DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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
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.
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:
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
Claims 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.
Claim Interpretation
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.
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
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.
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
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 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.
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 sunflower seeds 1 Tbsp ground organic raw sesame seeds” page 3 paras. 7-8 and 10-11). Note that although Takayasu fails to use the language “based on the result indicated on each of the plurality of diagnostic tests”, Takayasu still suggests the claim because Takayasu teaches the seed consumption based on the start of ovulation and Gilmour explicitly teaches that the diagnostic tests configured to detect PdG determine the start of ovulation (para. 188). Takayasu further teaches that “[c]ertain seeds carry certain fatty acids (a.k.a. oils), vitamins, and nutrients that help support our hormones” (page 2 para. 11).
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 modified the teachings of Gilmour to include the seed consumption system taught by Takayasu based on the result of the diagnostic tests of Gilmour, because Takayasu suggests that the seed consumption system supports optimal hormonal balance through the nutrients in the seeds and Gilmour is concerned with tracking the hormones of women. A person having ordinary skill in the art would have had a reasonable expectation of success because Takayasu describes the system as simple and both Gilmour and Takayasu are drawn to women’s hormonal balance through the cycle.
Claims 64-66 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Catt et al. (US 6,451,619 B1)-Cite No. 21 of IDS 8/18/2022 ("Catt").
Regarding claim 64, Catt teaches a fertility tracking system for evaluating a menstrual cycle (col. 2 lines 49-51), comprising: a plurality, of a quantity selected from the range inclusive of 4-15 (“Another independent aspect of the invention, which may nevertheless be combined to advantage with any method as set forth above, involves: a) providing the user with a plurality of disposable body fluid testing devices, said plurality preferably being at least 7” col. 8 lines 21-26), of diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in an applied fluid (“The following description is provided, by way of example only, in relation to the urinary hormones E3G, luteinizing hormone (LH), and pregnanediol-3-glucuronide (P3G)” col. 9 lines 27-29, “An "elevated" P3G level can be recorded, for example, when either the level of P3G detected is greater than the sum of the four previous recorded levels of P3G in the same menstrual cycle, or greater than 3500 ng/ml, whichever of these two thresholds is lower and is first achieved” col. 10 lines 33-37); and a plurality, of a quantity selected from the range inclusive of 7-25 (col. 8 lines 21-26, col. 9 lines 27-29), of diagnostic tests each configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in an applied fluid (“For practical purposes, a urinary LH concentration of 20 mIU/ml can be regarded as a universal threshold indicative of the LH surge under virtually all circumstances” col. 9 lines 47-50). Note that although Catt fails to use the language “configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL”, Catt still suggests the claim because Catt teaches testing “at least one analyte of significance in relation to the status of the ovulation cycle” (col. 6 lines 64-67 and col. 7 line 1) which reads on the claim and specifically teaches that LH is an example of such analyte and that “urinary LH concentration of 20 mIU/ml can be regarded as a universal threshold indicative of the LH surge” which inherently provides “configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL”. Similarly, although Catt fails to use the language “configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL”, Catt still suggests the claim because Catt teaches that pregnanediol-3-glucuronide (P3G) is an example of a significant analyte in relation to the status of the ovulation cycle (particularly with regards to the fertility window (col. 10 lines 29-30) ) and teaches detecting PdG at a level “greater than 3500 ng/ml” (col. 10 line 36), which inherently provides the diagnostic tests “configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL”. Catt further teaches that a quantity selected from the range inclusive of 4-15, and of a quantity selected from the range inclusive of 7-25 of tests enables the establishment of “a reference concentration value or signal for said analyte in the current cycle” (col. 7 lines 5-7) for “effective monitoring of the ovulation cycle” (col. 8 line 67). Catt further teaches that an “objective of the invention is to provide a testing regime which is a good balance between the desire to minimise the testing burden on the user and the need to give the user worthwhile advice about the fertility status” (col. 3 lines 4-7). Catt further teaches that “[m]ethods of detecting body fluid analytes, such as urinary hormone metabolites, suitable for the purposes of this method, are well known to those skilled in the art” (col. 10 lines 48-50).
Catt fails to teach the system of claim 64 in a manner consistent with anticipation, i.e. there is some picking and choosing involved in order to arrive at the instant claim.
Catt teaches the plurality of diagnostic tests and quantity in col. 8 lines 21-26 and suggests PdG in col. 10 lines 33-37 and LH in col. 9 lines 47-50.
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 embodiment drawn to the plurality of diagnostic tests from col. 8 lines 21-26 with the teachings of PdG in col. 10 lines 33-37 and LH in col. 9 lines 47-50 because Catt suggests that this enables efficient and effective fertility monitoring, which is a current need in the field, balancing the testing burden with the accuracy of the system. A person having ordinary skill in the art would have had a reasonable expectation of success given that Catt teaches that detecting PdG and LH is well known in the field.
Regarding claim 65, Catt further teaches further comprising a plurality, at a quantity selected from the range inclusive of 7-25, of diagnostic tests (col. 8 lines 21-26) configured to evaluate for the presence of FSH (“urinary analytes…Generally, the most suitable analytes are hormones and their metabolites. Follicle stimulating hormone (FSH) is an example” col. 3 lines 46 and 58-60) in urine (col. 3 line 46, “Conveniently, the body fluid can be urine” col. 7 line 58).
Regarding claim 66, Catt further teaches further comprising a plurality, of a quantity selected from the range inclusive of 7-25 (col. 8 lines 21-26), of diagnostic tests configured to evaluate for the presence of E3G in urine (“urinary analytes… estriol-3-glucuronide, estriol-16-glucuronide” col. 3 lines 46 and 52-53).
Regarding claim 69, Catt further teaches further comprising a single container to enclose the plurality of diagnostic tests together (“An important embodiment of the invention is a replacement pack, containing a plurality, preferably not more than 12, and ideally 7 to 10, of disposable testing devices to replenish a test kit” col. 5 lines 1-4).
Claim 70 is rejected under 35 U.S.C. 103 as being unpatentable over Catt (US 6,451,619 B1)-Cite No. 21 of IDS 8/18/2022 as applied to claim 64 above, and further in view of Takayasu and Ella “Superfood healthy pumpkin breakfast bars” Published October 10, 2017 (retrieved online https://pureella.com/healthy-superfood-pumpkin-breakfast-bars/ on 12/17/2025).
Regarding claim 70, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the threshold is interpreted to be “15 mIU/mL-50 mIU/mL” as in claim 64. Catt teaches the system of claim 64 as discussed above.
Catt further teaches that ovulation is determined using the diagnostic tests configured to detect for the presence or absence of LH at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL (col. 4 lines 37-39, “Once the LH surge has been detected, it can be said that ovulation is imminent” col. 9 lines 40-41 and 47-49).
Catt fails to teach further comprising at least one snack bar comprising pumpkin seeds and flax seeds (Applicant’s elected species), and a daily recurring instruction following menstruation to consume pumpkin seeds and flax seeds once daily until the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily until the onset of menstruation.
Takayasu teaches “seed cycling for hormonal imbalance” (Title). Takayasu further suggests comprising pumpkin seeds and flax seeds (page 2 para. 11, page 3 paras. 7-8 and 10-1), and a daily (“Then I use 2 Tbsp of the mixture each day” page 3 para. 3) recurring instruction following menstruation to consume pumpkin seeds and flax seeds once daily until the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily until the onset of menstruation (page 3 paras. 3, 5 and 7-8 and 10-1). Note that although Takayasu fails to use the language “until the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle”, Takayasu still suggests the claim because Takayasu teaches the seed consumption based on the start of ovulation and Catt explicitly teaches that the diagnostic tests configured to detect LH determine that ovulation is imminent. Takayasu further teaches that “[c]ertain seeds carry certain fatty acids (a.k.a. oils), vitamins, and nutrients that help support our hormones” (page 2 para. 11).
Ella teaches “Superfood healthy pumpkin breakfast bars” (Title). Ella teaches at least one snack bar comprising pumpkin seeds and flax seeds (“INGREDIENTS: 2 tablespoons ground flax…1/2 cup pumpkin seeds (divided)” page 7). Ella further teaches that the snack bars “are not only amazing and loaded with superfood power, but they are also naturally gluten-free, vegan and refined sugar free. And these are also nut-free which means school-safe!” (page 3 para. 2). Ella further teaches the detailed directions to make the snack bars (page 7).
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 modified the teachings of Catt to include the seed consumption system taught by Takayasu based on the result of the diagnostic tests of Catt, because Takayasu suggests that the seed consumption system supports optimal hormonal balance though the nutrients in the seeds and Catt is concerned with tracking the hormones of women. A person having ordinary skill in the art would have had a reasonable expectation of success because Takayasu describes the system as simple and both Catt and Takayasu are drawn to women’s hormonal balance through the cycle.
It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Catt in view of Takayasu to have the pumpkin seeds and flax seeds in a snack bar as taught by Ella, because Ella suggests that this makes a very delicious superfood. A person having ordinary skill in the art would have had a reasonable expectation of success because Ella teaches the recipe, i.e. detailed directions to make the snack bars.
Claim 74 is rejected under 35 U.S.C. 103 as being unpatentable over Catt (US 6,451,619 B1)-Cite No. 21 of IDS 8/18/2022 as applied to claim 64 above, and further in view of Divaraniya et al. (WO 2019246361 A1)- Cite No. 30 of IDS 8/18/2022 and Hua “Uses and Benefits of Compounded progesterone” Apr 26, 2019 (retrieved online https://www.harborcompounding.com/uses-and-benefits-of-compounded-progesterone on 12/17/2025).
Regarding claim 74, Catt teaches the system of claim 64 as discussed above.
Catt fails to teach further comprising a plurality of progesterone supplement doses, each formulated in an oil suspension.
Divaraniya teaches “systems for detecting analyte levels” (Title). Divaraniya further teaches “[a] woman is undergoing in vitro fertilization (IVF) treatment and must obtain frequent measurements of her fertility hormones and metabolites to ensure a successful procedure. …On days 17-27 of her menstrual cycle, the woman takes progesterone supplements to support her uterine lining and implantation” (para. 327).
Hua teaches “uses and benefits of compound progesterone” (Title). Hua teaches “solutions for…hormonal imbalance” (page 1 para. 1) and that “that progesterone is a hormone that is essential for the functions of all the systems in a woman’s body” (page 1 para. 2). Hua further teaches that progesterone supplements are normally either in an oil suspension or in a gel (“The main progesterone products manufactured by pharmaceutical companies are Progesterone in peanut oil softgel capsules (Prometrium) Progesterone in oil for intramuscular injection Progesterone vaginal gel (Crinone)” page 3 last paragraph). Hua further suggests that oil suspension progesterone supplements help the body “regain hormonal equilibrium” (page 4 para. 3). Hua further teaches that “the only FDA approved progesterone product that can be used in the treatment of menopause is Prometrium, which is progesterone in peanut oil capsules” (page 4 para. 1).
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 modified the teachings of Catt to rely on the progesterone supplements taught by Divaraniya because Divaraniya teaches that this supports the uterine lining and Catt is concerned with women’s fertility hormones. A person having ordinary skill in the art would have had a reasonable expectation of success because both Divaraniya and Catt teach systems comprising detecting hormones in women.
It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Catt in view of Divaraniya to rely on the progesterone supplements being each formulated in an oil suspension taught by Hua because Hua suggest this enables hormonal balance. A person having ordinary skill in the art would have had a reasonable expectation of success given that Hua suggests that most progesterone supplements are oil-based.
Claims 77-80 are rejected under 35 U.S.C. 103 as being unpatentable over Catt (US 6,451,619 B1) (Cite No. 21 of IDS 8/18/202).
Regarding claim 77, Catt suggests a fertility tracking system for evaluating a menstrual cycle, comprising: a plurality, of a quantity selected from the range inclusive of 10-25, of diagnostic tests (col. 8 lines 21-26), each diagnostic test configured to evaluate an applied fluid for at least the presence or absence of pregnanediol glucuronide (“Particular hormones selected are E3G, P3G and LH” col. 2 lines 33-34, col. 9 lines 27-29) at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL (col. 10 lines 33-37) in a first testing zone (“said readable signals are created by concentrating a first detectable material, preferably a labelled reagent, in a first detection zone of a porous carrier, such as a test strip, within said testing device and by concentrating a second detectable material, preferably a labelled reagent, in a second detection zone of said porous carrier” col. 4 lines 24-31) and the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in a second testing zone (“said first detection zone signal is indicative of the body fluid concentration of a first analyte, preferably luteinizing hormone (LH), which exhibits a significant concentration change closely associated with the time of actual ovulation” col. 4 lines 36-41, col. 9 lines 47-50). Catt further teaches that “the invention can readily be applied to data derived from the measurement…of other analytes of significance in relation to the status of the ovulation cycle” (col. 3 lines 55-58)
Catt teaches claim 77 by combining the embodiment drawn to the first and second testing zones, one of which is configured to evaluate LH (col. 4 lines 25-40), with the teaching of measuring PdG (col. 10 lines 33-37). In other words, substituting Catt’s “second detection zone …of…estrone-3-glucuronide (E3G)” (col. 4 lines 41-45) with PdG addresses the instant claim, i.e. a first testing zone for PdG and a second testing zone for LH.
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 modified the teachings of Catt to combine the embodiment drawn to first and second testing zones, one of which is configured to evaluate LH (col. 4 lines 25-40), with the teaching of measuring PdG (col. 10 lines 33-37), thereby addressing a first testing zone for PdG and a second testing zone for LH and the claim because Catt teaches that PdG testing can be used as a "back up" to LH testing. A person a having ordinary skill in the art would have been motivated to make such a modification in order to incorporate the “back up” to the LH measurement and strengthen the LH results and test. A person having ordinary skill in the art would have had a reasonable expectation of success given that both LH and PdG are indicative of infertility and Catt teaches that “the invention can readily be applied to data derived from the measurement…of other analytes of significance in relation to the status of the ovulation cycle” (col. 3 lines 55-58), therefore, Catt contemplates possible substitutions to the analyte detection zones.
Regarding claim 78, Catt suggests further comprising a diagnostic test key configured to map the color intensity of an indicated result to a concentration of a hormone or analyte correlating to the color intensity (“dipstick" technology with the assay result being provided by a coloured end point, the intensity of the colour being proportional to LH concentration. By providing the consumer with a colour chart which enables the daily result to be compared against a standard, the "LH surge" can be detected simply by eye” col. 20 lines 41-47).
Regarding claim 79, although the claim is indefinite (see 112b rejection above) in the interest of compact prosecution, “a testing zone” is interpreted as “a third testing zone”. Catt further suggests each diagnostic test configured to additionally evaluate for the concentration of FSH (“Follicle stimulating hormone (FSH) is an example” col. 3 lines 59-60) in a third testing zone (“determining the presence and/or concentration of two or more analytes in a single sample liquid… strip having two or more spacially distinct detection zones, col. 12 lines 35-48) and provide a result comprising a color intensity, the color intensity correlating to a concentration of FSH in the applied fluid (“the detectable material used as a label in the assay is one which will interact with light in the visible or near visible range, e.g. by adsorption. The wavelength of the electromagnetic radiation chosen is preferably at or near a wavelength which is strongly influenced, e.g. absorbed, by the label. For example, if the label is a substance which is strongly coloured, i.e. visible to the naked human eye when the material is concentrated, the ideal electromagnetic radiation is light of a complementary wavelength. Particulate direct labels, for example, metallic ( e.g. gold) sols, non-metallic elemental (e.g. Selenium, carbon) sols, dye sols and coloured latex (polystyrene) particles are ideal examples. For instance, in the case of blue-dyed latex particles, the ideal electromagnetic radiation is visible red light which will be strongly absorbed by the blue particles” col. 19 lines 3-16). Catt further teaches that “[a] yet further object of the invention is to provide an assay method/device in which multiple analytes in a single sample liquid can be determined accurately in a strip-format assay device which is interpreted instrumentally using electromagnetic radiation ( e.g. light) passed through the thickness of the assay strip” (col. 3 lines 27-32). Catt further suggests that there is a need of more efficient fertility tracking systems (“important objective of the invention is to provide such information while avoiding the necessity for tests to be conducted on a frequent ( e.g. daily) basis throughout every ovulation cycle” col. 1 lines 15-20).
Catt teaches claim 79 by combining the embodiment drawn to the third testing zone, particularly the teaching of a “strip having two or more spacially distinct detection
zones” (col. 12 lines 47-48), with the teaching of measuring FSH (col. 3 lines 59-60). In other words, including a third detection zone with FSH addresses the instant claim.
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 modified the teachings of Catt to combine the embodiment drawn to the testing zones, (col. 12 lines 47-48), with the teaching of measuring FSH (col. 3 lines 59-60), thereby addressing the claim because Catt teaches measuring FSH in a finite list of possible analytes to be used with the fertility tracking system (col. 3 lines 45-60). One would have been motivated to try picking FSH from said finite list because Catt teaches that there is a need in the field for more efficient fertility tracking systems and suggests that FSH is a possible predictable solution to such a need. A person having ordinary skill in the art would have had a reasonable expectation of success given that Catt teaches that it is an objective of the invention to “provide an assay method/device in which multiple analytes in a single sample liquid can be determined accurately in a strip-format assay device which is interpreted instrumentally using electromagnetic radiation ( e.g. light) passed through the thickness of the assay strip” (col. 3 lines 27-32) and teaches that the strip can have two or more spacially distinct detection zones.
Regarding claim 80, although the claim is indefinite (see 112b rejection above) in the interest of compact prosecution, “a testing zone” is interpreted as “a third testing zone”. Catt further suggests each diagnostic test configured to additionally evaluate for the concentration of E3G in a testing zone and provide a result comprising a color intensity, the color intensity correlating to a concentration of E3G in the applied fluid (col. 3 lines 27-32, col. 4 lines 11-65, col. 12 lines 47-48).
Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Catt as applied to claim 77 above, and further in view of Nara et al. (EP 2881471 A1).
Regarding claim 81, Catt teaches the system of claim 77 as discussed above.
Catt teaches a single container configured to enclose the plurality of diagnostic tests together (“An important embodiment of the invention is a replacement pack, containing a plurality, preferably not more than 12, and ideally 7 to 10, of disposable testing devices to replenish a test kit” col. 5 lines 1-4).
Catt fails to teach each diagnostic test placed individually into a sealed packet.
Nara teaches “Disposable Test Strip Device For Analyte Detection In A Body Liquid Sample” (Title). Nara further suggests each diagnostic test placed individually into a sealed packet (“Each test strip device implemented in accordance with any embodiment may either be packaged individually into a hermetically sealed package (foil or plastic, for example),” para. 109). Nara further teaches that “sealing is a necessary precaution to ensure that {bio)chemical components comprised within the test strip device would not evaporate, dry etc.” (para. 109).
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 modified the teachings of Catt to rely on the each diagnostic test placed individually into a sealed packet taught by Nara because Nara suggests that this protects the diagnostic test. A person having ordinary skill in the art would have had a reasonable expectation of success given that both Nara and Catt are drawn to test strips to for analyte detection in a body liquid sample.
Claim 82 is rejected under 35 U.S.C. 103 as being unpatentable over Catt as applied to claim 77 above, and further in view of Takayasu as evidenced by CoolConversion "An Tbsp of Pumpkin Seeds to Grams Conversion" (retrieved online https://coolconversion.com/cooking-volume-weight/a~tbsp~of~pumpkin+seeds~to~gram on 12/17/2025) and Mayo Clinic "Does ground flaxseed have more health benefits than whole flaxseed?" (Jan 31. 2023) (retrieved online https://www.mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/expert-answers/flaxseed/faq-20058354 on 12/17/2025).
Regarding claim 82, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the threshold is interpreted to be “15 mIU/mL-50 mIU/mL” as in claim 77. Catt teaches the system of claim 77 as discussed above.
Catt further teaches that ovulation is determined using the diagnostic tests configured to detect for the presence or absence of LH at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL (col. 4 lines 37-39, col. 9 lines 40-41 and 47-49).
Catt fails to teach further comprising at least one single consumable food item comprising pumpkin seeds in 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 (Applicant’s elected species), and commencing upon the occurrence of menstruation a daily recurring instruction to consume pumpkin seeds and flax seeds once daily, the daily recurring instruction to consume pumpkin seeds and flax seeds once daily terminating upon the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily, the daily recurring instruction to consume sesame seeds and sunflower seeds once daily terminating upon the onset of menstruation.
Takayasu teaches “seed cycling for hormonal imbalance” (Title). Takayasu further suggests comprising at least one single consumable food item comprising pumpkin seeds in 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 (Applicant’s elected species), and commencing upon the occurrence of menstruation a daily (page 3 para. 3) recurring instruction to consume pumpkin seeds and flax seeds once daily, the daily recurring instruction to consume pumpkin seeds and flax seeds once daily terminating upon the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily, the daily recurring instruction to consume sesame seeds and sunflower seeds once daily terminating upon the onset of menstruation (page 3 paras. 3, 5 and 7-8 and 10-1). Note that although Takayasu fails to use the language “terminating upon the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle”, Takayasu still suggests the claim because Takayasu teaches the seed consumption based on the start of ovulation and Catt explicitly teaches that the diagnostic tests configured to detect LH determine that ovulation is imminent. Note also that as evidenced by CoolConversion, the tablespoon of pumpkin seeds taught by Takayasu is equivalent to “7.44 grams” (page 1) and as evidenced by Mayo Clinic the tablespoon of flax seeds taught by Takayasu is equivalent to “7 grams” (page 1 para. 2). Therefore, Takayasu addresses “6.5-16 grams” of pumpkin seeds and flax seed. Takayasu further teaches that “[c]ertain seeds carry certain fatty acids (a.k.a. oils), vitamins, and nutrients that help support our hormones” (page 2 para. 11).
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 modified the teachings of Catt to include the consumable food items and daily recurring instructions to consume the food items commencing upon menstruation taught by Takayasu and terminating upon the result of the diagnostic tests of Catt, because Takayasu suggests that the seed consumption system supports optimal hormonal balance though the nutrients in the seeds and Catt is concerned with tracking the hormones of women. A person having ordinary skill in the art would have had a reasonable expectation of success because Takayasu describes the system as simple and both Catt and Takayasu are drawn to women’s hormonal balance through the cycle.
Pertinent Prior Art
Claims 67-68, 71-73, 75-76 and 83-85, which have an effective filing date of 7/2/2020 (see Priority section above), seem to be free of the prior art. However, from the claims mentioned above, claims 67-68, 71, 73, 75-76, 83 and 85 are rejected under non-statutory double patenting (see below).
Regarding claims 67-68, the prior art made of record and not relied upon is considered pertinent to applicant's disclosure is McCarthy et al. (US 20150094227 A1)-Cite No. 11 of IDS 8/18/2022 (“McCarthy”).
McCarthy teaches “an assay means to measure the absolute or relative amount of FSH in a sample from the subject; and an assay means to measure the absolute or relative amount of one or more progesterone metabolites in a sample from the subject” (Abstract).
However, there were no references found that taught or suggested “an instruction to commence testing for FSH, by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence of FSH on a date selected from the range of 2-3 days following the onset of menstruation; an instruction to commence testing for E3G by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence of E3G following at least a 1.5-fold decrease from one diagnostic test configured to evaluate for the presence of FSH to another diagnostic test configured to evaluate for the presence of FSH performed on a different day in the same menstrual cycle”.
Regarding claims 71-73 and 83-85, the closest prior art is considered to be Catt, Takayasu and Gilmour (the references cited in the rejections above). Specifically, Takayasu teaches the instructions to consume the seeds. Gilmour teaches that “the [subject monitoring system] SMS contains a user interface for displaying text, graphics, user-prompts, and various other information” para. 150, however, there is no reason or motivation to deliver the seed-consuming instructions through the system of Gilmour. There were no references that taught or suggested the combination of delivering the seed-consuming instructions through a smartphone, or the cartridge of the diagnostic test, or the display on a digital reader.
In fact, prior art made of record and not relied upon is considered pertinent to applicant's disclosure is Toler “Seed Cycling: I tried it. (And dug into the research on whether it works.)” Published Jan. 28, 2020 (retrieved online https://helloclue.com/articles/culture/seed-cycling-i-tried-it-and-dug-into-the-research-on-whether-it-works on 12/19/2020).
Toler seems to teach away from consuming the pumpkin seeds and flax seeds (“Evidence on seed cycling is non-existent” page 1, “Seed cycling is generally considered alternative medicine, and there isn't much science on its risks, benefits, or efficacy. Most reports of seed cycling are anecdotal” page 2 para. 3, “ I didn’t continue with seed cycling because I just became tired of eating the seeds” page 3) in systems drawn to fertility tracking (“Seed cycling is an alternative medicine practice believed to help regulate reproductive hormones” page 1 para. 1).
Regarding claims 75-76, the closest prior art is considered to be Catt, Divaraniya, Hua and Gilmour (the references cited in the rejections above). Specifically, Divaraniya teaches instructions to consume the progesterone supplements (para. 327). But, there were no references that taught or suggested consuming the progesterone supplements during the subsequent menstrual cycle following an indication of the absence of PdG at a threshold in the applied fluid on any diagnostic test taken during the timeframe of 7-10 days past ovulation or following an indication on a diagnostic test of the absence of PdG at a threshold in an applied fluid delivered in association with an application operating on a smartphone.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
U.S. Patent No. 11131665 B1
Claims 53-60 and 62-63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11131665 B1 in view of Gilmour.
Regarding claim 53, U.S. Patent No. 11131665 B1 recites a menstrual cycle tracking system (“A method for evaluating urine of a subject to estimate the fertile window” claim 1), comprising: one diagnostic test or a plurality of diagnostic tests each configured to evaluate a sample of bodily fluid from a subject (“testing the single sample of urine with one or both of a first lateral flow assay and a second lateral flow assay” claim 1) woman collected on a daily basis during a menstrual cycle (“determining that ovulation has occurred and that the fertile window has closed by … repeating the collecting, testing and determining steps, the fertile window opening date of the subject estimated as the date of the first positive result in a menstrual cycle of the subject … during the menstrual cycle” claim 1) 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 PdG threshold selected from within the range inclusive of 3-20 μg/ml” claim 1), 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 (“the result for the presence of PdG at or above the PdG threshold obtained by photographing a diagnostic test with the camera of a smartphone” claim 7) and the computing device further configured to store the one interpretation or a plurality of interpretations and display the one interpretation or plurality of interpretations based on the one result or plurality of results to a graphical user interface (“the smartphone further configured to utilize an application to collect, store and upon a display of the smartphone present the result for the presence of PdG at or above the PdG threshold” claim 8). Note that although U.S. Patent No. 11131665 B1 fails to use the language “system”, the method of U.S. Patent No. 11131665 B1 inherently provides a system because it involves several elements and is drawn to lateral flow assays to detect specific hormone and evaluate the fertility of a subject, which reads on a system as in the instant claim.
U.S. Patent No. 11131665 B1 fails to recite the computing device also evaluates the one result or plurality of results to generate one interpretation or a plurality of interpretations following the result and storing and displaying the interpretations.
Gilmour suggests a menstrual cycle tracking system (Title, Abstract), comprising: one diagnostic test or a plurality of diagnostic tests (para. 26) each configured to evaluate a sample of bodily fluid from a subject woman (para. 20) collected on a daily basis (para. 40) during a menstrual cycle (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 (Table 4, para. 242, 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 (para. 43, para. 139, para. 205), the computing device further configured to store the one interpretation or a plurality of interpretations (para. 43, 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 (para. 43, para. 150, para. 173, 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 inventions herein address these and other needs” (para. 17). Gilmour further teaches that “lateral flow diagnostic tests, are known in the art” (paras. 12-13).
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 modified the teachings of U.S. Patent No. 11131665 B1 to include the computing device also generating, storing and displaying the interpretations taught by Gilmour because Gilmour suggests this enables "many practical applications" in the field of menstrual cycle tracking systems. One would been motivated to make such a modification because Gilmour suggests that the device is simple, convenient and cost effective and addresses the current needs in the field. A person having ordinary skill in the art would have had a reasonable expectation of success because both U.S. Patent No. 11131665 B1 and Gilmour teach lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL.
Regarding claim 54, U.S. Patent No. 11131665 B1 in view of Gilmour address the system of claim 53 as discussed above.
U.S. Patent No. 11131665 B1 recites “estimating the fertile window dates” (claim 1).
U.S. Patent No. 11131665 B1 fails to recite 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.
Gilmour teaches 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 (para. 188, para. 190, see Table 4, para. 279). Gilmour further suggests this is an effective way to avoid pregnancy (“Avoidance of Pregnancy” para. 276).
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 modified the teachings of U.S. Patent No. 11131665 B1 to rely on the interpretation taught by Gilmour because Gilmour suggests this is an effective way to avoid pregnancy. A person having ordinary skill in the art would have had a reasonable expectation of success because both U.S. Patent No. 11131665 B1 and Gilmour teach lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL.
Regarding claim 55, U.S. Patent No. 11131665 B1 in view of Gilmour address the system of claim 53 as discussed above.
U.S. Patent No. 11131665 B1 fails to recite 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 FSH, E3G, LH, hCG and PdG.
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 (para. 117, para. 124, para. 177). Gilmour teaches that this enables multiplexing (para. 132).
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 modified the teachings of U.S. Patent No. 11131665 B1 to rely on 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 taught by Gilmour because Gilmour teaches that this enables assay multiplexing and both U.S. Patent No. 11131665 B1 and Gilmour are concerned with analyte detection. A person having ordinary skill in the art would have had a reasonable expectation of success because both U.S. Patent No. 11131665 B1 and Gilmour teach lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL.
Regarding claims 56-57, U.S. Patent No. 11131665 B1 in view of Gilmour address the system of claim 53 as discussed above.
U.S. Patent No. 11131665 B1 fails to recite 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 patient-facing information configured to operate in association with a computing device and communicatively connected storage medium; 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, 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
Gilmour 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 (para. 173); the patient-facing information configured to operate in association with a computing device and communicatively connected storage medium (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 (para. 151, para. 188, Example 12). 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 (para. 173, para. 158, para. 160). Gilmour suggests that this enables a more user-friendly system (“the SMS internal software is menu-driven for ease-of-use by subjects” para. 151).
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 modified the teachings of U.S. Patent No. 11131665 B1 to rely on the patient-facing application and the healthcare professional-facing application taught by Gilmour because Gilmour suggests that this enables a more user-friendly system. A person having ordinary skill in the art would have had a reasonable expectation of success because both U.S. Patent No. 11131665 B1 and Gilmour teach lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL.
Regarding claims 58-60, U.S. Patent No. 11131665 B1 in view of Gilmour address the system of claim 53 as discussed above.
U.S. Patent No. 11131665 B1 fails to recite further comprising a calendar configured to display the result or interpretation associated with each diagnostic test in a graphical user interface in association with the date and time each diagnostic test was performed, 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, 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.
Gilmour further suggests further comprising a calendar configured to display the result or interpretation associated with each diagnostic test in a graphical user interface (para. 194) in association with the date and time each diagnostic test was performed (para. 151). Gilmour further teaches that lateral flow tests are common in the field (paras. 12-13). Gilmour further 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 (para. 140, para. 147, para. 150). Gilmour further 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 (para. 167, para. 168, para. 170).
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 modified the teachings of U.S. Patent No. 11131665 B1 to rely on the calendar, the fertility tracking system, and the telemedicine system taught by Gilmour because it would have been an obvious matter or applying a known technique to a known method. In this case both U.S. Patent No. 11131665 B1 and Gilmour teach lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL. Gilmour simply applies the art-recognized technique of further comprising a calendar, a fertility tracking system, and a telemedicine system. Therefore, a person having ordinary skill in the art would have found it obvious to apply the technique of Gilmour to the base method taught by both U.S. Patent No. 11131665 B1 and Gilmour. A person having ordinary skill in the art would have had a reasonable expectation of success because Gilmour teaches that lateral flow tests are common in the field.
Regarding claim 62, U.S. Patent No. 11131665 B1 in view of Gilmour address the system of claim 53 as discussed above.
U.S. Patent No. 11131665 B1 recites 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, 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 fertile window opening date of the subject estimated as the date of the first positive result in a menstrual cycle of the subject for the presence of LH at or above the LH threshold” claim 1).
Regarding claim 63, U.S. Patent No. 11131665 B1 recites a fertility tracking system, 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, (“A method for evaluating urine of a subject to estimate the fertile window…the first lateral flow assay comprising: a sample pad configured to receive the urine sample, a receiving zone within a conjugate pad, the conjugate pad saturated with a conjugate comprising an anti-PdG antibody conjugated to a visual label in a concentration selected from the range inclusive of 1-10 μg/ml, a membrane comprising a testing zone, the testing zone comprising PdG conjugated to a carrier protein that binds PdG antigens at 8-32 molecules per carrier protein, and further configured to evaluate for the presence or absence of PdG at or above a PdG threshold, the PdG threshold selected from within the range inclusive of 3-20 μg/ml…the membrane further configured to provide an observable positive result for the presence of PdG in the sample of urine at the PdG threshold as indicated by the absence of the color of the visual label in the testing zone following the operation of the first lateral flow assay…and estimating the fertile window dates, optionally by repeating the collecting, testing and determining steps” claim 1). Note that although U.S. Patent No. 11131665 B1 fails to use the language “system”, the method of U.S. Patent No. 11131665 B1 inherently provides a system because it involves several elements and is drawn to lateral flow assays to detect specific hormone and evaluate the fertility of a subject, which reads on a system
U.S. Patent No. 11131665 B1 fails to recite the tests configured such that only one perceptible line observable on the diagnostic test indicates a positive result and a control line 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.
Gilmour suggests a fertility tracking system (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 (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 (para. 10, para. 106, para. 233, see Table 4). Gilmour further suggests that the control line enables only one perceptible line observable on the diagnostic test indicating a positive result and enables two perceptible lines observable on the diagnostic test indicating a negative result (Table 4). Gilmour further suggests that the control line enables outlier corrections and normalization (“The variability in conjugate pad release can be simply observed by repeat runs of a single hormone concentration where it displays itself either as general large strip to strip variation or high strip to strip repeatability with the occasional extreme outlier. Both of these types of variation can be partly corrected for by expressing the data relative to the control line, either as a fraction (T/T +C) or as a ratio (T/C)” para. 261).
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 modified the teachings of U.S. Patent No. 11131665 B1 to rely on the a control line, 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 taught by Gilmour because Gilmour suggests that this provides outlier correction and normalization. A person having ordinary skill in the art would have had a reasonable expectation of success both U.S. Patent No. 11131665 B1 and Gilmour teach competitive lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL using PdG conjugated to a carrier protein as the capture reagent and anti-PdG antibody conjugated to a visual label as the detection reagent.
Claim 61 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11131665 B1 in view of Gilmour as applied to claim 53 above, and further in view of Takayasu.
Regarding claim 61, U.S. Patent No. 11131665 B1 in view of Gilmour address the system of claim 53 as discussed above.
U.S. Patent No. 11131665 B1further 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 (“determining that ovulation has occurred and that the fertile window has closed by a positive result for the presence of PdG at the PdG threshold” claim 1).
U.S. Patent No. 11131665 B1 in view of Gilmour fail to recite 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 (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 (page 3 paras. 7-8 and 10-11). Note that although Takayasu fails to use the language “based on the result indicated on each of the plurality of diagnostic tests”, Takayasu still suggests the claim because Takayasu teaches the seed consumption based on the start of ovulation and U.S. Patent No. 11131665 B1 explicitly recites that the diagnostic tests configured to detect PdG determine the start of ovulation. Takayasu further teaches that “[c]ertain seeds carry certain fatty acids (a.k.a. oils), vitamins, and nutrients that help support our hormones” (page 2 para. 11).
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 modified the teachings of U.S. Patent No. 11131665 B1 in view of Gilmour to include the seed consumption system taught by Takayasu based on the result of the diagnostic tests of U.S. Patent No. 11131665 B1, because Takayasu suggests that the seed consumption system supports optimal hormonal balance through the nutrients in the seeds and U.S. Patent No. 11131665 B1 is concerned with tracking the hormones of women. A person having ordinary skill in the art would have had a reasonable expectation of success because Takayasu describes the system as simple and both U.S. Patent No. 11131665 B1 in view of Gilmour and Takayasu are drawn to women’s hormonal balance through the cycle.
Claims 64-66, 69 and 77-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11131665 B1 in view of Catt.
Regarding claim 64, U.S. Patent No. 11131665 B1 recites a tracking system for evaluating a menstrual cycle, comprising: a plurality of diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in an applied fluid; and a plurality of diagnostic tests each configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in an applied fluid (“A method for evaluating urine of a subject to estimate the fertile window…a first lateral flow assay and a second lateral flow assay…configured to evaluate for the presence or absence of PdG at or above a PdG threshold, the PdG threshold selected from within the range inclusive of 3-20 μg/ml…configured to evaluate for the presence or absence of LH at a LH threshold of no less than 20 ml U/ml…optionally by repeating the collecting, testing and determining steps” claim 1).
U.S. Patent No. 11131665 B1 fails to recite of a quantity selected from the range inclusive of 4-15, and of a quantity selected from the range inclusive of 7-25 of diagnostic tests.
Catt teaches a fertility tracking system for evaluating a menstrual cycle (col. 2 lines 49-51), comprising: a plurality, of a quantity selected from the range inclusive of 4-15 (col. 8 lines 21-26), of diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in an applied fluid (col. 9 lines 27-29, col. 10 lines 33-37); and a plurality, of a quantity selected from the range inclusive of 7-25 (col. 8 lines 21-26, col. 9 lines 27-29), of diagnostic tests each configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in an applied fluid (col. 9 lines 47-50). Catt teaches that a quantity selected from the range inclusive of 4-15, and of a quantity selected from the range inclusive of 7-25 of tests enables the establishment of “a reference concentration value or signal for said analyte in the current cycle” (col. 7 lines 5-7) for “effective monitoring of the ovulation cycle” (col. 8 line 67).
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 modified the teachings of U.S. Patent No. 11131665 B1 to rely on the a quantity selected from the range inclusive of 4-15, and of a quantity selected from the range inclusive of 7-25 of diagnostic tests taught by Catt because Catt suggests this enables effective monitoring of the ovulation cycle, by setting an initial reference concentration value to be used in tracking. A person having ordinary skill in the art would have had a reasonable expectation of success given that both U.S. Patent No. 11131665 B1 and Catt teach a tracking system for evaluating a menstrual cycle, comprising: a plurality of diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in an applied fluid; and a plurality of diagnostic tests each configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in an applied fluid.
Regarding claims 65-66, U.S. Patent No. 11131665 B1 in view of Catt address the system of claim 64 as discussed above.
U.S. Patent No. 11131665 B1 fails to recite further comprising a plurality, at a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of FSH in urine and further comprising a plurality, of a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of E3G in urine.
Catt further teaches further comprising a plurality, at a quantity selected from the range inclusive of 7-25, of diagnostic tests (col. 8 lines 21-26) configured to evaluate for the presence of FSH (col. 3 lines 46 and 58-60) in urine (col. 3 line 46, col. 7 line 58). Catt further teaches further comprising a plurality, of a quantity selected from the range inclusive of 7-25 (col. 8 lines 21-26), of diagnostic tests configured to evaluate for the presence of E3G in urine (col. 3 lines 46 and 52-53). Catt further teaches that “estriol-3-glucuronide, estriol-16- glucuronide [E3G]…Follicle stimulating hormone (FSH)…[are] an example” (col. 3 lines 59-60) of suitable analytes for monitoring the fertility status.
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 modified the teachings of U.S. Patent No. 11131665 B1 to rely on the plurality, at a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of FSH in urine and further comprising a plurality, of a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of E3G in urine taught by Catt because it would have been a simple matter of applying a known technique to a known method. In this case both U.S. Patent No. 11131665 B1 and Catt teach a tracking system for evaluating a menstrual cycle, comprising: a plurality of diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in an applied fluid; and a plurality of diagnostic tests each configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in an applied fluid. Catt simply applies the art-recognized technique of including the plurality, at a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of FSH in urine and further comprising a plurality, of a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of E3G in urine. Therefore, a person having ordinary skill in the art would have found it obvious to apply the technique of Catt to the base method taught by both of U.S. Patent No. 11131665 B1 and Catt. A person having ordinary skill in the art would have had a reasonable expectation of success given that Catt teaches that FSH and E3G are known and suitable analytes to be used with the fertility tracking system.
Regarding claim 69, U.S. Patent No. 11131665 B1 in view of Catt address the system of claim 64 as discussed above.
U.S. Patent No. 11131665 B1 fails to recite further comprising a single container to enclose the plurality of diagnostic tests together.
Catt further teaches further comprising a single container to enclose the plurality of diagnostic tests together (col. 5 lines 1-4). Catt teaches that the container can be used as a “replacement pack” (col. 5 lines 1-4).
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 modified the teachings of U.S. Patent No. 11131665 B1 to rely on the further comprising a single container to enclose the plurality of diagnostic tests together taught by Catt because Catt teaches that the container can be used as a replacement pack in the system. A person having ordinary skill in the art would have had a reasonable expectation of success because both U.S. Patent No. 11131665 B1 and Catt are drawn to a plurality of diagnostic tests.
Regarding claims 77 and 79-80, although claims 79-80 are indefinite (see 112b rejection above), in the interest of compact prosecution the “testing zone” is interpreted as “a third testing zone”. U.S. Patent No. 11131665 B1 recites a fertility tracking system for evaluating a menstrual cycle, comprising: a plurality of diagnostic tests each diagnostic test configured to evaluate an applied fluid for at least the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in a first testing zone (claim 1). U.S. Patent No. 11131665 B1 further recites a second testing zone (“the membrane comprising a second testing zone” claim 2). U.S. Patent No. 11131665 B1 further recites a second diagnostic test configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL (claim 1). Note that although U.S. Patent No. 11131665 B1 fails to use the language “system”, the method of U.S. Patent No. 11131665 B1 inherently provides a system because it involves several elements and is drawn to lateral flow assays to detect specific hormone and evaluate the fertility of a subject, which reads on a system
U.S. Patent No. 11131665 B1 fails to recite a quantity selected from the range inclusive of 10-25, of diagnostic tests and the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in a second testing zone. U.S. Patent No. 11131665 B1 fails to further recite each diagnostic test configured to additionally evaluate for the concentration of FSH in a testing zone and provide a result comprising a color intensity, the color intensity correlating to a concentration of FSH in the applied fluid. U.S. Patent No. 11131665 B1 fails to further recite each diagnostic test configured to additionally evaluate for the concentration of E3G in a testing zone and provide a result comprising a color intensity, the color intensity correlating to a concentration of E3G in the applied fluid.
Catt suggests a fertility tracking system for evaluating a menstrual cycle, comprising: a plurality, of a quantity selected from the range inclusive of 10-25, of diagnostic tests (col. 8 lines 21-26), each diagnostic test configured to evaluate an applied fluid for at least the presence or absence of pregnanediol glucuronide (col. 2 lines 33-34, col. 9 lines 27-29) at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL (col. 10 lines 33-37) in a first testing zone (col. 4 lines 24-31) and the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in a second testing zone (col. 4 lines 36-41, col. 9 lines 47-50). Catt further teaches that “the invention can readily be applied to data derived from the measurement…of other analytes of significance in relation to the status of the ovulation cycle” (col. 3 lines 55-58). Catt further suggests each diagnostic test configured to additionally evaluate for the concentration of FSH (col. 3 lines 59-60) in a third testing zone (col. 12 lines 35-60) and provide a result comprising a color intensity, the color intensity correlating to a concentration of FSH in the applied fluid (col. 19 lines 3-16). Catt further teaches that “[a] yet further object of the invention is to provide an assay method/device in which multiple analytes in a single sample liquid can be determined accurately in a strip-format assay device which is interpreted instrumentally using electromagnetic radiation ( e.g. light) passed through the thickness of the assay strip” (col. 3 lines 27-32). Catt further suggests that there is a need of more efficient fertility tracking systems (col. 1 lines 15-20). Catt further suggests each diagnostic test configured to additionally evaluate for the concentration of E3G in third testing zone and provide a result comprising a color intensity, the color intensity correlating to a concentration of E3G in the applied fluid (col. 3 lines 27-32, col. 12 lines 35-60). Catt further teaches that an “objective of the invention is to provide a testing regime which is a good balance between the desire to minimise the testing burden on the user and the need to give the user worthwhile advice about the fertility status” (col. 3 lines 4-7).
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 modified the teachings of U.S. Patent No. 11131665 B1 to combine the embodiment drawn to the second testing zone, with the teaching of measuring luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL, thereby addressing a first testing zone for PdG and a second testing zone for LH and claim 77 because Catt teaches that PdG and LH work together as a "back up" to each other, thereby strengthening the results of the test. It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of U.S. Patent No. 11131665 B1 to include a plurality, of a quantity selected from the range inclusive of 10-25, of diagnostic tests and a third testing zone for FSH or E3G in each diagnostic test because Catt suggests that this enables efficient and effective fertility monitoring, which is a current need in the field, balancing the testing burden with the accuracy of the system. A person having ordinary skill in the art would have had a reasonable expectation of success given that both LH and PdG are indicative of infertility. Furthermore, a person having ordinary skill in the art would have had a reasonable expectation of success given that both U.S. Patent No. 11131665 B1 and Catt teach a tracking system for evaluating a menstrual cycle.
Regarding claim 78, U.S. Patent No. 11131665 B1 in view of Catt address the system of claim 77 as discussed above.
U.S. Patent No. 11131665 B1 fails to recite further comprising a diagnostic test key configured to map the color intensity of an indicated result to a concentration of a hormone or analyte correlating to the color intensity.
Catt suggests further comprising a diagnostic test key configured to map the color intensity of an indicated result to a concentration of a hormone or analyte correlating to the color intensity (col. 20 lines 41-47). Catt teaches that this enables the results to be “detected simply by eye” (col. 20 line 46).
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 modified the teachings of U.S. Patent No. 11131665 B1 to rely on the diagnostic test key taught by Catt because Catt suggests that this enables the user to read the results of the test simply by eye. A person having ordinary skill in the art would have had a reasonable expectation of success given that both U.S. Patent No. 11131665 B1 and Catt teach a tracking system for evaluating a menstrual cycle.
Claim 70 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11131665 B1 in view of Catt as applied to claim 64 above, and further in view of Takayasu and Ella.
Regarding claim 70, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the threshold is interpreted to be “15 mIU/mL-50 mIU/mL” as in claim 64.
U.S. Patent No. 11131665 B1 in view of Catt address the system of claim 64 as discussed above.
U.S. Patent No. 11131665 B1 further teaches that ovulation is determined using the diagnostic tests configured to detect for the presence or absence of LH at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL (“determining that the fertile window has opened by observing a positive result for the presence of LH at or above the LH threshold” claim 1).
U.S. Patent No. 11131665 B1 in view of Catt fail to recite at least one snack bar comprising pumpkin seeds and flax seeds (Applicant’s elected species), and a daily recurring instruction following menstruation to consume pumpkin seeds and flax seeds once daily until the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily until the onset of menstruation.
Takayasu teaches “seed cycling for hormonal imbalance” (Title). Takayasu further suggests comprising pumpkin seeds and flax seeds (page 2 para. 11, page 3 paras. 7-8 and 10-1), and a daily (page 3 para. 3) recurring instruction following menstruation to consume pumpkin seeds and flax seeds once daily until the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily until the onset of menstruation (page 3 paras. 3, 5 and 7-8 and 10-1). Note that although Takayasu fails to use the language “until the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle”, Takayasu still suggests the claim because Takayasu teaches the seed consumption based on the start of ovulation and U.S. Patent No. 11131665 B1 explicitly teaches that the diagnostic tests configured to detect LH determine that ovulation is imminent. Takayasu further teaches that “[c]ertain seeds carry certain fatty acids (a.k.a. oils), vitamins, and nutrients that help support our hormones” (page 2 para. 11).
Ella teaches “Superfood healthy pumpkin breakfast bars” (Title). Ella teaches at least one snack bar comprising pumpkin seeds and flax seeds (page 7). Ella further teaches that the snack bars “are not only amazing and loaded with superfood power, but they are also naturally gluten-free, vegan and refined sugar free. And these are also nut-free which means school-safe!” (page 3 para. 2). Ella further teaches the detailed directions to make the snack bars (page 7).
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 modified the teachings of U.S. Patent No. 11131665 B1 in view of Catt to include the seed consumption system taught by Takayasu based on the result of the diagnostic tests of U.S. Patent No. 11131665 B1, because Takayasu suggests that the seed consumption system supports optimal hormonal balance though the nutrients in the seeds and U.S. Patent No. 11131665 B1 is concerned with tracking the hormones of women. A person having ordinary skill in the art would have had a reasonable expectation of success because Takayasu describes the system as simple and both U.S. Patent No. 11131665 B1in view of Catt and Takayasu are drawn to women’s hormonal balance through the cycle.
It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of U.S. Patent No. 11131665 B1 in view of Catt and Takayasu to have the pumpkin seeds and flax seeds in a snack bar as taught by Ella, because Ella suggests that this makes a very delicious superfood. A person having ordinary skill in the art would have had a reasonable expectation of success because Ella teaches the recipe, i.e. detailed directions to make the snack bars.
Claim 74 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11131665 B1 in view of Catt as applied to claim 64 above, and further in view of Divaraniya and Hua.
Regarding claim 74, U.S. Patent No. 11131665 B1 in view of Catt address the system of claim 64 as discussed above.
U.S. Patent No. 11131665 B1 in view of Catt fail to recite further comprising a plurality of progesterone supplement doses, each formulated in an oil suspension.
Divaraniya teaches “systems for detecting analyte levels” (Title). Divaraniya further teaches “[a] woman is undergoing in vitro fertilization (IVF) treatment and must obtain frequent measurements of her fertility hormones and metabolites to ensure a successful procedure. …On days 17-27 of her menstrual cycle, the woman takes progesterone supplements to support her uterine lining and implantation” (para. 327).
Hua teaches “uses and benefits of compound progesterone” (Title). Hua teaches “solutions for…hormonal imbalance” (page 1 para. 1) and that “that progesterone is a hormone that is essential for the functions of all the systems in a woman’s body” (page 1 para. 2). Hua further teaches that progesterone supplements are normally either in an oil suspension or in a gel (page 3 last paragraph). Hua further suggests that oil suspension progesterone supplements help the body “regain hormonal equilibrium” (page 4 para. 3). Hua further teaches that “the only FDA approved progesterone product that can be used in the treatment of menopause is Prometrium, which is progesterone in peanut oil capsules” (page 4 para. 1).
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 modified the teachings of U.S. Patent No. 11131665 B1 in view of Catt to rely on the progesterone supplements taught by Divaraniya because Divaraniya teaches that this supports the uterine lining and Catt is concerned with women’s fertility hormones. A person having ordinary skill in the art would have had a reasonable expectation of success because both Divaraniya and U.S. Patent No. 11131665 B1 in view of Catt teach systems comprising detecting hormones in women.
It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of U.S. Patent No. 11131665 B1 in view of Catt and Divaraniya to rely on the progesterone supplements being each formulated in an oil suspension taught by Hua because Hua suggest this enables hormonal balance. A person having ordinary skill in the art would have had a reasonable expectation of success given that Hua suggests that most progesterone supplements are oil-based.
Claim 81 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11131665 B1 in view of Catt as applied to claim 77 above, and further in view of Nara.
Regarding claim 81, U.S. Patent No. 11131665 B1 in view of Catt recite the system of claim 77 as discussed above.
Catt further teaches a single container configured to enclose the plurality of diagnostic tests together (col. 5 lines 1-4).
U.S. Patent No. 11131665 B1 in view of Catt fail to recite each diagnostic test placed individually into a sealed packet.
Nara teaches “Disposable Test Strip Device For Analyte Detection In A Body Liquid Sample” (Title). Nara further suggests each diagnostic test placed individually into a sealed packet (para. 109). Nara further teaches that “sealing is a necessary precaution to ensure that {bio)chemical components comprised within the test strip device would not evaporate, dry etc.” (para. 109).
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 modified the teachings of U.S. Patent No. 11131665 B1 in view of Catt to rely on the each diagnostic test placed individually into a sealed packet taught by Nara because Nara suggests that this protects the diagnostic test. A person having ordinary skill in the art would have had a reasonable expectation of success given that both Nara and U.S. Patent No. 11131665 B1 in view of Catt are drawn to test strips to for analyte detection in a body liquid sample.
Claim 82 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11131665 B1 in view of Catt as applied to claim 77 above, and further in view of Takayasu as evidenced by CoolConversion and Mayo Clinic.
Regarding claim 82, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the threshold is interpreted to be “15 mIU/mL-50 mIU/mL” as in claim 77.
U.S. Patent No. 11131665 B1 in view of Catt recite the system of claim 77 as discussed above.
U.S. Patent No. 11131665 B1 further recites that ovulation is determined using the diagnostic tests configured to detect for the presence or absence of LH at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL (claim 1).
U.S. Patent No. 11131665 B1 in view of Catt fail to recite further comprising at least one single consumable food item comprising pumpkin seeds in 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 (Applicant’s elected species), and commencing upon the occurrence of menstruation a daily recurring instruction to consume pumpkin seeds and flax seeds once daily, the daily recurring instruction to consume pumpkin seeds and flax seeds once daily terminating upon the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily, the daily recurring instruction to consume sesame seeds and sunflower seeds once daily terminating upon the onset of menstruation.
Takayasu teaches “seed cycling for hormonal imbalance” (Title). Takayasu further suggests comprising at least one single consumable food item comprising pumpkin seeds in 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 (Applicant’s elected species), and commencing upon the occurrence of menstruation a daily (page 3 para. 3) recurring instruction to consume pumpkin seeds and flax seeds once daily, the daily recurring instruction to consume pumpkin seeds and flax seeds once daily terminating upon the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily, the daily recurring instruction to consume sesame seeds and sunflower seeds once daily terminating upon the onset of menstruation (page 3 paras. 3, 5 and 7-8 and 10-1). Note that as evidenced by CoolConversion, the tablespoon of pumpkin seeds taught by Takayasu is equivalent to “7.44 grams” (page 1) and as evidenced by Mayo Clinic the tablespoon of flax seeds taught by Takayasu is equivalent to “7 grams” (page 1 para. 2). Therefore, Takayasu addresses “6.5-16 grams” of pumpkin seeds and flax seed. Note that although Takayasu fails to use the language “until the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle”, Takayasu still suggests the claim because Takayasu teaches the seed consumption based on the start of ovulation and U.S. Patent No. 11131665 B1 explicitly teaches that the diagnostic tests configured to detect LH determine that ovulation is imminent. Takayasu further teaches that “[c]ertain seeds carry certain fatty acids (a.k.a. oils), vitamins, and nutrients that help support our hormones” (page 2 para. 11).
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 modified the teachings of U.S. Patent No. 11131665 B1 in view of Catt to include the consumable food items and daily recurring instructions to consume the food items commencing upon menstruation taught by Takayasu and terminating upon the result of the diagnostic tests of U.S. Patent No. 11131665 B1, because Takayasu suggests that the seed consumption system supports optimal hormonal balance though the nutrients in the seeds and U.S. Patent No. 11131665 B1 in view of Catt is concerned with tracking the hormones of women. A person having ordinary skill in the art would have had a reasonable expectation of success because Takayasu describes the system as simple and both U.S. Patent No. 11131665 B1 in view of Catt and Takayasu are drawn to women’s hormonal balance through the cycle.
U.S. Patent No. 11573225 B2
Claims 53-60 and 62-63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11573225 B2 in view of Gilmour.
Regarding claim 53, U.S. Patent No. 11573225 B2 recites a menstrual cycle tracking system (“a fertility tracking system for evaluating a menstrual cycle” claim 1) comprising: one diagnostic test or a plurality of diagnostic tests each configured to evaluate a sample of bodily fluid from a subject (“comprising: a plurality of diagnostic tests, wherein each diagnostic test comprises: a sample pad configured to collect an applied sample” claim 1, “wherein the applied sample comprises urine of the subject” claim 15) woman collected on a daily basis during a menstrual cycle (“ to perform a diagnostic test configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold on each of the days during a range of days 7-10” claim 11) 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 (“wherein at least one of the plurality of diagnostic tests is configured to evaluate for the presence or absence of pregnanediol glucuronide (PdG) at a threshold selected from 3 μg/mL-20 μg/mL in an applied fluid” claim 1) 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, the computing device further configured to display the one interpretation or plurality of interpretations based on the one result or plurality of results to a graphical user interface (“an application configured to…capture an image or plurality of images of each diagnostic test…interpret a result or a plurality of results for each of the images by detecting the color intensity within the one or more testing zones for each of the images of diagnostic tests and correlating the detected color intensity or color intensities with a result, and display the result or the plurality of results indicated by the image of a diagnostic test or the plurality of images each of a diagnostic test on a graphical user interface” claim 1, “the application configured to interpret a result based on the indications provided in each of the plurality of testing zones on each photographed test and display the result on the graphical user interface of a smart device” claim 6).
U.S. Patent No. 11573225 B2 fails to recite storing the interpretations.
Gilmour suggests a menstrual cycle tracking system (Title, Abstract), comprising: one diagnostic test or a plurality of diagnostic tests (para. 26) each configured to evaluate a sample of bodily fluid from a subject woman (para. 20) collected on a daily basis (para. 40) during a menstrual cycle (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 (Table 4, para. 242, 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 (para. 43, para. 139, para. 205), the computing device further configured to store the one interpretation or a plurality of interpretations (para. 43, 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 (para. 43, para. 150, para. 173, 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 inventions herein address these and other needs” (para. 17). Gilmour further teaches that “lateral flow diagnostic tests, are known in the art” (paras. 12-13).
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 modified the teachings of U.S. Patent No. 11573225 B2 to include the computing device also storing the interpretations as taught by Gilmour because Gilmour suggests this enables "many practical applications" in the field of menstrual cycle tracking systems. One would been motivated to make such a modification because Gilmour suggests that such devices address the current needs in the field. A person having ordinary skill in the art would have had a reasonable expectation of success because both U.S. Patent No. 11573225 B2 and Gilmour teach lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL.
Regarding claim 54, U.S. Patent No. 11573225 B2 in view of Gilmour address the system of claim 53 as discussed above.
U.S. Patent No. 11573225 B2 recites 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 (“following a result of the presence of PdG at a threshold interpreted by the application; 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 9).
Regarding claim 55, U.S. Patent No. 11573225 B2 in view of Gilmour address the system of claim 53 as discussed above.
U.S. Patent No. 11573225 B2 further recite 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 FSH, E3G, LH, hCG and PdG (“at least one of the plurality of diagnostic tests comprises a plurality of testing zones, and wherein the application is configured to determine which of the testing zones on each diagnostic test is associated with the evaluation of PdG or LH” claim 6).
Regarding claims 56-57, U.S. Patent No. 11573225 B2 in view of Gilmour address the system of claim 53 as discussed above.
U.S. Patent No. 11573225 B2 fails to recite 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 patient-facing information configured to operate in association with a computing device and communicatively connected storage medium; 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, 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
Gilmour 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 (para. 173); the patient-facing information configured to operate in association with a computing device and communicatively connected storage medium (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 (para. 151, para. 188, Example 12). 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 (para. 173, para. 158, para. 160). Gilmour suggests that this enables a more user-friendly system (“the SMS internal software is menu-driven for ease-of-use by subjects” para. 151).
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 modified the teachings of U.S. Patent No. 11573225 B2 to rely on the patient-facing application and the healthcare professional-facing application taught by Gilmour because Gilmour suggests that this enables a more user-friendly system. A person having ordinary skill in the art would have had a reasonable expectation of success because both U.S. Patent No. 11573225 B2 and Gilmour teach lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL.
Regarding claims 58-60, U.S. Patent No. 11573225 B2 in view of Gilmour address the system of claim 53 as discussed above.
U.S. Patent No. 11573225 B2 fails to recite further comprising a calendar configured to display the result or interpretation associated with each diagnostic test in a graphical user interface in association with the date and time each diagnostic test was performed, 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, 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.
Gilmour further suggests further comprising a calendar configured to display the result or interpretation associated with each diagnostic test in a graphical user interface (para. 194) in association with the date and time each diagnostic test was performed (para. 151). Gilmour further teaches that lateral flow tests are common in the field (paras. 12-13). Gilmour further 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 (para. 140, para. 147, para. 150). Gilmour further 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 (para. 167, para. 168, para. 170).
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 modified the teachings of U.S. Patent No. 11573225 B2 to rely on the calendar, fertility tracking system, and telemedicine system taught by Gilmour because it would have been an obvious matter or applying a known technique to a known method. In this case both U.S. Patent No. 11573225 B2 and Gilmour teach lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL. Gilmour simply applies the art-recognized technique of further comprising a calendar, a fertility tracking system, and a telemedicine system. Therefore, a person having ordinary skill in the art would have found it obvious to apply the technique of Gilmour to the base method taught by both U.S. Patent No. 11573225 B2 and Gilmour. A person having ordinary skill in the art would have had a reasonable expectation of success because Gilmour teaches that lateral flow tests are common in the field.
Regarding claim 61, U.S. Patent No. 11573225 B2 in view of Gilmour address the system of claim 53 as discussed above.
U.S. Patent No. 11573225 B2 further recites 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 (“at least one food item comprising pumpkin seeds and flax seeds and at least one food item comprising sesame seeds and sunflower seeds, and a recurring instruction delivered via the graphical user interface application during the menstrual cycle of the subject to consume pumpkin seeds and flax seeds until the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a recurring instruction delivered via the graphical user interface of the application to consume sesame seeds and sunflower seeds until the onset of menstruation” claim 10).
Regarding claim 62, U.S. Patent No. 11573225 B2 in view of Gilmour address the system of claim 53 as discussed above.
U.S. Patent No. 11573225 B2 further recites 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, 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 (claims 1 and 9).
Regarding claim 63, U.S. Patent No. 11573225 B2 recites a fertility tracking system, 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 (“competitive assay format” claim 1).
U.S. Patent No. 11573225 B2 fails to recite configured such that only one perceptible line observable on the diagnostic test indicates a positive result and a control line 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.
Gilmour suggests a fertility tracking system (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 (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 (para. 10, para. 106, para. 233, see Table 4). Gilmour further suggests that the control line enables only one perceptible line observable on the diagnostic test indicating a positive result and enables two perceptible lines observable on the diagnostic test indicating a negative result (Table 4). Gilmour further suggests that the control line enables outlier corrections and normalization (“The variability in conjugate pad release can be simply observed by repeat runs of a single hormone concentration where it displays itself either as general large strip to strip variation or high strip to strip repeatability with the occasional extreme outlier. Both of these types of variation can be partly corrected for by expressing the data relative to the control line, either as a fraction (T/T +C) or as a ratio (T/C)” para. 261).
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 modified the teachings of U.S. Patent No. 11573225 B2 to rely on the a control line, 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 taught by Gilmour because Gilmour suggests that this provides outlier correction and normalization. A person having ordinary skill in the art would have had a reasonable expectation of success both U.S. Patent No. 11573225 B2 and Gilmour teach competitive lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL.
Claims 64-69, 77-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11573225 B2 in view of Catt.
Regarding claim 64, U.S. Patent No. 11573225 B2 recites a tracking system for evaluating a menstrual cycle, comprising: a plurality of diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in an applied fluid; and a plurality of diagnostic tests each configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in an applied fluid (“plurality of diagnostic tests is configured to evaluate for the presence or absence of pregnanediol glucuronide (PdG) at a threshold selected from 3 μg/mL-20 μg/mL in an applied fluid… plurality of diagnostic tests is configured to evaluate for the presence or absence of luteinizing hormone (LH) at a threshold selected from 15 mIU/mL-50 mIU/mL” claim 1).
U.S. Patent No. 11573225 B2 fails to recite of a quantity selected from the range inclusive of 4-15, and of a quantity selected from the range inclusive of 7-25 of diagnostic tests.
Catt teaches a fertility tracking system for evaluating a menstrual cycle (col. 2 lines 59-61), comprising: a plurality, of a quantity selected from the range inclusive of 4-15 (col. 8 lines 21-26), of diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in an applied fluid (col. 9 lines 27-29, col. 10 lines 33-37); and a plurality, of a quantity selected from the range inclusive of 7-25 (col. 8 lines 21-26, col. 9 lines 27-29), of diagnostic tests each configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in an applied fluid (col. 9 lines 47-50). Catt teaches that a quantity selected from the range inclusive of 4-15, and of a quantity selected from the range inclusive of 7-25 of tests enables the establishment of “a reference concentration value or signal for said analyte in the current cycle” (col. 7 lines 5-7) for “effective monitoring of the ovulation cycle” (col. 8 line 67).
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 modified the teachings of U.S. Patent No. 11573225 B2 to rely on the a quantity selected from the range inclusive of 4-15, and of a quantity selected from the range inclusive of 7-25 of diagnostic tests taught by Catt because Catt suggests this enables effective monitoring of the ovulation cycle, by setting an initial reference concentration value to be used in tracking. A person having ordinary skill in the art would have had a reasonable expectation of success given that both U.S. Patent No. 11573225 B2 and Catt teach a tracking system for evaluating a menstrual cycle, comprising: a plurality of diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in an applied fluid; and a plurality of diagnostic tests each configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in an applied fluid.
Regarding claims 65-66, U.S. Patent No. 11573225 B2 in view of Catt address the system of claim 64 as discussed above.
U.S. Patent No. 11573225 B2 further recites further comprising a plurality of diagnostic tests configured to evaluate for the presence of FSH in urine (“at least one diagnostic test configured to evaluate for the presence or absence of FSH” claim 2, “claim 15) and further comprising a plurality diagnostic tests configured to evaluate for the presence of E3G in urine (“the application further configured to simultaneously evaluate one diagnostic test or a plurality of diagnostic tests for the presence or absence of LH and E3G” claim 3).
U.S. Patent No. 11573225 B2 fails to recite further at a quantity selected from the range inclusive of 7-25, and the range inclusive of 7-25.
Catt further teaches further comprising a plurality, at a quantity selected from the range inclusive of 7-25, of diagnostic tests (col. 8 lines 21-26) configured to evaluate for the presence of FSH (col. 3 lines 46 and 58-60) in urine (col. 3 line 46, col. 7 line 58). Catt further teaches further comprising a plurality, of a quantity selected from the range inclusive of 7-25 (col. 8 lines 21-26), of diagnostic tests configured to evaluate for the presence of E3G in urine (col. 3 lines 46 and 52-53). Catt further teaches that “estriol-3-glucuronide, estriol-16- glucuronide [E3G]…Follicle stimulating hormone (FSH)…[are] an example” (col. 3 lines 59-60) of suitable analytes for monitoring the fertility status.
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 modified the teachings of U.S. Patent No. 11573225 B2 to rely on the plurality, at a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of FSH in urine and further comprising a plurality, of a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of E3G in urine taught by Catt because it would have been a simple matter of applying a known technique to a known method. In this case both U.S. Patent No. 11573225 B2 and Catt teach a tracking system for evaluating a menstrual cycle, comprising: a plurality of diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in an applied fluid; and a plurality of diagnostic tests each configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in an applied fluid, as well as diagnostic tests for FSH and E3G. Catt simply applies the art-recognized technique of including the plurality, at a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of FSH in urine and further comprising a plurality, of a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of E3G in urine. Therefore, a person having ordinary skill in the art would have found it obvious to apply the technique of Catt to the base method taught by both of U.S. Patent No. 11573225 B2 and Catt. A person having ordinary skill in the art would have had a reasonable expectation of success given that Catt teaches that FSH and E3G are suitable analytes to be used with the fertility tracking system and both U.S. Patent No. 11573225 B2 and Catt teach diagnostic tests for FSH and E3G.
Regarding claim 67, U.S. Patent No. 11573225 B2 in view of Catt address the system of claim 64 as discussed above.
U.S. Patent No. 11573225 B2 further recites additionally comprising instructions for utilization, comprising: an instruction to commence testing for FSH, by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence of FSH on a date selected from the range of 2-3 days following the onset of menstruation (“an instruction to commence testing for FSH, by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence of FSH on a date selected from the range of 2-7 days following the onset of menstruation” claim 9); an instruction to commence testing for E3G by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence of E3G following at least a 1.5-fold decrease from one diagnostic test configured to evaluate for the presence of FSH to another diagnostic test configured to evaluate for the presence of FSH performed on a different day in the same menstrual cycle (“an indication to commence testing for the estrogen following a result of a 1.5-fold decrease in FSH interpreted by the application within a single menstrual cycle” claim 9, claim 3); an instruction to commence testing for LH by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence or absence of LH at a threshold following at least an 1.5 fold increase from one diagnostic test configured to evaluate for the presence of E3G to another diagnostic test configured to evaluate for the presence of E3G performed on a different day in the same menstrual cycle (“an instruction to commence testing for LH by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence or absence of LH at a threshold following at least an 1.5 fold increase from one diagnostic test configured to evaluate for the presence of estrogen to another diagnostic test configured to evaluate for the presence of estrogen performed on a different day in the same menstrual cycle” claim 9); and an instruction to commence testing for PdG by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence of PdG at a threshold following a positive result for LH on a diagnostic test obtained within the same menstrual cycle (“an instruction to commence testing for PdG by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence of PdG at a threshold following a positive result for LH on a diagnostic test obtained within the same menstrual cycle” claim 9).
Regarding claim 68, U.S. Patent No. 11573225 B2 in view of Catt address the system of claim 67 as discussed above.
U.S. Patent No. 11573225 B2 further recites the instructions for utilization formatted for digital delivery via a computing device or a digital reader (“the application configured to display a prompt on the graphical user interface” claim 9).
Regarding claim 69, U.S. Patent No. 11573225 B2 in view of Catt address the system of claim 64 as discussed above.
U.S. Patent No. 11573225 B2 fails to recite further comprising a single container to enclose the plurality of diagnostic tests together.
Catt further teaches further comprising a single container to enclose the plurality of diagnostic tests together (col. 5 lines 1-4). Catt teaches that the container can be used as a “replacement pack” (col. 5 lines 1-4).
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 modified the teachings of U.S. Patent No. 11573225 B2 to rely on the further comprising a single container to enclose the plurality of diagnostic tests together taught by Catt because Catt teaches that the container can be used as a replacement pack in the system. A person having ordinary skill in the art would have had a reasonable expectation of success because both U.S. Patent No. 11573225 B2 and Catt are drawn to a plurality of diagnostic tests.
Regarding claims 77 and 79-80, although claims 79-80 are indefinite (see 112b rejection above), in the interest of compact prosecution the “testing zone” is interpreted as “a third testing zone”. U.S. Patent No. 11573225 B2 further recites a fertility tracking system for evaluating a menstrual cycle, comprising: a plurality of diagnostic tests each diagnostic test configured to evaluate an applied fluid for at least the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in a first testing zone (claim 1). U.S. Patent No. 11573225 B2 further recites a second testing zone and a “plurality of testing zones” (“at least one of the plurality of diagnostic tests comprises a plurality of testing zones” claim 6). U.S. Patent No. 11573225 B2 further recites a second diagnostic test configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL (claim 1).
U.S. Patent No. 11573225 B2 fails to recite a quantity selected from the range inclusive of 10-25, of diagnostic tests and the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in a second testing zone. U.S. Patent No. 11573225 B2 fails to further recite each diagnostic test configured to additionally evaluate for the concentration of FSH in a testing zone and provide a result comprising a color intensity, the color intensity correlating to a concentration of FSH in the applied fluid. U.S. Patent No. 11573225 B2 fails to further recite each diagnostic test configured to additionally evaluate for the concentration of E3G in a testing zone and provide a result comprising a color intensity, the color intensity correlating to a concentration of E3G in the applied fluid.
Catt suggests a fertility tracking system for evaluating a menstrual cycle, comprising: a plurality, of a quantity selected from the range inclusive of 10-25, of diagnostic tests (col. 8 lines 21-26), each diagnostic test configured to evaluate an applied fluid for at least the presence or absence of pregnanediol glucuronide (col. 2 lines 33-34, col. 9 lines 27-29) at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL (col. 10 lines 33-37) in a first testing zone (col. 4 lines 24-31) and the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in a second testing zone (col. 4 lines 36-41, col. 9 lines 47-50). Catt further teaches that “the invention can readily be applied to data derived from the measurement…of other analytes of significance in relation to the status of the ovulation cycle” (col. 3 lines 55-58). Catt further suggests each diagnostic test configured to additionally evaluate for the concentration of FSH (col. 3 lines 59-60) in a third testing zone (col. 12 lines 35-60) and provide a result comprising a color intensity, the color intensity correlating to a concentration of FSH in the applied fluid (col. 19 lines 3-16). Catt further teaches that “[a] yet further object of the invention is to provide an assay method/device in which multiple analytes in a single sample liquid can be determined accurately in a strip-format assay device which is interpreted instrumentally using electromagnetic radiation ( e.g. light) passed through the thickness of the assay strip” (col. 3 lines 27-32). Catt further suggests that there is a need of more efficient fertility tracking systems (col. 1 lines 15-20). Catt further suggests each diagnostic test configured to additionally evaluate for the concentration of E3G in a testing zone and provide a result comprising a color intensity, the color intensity correlating to a concentration of E3G in the applied fluid (col. 3 lines 27-32, col. 12 lines 35-60). Catt further teaches that an “objective of the invention is to provide a testing regime which is a good balance between the desire to minimise the testing burden on the user and the need to give the user worthwhile advice about the fertility status” (col. 3 lines 4-7).
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 modified the teachings of U.S. Patent No. 11573225 B2 to combine the embodiment drawn to the second testing zone, with the teaching of measuring luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL, thereby addressing a first testing zone for PdG and a second testing zone for LH and claim 77 because Catt teaches that PdG and LH work together as a "back up" to each other, thereby strengthening the results of the test. It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of U.S. Patent No. 11573225 B2 to include a plurality, of a quantity selected from the range inclusive of 10-25, of diagnostic tests and a third testing zone for FSH or E3G in each diagnostic test because Catt suggests that this enables efficient and effective fertility monitoring, which is a current need in the field, balancing the testing burden with the accuracy of the system. A person having ordinary skill in the art would have had a reasonable expectation of success given that both LH and PdG are indicative of infertility and Catt teaches that “the invention can readily be applied to data derived from the measurement…of other analytes of significance in relation to the status of the ovulation cycle” (col. 3 lines 55-58), also U.S. Patent No. 11573225 B2 contemplates two or more testing zones in each diagnostic test. Furthermore, a person having ordinary skill in the art would have had a reasonable expectation of success given that both U.S. Patent No. 11573225 B2 and Catt teach a tracking system for evaluating a menstrual cycle.
Regarding claim 78, U.S. Patent No. 11573225 B2 in view of Catt address the system of claim 77 as discussed above.
U.S. Patent No. 11573225 B2 further recites further comprising a diagnostic test key configured to map the color intensity of an indicated result to a concentration of a hormone or analyte correlating to the color intensity (“further comprising a diagnostic test key displayed upon the graphical user interface and configured to provide a visual relationship of a color intensity of a result indicated on an image of a diagnostic test to a concentration of a hormone or analyte correlating to the color intensity” claim 13).
Claims 70-71 and 73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11573225 B2 in view of Catt as applied to claim 64 above, and further in view of Ella.
Regarding claim 70, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the threshold is interpreted to be “15 mIU/mL-50 mIU/mL” as in claim 64.
U.S. Patent No. 11573225 B2 in view of Catt address the system of claim 64 as discussed above.
U.S. Patent No. 11573225 B2 further recites further comprising pumpkin seeds and flax seeds (Applicant’s elected species), and a daily recurring instruction following menstruation to consume pumpkin seeds and flax seeds once daily until the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily until the onset of menstruation (“further comprising: at least one food item comprising pumpkin seeds and flax seeds and at least one food item comprising sesame seeds and sunflower seeds, and a recurring instruction delivered via the graphical user interface application during the menstrual cycle of the subject to consume pumpkin seeds and flax seeds until the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a recurring instruction delivered via the graphical user interface of the application to consume sesame seeds and sunflower seeds until the onset of menstruation” claim 10, claim 1).
U.S. Patent No. 11573225 B2 in view of Catt fail to recite the pumpkin seeds and flax seeds in a snack bar.
Ella teaches “Superfood healthy pumpkin breakfast bars” (Title). Ella teaches at least one snack bar comprising pumpkin seeds and flax seeds (page 7). Ella further teaches that the snack bars “are not only amazing and loaded with superfood power, but they are also naturally gluten-free, vegan and refined sugar free. And these are also nut-free which means school-safe!” (page 3 para. 2). Ella further teaches the detailed directions to make the snack bars (page 7).
It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of U.S. Patent No. 11573225 B2 in view of Catt to have the pumpkin seeds and flax seeds in a snack bar as taught by Ella, because Ella suggests that this makes a very delicious superfood. A person having ordinary skill in the art would have had a reasonable expectation of success because Ella teaches the recipe, i.e. detailed directions to make the snack bars.
Regarding claims 71 and 73, U.S. Patent No. 11573225 B2 in view of Catt and Ella address the system of claim 70 as discussed above.
U.S. Patent No. 11573225 B2 further recites each daily recurring instruction delivered via the graphical user interface associated with an application operating on a smartphone, via a display integrated into a digital reader (“display the result on the graphical user interface of a smart device” claim 6, claim 10).
Claims 74-76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11573225 B2 in view of Catt as applied to claim 64 above, and further in view of Divaraniya and Hua.
Regarding claim 74, U.S. Patent No. 11573225 B2 in view of Catt address the system of claim 64 as discussed above.
U.S. Patent No. 11573225 B2 further recites further comprising progesterone supplement (“the progesterone supplement” claim 12).
U.S. Patent No. 11573225 B2 in view of Catt fail to recite plurality of progesterone supplement doses each formulated in an oil suspension.
Divaraniya teaches “systems for detecting analyte levels” (Title). Divaraniya further teaches “[a] woman is undergoing in vitro fertilization (IVF) treatment and must obtain frequent measurements of her fertility hormones and metabolites to ensure a successful procedure. …On days 17-27 of her menstrual cycle, the woman takes progesterone supplements to support her uterine lining and implantation” (para. 327).
Hua teaches “uses and benefits of compound progesterone” (Title). Hua teaches “solutions for…hormonal imbalance” (page 1 para. 1) and that “that progesterone is a hormone that is essential for the functions of all the systems in a woman’s body” (page 1 para. 2). Hua further teaches that progesterone supplements are normally either in an oil suspension or in a gel (page 3 last paragraph). Hua further suggests that oil suspension progesterone supplements help the body “regain hormonal equilibrium” (page 4 para. 3). Hua further teaches that “the only FDA approved progesterone product that can be used in the treatment of menopause is Prometrium, which is progesterone in peanut oil capsules” (page 4 para. 1).
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 modified the teachings of U.S. Patent No. 11573225 B2 in view of Catt to rely on the progesterone supplement doses taught by Divaraniya because Divaraniya teaches that this supports the uterine lining and Catt is concerned with women’s fertility hormones. A person having ordinary skill in the art would have had a reasonable expectation of success because both Divaraniya and U.S. Patent No. 11573225 B2 in view of Catt teach systems comprising detecting hormones in women.
It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of U.S. Patent No. 11573225 B2 in view of Catt and Divaraniya to rely on the progesterone supplements being each formulated in an oil suspension taught by Hua because Hua suggest this enables hormonal balance. A person having ordinary skill in the art would have had a reasonable expectation of success given that Hua suggests that most progesterone supplements are oil-based.
Regarding claim 75, U.S. Patent No. 11573225 B2 in view of Catt address the system of claim 64 as discussed above.
U.S. Patent No. 11573225 B2 further recites further comprising an instruction to consume the plurality of progesterone supplement doses during the subsequent menstrual cycle following an indication of the absence of PdG at a threshold in the applied fluid on any diagnostic test taken during the timeframe of 7-10 days past ovulation (“and an instruction delivered via the graphical user interface to consume the progesterone supplement during the subsequent menstrual cycle following an indication of the absence of PdG at a threshold in the applied sample on any date following a positive result on a diagnostic test configured to evaluate for the presence or absence of LH in the said subsequent menstrual cycle of the subject” claim 12, “calculate an ovulation score based upon the number of days during the range of days 7-10 following the first result on a diagnostic test indicating the presence of LH at a threshold” claim 11, claim 9).
Regarding claim 76, U.S. Patent No. 11573225 B2 in view of Catt address the system of claim 64 as discussed above.
U.S. Patent No. 11573225 B2 further recites the instruction to ingest the progesterone supplement following an indication on a diagnostic test of the absence of PdG at a threshold in an applied fluid delivered in association with an application operating on a smartphone (“display the result on the graphical user interface of a smart device” claim 6, claim 12).
Claim 81 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim17 of U.S. Patent No. 11573225 B2 in view of Catt as applied to claim 77 above, and further in view of Nara.
Regarding claim 81, U.S. Patent No. 11573225 B2 in view of Catt recite the system of claim 77 as discussed above.
Catt further teaches a single container configured to enclose the plurality of diagnostic tests together (col. 5 lines 1-4).
U.S. Patent No. 11573225 B21 in view of Catt fail to recite each diagnostic test placed individually into a sealed packet.
Nara teaches “Disposable Test Strip Device For Analyte Detection In A Body Liquid Sample” (Title). Nara further suggests each diagnostic test placed individually into a sealed packet (para. 109). Nara further teaches that “sealing is a necessary precaution to ensure that {bio)chemical components comprised within the test strip device would not evaporate, dry etc.” (para. 109).
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 modified the teachings of U.S. Patent No. 11573225 B2 in view of Catt to rely on the each diagnostic test placed individually into a sealed packet taught by Nara because Nara suggests that this protects the diagnostic test. A person having ordinary skill in the art would have had a reasonable expectation of success given that both Nara and U.S. Patent No. 11573225 B2 in view of Catt are drawn to test strips to for analyte detection in a body liquid sample.
Claim 82-83 and 85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11573225 B2 in view of Catt as applied to claim 77 above, and further in view of Takayasu as evidenced by CoolConversion and Mayo Clinic.
Regarding claim 82, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the threshold is interpreted to be “15 mIU/mL-50 mIU/mL” as in claim 77.
U.S. Patent No. 11573225 B2 in view of Catt recite the system of claim 77 as discussed above.
U.S. Patent No. 11573225 B2 further recites further comprising at least one single consumable food item comprising pumpkin seeds and flax seeds (Applicant’s elected species), and commencing upon the occurrence of menstruation a daily recurring instruction to consume pumpkin seeds and flax seeds once daily, the daily recurring instruction to consume pumpkin seeds and flax seeds once daily terminating upon the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily, the daily recurring instruction to consume sesame seeds and sunflower seeds once daily terminating upon the onset of menstruation (claims 1 and 10).
U.S. Patent No. 11573225 B2 in view of Catt fail to recite in an amount selected from the range inclusive of 6.5 grams-16 grams.
Takayasu teaches “seed cycling for hormonal imbalance” (Title). Takayasu further suggests comprising at least one single consumable food item comprising pumpkin seeds in 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 (Applicant’s elected species), and commencing upon the occurrence of menstruation a daily (page 3 para. 3) recurring instruction to consume pumpkin seeds and flax seeds once daily, the daily recurring instruction to consume pumpkin seeds and flax seeds once daily terminating upon the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily, the daily recurring instruction to consume sesame seeds and sunflower seeds once daily terminating upon the onset of menstruation (page 3 paras. 3, 5 and 7-8 and 10-1). Note that as evidenced by CoolConversion, the tablespoon of pumpkin seeds taught by Takayasu is equivalent to “7.44 grams” (page 1) and as evidenced by Mayo Clinic the tablespoon of flax seeds taught by Takayasu is equivalent to “7 grams” (page 1 para. 2). Therefore, Takayasu addresses “6.5-16 grams” of pumpkin seeds and flax seed. Takayasu further teaches that “[c]ertain seeds carry certain fatty acids (a.k.a. oils), vitamins, and nutrients that help support our hormones” (page 2 para. 11).
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 modified the teachings of U.S. Patent No. 11573225 B2 in view of Catt to include the amount of 6.5-16 grams of seeds taught by Takayasu, because Takayasu suggests that such amounts support optimal hormonal balance though the nutrients in the seeds and U.S. Patent No. 11573225 B2 in view of Catt is concerned with tracking the hormones of women. A person having ordinary skill in the art would have had a reasonable expectation of success because Takayasu describes the system as simple and both U.S. Patent No. 11573225 B2 in view of Catt and Takayasu are drawn to women’s hormonal balance through the cycle.
Regarding claims 83 and 85, U.S. Patent No. 11573225 B2 in view of Catt and Takayasu address the system of claim 82 as discussed above.
U.S. Patent No. 11573225 B2 further recites each daily recurring instruction delivered via the graphical user interface associated with an application operating on a smartphone, via a display integrated into a digital reader (“display the result on the graphical user interface of a smart device” claim 6, claim 10).
Copending Application No. 18094261
Claims 53-60 and 62-63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21-36 of copending Application No. 18094261 in view of Gilmour.
Regarding claim 53, copending Application No. 18094261 recites a menstrual cycle tracking system (“A fertility tracking system for evaluating a menstrual cycle” claim 21), comprising: one diagnostic test or a plurality of diagnostic tests each configured to evaluate a sample of bodily fluid from a subject (“a lateral flow assay configured to evaluate for the presence or absence of hormones or hormonal analytes within a fluid sample placed into contact with the lateral flow assay, wherein the hormones or hormonal analytes comprise pregnanediol glucuronide, luteinizing hormone, and estrogen or a metabolite of estrogen” claim 21) woman collected on a daily basis during a menstrual cycle (“an interpretation comprising an indication that the subject woman has sufficiently ovulated, following a result of the presence of PdG at a threshold interpreted by the application on at least two tests each on separate days during the period of 7-10 days past ovulation” claim 36) 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 (“wherein the lateral flow assay comprises a plurality of testing zones, wherein the testing zones comprising at least one testing zone configured to evaluate an applied fluid for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-20 μg/mL” claim 34), 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 (“ further comprising a data analyzer configured to receive the optical signals, wherein the data analyzer is in operable communication with a reader device” claim 28) and evaluate the one result or a plurality of results to generate one interpretation or a plurality of interpretations (“further comprising a processor configured to interpret the optical signals obtained from within each result indication line and discern among the wavelengths to generate a result” claim 24) the computing device further configured to display the one interpretation or plurality of interpretations based on the one result or plurality of results to a graphical user interface (“the smartphone further configured to utilize an application to collect, store and upon a display of the smartphone present the result for the presence of PdG at or above the PdG threshold” claim 8).
Copending Application No. 18094261 fails to teach the computing device further configured to store the interpretations.
Gilmour suggests a menstrual cycle tracking system (Title, Abstract), comprising: one diagnostic test or a plurality of diagnostic tests (para. 26) each configured to evaluate a sample of bodily fluid from a subject woman (para. 20) collected on a daily basis (para. 40) during a menstrual cycle (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 (Table 4, para. 242, 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 (para. 43, para. 139, para. 205), the computing device further configured to store the one interpretation or a plurality of interpretations (para. 43, 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 (para. 43, para. 150, para. 173, 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 inventions herein address these and other needs” (para. 17). Gilmour further teaches that “lateral flow diagnostic tests, are known in the art” (paras. 12-13).
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 modified the teachings of copending Application No. 18094261 to include the computing device also storing the interpretations as taught by Gilmour because Gilmour suggests this enables "many practical applications" in the field of menstrual cycle tracking systems. One would been motivated to make such a modification because Gilmour suggests that this addresses the current needs in the field. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 18094261 and Gilmour teach lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL and computing devices.
Regarding claim 54, copending Application No. 18094261 in view of Gilmour address the system of claim 53 as discussed above.
Copending Application No. 18094261 further recites 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 (“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, following a result of the presence of PdG at a threshold interpreted by the application” claim 36).
Regarding claim 55, copending Application No. 18094261 in view of Gilmour address the system of claim 53 as discussed above.
Copending Application No. 18094261 further recites 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 FSH, E3G, LH, hCG and PdG (“wherein the lateral flow assay comprises a plurality of testing zones, wherein the testing zones comprising at least one testing zone configured to evaluate an applied fluid for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-20 μg/mL and at least one testing zone configured to evaluate an applied fluid for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL” claim 34).
Regarding claims 56-57, copending Application No. 18094261 in view of Gilmour address the system of claim 53 as discussed above.
Copending Application No. 18094261 fails to recite 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 patient-facing information configured to operate in association with a computing device and communicatively connected storage medium; 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, 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
Gilmour 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 (para. 173); the patient-facing information configured to operate in association with a computing device and communicatively connected storage medium (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 (para. 151, para. 188, Example 12). 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 (para. 173, para. 158, para. 160). Gilmour suggests that this enables a more user-friendly system (“the SMS internal software is menu-driven for ease-of-use by subjects” para. 151).
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 modified the teachings of copending Application No. 18094261 to rely on the patient-facing application and the healthcare professional-facing application taught by Gilmour because Gilmour suggests that this enables a more user-friendly system. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 18094261 and Gilmour teach lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL and a computing device.
Regarding claims 58 and 60, copending Application No. 18094261 in view of Gilmour address the system of claim 53 as discussed above.
Copending Application No. 18094261 fails to recite further comprising a calendar configured to display the result or interpretation associated with each diagnostic test in a graphical user interface in association with the date and time each diagnostic test was performed, 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.
Gilmour further suggests further comprising a calendar configured to display the result or interpretation associated with each diagnostic test in a graphical user interface (para. 194) in association with the date and time each diagnostic test was performed (para. 151). Gilmour further teaches that lateral flow tests are common in the field (paras. 12-13). Gilmour further 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 (para. 167, para. 168, para. 170).
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 modified the teachings of copending Application No. 18094261 to rely on the calendar and telemedicine system taught by Gilmour because it would have been an obvious matter or applying a known technique to a known method. In this case both copending Application No. 18094261 and Gilmour teach lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL and computing device. Gilmour simply applies the art-recognized technique of further comprising a calendar and the telemedicine system. Therefore, a person having ordinary skill in the art would have found it obvious to apply the technique of Gilmour to the base method taught by both copending Application No. 18094261 and Gilmour. A person having ordinary skill in the art would have had a reasonable expectation of success because Gilmour teaches that lateral flow tests are common in the field.
Regarding claim 59, copending Application No. 18094261 in view of Gilmour address the system of claim 53 as discussed above.
Copending Application No. 18094261 further recites 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 (“further comprising an application configured to display a prompt on a graphical user interface, the prompt comprising… an indication of the fertile window opening and the appropriate time to engage in intercourse for conception following a result of a 1.5-fold decrease in FSH interpreted by the application within a single menstrual cycle” claim 36).
Regarding claim 62, copending Application No. 18094261 in view of Gilmour address the system of claim 53 as discussed above.
Copending Application No. 18094261 recites 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, 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 (“an indication of the fertile window opening and the appropriate time to engage in intercourse for conception following a result of a 1.5-fold decrease in FSH interpreted by the application within a single menstrual cycle…an indication that ovulation has occurred the infertile period has begun, following a result of the presence of PdG at a threshold interpreted by the application” claim 36).
Regarding claim 63, copending Application No. 18094261 recites a fertility tracking system, 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 (claims 21 and 34-35).
Copending Application No. 18094261 fails to recite the tests configured such that only one perceptible line observable on the diagnostic test indicates a positive result and a control line 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.
Gilmour suggests a fertility tracking system (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 (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 (para. 10, para. 106, para. 233, see Table 4). Gilmour further suggests that the control line enables only one perceptible line observable on the diagnostic test indicating a positive result and enables two perceptible lines observable on the diagnostic test indicating a negative result (Table 4). Gilmour further suggests that the control line enables outlier corrections and normalization (“The variability in conjugate pad release can be simply observed by repeat runs of a single hormone concentration where it displays itself either as general large strip to strip variation or high strip to strip repeatability with the occasional extreme outlier. Both of these types of variation can be partly corrected for by expressing the data relative to the control line, either as a fraction (T/T +C) or as a ratio (T/C)” para. 261).
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 modified the teachings of copending Application No. 18094261 to rely on a control line, 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 taught by Gilmour because Gilmour suggests that this provides outlier correction and normalization. A person having ordinary skill in the art would have had a reasonable expectation of success both copending Application No. 18094261 and Gilmour teach competitive lateral flow tests for pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL.
Claim 61 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21-36 of copending Application No. 18094261 in view of Gilmour as applied to claim 53 above, and further in view of Takayasu.
Regarding claim 61, copending Application No. 18094261 in view of Gilmour address the system of claim 53 as discussed above.
Copending Application No. 18094261 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 (“an indication that ovulation has occurred the infertile period has begun, following a result of the presence of PdG at a threshold interpreted by the application;” claim36).
Copending Application No. 18094261 in view of Gilmour fail to recite 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 (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 (page 3 paras. 7-8 and 10-11). Note that although Takayasu fails to use the language “based on the result indicated on each of the plurality of diagnostic tests”, Takayasu still suggests the claim because Takayasu teaches the seed consumption based on the start of ovulation and copending Application No. 18094261 explicitly recites that the diagnostic tests configured to detect PdG determine the start of ovulation. Takayasu further teaches that “[c]ertain seeds carry certain fatty acids (a.k.a. oils), vitamins, and nutrients that help support our hormones” (page 2 para. 11).
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 modified the teachings of copending Application No. 18094261 in view of Gilmour to include the seed consumption system taught by Takayasu based on the result of the diagnostic tests of copending Application No. 18094261, because Takayasu suggests that the seed consumption system supports optimal hormonal balance through the nutrients in the seeds and copending Application No. 18094261 is concerned with tracking the hormones of women. A person having ordinary skill in the art would have had a reasonable expectation of success because Takayasu describes the system as simple and both copending Application No. 18094261 in view of Gilmour and Takayasu are drawn to women’s hormonal balance through the cycle.
Claims 64-69 and 77-80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21-36 of copending Application No. 18094261 in view of Catt.
Regarding claim 64, copending Application No. 18094261 recites a tracking system for evaluating a menstrual cycle, comprising: a plurality of diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in an applied fluid; and a plurality of diagnostic tests each configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in an applied fluid (claims 21, 34, “plurality of diagnostic tests” claim 36).
Copending Application No. 18094261 fails to recite of a quantity selected from the range inclusive of 4-15, and of a quantity selected from the range inclusive of 7-25 of diagnostic tests.
Catt teaches a fertility tracking system for evaluating a menstrual cycle (col. 2 lines 49-61), comprising: a plurality, of a quantity selected from the range inclusive of 4-15 (col. 8 lines 21-26), of diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in an applied fluid (col. 9 lines 27-29, col. 10 lines 33-37); and a plurality, of a quantity selected from the range inclusive of 7-25 (col. 8 lines 21-26, col. 9 lines 27-29), of diagnostic tests each configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in an applied fluid (col. 9 lines 47-50). Catt teaches that a quantity selected from the range inclusive of 4-15, and of a quantity selected from the range inclusive of 7-25 of tests enables the establishment of “a reference concentration value or signal for said analyte in the current cycle” (col. 7 lines 5-7) for “effective monitoring of the ovulation cycle” (col. 8 line 67).
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 modified the teachings of copending Application No. 18094261 to rely on the a quantity selected from the range inclusive of 4-15, and of a quantity selected from the range inclusive of 7-25 of diagnostic tests taught by Catt because Catt suggests this enables effective monitoring of the ovulation cycle, by setting an initial reference concentration value to be used in tracking. A person having ordinary skill in the art would have had a reasonable expectation of success given that both copending Application No. 18094261 and Catt teach a tracking system for evaluating a menstrual cycle, comprising: a plurality of diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in an applied fluid; and a plurality of diagnostic tests each configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in an applied fluid.
Regarding claims 65-66, copending Application No. 18094261 in view of Catt address the system of claim 64 as discussed above.
Copending Application No. 18094261 further recites diagnostic tests configured to evaluate for the presence of FSH (“wherein the hormones or hormonal analytes further comprise FSH” claim 33).
Copending Application No. 18094261 fails to recite the FSH tests at a quantity selected from the range inclusive of 7-25 and in urine, and further comprising a plurality, of a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of E3G in urine.
Catt further teaches further comprising a plurality, at a quantity selected from the range inclusive of 7-25, of diagnostic tests (col. 8 lines 21-26) configured to evaluate for the presence of FSH (col. 3 lines 46 and 58-60) in urine (col. 3 line 46, col. 7 line 58). Catt further teaches further comprising a plurality, of a quantity selected from the range inclusive of 7-25 (col. 8 lines 21-26), of diagnostic tests configured to evaluate for the presence of E3G in urine (col. 3 lines 46 and 52-53). Catt further teaches that “estriol-3-glucuronide, estriol-16- glucuronide [E3G]…Follicle stimulating hormone (FSH)…[are] an example” (col. 3 lines 59-60) of suitable analytes for monitoring the fertility status.
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 modified the teachings of copending Application No. 18094261 to rely on the plurality, at a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of FSH in urine and further comprising a plurality, of a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of E3G in urine taught by Catt because it would have been a simple matter of applying a known technique to a known method. In this case both copending Application No. 18094261 and Catt teach a tracking system for evaluating a menstrual cycle, comprising: a plurality of diagnostic tests each configured to evaluate for the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in an applied fluid; a plurality of diagnostic tests each configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in an applied fluid, tests for FSH. Catt simply applies the art-recognized technique of including the plurality, at a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of FSH in urine and further comprising a plurality, of a quantity selected from the range inclusive of 7-25, of diagnostic tests configured to evaluate for the presence of E3G in urine. Therefore, a person having ordinary skill in the art would have found it obvious to apply the technique of Catt to the base method taught by both of copending Application No. 18094261 and Catt. A person having ordinary skill in the art would have had a reasonable expectation of success given that Catt teaches that FSH and E3G are suitable analytes to be used with the fertility tracking system.
Regarding claim 67, copending Application No. 18094261 in view of Catt address the system of claim 64 as discussed above.
Copending Application No. 18094261 further recites additionally comprising instructions for utilization, comprising: an instruction to commence testing for FSH, by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence of FSH on a date selected from the range of 2-3 days following the onset of menstruation (“an instruction to commence testing for FSH, by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence of FSH on a date selected from the range of 2-7 days following the onset of menstruation” claim 36); an instruction to commence testing for E3G by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence of E3G following at least a 1.5-fold decrease from one diagnostic test configured to evaluate for the presence of FSH to another diagnostic test configured to evaluate for the presence of FSH performed on a different day in the same menstrual cycle (“an indication to commence testing for the estrogen following a result of a 1.5-fold decrease in FSH interpreted by the application within a single menstrual cycle, or on the eighth day of the menstrual cycle, whichever occurs first” claim 36); an instruction to commence testing for LH by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence or absence of LH at a threshold following at least an 1.5 fold increase from one diagnostic test configured to evaluate for the presence of E3G to another diagnostic test configured to evaluate for the presence of E3G performed on a different day in the same menstrual cycle (“an instruction to commence testing for LH by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence or absence of LH at a threshold following at least a 1.5 fold increase from one diagnostic test configured to evaluate for the presence of estrogen to another diagnostic test configured to evaluate for the presence of estrogen performed on a different day in the same menstrual cycle;” claim 36); and an instruction to commence testing for PdG by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence of PdG at a threshold following a positive result for LH on a diagnostic test obtained within the same menstrual cycle (“an instruction to commence testing for PdG by utilizing a single diagnostic test from a plurality of diagnostic tests each configured to evaluate for the presence of PdG at a threshold following a positive result for LH on a diagnostic test obtained within the same menstrual cycle” claim 36).
Regarding claim 68, copending Application No. 18094261 in view of Catt address the system of claim 64 as discussed above.
Copending Application No. 18094261 further recites the instructions for utilization formatted for digital delivery via a computing device or a digital reader (“further comprising an
application configured to display a prompt on a graphical user interface, the prompt comprising a message selected from the group consisting of:” claim 36, claim 28).
Regarding claim 69, copending Application No. 18094261 in view of Catt address the system of claim 64 as discussed above.
Copending Application No. 18094261 fails to recite further comprising a single container to enclose the plurality of diagnostic tests together.
Catt further teaches further comprising a single container to enclose the plurality of diagnostic tests together (col. 5 lines 1-4). Catt teaches that the container can be used as a “replacement pack” (col. 5 lines 1-4).
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 modified the teachings of copending Application No. 18094261 to rely on the further comprising a single container to enclose the taught by Catt because Catt teaches that the container can be used as a replacement pack in the system. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 18094261 and Catt are drawn to a plurality of diagnostic tests.
Regarding claim 77, copending Application No. 18094261 recites a fertility tracking system for evaluating a menstrual cycle, comprising: a plurality of diagnostic tests each diagnostic test configured to evaluate an applied fluid for at least the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL in a first testing zone (claim 21, 34 and 36). Copending Application No. 18094261 further recites a “plurality of testing zones” claim 34. Copending Application No. further recites a second testing zone configured to evaluate for the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL (claim 34).
Copending Application No. 18094261 fails to recite a quantity selected from the range inclusive of 10-25 of diagnostic tests.
Catt suggests a fertility tracking system for evaluating a menstrual cycle, comprising: a plurality, of a quantity selected from the range inclusive of 10-25, of diagnostic tests (col. 8 lines 21-26), each diagnostic test configured to evaluate an applied fluid for at least the presence or absence of pregnanediol glucuronide (col. 2 lines 33-34, col. 9 lines 27-29) at a threshold selected from the range inclusive of 1 μg/mL-10 μg/mL (col. 10 lines 33-37) in a first testing zone (col. 4 lines 24-31) and the presence or absence of luteinizing hormone at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL in a second testing zone (col. 4 lines 36-41, col. 9 lines 47-50). Catt further teaches that “the invention can readily be applied to data derived from the measurement…of other analytes of significance in relation to the status of the ovulation cycle” (col. 3 lines 55-58).
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 modified the teachings of copending Application No. 18094261 to rely on the quantity selected from the range inclusive of 10-25 of diagnostic tests taught by Catt because Catt suggests that this enables efficient and effective fertility monitoring, which is a current need in the field, balancing the testing burden with the accuracy of the system. A person having ordinary skill in the art would have had a reasonable expectation of success given that both copending Application No. 18094261 and Catt teach a tracking system for evaluating a menstrual cycle.
Regarding claim 78, copending Application No. 18094261 in view of Catt address the system of claim 77 as discussed above.
Copending Application No. 18094261 further recites further comprising a diagnostic test key configured to map the color intensity of an indicated result to a concentration of a hormone or analyte correlating to the color intensity (“wherein the interpretation of the optical signals is made with the assistance of the color intensity key, wherein the color intensity key is pre-configured to indicate the presence of specified quantities of hormones and/or hormonal analytes following the application of fluorescent light from the fluorescent light source to the system utilizing at least one fluorophore based upon the evident color intensity(ies)” Claim 25).
Regarding claim 79, although indefinite (see 112b rejection above), in the interest of compact prosecution the “testing zone” is interpreted as “a third testing zone”. Copending Application No. 18094261 in view of Catt address the system of claim 77 as discussed above.
Copending Application No. 18094261 further recites recite each diagnostic test configured to additionally evaluate for the concentration of FSH in a testing zone and provide a result comprising a color intensity, the color intensity correlating to a concentration of FSH in the applied fluid (“wherein the hormones or hormonal analytes further comprise FSH” claim 33, claim 21, claim 25, claim 34).
Regarding claim 80, although indefinite (see 112b rejection above), in the interest of compact prosecution the “testing zone” is interpreted as “a third testing zone”.
Copending Application No. 18094261 in view of Catt address the system of claim 77 as discussed above.
Copending Application No. 18094261 fails to recite each diagnostic test configured to additionally evaluate for the concentration of E3G in a testing zone and provide a result comprising a color intensity, the color intensity correlating to a concentration of E3G in the applied fluid.
Catt further suggests each diagnostic test configured to additionally evaluate for the concentration of E3G in a testing zone and provide a result comprising a color intensity, the color intensity correlating to a concentration of E3G in the applied fluid (col. 3 lines 27-32, col. 12 lines 35-60). Catt further teaches that an “objective of the invention is to provide a testing regime which is a good balance between the desire to minimise the testing burden on the user and the need to give the user worthwhile advice about the fertility status” (col. 3 lines 4-7).
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 modified the teachings of copending Application No. 18094261 to include a third testing zone for E3G in each diagnostic test because Catt suggests that this enables efficient and effective fertility monitoring, which is a current need in the field, balancing the testing burden with the accuracy of the system. A person having ordinary skill in the art would have had a reasonable expectation of success given that Catt teaches that “the invention can readily be applied to data derived from the measurement…of other analytes of significance in relation to the status of the ovulation cycle” (col. 3 lines 55-58), also copending Application No. 18094261 contemplates multiple testing zones in each diagnostic test. Furthermore, a person having ordinary skill in the art would have had a reasonable expectation of success given that both Copending Application No. 18094261 and Catt teach a tracking system for evaluating a menstrual cycle.
Claim 70 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21-36 of copending Application No. 18094261 in view of Catt as applied to claim 64 above, and further in view of Takayasu and Ella.
Regarding claim 70, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the threshold is interpreted to be “15 mIU/mL-50 mIU/mL” as in claim 64.
Copending Application No. 18094261 in view of Catt address the system of claim 64 as discussed above.
Copending Application No. 18094261 further teaches that ovulation is determined using the diagnostic tests configured to detect for the presence or absence of LH at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL (claims 21, 34 and 36).
Copending Application No. 18094261 in view of Catt fail to recite at least one snack bar comprising pumpkin seeds and flax seeds (Applicant’s elected species), and a daily recurring instruction following menstruation to consume pumpkin seeds and flax seeds once daily until the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily until the onset of menstruation.
Takayasu teaches “seed cycling for hormonal imbalance” (Title). Takayasu further suggests comprising pumpkin seeds and flax seeds (page 2 para. 11, page 3 paras. 7-8 and 10-1), and a daily (page 3 para. 3) recurring instruction following menstruation to consume pumpkin seeds and flax seeds once daily until the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily until the onset of menstruation (page 3 paras. 3, 5 and 7-8 and 10-1). Note that although Takayasu fails to use the language “until the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle”, Takayasu still suggests the claim because Takayasu teaches the seed consumption based on the start of ovulation and copending Application No. 18094261 explicitly teaches that the diagnostic tests configured to detect LH determine that ovulation is imminent. Takayasu further teaches that “[c]ertain seeds carry certain fatty acids (a.k.a. oils), vitamins, and nutrients that help support our hormones” (page 2 para. 11).
Ella teaches “Superfood healthy pumpkin breakfast bars” (Title). Ella teaches at least one snack bar comprising pumpkin seeds and flax seeds (page 7). Ella further teaches that the snack bars “are not only amazing and loaded with superfood power, but they are also naturally gluten-free, vegan and refined sugar free. And these are also nut-free which means school-safe!” (page 3 para. 2). Ella further teaches the detailed directions to make the snack bars (page 7).
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 modified the teachings of copending Application No. 18094261 in view of Catt to include the seed consumption system taught by Takayasu based on the result of the diagnostic tests of copending Application No. 18094261, because Takayasu suggests that the seed consumption system supports optimal hormonal balance though the nutrients in the seeds and copending Application No. 18094261 is concerned with tracking the hormones of women. A person having ordinary skill in the art would have had a reasonable expectation of success because Takayasu describes the system as simple and both copending Application No. 18094261 in view of Catt and Takayasu are drawn to women’s hormonal balance through the cycle.
It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of copending Application No. 18094261 in view of Catt and Takayasu to have the pumpkin seeds and flax seeds in a snack bar as taught by Ella, because Ella suggests that this makes a very delicious superfood. A person having ordinary skill in the art would have had a reasonable expectation of success because Ella teaches the recipe, i.e. detailed directions to make the snack bars.
Claim 74 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-36 of copending Application No. 18094261 in view of Catt as applied to claim 64 above, and further in view of Divaraniya and Hua.
Regarding claim 74, copending Application No. 18094261 in view of Catt address the system of claim 64 as discussed above.
Copending Application No. 18094261 in view of Catt fail to recite further comprising a plurality of progesterone supplement doses, each formulated in an oil suspension.
Divaraniya teaches “systems for detecting analyte levels” (Title). Divaraniya further teaches “[a] woman is undergoing in vitro fertilization (IVF) treatment and must obtain frequent measurements of her fertility hormones and metabolites to ensure a successful procedure. …On days 17-27 of her menstrual cycle, the woman takes progesterone supplements to support her uterine lining and implantation” (para. 327).
Hua teaches “uses and benefits of compound progesterone” (Title). Hua teaches “solutions for…hormonal imbalance” (page 1 para. 1) and that “that progesterone is a hormone that is essential for the functions of all the systems in a woman’s body” (page 1 para. 2). Hua further teaches that progesterone supplements are normally either in an oil suspension or in a gel (page 3 last paragraph). Hua further suggests that oil suspension progesterone supplements help the body “regain hormonal equilibrium” (page 4 para. 3). Hua further teaches that “the only FDA approved progesterone product that can be used in the treatment of menopause is Prometrium, which is progesterone in peanut oil capsules” (page 4 para. 1).
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 modified the teachings of copending Application No. 18094261 in view of Catt to rely on the progesterone supplements taught by Divaraniya because Divaraniya teaches that this supports the uterine lining and copending Application No. 18094261 in view of Catt is concerned with women’s fertility hormones. A person having ordinary skill in the art would have had a reasonable expectation of success because both Divaraniya and copending Application No. 18094261 in view of Catt teach systems comprising detecting hormones in women.
It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of copending Application No. 18094261 in view of Catt and Divaraniya to rely on the progesterone supplements being each formulated in an oil suspension taught by Hua because Hua suggest this enables hormonal balance. A person having ordinary skill in the art would have had a reasonable expectation of success given that Hua suggests that most progesterone supplements are oil-based.
Claim 81 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-36 of copending Application No. 18094261 in view of Catt as applied to claim 77 above, and further in view of Nara.
Regarding claim 81, copending Application No. 18094261 in view of Catt recite the system of claim 77 as discussed above.
Catt further teaches a single container configured to enclose the plurality of diagnostic tests together (col. 5 lines 1-4).
Copending Application No. 18094261 in view of Catt fail to recite each diagnostic test placed individually into a sealed packet.
Nara teaches “Disposable Test Strip Device For Analyte Detection In A Body Liquid Sample” (Title). Nara further suggests each diagnostic test placed individually into a sealed packet (para. 109). Nara further teaches that “sealing is a necessary precaution to ensure that {bio)chemical components comprised within the test strip device would not evaporate, dry etc.” (para. 109).
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 modified the teachings of copending Application No. 18094261 in view of Catt to rely on the each diagnostic test placed individually into a sealed packet taught by Nara because Nara suggests that this protects the diagnostic test. A person having ordinary skill in the art would have had a reasonable expectation of success given that both Nara and copending Application No. 18094261 in view of Catt are drawn to test strips to for analyte detection in a body liquid sample.
Claim 82 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-36 of copending Application No. 18094261 in view of Catt as applied to claim 77 above, and further in view of Takayasu as evidenced by CoolConversion and Mayo Clinic.
Regarding claim 82, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the threshold is interpreted to be “15 mIU/mL-50 mIU/mL” as in claim 77.
Copending Application No. 18094261 in view of Catt recite the system of claim 77 as discussed above.
Copending Application No. 18094261 further recites that ovulation is determined using the diagnostic tests configured to detect for the presence or absence of LH at a threshold selected from the range inclusive of 15 mIU/mL-50 mIU/mL (claims 21, 34 and 36).
Copending Application No. 18094261 in view of Catt fail to recite further comprising at least one single consumable food item comprising pumpkin seeds in 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 (Applicant’s elected species), and commencing upon the occurrence of menstruation a daily recurring instruction to consume pumpkin seeds and flax seeds once daily, the daily recurring instruction to consume pumpkin seeds and flax seeds once daily terminating upon the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily, the daily recurring instruction to consume sesame seeds and sunflower seeds once daily terminating upon the onset of menstruation.
Takayasu teaches “seed cycling for hormonal imbalance” (Title). Takayasu further suggests comprising at least one single consumable food item comprising pumpkin seeds in 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 (Applicant’s elected species), and commencing upon the occurrence of menstruation a daily (page 3 para. 3) recurring instruction to consume pumpkin seeds and flax seeds once daily, the daily recurring instruction to consume pumpkin seeds and flax seeds once daily terminating upon the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, and following the occurrence of a diagnostic test result indicating the presence of LH at a threshold on any day during the cycle, a daily recurring instruction to consume sesame seeds and sunflower seeds once daily, the daily recurring instruction to consume sesame seeds and sunflower seeds once daily terminating upon the onset of menstruation (page 3 paras. 3, 5 and 7-8 and 10-1). Note that as evidenced by CoolConversion, the tablespoon of pumpkin seeds taught by Takayasu is equivalent to “7.44 grams” (page 1) and as evidenced by Mayo Clinic the tablespoon of flax seeds taught by Takayasu is equivalent to “7 grams” (page 1 para. 2). Therefore, Takayasu addresses “6.5-16 grams” of pumpkin seeds and flax seed. Takayasu further teaches that “[c]ertain seeds carry certain fatty acids (a.k.a. oils), vitamins, and nutrients that help support our hormones” (page 2 para. 11).
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 modified the teachings of copending Application No. 18094261 in view of Catt to include the consumable food items and daily recurring instructions to consume the food items commencing upon menstruation taught by Takayasu and terminating upon the result of the diagnostic tests of copending Application No. 18094261, because Takayasu suggests that the seed consumption system supports optimal hormonal balance though the nutrients in the seeds and copending Application No. 18094261 in view of Catt is concerned with tracking the hormones of women. A person having ordinary skill in the art would have had a reasonable expectation of success because Takayasu describes the system as simple and both copending Application No. 18094261 in view of Catt and Takayasu are drawn to women’s hormonal balance through the cycle.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/Fernando Ivich/ Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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