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 .
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.
Claim(s) 1-7, 9-15, 19-22, 24-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gokulakrishnan et al (Determination of persulphates using N,N-diethyl-p-phenylenediamine as colorimetric reagent: Oxidative coloration and degradation of the reagent without bactericidal effect in water”, Chemical Engineering Journal 286 (2016) 223–231 in view of Lu et al, “Nitrophenylboronic Acids as Highly Chemoselective Probes To Detect Hydrogen Peroxide in Foods and Agricultural Products” J. Agric. Food Chem. 2011, 59, 11403–11406.
Regarding claims 1, 27, Gokulakrishnan teach a method and kit of detecting or quantifying HS05- in an aqueous solution, comprising:
comparing an electromagnetic radiation absorbance measurement of a mixture of a reagent solution and a sample to a standard calibration profile to determine the presence or amount of HSO5- in the sample;
wherein the absorbance measurement includes at least a portion of the wavelength range from about 380-450 nm (Fig. 1A: 200nm to 800nm); and
the reagent solution includes N,N-diethyl-pphenylenediamine (DPD) in phosphate buffer (p. 224, col. 2, Secion 2.2; the DPD is oxidized by persulphates without the need for the enzyme peroxidase), an aqueous vehicle (implied by Section 2 on p. 224, "Millipore water was used for preparing all solutions").
Gokulakrishnan is silent to the reagent solution includes para-nitrophenyl boronic acid.
Lu et al teach detecting pollutants such as the chlorine free sterilization agent of peroxide using the nonenzymatic colorimetric method using para-nitrophenylboronic (p-NPBA) having a high sensitivity and fast reaction kinetics (Abstract). Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the DPD of Gokulakrishnan for the para-nitrophenylboronic acid of Lue et al to provide the above advantage of providing a non-enzymatic colorimetric reagent with high sensitivity and fast reaction kinetics.
Regarding claim 2-7, Gokulakrishnan/Lu teach the pH of 9.0 in carbonate/bicarbonate buffer (Lu: P. 11405 col.1 para. 1: reads on "pH of not less than about 7.5" "Claim 3 (original): The method of claim 1, wherein the reagent solution has a pH of about ±0.5 pH of the pKa of the buffer" "the pH is at least 7.15" "buffer has a pKa of at least 7.5" "the pH is at least 8.5 or at least 9.5" "the pH is about 9.2, 10.3, 11.1, or 12.4")
Regarding claim 9, Gokulakrishnan/Lu teach the pH of 9.0 in carbonate/bicarbonate buffer (Lu: P. 11405 col.1 para. 1: reads on "bicarbonate")
Regarding claim 10-12, Gokulakrishnan/Lu teach the para- nitrophenyl boronic acid is present in the reagent solution in a concentration of from 0.5 mM to less than 5.0 mM; concentration of from 1.0 mM to less than 4.0 mM; concentration of about 2.0 mM. (Lu: P. 11405 col. 1-2 para 3: 1,2, 5 mM)
Regarding claim 13-14, Gokulakrishnan/Lu teach the buffer is present in the reagent solution in a concentration of about 5.0 mM to about 200 mM; 5.0 mM to about 100 mM (Lu: P. 11405 col. 1 para 3: 75mM carbonate/bicarbonate).
Regarding claim 15, Gokulakrishnan/Lu teach the buffer is present in the mixture in a concentration of about 2.0 mM to about 50 mM (Gokulakrishnan; Fig. 4: phosphate buffer 50mM).
Regarding claims 19-21, Gokulakrishnan/Lu teach the 10-100uM of PMS detected. Gokulakrishnan/Lu do not specifically describe the sample that has a concentration of about 100 g/L or more of HSO5-; the sample has a concentration of about 0.1 ppm or more of HSO5-; a concentration of about 500 g/L or more of HSO5-. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a concentration of HSO- is a result effective variable that gives the well known and expected results of providing a sample with a concentration of PMS to be detected. In the absence of a showing of unexpected results, the Office maintains the concentration of the samples of HS05- of 0.1 ppm, 100g/L or more, 500g/L or more would have been within the skill of the art as optimization of a results effective variable.
Regarding claims 22, Gokulakrishnan/Lu teach the absorbance measurement is performed visually or mechanically. (Gokulakrishnan: p. 226 Fig. 1)
Regarding claims 24, Gokulakrishnan/Lu teach the absorbance measurement includes a wavelength of about 405 nm.(Gokulakrishnan: p. 226 Fig. 1 includes 405nm)
Regarding claims 25, Gokulakrishnan/Lu teach the comparison is performed within 60 seconds of mixing the reagent solution and the sample. (Gokulakrishnan: Fig. 5B: comparison at 0 min)
Regarding claims 26, Gokulakrishnan/Lu teach buffer does not include carbonate or bicarbonate (Gokulakrishnan: p. 227 col. 1 para. 1: phosphate buffer).
Specifically regarding claim 27, Regarding "instructions for use" It is noted that nonfunctional printed matter does not distinguish claimed product from otherwise identical prior art product. Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, **>367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004)< (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed.). See also In re Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983)("Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability …. [T ]he critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate.") (see MPEP 2112.01)
Claim(s) 16 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gokulakrishnan/Lu and further in view of Starna, "Why it's a good idea to use black walled self masking cuvettes" 7/13/2007, accessed on wayback machine. https://web.archive.org/web/20070713064646/https://www.starna.de/deutschland/d_tech/techblackwall.html
Regarding claims 16 and 28, Gokulakrishnan/Lu are silent to a container that substantially blocks transmission of electromagnetic radiation having a wavelength of about one of: 10-750 nm; 200-500 nm; or 350-500 nm; a container that partially or completely blocks transmission of visible light, ultraviolet light, or visible and ultraviolet light.
Starna teach black walled self masking cuvettes have black walls that block at least visible light to reduce the background noise and stray light. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the black walled self masking cuvette of Starna to provide the above advantage of reducing background and stray light during the measurements.
Specifically regarding claim 28, kit further includes a color-coded reference corresponding to HS05- concentrations. It is desirable to provide color-coded reference for colorimetric results to be rapidly read in real time. Therefore it would have been obvious to include color-coded reference corresponding to HS05- concentrations choosing from a finite number of identified, predictable solutions to rapidly visualize the colorimetric results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Dennis White/Primary Examiner, Art Unit 1758
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