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.
Claims 1-16, 23, 24, 47, and 62 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of the sought composition for its intended functionality are indefinitely provided for herein.
With respect to the recitation “…has an absorbance at a detectable wavelength in response to the phosphate concentration in the solution” the language “in response to” is not clearly understood.
It appears that Applicant intends to recite something on the order of “has an absorbance at a detectable wavelength that correlates with the phosphate concentration in the solution.”
Further, claim 1 recites the limitation "the phosphate concentration". There is insufficient antecedent basis for this limitation in the claim.
Applicant may intend to merely recite “a phosphate concentration.”
With regard to claims 12-14, the metes and bounds of the claims are indefinitely provided as “ferrous iron salt” is recited in claim 12, while also recited in claim 14 that sets forth a further element of a sample pretreatment neutralizer catalyst comprising a choice of “ferrous iron salt.”
First, does Applicant intend that there are two sample pretreatment neutralizer catalyst given the usage of “further comprising” in claim 14, or does Applicant merely intend to further define the prior-recited sample pretreatment neutralizer catalyst of claim 12?
To this end and as “ferrous iron salt” has already been recited such that its inclusion in claim 14 is redundant and indefinite, does Applicant intend to recite something on the order of “…wherein the sample pretreatment neutralizer catalyst comprises ferrous iron salt, and wherein the ferrous iron salt comprises one or more…[those ferrous iron salts recited in cl. 14]”?
With regard to claim 24, the recitation “the lyophilized composition” lacks proper antecedent basis in the claims wherein Applicant may recite a lyophilized composition.
With regard to claim 47, the recitation “the same volume” lacks proper antecedent basis and Applicant may recite “a same volume.”
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) 1-5 is/are rejected under 35 U.S.C. 1023 as being unpatentable over Evtodienko et al. (USPN 5,858,797), hereafter Evtodienko in view of Murphy and Riley (Analytica Chim. Acta, 27, 31-36, 1962).
Evtodienko discloses a composition for determining a/the phosphate concentration of a solution comprising an indicator (malachite green as in leuco malachite green, and also as in cls. 2&3), a molybdate salt (ammonium molybdate, and as in cls. 4&5), buffer (cyclamic acid and its conjugate base cyclamate salt), a sulfate salt (sodium bisulfate in the extractant that is used in conjunction with the indicator, molybdate salt, buffer, and one or more excipients to determine phosphate concentration in which the sodium bisulfate is construed as a part of the composition for determining phosphate concentration as claimed given its utilization in concert with the other reagents), and one or more excipients (i.e. PEG and/or PVP), wherein the composition has an absorbance at a detectable wavelength in response to the phosphate concentration in the solution. Evtodienko discloses application for the determination of phosphorous or phosphates in test samples such as soil, ground water, and biological materials (lines 9-12, col. 3).
With regard to claim 1, Evtodienko does not specifically disclose a reaction accelerant within the composition.
However, Evtodienko acknowledges the known analogous prior art of Murphy and Riley (Analytica Chim. Acta, 27, 31-36, 1962) disclosing a method for determining phosphorous/phosphoates by conversion of phosphate to 12-molybdophosphoric acid and utilizing antimony to speed up the reaction (lines 15-25, col. 2 of Evtodienko and also seen through the appended Murphy and Riley disclosure).
It would have been obvious to one of ordinary skill in the art to modify Evtodienko to include a reaction accelerant as in antimony such as taught by the analogous art of Murphy and Riley in order to speed up the reaction and thus provide a faster result such as would be appreciated as in applications of field testing (as seen in Evtodienko; lines 52-53, col. 2) and would have a reasonable expectation of success therein in likewise converting phosphate to 12-molybdophosphoric acid.
Claim(s) 24, 47, and 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Etovdienko and Murphy&Riley as applied to claims 1-5 above, and further in view of Agarwal et al. (US 2011/0092377), hereafter Agarwall and Dragna et al. (US 2018/0156763).
Evtodienko and Murphy&Riley do not specifically disclose the kit, method therewith, and method of making such kit as in claims 24, 47, and 62.
Agarwal discloses a high throughput method and device for analysis of contamination in environmental samples utilizing an optical multiwell plate reader for the samples provided in the multiwell plate, including utilizing absorbance measurements for assessing target analyte concentration (pars.[0002,0004,0005,0026,0055], for example).
Dragna discloses colorimetric compositions for determining concentration of an analyte wherein the kit includes a lyophilized composition having an absorbance at a detectable wavelength in response to an analyte of the solution, and providing spectrophotometric analysis thereof by a spectrophotometer for assessing the absorbance at given wavelengths to assess the analyte’s concentration (abstract, pars.[0004,0005,0011,0024]).
It would have been obvious to one of ordinary skill in the art to modify Evtodienko/Murphy&Riley to provide an assay kit comprising a microwell plate with the previously-provided composition as in cl. 1 that is lyophilized such as suggested by the analogous art of Agarwal to high-throughput screening for analysis of contaminants in environmental samples wherein such a kit and methodology of determining (and the making of such a kit) provides a means for optically assaying a plurality of samples for their detected absorbance(s) and correlated concentration(s) in response to the excitation wavelength(s) in a short time frame that affords a large amount of data to more accurately reflect the overall environment over the course of many samples or to asses various sample from different environments at once, and wherein providing such composition as lyophilized such as taught by the analogous art of Dragna provides the composition in a stable form that stabilizes and preserves such composition to be utilized in the likewise colorimetric optical absorption analysis (i.e. spectrophotometric analysis with a spectrophotometer) to assess the analytes’ concentration. To this end, it is also noted that Evtodienko likewise contemplates utilizing the test composition/device for use in field testing as well as in laboratories for performing phosphorous testing procedures on large numbers of test samples (lines 50-54, col. 2).
Further, while not explicitly disclosed in Agarwal/Dragna, it would have been obvious to one of ordinary skill in the art to add a substantially same volume of the analyte composition to each of the plurality of wells in order to provide controlled and parallel conditions in which the optical absorbance measurements are carried out and thus achieve more accurate data therewith.
Allowable Subject Matter
Claims 6-16, and 23 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 6-16, and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not teach or fairly suggest the composition for determining phosphate concentration of a solution as provided in the above-cited claims with its particular elements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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/NEIL N TURK/Primary Examiner, Art Unit 1798