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 .
Election/Restriction
Applicant’s election of Claims 24-27 and 32-53 in the reply filed on December 1, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Information Disclosure Statement
The information disclosure statement filed 3/27/23 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. The copy of Cite No. CB Polesel is illegible.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 24 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim(s) is/are directed to a signal per se, mere information in the form of data. Claim 24 is drawn to “a computer readable medium.” The instant specification at para. [0131] indicates that computer readable media may be “any available media that is accessible by computer system/server 712, and it includes both volatile and non-volatile media, removable and non-removable media.”
MPEP 2106.03(II) states: “the BRI of machine readable media can encompass non-statutory transitory forms of signal transmission, such as a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the BRI encompasses transitory forms of signal transmission, a rejection under 35 U.S.C. 101 as failing to claim statutory subject matter would be appropriate. Thus, a claim to a computer readable medium that can be a compact disc or a carrier wave covers a non-statutory embodiment and therefore should be rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. See, e.g., Mentor Graphics v. EVE-USA, Inc., 851 F.3d at 1294-95, 112 USPQ2d at 1134 (claims to a “machine-readable medium” were non-statutory, because their scope encompassed both statutory random-access memory and non-statutory carrier waves).”
Claim 24 encompasses transitory forms of signal transmission and therefore, fails to claim statutory subject matter. Examiner encourages applicant to amend the claim to recite non-transitory computer readable medium.
MPEP2106.03(II) indicates that “when a claim fails under Step 1 (Step 1: NO), but it appears from applicant’s disclosure that the claim could be amended to fall within a statutory category (Step 1: YES), the analysis should proceed to determine whether such an amended claim would qualify as eligible at Pathway A, B or C.” Since amending the claim to recite a non-transitory CRM would pass STEP 1, further analysis for claim 24 is undertaken below.
Claims 24-27, 32-53 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 24 recites a computer readable medium configured for the method for determining a stage of menopause, claim 25 recites a processor comprising the computer readable medium configured for the method and claim 26 recites a kit comprising test strips and the computer readable medium configured for the method. The claims recite receiving a collection of input comprising at least one of cycle information, age, and follicle-stimulating; assigning a category to each input data; determining based the category, the stage of menopause for the subject; and outputting the determined stage if menopause.
The limitations “assigning a category to each input data; determining based the category, the stage of menopause for the subject” under their broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components for claims 24-26. Within the context of the claim nothing precludes the steps from being executed mentally; with the exception of reciting “a computer readable medium when executed by a processor”. For example, indicating the stage of menopause involves using the following common denominators: ("receiving a collection… assigning a category.., determining based on...outputting the determined stage..”); these imply performing mental perception, attention, memory and/or decision. Decisions are a result of thought of cognitive processing activity and/or styles. If the claim limitations, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components, then the claim limitations fall within the "Mental Processes" grouping of abstract ideas (MPEP 2106.05(f)). Accordingly, the claims recite abstract ideas (Step 2A: Prong 1: Yes).
This judicial exception is not integrated into a practical application because the claims do not recite any additional elements that reflects an improvement to technology or applies or uses the judicial exception in some other meaningful way (Step 2A, Prong 2: No). In particular, Claims 24 and 25 recite the additional elements of the CRM and processor to perform the determinations and Claim 26 recites test strips for detection of FSH. The claimed limitations do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims only recite a CRM or processor to perform the steps, but this broadly claimed element does not appear to be a particular machine. The processor and memory are recited at a high-level of generality (i.e., as generic computer) such that it amounts no more than mere instructions to apply the exception using a generic computer component; wherein a general purpose computer is not a particular machine (MPEP 2106.05(b)). The test strips of claim 26 are extra solution activity and do not amount to an inventive concept.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional element of (“when executed by a processor perform a method of comprising receiving a collection….assigning a category.., determining based on...outputting the determined stage..”) amounts to mere instructions to apply the exception via a generic computer readable component. Mere instructions to apply an exception has no grounds for inventive concept, thus the claim is not patent eligible. With respect to claim 26, the additional element of test strips for detection of FSH in a sample is well understood, routine and conventional as evidenced by Beckley et. al. (WO2021034412A1). Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). The claims are not patent eligible.
Dependent claims 25-23 further recites limitations of which alone or in combination do not amount to significantly more.
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 24-27, 32-53 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.
Regarding claim 24, the claim recites the limitation "the subject" in ln. 6. There is insufficient antecedent basis for this limitation in the claim. It is noted that claims 35-37, 41, 44 and 53 also recite the limitation “the subject” for which there is insufficient antecedent basis. Examiner suggests amending claim 24 to recite “a subject” to provide antecedent basis for the term and would also cure the issue for claims 35-37, 41-44, and 53 because antecedent basis would provide by way of amendment to claim 24.
Claims 25-27 and 32-53 are rejected due to their dependency on claim 24.
Regarding claim 38, the terms “high FSH” and “low FSH” in claim 38 are relative terms which renders the claim indefinite. The terms “high” and “low” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification at paras. [0111]-[0113] provides examples of high/low FSH as being a certain number of samples above the threshold but the specification does not provide sufficient guidance as to the meanings of the terms so that one of ordinary skill in the art would know the metes and bounds of the claim. Further clarification is requested.
Regarding claim 48, the terms “long cycle length” and “regular cycle length” in claim 48 are relative terms which renders the claim indefinite. The terms “long” and “regular” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification at paras. [0049]-[0051] provides examples of long/regular cycles as being a certain number of days but the specification does not provide sufficient guidance as to the meanings of the terms so that one of ordinary skill in the art would know the metes and bounds of the claim. Further clarification is requested.
Regarding claim 50, the terms “low cycle variability” and “high cycle variability” in claim 50 are relative terms which renders the claim indefinite. The terms “low” and “high” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification at para. [0053] provides examples of low/high cycle variability as being a certain number of differing cycle days but the specification does not provide sufficient guidance as to the meanings of the terms so that one of ordinary skill in the art would know the metes and bounds of the claim. Further clarification is requested.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 24-27, 32, 34-36, 45-46, 51-53 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beckley et. al. (WO2021034412A1).
Regarding claim 24, Beckley teaches a computer readable medium configured to when executed by a processor perform a method ([0050], [0082], [0090], [0096], [0108], [0122], [0145], [0196], a menstrual cycle testing system comprising a patient facing application, computing device … useful in capturing, processing and storing the results).
Beckley teaches receiving a collection of input comprising at least once cycle information ( [0196]“series of diagnostic tests…woman’s bodily fluid within a single menstrual cycle…a message delivered…to a display…menopause started”), age( [0196]“ “above a certain age(in example, 35 years old)”), follicle stimulating hormone (FSH) information ( [0196]“where a 1.5 fold decrease in FSH…display stating ovulation…not to occur”).
Beckley teaches assigning a category to each input data ( [0196] “1.5 fold decrease FSH is not observed…above a certain age…likelihood that menopause has started, three…nonovulating cycles...below certain age…PCOS or other, non-ovulating cycles above a certain age…menopause started…1.5 decrease in FSH…fertile window has opened.”)
determining based on category the stage of menopause the stage of menopause for the subject ( [0196] “1.5 fold decrease in FSH is not observed…diagnostic tests performed on a subject woman…within a single menstrual cycle, optionally only if the woman is above a certain age (in an example, 35 years old)… display suggesting a likelihood that menopause has started”);
outputting the determined stage([0169], [0143], [0094], [0196]“a message is delivered via a graphical user interface…suggesting likelihood that menopause has started”).
Regarding claim 25 Beckley teaches a processor comprising the computer readable medium ([0109], [0112], [0124], processor comprising storage) of claim 24 (see rejection above).
Regarding claim 26, Beckley teaches a kit ([0050], Menstrual test system including diagnostic test, computing device, patient app, processor etc.; Examiner notes Beckley’s teachings of a system meet the instant recitation of a "kit" since the assembled system of Beckley is merely an assembled kit) comprising:
a plurality of test strips for a quantitative or qualitative detection of follicle-stimulating hormone (FSH) in a sample ([0068] teaches “diagnostic test configured …third testing zone configured…presence or absence of…(E3F or FSH) at a threshold …diagnostic test optionally configured as a test strips…testing analytes and/or hormones);
and the computer readable medium ([0109], [0112], [0124], processor comprising storage) according to claim 24 (see rejection above).
Regarding claim 27, Beckley teaches wherein each test strip is configured to:
determine a concentration of FSH in a sample ([0065] teaches “one or more testing zones each configured to detect…follicle stimulating hormone at a threshold”);
compare the concentration to a threshold (0188] discloses to evaluate for a FSH threshold is useful because it signals the opening of the fertile window. Moreover, Beckley teaches presence of FSH equivalent to 1.5 fold decrease compared to prior diagnostic test, indicates the presence of FSH performed in the same menstrual cycle”);
determine whether the concentration is positive or negative based on the comparison; ([0065] teaches “diagnostic test consisting of a lateral flow assay…third testing zone a positive or negative result..third testing zone is selected… follicle stimulating hormone with a threshold set a concentration3-20mIU/ml.”) ;
output a determination of one of positive, negative, or error; ([0068] teaches “the diagnostic device is associated with a digital reader…third testing zone to evaluate presence or absence…(optionally FSH or hCG)).
Regarding claim 32, Beckley teaches wherein the determined stage of menopause is one of four stages of menopause ( [0196] teaches “three or more non-ovulatory cycles..suggests a likelihood of menopause started,1.5 fold decrease in FSH not observed ..on diagnostic test..likelihood of menopause started.”).
Regarding claim 34, Beckley teaches wherein cycle information comprises one or more of: a time since a start of a last menstrual bleed, a cycle length, and a variability of cycle length ( [0196] , menstrual cycle…between onset menstruation in first menstrual cycle and onset of menstruation in subsequent, average menstrual cycle…number of recent cycles optionally 6 menstrual cycles and determining the average…).
Regarding claim 35, Beckley teaches wherein:
the cycle length comprises a cycle length of previous and/or current cycles of the subject ( [0196] , menstrual cycle…between onset menstruation in first menstrual cycle and onset of menstruation in subsequent, average menstrual cycle…number of recent cycles optionally 6 menstrual cycles and determining the average…;
and the variability of cycle length comprises a variability of cycle length of previous and/or current cycles of the subject ([0099] series of diagnostic tests performed daily……correlating to a menstrual, to detect a trend…form one menstrual cycle to at least…plurality of other menstrual cycles.”).
Regarding claim 36, Beckley teaches wherein the outputting the determined stage of menopause comprises sending an alert to the subject, wherein the alert comprises the determined stage of menopause and information determined by the stage of menopause and the input data, (Beckley [0196] teaches “the system and/or user…above a certain age…a message is delivered via the graphical user interface….a likelihood that menopause has started”..).
Regarding claim 45, Beckley teaches the time since the start of the last menstrual bleed is a menstrual bleed category based on whether a length of absence from the last cycle is above an absence threshold ( [0196], a 1.5 fold decrease in FSH not observed…within a single menstrual cycle…above a certain age…menopause has started…three or more consecutive non-ovulatory cycles …above a certain age...menopause has started…1.5 fold decrease is observed…above a certain age...fertile window has opened).
Regarding Claim 46, Beckley teaches wherein the absences category is one of: menstrual bleed present or menstrual bleed absent, ([0145] teaches “a calendar 5000..due to the cyclical nature of the menstrual cycle ..due to specific trends observable within a calendar..and the ability to identify specific phases of menstrual cycle and group certain messages …menstrual cycle.”).
Regrading Claim 51, Beckley teaches the age category is based on the value of the age ( [0196] , above a certain age in an example 35 years old).
Regarding Claim 52, Beckley teaches the age category is one of young, middle, or late adulthood, ([0196], above a certain age in an example 35 years old).
Regarding claim 53, Beckley teaches wherein determining, based on the input data, the stage of menopause for the subject comprises one of: a determination made from a look-up table, a determination made from an algorithm, or a determination made from an artificial intelligence (AI), neural network or machine learning model, ( [0088] teaches “results 404 of the…professional user via the graphical user interface of the Healthcare Professional-Facing Application optionally facilitated by sending….. results of one or a plurality of diagnostic test(s) relevant to a particular patient to a clinical decision support system, via API connection the healthcare professional user’s EMR or other healthcare systems, or via API connection to other databases configured to cross reference collected and/or interpreted”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Beckley et. al. (WO2021034412A1) in view of De Zambotti (WO2022098737A1).
Regarding claim 33, Beckley teaches menopause tracking [00196] but fails to explicitly teach wherein the four stages of menopause comprise: pre-menopause, early peri-menopause, late peri-menopause and post-menopause.
De Zambotti teaches menopause-state prediction and expressly discloses that the different states of menopause include pre-menopause, menopause transition, and post-menopause, with the menopause transition including early perimenopause and late perimenopause, [0052]. De Zambotti teaches that many women have difficulty recognizing menopause transition because menopause features vary across users and over time, and that women desire user-specific menopause-state information for family planning and symptom management, [0001], [0031].
It would have been obvious to one of ordinary skill before the effective filing date of the invention modify the menopause tracking of Beckley to use the specific four-stage menopause classification taught by De Zambotti because doing so would improve the specificity and usefulness of the menopause-related output generated for the user, particularly for tracking progression through menopause and supporting personal health and family-planning decisions. (De Zambotti, paras. [0018], [0052], [0055])
Claims 37-42, 47-50 are rejected under 35 U.S.C. 103 as being unpatentable over Beckley et. al. (WO2021034412A1) in view of Coley et.al., (US2004235183A1).
Regarding claim 37, Beckley teaches wherein the FSH information is based on a plurality of samples obtained from the subject and an FSH concentration above or at an FSH threshold. ([0196] teaches “1.5 fold decrease in FSH is not observed…diagnostic tests performed on a subject woman…within a single menstrual cycle, optionally only if the woman is above a certain age (in an example, 35 years old… display suggesting a likelihood that menopause has started, repeated collection of samples over multiple days, threshold-based FSH testing, and interpretation of repeated FSH results, including persistently high FSH [0065]-[0068], [0093]-[0099], [0169], [0188]-[0191]).
Beckley does not explicitly disclose assigning FSH information into an FSH category based on how many of a plurality of samples are at or above an FSH threshold.
Coley [0031] teaches an essential feature of the present invention…are made for a plurality of cycles. Moreover, Coley [0066] teaches table 1 shows comparison…urinary FSH determination between…normal fertility…reduced fertility…based on a threshold level.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the data collection and results of Beckley to have a FSH category based how many samples of the samples have a FSH concentration above or at an FSH threshold because Coley teaches a comparison of FSH determination (see Table 1) and counting the number of threshold-positive FSH samples is merely a routine way to quantify persistence/trend information already taught by Beckley.
Regarding claim 38, Beckley teaches wherein the FSH category is one of: high FSH, variable FSH, or low FSH. ( [0188], presence or absence of FSH at a threshold….selected from the range inclusive of 7-25 diagnostic tests...FSH in an amount…1.5 fold decrease as compared to prior diagnostic test…the presence of FSH performed in the same menstrual cycle”). Beckley does not teach a FSH category as either high, variable, or low FSH.)
Regarding claim 39, Beckley fails to explicitly teach wherein the FSH threshold is 10-30mlU/ml but Beckley teaches the FSH threshold is 3-20mIU/ml ([0065]) which overlaps with applicant’s claimed range of 10-30mlU/ml. In the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists. MPEP § 2144.05. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the threshold of Beckley to be within the range of overlapping portion of the claimed range because such a threshold was recognized as providing pertinent data for menopause determination.
Regarding claim 40, Beckley teaches follicle stimulating hormone (FSH) with a threshold set at a concentration chosen from the range inclusive of 3-20 mlU/ml ([0065]) and therefore fails to teach wherein the FSH threshold is 25mlU/ml. However, Beckley teaches a threshold-based FSH assay, thereby recognizing the threshold concentration as affecting the result obtained from the assay. Since this particular parameter is recognized as result-effective variable, i.e. a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05(II). Here, the exact FSH threshold is an assay design parameter that affects whether samples are classified as above or below threshold. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to optimize Beckley’s disclosed FSH threshold and select 25 mIU/ml as a workable value. A person of ordinary skill in the art would have understood that varying the threshold would predictably affect the classification of test results and could be adjusted depending the target population.
Regarding claim 41, Beckley teaches wherein a number of test results obtained from the subject is at least three ([0097] teaches “message 501 is generated….user to utilize first morning urine in association with the diagnostic test 100….an example, LH tests can be performed up to 3 times per day…to incorporate enough diagnostic tests 100 to evaluate thrice daily.”)
Regarding claim 42, Beckley teaches wherein the samples are obtained on one of: alternate days; consecutive days; or non-consecutive pre-defined days, ([0093], patient user to conduct multiple diagnostic tests 100 each taken once every day for a number of consecutive days).
Regarding claim 43, Beckley teaches wherein the sample is a urine sample ([0233] urine sample).
Regarding claim 44, Beckley teaches wherein the sample is obtained from the subject on any day of the subject's cycle, ( [0190] which teaches “plurality of diagnostic test 100…evaluate only one hormone and/or analyte…the presence or absence of FSH…on a daily basis…the range inclusive of 2-3 days...subject menstruation in menstrual cycle.”).
Claims 47-50 are rejected under 35 U.S.C. 103 as being unpatentable over Beckley et. al. (WO2021034412A1) in view of den Tonkelar et. al Menstrual cycle length preceding menopause in relation to age at menopause(1998).
Regarding claim 47, Beckley teaches wherein the cycle length is assigned into a cycle length category based on whether previous or current cycle length is above a cycle length threshold, (Beckley [0196] teaches “average menstrual cycle length calculated...recent menstrual cycles optically 6 menstrual cycles..”) Beckley does not teach a cycle length based on whether previous or current cycle length is above a cycle length threshold.
Den Tonkelar et. al Menstrual cycle length preceding menopause in relation to age at menopause 1998 abstract teaches (“median of the mean menstrual cycle length per woman …the median of standard deviation of the mean menstrual cycle length per woman…menopause in three age categories”). Den Tonkelar (column 2, paragraph 1, p. 117) teaches (“9 years prior to menopause…55-59 years have…higher mean menstrual cycle length (MP) than… menopause between 4-49 and 50-54 years(p=0.0008”) See table 1. Moreover, Den Tonkelar (column 1, paragraph 1, p.118) teaches (“SP also increases when age is at menopause”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the testing of Beckley to have a cycle length category based on previous or current cycle length threshold because Den Tonkelar (column 1 paragraph 3, p. 117) teaches median and mean of mean cycle length per woman (MP) and standard deviation of cycle lengths per woman (SP) groups were calculated at different ages at menopause as well as the standard deviation. This is beneficial because using this method does not necessitate knowing how and when the cycles changed in the individual women and Column 1, paragraph 2, p.121) discloses the results are in accordance from the menstrual and Reproductive History Research Program (MRHRP)7.
Regarding claim 48, Modified Beckley teaches wherein the cycle length category is one of long cycle length or regular cycle length (Den Tonkelar, column 1 paragraph 3, p. 117).
Regarding claim 49, Beckley teaches average menstrual cycle length calculated...recent menstrual cycles optically 6 menstrual cycles, [0196]. Beckley does not teach wherein the variability of cycle length is assigned into a variability category based on whether the variability of cycle length is above a variability threshold,
Den Tonkelar (column 1, paragraph 1, p. 120) teaches (“variability in cycle length per woman increases, variability is not larger…compared with women…earlier age of menopause…(p=0.016) see Figure 2”). Moreover, Den Tonkelar (column 2, paragraph 2, p. 121) teaches (“a tendency towards a larger standard deviation of MP reflects larger between person variance for women with late ate at menopause; See Table 1”.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to assigned a variability category based on variance of cycle length because, Den Tonkelar (column 2, paragraph 2, p. 121) teaches (“the MRHRP reported larger variability in length of menstrual cycles in with late age at menopause and based on a larger standard deviation of the mean menstrual cycle length…”) and this would assist with menopause stage determination. This finding relates to findings in Den Tonkelar see Table 1.
Regarding claim 50, Modified Beckley teaches wherein the variability category is one of low cycle variability or high cycle variability (Den Tonkelar, Table 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REESHEDA T JONES whose telephone number is (571)272-4039. The examiner can normally be reached 9:30am-5:00pm.
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/R.T.J./Examiner, Art Unit 1796
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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