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 .
Status of Claims
The claim set submitted on 01 JULY 2024 is acknowledged and considered. In the claim set, Claims 1-7 are presented and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01 JULY 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 14 AUGUST 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 17 JANUARY 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 09 JULY 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 3 is objected to because of the following informalities: In the instant claim, there is a random “(3)” in line 1; this should be deleted. Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over BAHAR, US Publication No. 2017/0356922 A1, submitted on the Information Disclosure Statement on 01 JULY 2024; US Patent Application Publications Cite No. 2, and further in view of WALLACE-DAVIS, US Publication No. 2011/0086373 A1, submitted on the Information Disclosure Statement on 01 JULY 2024; US Patent Application Publications Cite No. 1.
Applicant’s invention is directed towards a kit.
Regarding Claim 1, the reference BAHAR discloses a kit for use in a method for detecting the presence and/or concentration of a target hydrophobic analyte in a biological sample, abstract, [0019], the kit comprising:
a pretreatment reagent that digests lipoprotein particles, wherein the pretreatment reagent comprises protease, lipase, and a cofactor for lipase; and
at least one assay reagent capable of detecting a hydrophobic analyte for determining a concentration of target hydrophobic analyte present in the sample, [0019, 0025, 0027-0028].
The BAHAR reference discloses the claimed invention, but is silent in regards to combining a pretreatment reagent that digests lipoprotein particles, wherein the pretreatment reagent comprises protease, lipase, and a cofactor for lipase.
The reference WALLACE-DAVIS discloses a kit for use in a method for detecting the presence and/or concentration of a target hydrophobic analyte in a biological sample, abstract, [0087], the kit comprising:
a pretreatment reagent that digests lipoprotein particles, wherein the pretreatment reagent comprises protease, lipase, and a cofactor for lipase, [0006-0020, 0051, 0068, 0070, 0148]; and
at least one assay reagent capable of detecting an analyte, Claim 2, [0014-0020, 0053].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention of BAHAR with the pretreatment reagent that digests lipoprotein particles as taught by WALLACE-DAVIS to remove any interfering lipoproteins by routine experimentation to optimize obtaining more accurate analyte concentrations with the effects of interferents reduced or eliminated, [0020, 0068, 0088, 0148].
Additional Disclosures Included are: Claim 2: wherein the kit of claim 1, wherein the target hydrophobic analyte is selected from the group consisting of vitamin D, tacrolimus, sirolimus, everolimus, estrogen, estrone, estradiol, estriol, alfatradiol, cyclosporine, ethinylestradiol, esterified estrogens, moxestrol, quinestrol, progestins, progesterone, androgens, testosterone, dihydrotestosterone (DHT), dehydroepiandrosterone (DHEA), DHEA sulfate, androstenedione, aldosterone, cortisol, catecholamine, 25-hydroxy Vitamin D2, 25-hydroxy Vitamin D3, 1,25-dihydroxy Vitamin D2, and 1,25-dihydroxy Vitamin D3, BAHAR [0007, 0017, 0018], Claim 5, vitamin D.; Claim 3: wherein the kit of claim 1, wherein the at least one assay reagent of is further defined as an immunoassay reagent, BAHAR [0027, 0028], antibody as one reagent are referred to as immunoassay. ; Claim 4: wherein the kit of claim 1, wherein lipase is present in the pretreatment reagent at a concentration in a range of from about 0.1 mg/mL to about 20 mg/mL, WALLACE-DAVIS [0148-0151], 20mg/mL lipase, [0196, 0198], 12.5 mg/mL lipase, [0241-0244]. ; Claim 5: wherein the kit of claim 1, wherein the cofactor for lipase comprises bile acid and/or a salt thereof, WALLACE-DAVIS, [0007, 0015, 0024, 0048, 0068], one or more bile acid derivatives or salts thereof. ; Claim 6: wherein the method of claim 1, wherein the kit of claim 1, wherein the pretreatment reagent further comprises at least one additional substance selected from the group consisting of a surfactant, pepsin, amylase, and combinations thereof, WALLACE-DAVIS [0007, 0015, 0024, 0048, 0051], surfactant comprising one or more bile acid derivatives or salts thereof, to break down the lipoprotein structure; and Claim 7: wherein the kit of claim 1, wherein the cofactor for lipase comprises bile acid and/or a salt thereof, and wherein the pretreatment reagent further comprises a surfactant, WALLACE-DAVIS [0024, 0068, 0048], bile acid derivative or salts thereof a as a surfactant to break down lipoproteins.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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