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 .
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.
Claim(s) 21 and 29 contain(s) the trademark/trade name Tergitol. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe surfactants such as Tergitol 15-S-9, 15-S-3, and Tergitol TMN-6, which correspond to oil-soluble secondary alcohol ethnoxylate, water-soluble liquid, and water-soluble ethnoxylated alcohol respectively and, accordingly, the identification/description is 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.
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.
Claim(s) 17, 18, 25 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walshe (US 20140322724 A1) as cited in previous Office Action in view of Brady (Development of a lateral flow point of care test for the rapid detection and measurement of haptoglobin in bovine milk, page 67-70, 2016) as cited in IDS.
Regarding claims 17 and 25, Walshe discloses a method of automatically measuring (a method for the detection of a target analyte in a sample… para. [0019]) acute phase protein (para. [0013]) in a raw milk sample (liquid sample is a bodily fluid…selected from…milk, para. [0027]), the method comprising
providing a raw milk sample potentially comprising haptoglobin (applying the sample to a solid phase carrier material, para. [0019]);
providing a dry stick (applying the sample to a solid phase carrier material, para. [0019]), the dry stick (Fig. 2) being a competitive lateral flow stick for measuring acute phase protein (para. [0013]) in a raw milk sample (para. [0027]), said dry stick comprising a base bad capable of allowing lateral flow of fluid therethrough (conjugate pad, para. [0076]), the base pad comprising:
a labelled-control conjugate and a labelled-conjugate diffusibly arranged herein (antibody-labelled gold, para. [0076]), wherein said labelled conjugate binds the acute phase protein, and wherein a complex is formed between said labelled-conjugate and said acute phase protein when said dry stick is in use (the labelled antibody and analyte coated gold will react to form an antibody-analyte gold complex, para. [0091]);
a test line comprising immobilized target analyte (Test line 1, Fig. 2; para. [0076]), wherein said immobilised target analyte bind to said labelled-conjugate when not in said complex (para. [0076]); and
a control line (control line 4, Fig. 2), the control line being spaced from said test line (Fig. 2), and wherein the control line comprises control analyte that binds to said labelled-control conjugate (…this second gold particle was used to generate a control line to enable visual observation of the control line. Para. [0106]);
automatically applying said sample to said dry stick (applying the sample to a solid phase carrier material, para. [0019]);
allowing said sample to flow through the test line and said control line on said dry stick (Walsh discloses the method involves using a lateral flow assay with test and control line, which implicitly requiring the sample to fully through the LFA device);
determining the amount of analyte from said test line and from said control line (The response is inversely proportional to the amount of analyte in the sample. Para. [0017]; Suitably, the analyte is quantitatively detected in accordance with the signal generated at the test line. Para. [0029]; If analyte is present in the sample, the target SAA analyte reacts with the antibody on the antibody-labelled gold in proportion to the amount of SAA present until such time as all the antibody binding sites on the gold are occupied by SAA in the sample. Para. [0075]).
Walshe does not exemplify the embodiment with haptoglobin. However, Walshe discloses haptoglobin as a potential alternatives acute phase proteins (Examples of APP's known for diagnostic and prognostic purposes include haptoglobin, CRP and serum amyloid A (SAA). Para. [0013]).
In an analogous art, Brady discloses that detection of haptoglobin in milk via lateral flow type devices is possible (pg 69, para 3 ; Fig 1). The LFA strip comprises Sheep anti-bovine Hp IgG (2), conjugated to colloidal gold (Materials & Methods, pg 69) and haptoglobin concentration can be determined semi-quantitatively (Fig. 1, pg 70).
It would have been obvious to one of ordinary skill in the art to have replaced the haptoglobin dry stick of Brady with the SAA drystick in the method of Walshe to derive the claimed invention and has a reasonable expectation of success. One of skill in the art would be motivated to do so because Walshe discloses the method is specifically design for testing of acute phase proteins, in which haptoglobin and SAA are classified into. Furthermore, both Walshe and Brady achieved detection and quantification using a test strip coated with conjugated colloidal gold particles. As a result, one would like conclude that the dry stick of Walshe can be replaced with haptoglobin dry stick without substantial complexity.
Regarding claims 18 and 26, Modified Walshe discloses the claimed invention as discussed above in claim 17 and 25 respectively. Walshe (after incorporation with Brady) discloses raw milk sample is provided in a defined amount (5 μl of sample was applied to the end of the test strip followed by addition of 100 μl of a PBS buffer. Para. [0100]).
Claim(s) 19-22 and 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walshe in view of Brady as applied to claims 17 and 25 above, and further in view of Berlina (Quantum dot-based lateral flow immunoassay for detection of chloramphenicol in milk, 2013).
Regarding claim 19-22 and 27-30, Modified Walshe discloses the claimed invention as discussed above in claims 17 and 25 respectively. Neither Walshe nor Berlina discloses the raw milk sample is mixed with a diluent comprising a surfactant, prior to applying said raw milk sample to said dry stick, wherein said surfactant is present in the diluent in a concentration of 0.1-4 w/w% and the surfactant is Tween-20.
In an analogous art, Berlina discloses a method of testing for chloramphenicol in milk using lateral flow immunoassay. Berlina discloses the need for preparing milk for eliminating matrix effect (any component in the sample that may interfere with antibody binding or fluid migration) by either centrifugation or dilution with buffer (Sample preparation). Berlina preferred sample dilution since the sample dilution is faster than centrifugation. For example, Berlina diluted the sample by 20 with 5% Tween-20 in PBS (However, for the field assays, we preferred sample dilution instead of centrifugation for the fat removal since the use of this procedure increased the analysis time. But the assay of excessively dilute samples can cause false-negative results. Consequently, the samples were diluted by 20 with 5 % Tween-20 in PBS. Results and Discussion, para. 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added the sample of the method of Modified Walshe to a Tween-20 surfactant, as taught by Berlina, before applying the mixed sample onto the dry stick, to derive the claimed invention. Adding surfactant such as Tween-20 defats the milk sample and mitigates unwanted matrix effect (Berlina, Sample Preparation).
Regarding the limitation of surfactant is present in the diluent in a concentration of 0.1-4 w/w%, Berlina (after modification with Walshe) discloses the milk-buffer ratio of (4:1 v/v) and the PBS buffer contains 5% Tween-20 (by weight) (Results and Discussion, para. 10) and the claimed diluent concentration. See calculation below.
Assuming mL basis, 4:1 v/v translates to 4 mL of milk to 1 mL of PBS buffer. Whole milk has density of 1.03g/mL and PBS has solution density of 1.0 g/mL. 5% of Tween-20 is 0.05 g/mL of PBS solution. Weight percent of Tween-20 in the diluent mixture is calculated to be
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Claim(s) 23-24 and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walshe in view of Brady as applied to claims 17 and 25 above respectively, and further in view of Campbell (Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool, 2016).
Regarding claims 23 and 31, Modified Walshe discloses the claimed invention as discussed above in claims 17 and 25. Though Walshe discloses a calibration curve (Fig. 1, para. [0059], [0102], [0119]), neither Walshe nor Brady explicitly discloses the step of determining haptoglobin by using a signal ratio obtained by dividing test signal with a sum of said test signal and control signal, and following using said signal ratio to retrieve amount of haptoglobin from a look-up table or by applying a mathematical model.
The claimed calculation step is a conventional way of calibrating a measurement. In an analogous art, Campbell discloses a calculation/determination procedure for analyte (immunoglobin protein) in LFD device after the signals have been scanned. Campbell discloses step of determining immunoglobin amounts by using a signal ratio obtained by dividing test signal with a sum of said test signal and control signal (The ratio of the amount of absorbance at the test line (T: κ or λ) to the amount of absorbance at the control line (C) is calculated as T/T+C to provide a normalised absorbance. Fig. 1 caption, page 426), and following using said signal ratio to retrieve amount of haptoglobin from a look-up table or by applying a mathematical model (The values of sample T/T+C for κ and λ are compared to those from stored κ and λ calibration curves to provide κ FLC and λ FLC levels for the sample (mg/L) and the κ:λ FLC ratio is calculated. Fig. 1 caption, page 426). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporated a method of determining the amount of haptoglobin based on calibration curve/mathematical model based on normalized absorbance to the method of Modified Walshe based on the teaching of Campbell as it is known in art that normalizing absorbance values are typically used in order to compensate for instrument fluctuations.
Regarding claims 24 and 32, Modified Walshe discloses the claimed invention as discussed above in claim 23 and 31 respectively. Walshe discloses the test signal and/or control signal is measured using an optical device (para. [0035]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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/M.H./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758
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