject can be performed by the following steps…and communicating, transmitting, or displaying the identified subject status and/or a therapeutic management recommendation for one or more subjects” para. 43, “the SMS [subject monitoring system] contains a user interface for displaying text, graphics, user-prompts, and various other information” para. 150, “a computer program is used to enter data daily, and to obtain a graphical display” para. 173, “a computer program can be used by a home user for providing information on the use of the system and to permit display of the data on a daily basis” para. 194). Gilmour further suggests that tracking “the ovulatory cycle has many practical applications” (para. 4). Gilmour further teaches that “[t]here is a need for better in-home and on-site fertility status assays that rivals the accuracy of assays performed in clinical settings, and which are simple, convenient, and cost effective. The use of quantitative strips offers a more flexible system for on-site and home fertility care than Monitors such as described in Blackwell L. F., et al., Id, which although accurate suffer from the disadvantage of not having the ease of use provided by a quantitative strip system such as described herein. Such assays would provide considerable savings and enable accurate and cost-effective daily monitoring of ovarian activity. Additionally, a quantitative home assay kit with improved accuracy over other strip systems is needed. The inventions herein address these and other needs” (para. 17). Gilmour further teaches that “[r]epresentative examples of membrane based diagnostic tests, including lateral flow diagnostic tests, are known in the art… Various solid phase testing devices such as dipsticks and chromatographic strips, which may readily be adapted for use in determining urinary analytes, are also known in the art” (paras. 12-13). Gilmour teaches that “[a] particularly suitable progesterone metabolite for detection is pregnanediol glucuronide (PdG)” (para. 118). Gilmour fails to teach the menstrual cycle tracking system of claim 53 in a manner consistent with anticipation because Gilmour fails to teach the menstrual cycle tracking system of claim 53 in a single embodiment, i.e. there is some picking and choosing involved in order to arrive at the claimed system. Gilmour teaches the diagnostic tests to PdG in Example 12 and teaches the computing device in paragraphs 43 and 139. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Gilmour from different embodiments, i.e. the diagnostic test of PdG of Example 12 with the computing device of paragraphs 43 and 139 because Gilmour teaches that there is a current need for better in-home fertility status assays and teaches that "[t]he inventions herein address these and other needs" (para. 17), thereby suggesting using the computing device with the PdG diagnostic test, i.e. in order to provide improved fertility tests based on PdG. One would have been motivated to try combining the diagnostic test of PdG of Example 12 with the computing device of paragraphs 43 and 139 of Gilmour because Gilmour suggests that tracking “the ovulatory cycle has many practical applications” (para. 4). A person having ordinary skill in the art would have had a reasonable expectation of success given that Gilmour suggests that lateral flow diagnostic test are well known in the art. Also, Gilmour teaches that “[a] particularly suitable progesterone metabolite for detection is pregnanediol glucuronide (PdG)” (para. 118). Regarding claim 54, although the claim is indefinite, in the interest of compact prosecution, “a threshold” is interpreted as “1 μg/mL-10 μg/mL” as in claim 53. Gilmour further suggests Applicant’s elected species, i.e. following a result of the presence of PdG at a threshold, an interpretation comprising an indication that the subject woman may engage in sexual intercourse with a low risk of conceiving until the onset of menstruation in the subsequent menstrual cycle (“If the PdG excretion rate increases to equal or exceed a predetermined threshold value, a determination is made that ovulation has likely occurred. This can be confirmed by continued monitoring of PdG until the level exceeds a predetermined level, which may be set at 10 μmol/24 h for PdG” para. 188, “Once this predetermined PdG threshold is exceeded, a determination can be made that the woman is in the luteal phase infertile period and can no longer conceive in that cycle” para. 190, see Table 4 showing that 10 μmol/24 h is equal to 1.38 μg/mL, “The above data can be utilised to avoid conception by avoiding intercourse after day 12 since day 13 is day 1 of the fertile window (Blackwell, L. F. and Brown}. B. Steroids, 57, 554 (1992). Once the PdG value exceeds the cut-off intercourse ( day 18 in the above example) may be resumed since the cycle is infertile until the next bleed. Examples of the use of this protocol may be found in Brown et al., American Journal of Obstetrics and Gynecology-Supplement 165: 2008-11 (1991 ). Clearly the present invention lends itself to a similar usage” para. 279). Regarding claim 55, Gilmour further suggests the plurality of diagnostic tests comprising a plurality of testing zones and corresponding result indication lines each configured to evaluate for the presence or absence of a hormone or analyte selected from the group consisting of E3G, FSH, LH and PdG (“Examples of estrogen metabolites that may be detected include… 16-glucuronide-estriol” para. 117, “One, two, or more analytes may be captured on a single strip, such as a single lateral flow strip. For example, in some embodiments, more than one antibody is immobilized to a single capture element such that a single capture element ( e.g. a strip) is capable of detecting one or more analytes. Antibodies or other binding agents may be conjugated to or associated with a detection element. In one embodiment, a single strip comprising antibodies against estrone glucuronide and antibodies against pregnanediol glucuronide is provided” para. 124, “For most applications described herein, estrone glucuronide and pregnanediol glucuronide are the most useful analytes to measure. However, other analytes may be monitored. Follicle stimulating hormone (FSH) and luteinizing hormone (LH) may rise but unless the ovarian events are confirmed by, for example, ultrasound, or a functional test, the following events are assumed but not proven” para. 177). Note that although Gilmour fails to use the language “plurality of testing zones and corresponding result indication lines each configured to evaluate for the presence or absence of a hormone or analyte selected from the group consisting of FSH, E3G, LH and PdG” the teaching that the lateral flow strips each can detect different analytes by immobilizing different capture elements, i.e. antibodies, to the strip, and the suggestion of monitoring FSH and LH (para. 177), reads on the instant claim. A person having ordinary skill in the art would have had a reasonable expectation of success because Gilmour teaches that measuring LH is standard in menstrual cycle tracking systems since LH peak is associated with the menstrual cycle (“[i]n-home assays developed for monitoring ovulation include those based on use of sandwich assays to monitor urinary levels of luteinizing hormone (LH). LH levels peak approximately one day prior to ovulation, and the change in levels is generally large enough that measuring the LH change can be visualized by the human eye on a color coded standardized chart” para. 14). Regarding claim 56, although the claim is indefinite, in the interest of compact prosecution, “the patient-facing information” is interpreted as “the patient-facing application”, and the threshold is interpreted as“1 μg/mL-10 μg/mL” as in claim 53. Gilmour further suggests further comprising a patient facing application, the patient-facing application comprising a patient profile, an electronic personal health information exporter, and a graphical user interface (“The program has a user mode and an advisor mode. The user mode allows the user to email her file to an advisor who can open it up in the advisor copy and see the cycle unfolding” para. 173); the patient-facing information configured to operate in association with a computing device and communicatively connected storage medium (“the SMS contains a user interface for displaying text, graphics, user-prompts, and various other information. In certain other embodiments, the SMS user interface may serve as the primary means of communication between the CDPS server and the subject” para. 150 “The communication links can be a device” para. 140); and the patient-facing application configured to record and store the result indicated on at least a diagnostic test configured to detect for the presence or absence of pregnanediol glucuronide at a threshold (“the data entered within the fertility monitoring SMS is stored with date and time information” para. 151, para. 188, Example 12). Regarding claim 57, Gilmour further suggests further comprising a healthcare professional-facing application, the healthcare professional-facing application comprising a healthcare profile, a ePHI importer/exporter and a graphical user interface (“The program has a user mode and an advisor mode. The user mode allows the user to email her file to an advisor who can open it up in the advisor copy and see the cycle unfolding. The advisor mode also has access to a database” para. 173, “a CDPS server performs various other functions including allowing case managers to change the fertility planning program for subjects when a subject downloads data to a CDPS server. In certain embodiments, a CDPS server may include a "tickler system" for reminding case managers to verify that communications with subjects have occurred and for verifying that conditions requiring intervention or medical attention have been resolved” para. 158, “case managers access a CDPS server via a case manager CPU (CMC) CMC preferably includes a central processing unit, a display, a pointing device, a keyboard, access to persistent data storage, and an Internet connection, for connecting to the internet” para. 160). Regarding claim 58, Gilmour further suggests further comprising a calendar configured to display the result or interpretation associated with each diagnostic test in a graphical user interface (“a computer program can be used by a home user for …display of the data on a daily basis” para. 194) in association with the date and time each diagnostic test was performed (“In certain embodiments, the data entered within the fertility monitoring SMS is stored with date and time information and can be alarm initiated (e.g. a subject or SMS can be prompted to perform a task or function). In certain embodiments, the SMS internal software analyzes the entered data and continuously informs the subject of her fertility status and prescribed regimen.” para. 151). Note that although Gilmour fails to use the language “calendar” and “graphical user interface” the teachings of storing date and time information with the capability of displaying “the data on a daily basis” and “continuously informs the subject of here fertility status” inherently suggests the instant claim. More specifically, the language “continuously” of Gilmour (para. 151) inherently provides “in association with the date and time each diagnostic test was performed”. Also, the “display” of Gilmour (para. 194) and “alarm initiated” prompts (para. 151) suggests “graphical user interface” of the instant claim, and “daily basis” (para. 194) suggests “calendar” of the instant claim. Regarding claim 59, Gilmour suggests further comprising a fertility tracking system comprising instructions for the sequence and timing to perform the diagnostic tests, the instructions delivered via a graphical user interface operated in association with the computing device (“The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart block or blocks” para. 140, “A SMS may provide capability for downloading subject data to CDPS server at specified time intervals or in real time, capability for communicating messages, updates to physician or healthcare provider, instructions and fertility management regimens, fixed or contingent self-monitoring schedules, or other feedback from CDPS server” para. 147, “the SMS contains a user interface for displaying text, graphics, user-prompts, and various other information. In certain other embodiments, the SMS user interface may serve as the primary means of communication between the COPS server and the subject” para. 150). Note that although Gilmour fails to use the language “a fertility tracking system comprising instructions for the sequence and timing to perform the diagnostic tests, the instructions delivered via a graphical user interface operated in association with the computing device” the teaching of downloading instructions and fertility management regimens from the CDPS server via a graphical user interface inherently provides “a fertility tracking system comprising instructions for the sequence and timing to perform the diagnostic tests, the instructions delivered via a graphical user interface operated in association with the computing device”. Regarding claim 60, Gilmour suggests further comprising a telemedicine system configured to facilitate the scheduling and conduct of a telemedicine appointment with a healthcare professional for further evaluation of the plurality of diagnostic tests (“Analyzing subject data…a case manager may be presented with an option to contact a subject. The case manager may contact a subject, via telephone, e-mail, AVM and facsimile transmission” para. 167, “a case manager may be presented with an option to schedule a subject for a visit with a health care provider or with an option to seek expert fertility medical input. If these options are selected, the present invention facilitates scheduling a subject to visit a health care provider or obtaining input from a medical expert. In certain embodiments, a case manager may provide that no action is required for a particular fertility condition and may remove an identified fertility condition from an active condition list for a particular subject after reviewing available data” para. 168, “In certain embodiments, special messages related to scheduling office appointments ask the subject to make an appointment with a named professional and provide his or her phone number” para. 170). Regarding claim 62, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the E3G threshold is interpreted as an increase of E3G above a preceding baseline, and the PdG threshold is interpreted as“1 μg/mL-10 μg/mL” as in claim 53. Gilmour further suggests further comprising a predicting fertile window system configured to provide a notification that the fertile period has begun following an indication on a diagnostic test performed during the menstrual cycle that LH is present at a threshold or an indication on a diagnostic test performed during the menstrual cycle that FSH and/or E3G is present at a threshold (“estrogen metabolites and progesterone metabolites (e.g. those indicative of fertility)” para. 116, “Examples of estrogen metabolites that may be detected include…16-glucuronide-estriol” para. 117, “An example of a method of monitoring a subject can be performed by the following steps… displaying the identified subject status” para. 43, “the SMS contains a user interface for displaying text, graphics, user-prompts, and various other information” para. 150 “ElG Excretion Rates as a Marker for the Beginning of the Fertile Period” para. 246, “For ElG excretion rates obtained with time diluted urine samples and using the day of the first statistically significant rise above the preceding baseline as determined by the Trigg's tracking signal for the beginning of the fertile window (Blackwell, L. F. and Brown J.B. Steroids, 57, 554 (1992) to the day following the mid-cycle peak in ElG excretion, the prospective warning of ovulation given for 20 cycles from published RIA data (Blackwell L. F., et al., Steroids 68:465-476 (2003) was as shown in FIG. 5” para. 247), and configured to provide a notification that the fertile period has ended following an indication on a diagnostic test performed during the menstrual cycle that PdG is present at a threshold (“the PdG threshold that marks the end of fertility is set at ≥6.3 μmol/24 hr (Blackwell, L. F., et al. Steroids, 63, 5. (1998)… Normalising for the MAR system this translated into excretion rate readings of 2.2… μmol PdG/24 hr” para. 245, “PdG Excretion Rates as a Marker for the End of the Fertile Period The use of a PdG threshold has an additional advantage over other markers for defining the end of the fertile period that extends past its temporal relationship with ovulation” para. 248, see Table 4 showing that ≥2.2 μmol PdG/24 hr encompasses“1 μg/mL-10 μg/mL”). Note that although Gilmour fails to use the language “E3G is present at a threshold”, the teaching of estrogen metabolites being indicators of fertility and that E3G is an example of an estrogen metabolite that may be detected suggests that the threshold for the estrogen metabolite E1G is applicable to the estrogen metabolite E3G of the instant claims. A person having ordinary skill in the art would have had a reasonable expectation of success because Gilmour teaches that estrogen metabolites are indicative of fertility. Regarding claim 63, Gilmour suggests a fertility tracking system (“a fertility monitoring system is provided” para. 27) , comprising: a plurality of diagnostic tests each consisting of a lateral flow assay, each lateral flow assay comprising a testing zone and corresponding result indication line configured to detect for the presence or absence of pregnanediol glucuronide in urine at a threshold selected from the range of 1 μg/mL-10 μg/mL (para. 26, Table 4, paras. 242-243) and a control line (“by the MAR readings for the test line with the control line (T/C)” para. 242), configured such that only one perceptible line observable on the diagnostic test indicates a positive result and the presence of two perceptible lines observable on the diagnostic test indicates a negative result for the presence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL (“In a competitive immunoassay…The amount of the unknown component present in inversely related the amount of bound tagged component” para. 10, “An immunoreactive specific binding member can be an antibody, an antigen, or an antibody/antigen complex that is capable of binding either to the analyte as in a sandwich assay, to the capture reagent as in a competitive assay, or to the ancillary specific binding member as in an indirect assay” para. 106, “Nitrocellulose Membrane Preparation for the PdG Assay This was performed using the identical procedure to above, but with the BSA-ElG replaced with BSA-PdG capture material” para. 233, see Table 4 showing how when the PdG threshold reaches 1 μg/mL-10 μg/mL, the ratio of the test line and the control line decreases to ~0.07 compared to 3.43 when there is no PdG). Note that although Gilmour fails to use the language “configured such that only one perceptible line observable on the diagnostic test indicates a positive result and the presence of two perceptible lines observable on the diagnostic test indicates a negative result for the presence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL -10 μg/mL” the teaching of using a competitive lateral flow immunoassay for PdG that results in a high test line to control line ratio with low PdG and high test line to control line ratio with high PdG suggests that there is only one control line when there is a positive result and two lines (test and control) when there is a negative result. Furthermore, although Gilmour fails to use the language “perceptible line observable on the diagnostic test”, the teaching that the ratio of the test line and control line (T/C) increases more than an order of magnitude between 1 μg/mL PdG and 0 suggests a second perceptible line observable on the diagnostic test. Furthermore, Gilmour teaches that one can optimize the sensitivity of the antibodies used in order to adjust the working range of the PdG concentration of the assay (“For best results it is essential that the measurements be made in the working range of the standard curve…Similarly with the current antibodies used in the MAR PdG assay system, the optimum PdG standard curve covers the excretion rate range from 0.002 to 10 μmol/24 hr. Thus the current antibodies require a 1/5 dilution of the time-diluted samples for the ElG test and a 1/25 dilution for the PdG test. To avoid these dilutions in normal cycles, new antibodies need to be raised with characteristics such that no dilution of the time-diluted samples is necessary for normal menstrual cycles” paras, 250-253), thereby addressing “configured such that only one perceptible line observable on the diagnostic test indicates a positive result and the presence of two perceptible lines observable on the diagnostic test indicates a negative result for the presence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL -10 μg/mL”. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the antibodies of Gilmour in order to configure the assay such that only one perceptible line observable on the diagnostic test indicates a positive result and the presence of two perceptible lines observable on the diagnostic test indicates a negative result for the presence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL -10 μg/mL because Gilmour teaches that this would "avoid dilutions" which saves time. A person having ordinary skill in the art would have had a reasonable expectation of success given that Gilmour teaches that lateral flow diagnostic test are well known in the art . 07-22-aia AIA Claim 61 is rejected under 35 U.S.C. 103 as being unpatentable over Gilmour as applied to claim 53 above, and further in view of Takayasu "Seed Cycling For Hormonal Imbalance" Published: Jan 22, 2019 (retrieved online https://www.stamfordhealth.org/healthflash-blog/integrative-medicine/seed-cycling/ on 12/17/2025) . Regarding claim 61, Gilmour teaches the system of claim 53 as discussed above. Gilmour further teaches that ovulation is determined using the diagnostic tests configured to detect for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL (“If the PdG excretion rate increases to equal or exceed a predetermined threshold value, a determination is made that ovulation has likely occurred. This can be confirmed by continued monitoring of PdG until the level exceeds a predetermined level, which may be set at 10 μmol/24 h for PdG” para. 188). Gilmour fails to teach further comprising a seed consumption system, configured to prompt a user to consume specified seeds based on the result indicated on each of the plurality of diagnostic tests. Takayasu teaches “seed cycling for hormonal imbalance” (Title). Takayasu further suggests further comprising a seed consumption system (“Seed Cycling is using Nature’s goodness to your advantage. It’s simply eating different types of seeds at different times in the menstrual cycle to support optimal hormonal balance of estrogen and progesterone” page 2 para. 11), configured to prompt a user to consume specified seeds based on the result indicated on each of the plurality of diagnostic tests (“Give this protocol about 3-4 months to see a change” page 3 para. 5, “DAY 1 OF PERIOD UNTIL OVULATION (NEW MOON TO FULL MOON) 1 Tbsp ground organic raw pumpkin seeds 1 Tbsp ground organic raw flax seeds…OVULATION UNTIL START OF NEXT PERIOD (FULL MOON TO NEW MOON) 1 Tbsp ground organic raw sunfl