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 .
Election/Restrictions
Applicant's election with traverse of restriction requirement and election of group II, claims 12-17, drawn to a method [300] for determining fertility level in a female subject based on a plurality of analytes present in a biological sample from the female subject, in the reply filed on 02/04/2026 is acknowledged. The traversal is on the grounds that Group I-III are linked by a single general inventive concept and share the same corresponding special technical feature. This is not found persuasive because the restriction was found to have meet the requirements of 37 CFR 1.475 as a 371 application, as the groups are found to have a common technical feature in view of Catt et al. (US PG-Pub 20050171454 A1, as cited in prior office action), where Catt et al. teaches determining concentrations or levels, and/or rates of change in concentration of levels of analytes selected from one or more Estradiol glucuronide (E3G), Luteinizing Hormones (LH), Pregnanediol Glucuronide (PdG), Follicle-stimulating hormone (FSH), and human chorionic gonadotropin(hCG).
The requirement is still deemed proper and is therefore made FINAL.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. IN 202011024012, filed on 12/08/2021.
Drawings
The drawings are objected to because Figure 4A and 4B contain illegible text within the graphs. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
The claim numbering issue has been resolved and the objection withdrawn.
Claim 12 objected to because of the following informalities:
-As claim 1 is withdrawn from election with the expanded abbreviations of E3G, LH, PdG and FSH, the expanded abbreviations should be moved to claim 12.
-Claim 12 references “steps 3 and 2”, but the steps are not numbered. Add numbering to each step of the method.
Appropriate correction is required.
Claim Interpretation
The examiner is using their broadest reasonable interpretation of a “biochemical reagent” from claim 12 to comprise detectable labels that emits a signal when bound to an analyte. Additionally, the examiner is interpreting “a characteristic colour” to represent fluorescence as a signal as emitted light can encompass any kind of color based on the fluorescing particles used.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 12-17 are rejected under 35 U.S.C. 101 because it constitutes abstract ideas.
Regarding independent claim 12, a two-step analysis is performed:Step 1: Does the claim fall within a statutory category?
Yes, it is a method/process.
Step 2A, Prong 1: Identify the law of nature/natural phenomenon/abstract ideas. A method [300] for determining fertility level in a female subject based on a plurality of analytes present in a biological sample from the female subject, the method [300] comprising:
- pre-treating, at a test strip [110], the biological sample received from the female body, wherein the plurality of analytes present in the biological sample are E3G, LH, PdG and FSH;
- reacting said pre-treated biological sample with a detector reagent comprising one or more detector antibodies, wherein said detector reagent is present in one or more conjugate pads [202A, 202B], and each of the plurality of analytes of the reacted biological sample further flows to corresponding detecting zone [203A, 203B, 203C, 203D];
- reacting each of the plurality of analytes, of the reacted biological sample, with corresponding biochemical reagent at the corresponding detecting zone [203A-203D] producing a characteristic colour on one or more control lines [204A, 204B, 204C] for each of the plurality of analytes, wherein the corresponding biochemical reagent is covalently attached to magnetic and electronically charged labels;
- determining, by a user device [130], a concentration value of each of the plurality of analytes based on the reactions of step 3 and step 2; and
- analysing, by the user device [130], a comparison between the measured concentration value and pre-defined concentration value of each of the plurality of analytes to determine the fertility level.
Making a comparison between a measured concentration value and a pre-defined concentration value of a plurality of analytes to determine the fertility level is considered a mental process, where it is evaluated based on one’s observation, evaluation, judgment and opinion using data as comparison, making this an abstract idea.
Step 2A Prong 2: Has the abstract idea been integrated into a particular practical application?
The claim as a whole does not integrate the abstract idea into a practical application. Other than the abstract idea, claim 12 recites the additional elements: a test strip, a biological sample from a female subject, a detector reagent in conjugate pads, detecting zones, biochemical reagents, control lines, magnetic and electrically charged labels, and a user device. With respect to mentioned additional elements, they represent insignificant extra solution activity (e.g., mere data gathering). Thus, there is no application of the abstract idea, much less a particular practical application.
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
Claim 12 does not provide an inventive concept (significantly more than the abstract idea). A test strip, a biological sample from a female subject, a detector reagent in conjugate pads, detecting zones, biochemical reagents, control lines, magnetic and electrically charged labels, and a user device are considered insignificant extra solution activity (e.g., mere data gathering). Furthermore, the additional elements above, alone and in combination within claim 12 as a whole, are well understood, routine, and conventional activities within the prior art (See 35 U.S.C. 103 rejections)
Dependent claims 13-17 do not resolve any of the issues discussed above because they involve limitations with more insignificant extra-solution activity (e.g., biological samples, types of concentration values).
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.
Claims 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Qiu et al. (US PG-Pub 20200300776 A1), in view of Brenner et al. (US PG-Pub 20180106799 A1).
Regarding claim 12, Qiu et al. teaches methods, devices, and kits useful for performing immunoassay tests on a sample, for example, to diagnose a disease or to provide information regarding a biological state or condition of a female subject (e.g., fertility status). It can also be suitable for detecting the presences of a wide variety of analytes in a sample. The detected analytes by the immunoassay are luteinizing hormone (LH), estrone-3-glucoronide (E3G), and human chorionic gonadotropin (hCG) (see Qiu et al., [0029], [0037], [0050]). Qiu et al. further teaches that the immunoassay device can determine the presence of a first and second analyte in a biological sample, comprising a test strip defining a flow path and comprising: at a first end, a sample zone configured to be contacted with a biological sample suspected of containing the first analyte and the second analyte (see Qiu et al., [0032]). The test strip further comprises a labeling zone, also referred as a conjugate pad, that is positioned on a flow path of the test strip. The labelling zone may comprise at least a first and second detection reagent (e.g., anti-E3G antibody, anti-LH antibody) adsorbed on the surface of the zone, for binding onto a first and second analyte when present in a sample. The test strip further comprises a capture zone, or a test zone, positioned on the flow path of the test strip downstream of the labeling zone such that the sample can flow from the labeling zone to the capture zone. The capture zones can then emit an optical signal from a fluorescent label present which increases or decreases based on the analyte present in the biological sample (see Qiu et al., [0003], [0053], [0059]). The detection reagents may be conjugated or otherwise attached to a detectable label, which may be a fluorophore, an enzyme, a quencher, an enzyme inhibitor, a radioactive label, one member of a binding pair or any combination thereof (see Qiu et al., [0056]). Qiu et al. additionally teaches a diagnostic test system, comprising a port for receiving an assay device, a data analyzer with processors configured to: A) receive said optical signals (e.g., from fluorescence); and B) determine an amount or concentration of at least a first analyte and a second analyte present in a biological sample based on said optical signals (see Qui et al., [0073], [0077]). In some cases, a decrease in the first optical signal and an increase in the second optical signal (relative to a healthy control) are indicative of a time of an elevated ovulation cycle of a mammal, where it is known that a presence or absence of analytes may indicate that a female subject has an elevated fertility or is at a particular period of time in an ovulation cycle (see Qui et al., [0003], [0052]).
Qiu et al. fails to teach wherein the corresponding biochemical reagent is covalently attached to magnetic and electronically charged labels.
However, in the analogous art of a test device for detecting an analyte in a saliva sample and method of use, Brenner et al. teaches using immunoassay in determining the presence of an analyte in a bodily fluid to assess for hormone(s), ovulation, pregnancy and/or fertility for a user. It uses a lateral flow assay test strip, where labelled reagents with affinity to binding to analytes are used. The labels for it depends on the intended detection method, and may comprise a particle label such as colloidal gold label, latex particle label, electrochemical particle label, magnetic particle label, nanoparticle label and quantum dot label (see Brenner et al., [0002], [0004], [0151]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the immunoassay methods and devices of Qiu et al. to incorporate an electrochemical particle label and magnetic particle labels in addition to the other labels used by Qiu et al. (as taught by Brenner et al.), for the benefit of being able to use differing assay formats such as electronic, fluorescent or magnetic reader to assess detectable signals for quantitative detection of the analytes (see Brenner et al., [0197]-[0198]).
Regarding claim 13, the combination of Qiu et al. and Brenner et al. teaches the exact limitations of claim 13. Specifically, Qiu et al. teaches the method as claimed in claim 12, further comprising transmitting information to the user device, wherein said information comprises the reaction of pre-treated biological sample with the detector reagent, the reaction of each of the plurality of analytes with the corresponding biochemical reagent and the characteristic color for each of the plurality of analytes (see Qiu et al., [0077], [0116], disclosing the diagnostic test device is configured to scan the immunoassay device and measure the levels of fluorescent label present at the first and second capture region. The diagnostic test device is further configured to measure the levels of fluorescent label present at the first and second control region corresponding to the amount of excess first and second detection reagent present in the control zone, allowing to determine how many analytes reacted with the detection reagents corresponding to the remaining detection reagents. The diagnostic test device also comprises a data analyzer which is in operable communication with a reader device, and can analyze the amount of optical signals produced at the capture zone of an immunoassay device to determine an amount or concentration of analytes present in the sample.).
Regarding claim 14, the combination of Qiu et al. and Brenner et al. teaches the exact limitations of claim 14. Specifically, Qiu et al. teaches the method as claimed in claim 12, further comprising monitoring the fertility level using the user device (see Qiu et al., [0045], disclosing that the immunoassay device can obtain more than one sample over a period of a time, for example, to monitor disease progression or to monitor a biological state or condition (e.g., fertility status).).
Regarding claim 15, the combination of Qiu et al. and Brenner et al. teaches the exact limitations of claim 15. Specifically, Qiu et al. teaches the method as claimed in claim 12, wherein said biological sample is one of blood, urine, plasma and serum (see Qiu et al., [0036], disclosing the sample is a biological sample, including whole blood, blood plasma, blood serum, urine, saliva, sweat, etc.).
Regarding claim 16, the combination of Qiu et al. and Brenner et al. teaches the exact limitations of claim 16. Specifically, Qiu et al. teaches the method as claimed in claim 12, wherein the reacted biological sample refers to a combination of the biological sample and the one or detector antibodies (see Qiu et al., [0053], disclosing the detection reagent may specifically bind to an analyte, when present in the sample, thereby forming an analyte detection reagent complex.).
Regarding claim 17, the combination of Qiu et al. and Brenner et al. teaches the exact limitations of claim 17. Specifically, Qiu et al. teaches the method as claimed in claim 12, wherein said concentration value is relative concentration and absolute concentration (see Qiu et al., [0092], disclosing data collected by and transmitted by the diagnostic test system may include results of the immunoassay test performed on the immunoassay test device. For example, the data may include the concentrations of analytes, where the concentrations may be relative concentrations or absolute concentrations.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tracy C Colena whose telephone number is (571)272-1625. The examiner can normally be reached Mon-Thus 8:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRACY CHING-TIAN COLENA/ Examiner, Art Unit 1797
/JENNIFER WECKER/ Primary Examiner, Art Unit 1797