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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 2, 5-12, and 15-23 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
With respect to the rejection under 35 U.S.C. 101, Applicant has amended the claims this overcome the rejection, thus the claims are no longer considered as being directed to an abstract idea without significantly more.
With respect to the rejections under 35 U.S.C. 102, Applicant has amended independent claim 1 such that it is no longer anticipated by reference to Villarreal (WO 2016/094409) as cited in the previous Office Action. However, as detailed below, independent claim 1 now stands rejected under 35 U.S.C. 103 as being obvious over the combination of Villarreal (WO 2016/094409) in view of Tariyal et al., (US 2016/0324506) who in combination teach all the limitations of independent claim 1. Because reference to Tariyal et al., is newly cited, the Examiner will not argue the merits of its teachings here, but will instead rely on the rejection detailed below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 5-10, 16, and 19-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Villarreal (WO 2016/094409) in view of Tariyal et al., (US 2016/0324506).
Regarding claim 1, Villarreal teaches methods and devices for female health monitoring comprising obtaining a first sample of a female subject's menstrual fluid on a collection device (paragraphs 0008, 0011, 0063), measuring the presence, absence, or level of one or more biomarkers (paragraph 0011), and repeating the sampling and measuring steps on subsequent samples wherein proteins are extracted and measured (paragraphs 0027, 0032, 0043, 0051, 0055). Villarreal does not teach performing mass spectrometry on proteins extracted from the sample.
Tariyal et al., teach a method for monitoring health wherein a sample collector is utilized to collect menstrual fluid (paragraph 0105), and performing mass spectrometry proteomic analysis on the sample (paragraph 0128). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. Reference to Tariyal et al., teach that mass spectrometry is known for downstream sample analysis, and can be utilized as a tool for proper diagnosis of specific health conditions (paragraph 0128).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Villarreal in view of Tariyal et al., wherein mass spectrometry is utilized to analyze a sample as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Regarding claim 2, Villarreal teaches measuring HbA1c (paragraph 0028).
Regarding claim 5, Villarreal teaches obtaining a sample from a tampon, pad, or menstrual cup (paragraph 0065).
Regarding claim 6, Villarreal teaches sampling once every month, every 3 months, every 6 months, every 9 months or about once every year (paragraphs 0016, 0018).
Regarding claims 7 and 8, Villarreal teaches a disposable cartridge capable of being inserted into a wireless device such as a personal communication device (paragraph 0008).
Regarding claim 9, Villarreal teaches measuring glycodelin (paragraph 0049).
Regarding claim 10, Villarreal teaches measuring fibrinogen (paragraph 0033).
Regarding claim 16, Villarreal teaches measuring serotransferrin (paragraph 0058 Table).
Regarding claim 19, Villarreal teaches measuring estrogen (paragraph 0034).
Regarding claim 20, Villarreal teaches providing a database for storing biomarker information (paragraph 0079).
Regarding claim 21, Villarreal teaches determining average and trend levels of biomarkers (paragraph 0011).
Regarding claims 22 and 23, Villarreal teaches baseline, short-term, or long-term health information to indicate a disease or disorder (paragraph 0018).
Claim(s) 11, 12, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Villarreal (WO 2016/094409) in view of Tariyal et al., (US 2016/0324506) as applied to claim 1 above, and further in view of Villarreal (WO 2019/074954).
Regarding claims 11, 12, 17, and 18, Villarreal in view of Tariyal et al., do not teach peroxiredoxin-2, Lon protease homolog 2, peroxisomal, TANC1, and Teashirt homolog 2 as measured biomarkers.
Villarreal '954 teaches a method of measuring biomarkers for patient stratification in bodily fluids wherein menstrual fluid (page 4 lines 17-21) is measured for peroxiredoxin-2, Lon protease homolog 2, peroxisomal, TANC1, and Teashirt homolog 2 (page 9 line 31- page 10 line 2). Villarreal teaches that it is advantageous to measure peroxiredoxin-2, Lon protease homolog 2, peroxisomal, TANC1, and Teashirt homolog 2 as a means of providing early and continuous detection, tracking, and treatment of women's diseases (page 10 lines 2-6).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Villarreal in view of Tariyal et al to measure peroxiredoxin-2, Lon protease homolog 2, peroxisomal, TANC1, and Teashirt homolog2 in order to provide early and continuous detection, tracking, and treatment of women's diseases as taught by Villarreal '954.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Villarreal (WO 2016/094409) in view of Tariyal et al., (US 2016/0324506) as applied to claim 1 above, and further in view of Tariyal et al., (US 2019/0125316).
Regarding claim 15, Villarreal in view of Tariyal et al., ‘506 do not teach phosphatidylinositol 4-phosphate 5-kinase type alpha as a suitable biomarker.
Tariyal et al., ‘316 teach a method of monitoring a health condition wherein menstrual fluid is a suitable biological sample (paragraph 0232). Tariyal et al., also teach phosphatidylinositol 4 phosphate 5-kinasetype alpha as a suitable biomarker for monitoring a health condition (Table 8). The Examiner is reading this limitation as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. Reference to Tariyal et al., clearly teach that phosphatidylinositol 4-phosphate 5-kinase type alpha in menstrual fluid is utilized to monitor a health condition, thus one of ordinary skill in the art would have found it obvious to measure phosphatidylinositol 4-phosphate 5-kinase type alpha as a suitable biomarker for monitoring baseline, short term, and long term health trends as taught by Villarreal.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Villarreal in view of Tariyal et al., ‘506 wherein phosphatidylinositol 4-phosphate 5-kinase type alpha is measured as a biomarker as combining prior art elements according to known methods requires only routine skill in the art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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