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 § 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 8 and 9 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.
For claim 8, the term “preferably” renders the claim indefinite as the Examiner is unable to determine if the claim requires creatinine at the concentration range recited in the claim, or if the claim only requires the presence of creatinine in the quality control solution regardless of the concentration.
For claim 9, the term “preferably” renders the claim indefinite as the Examiner is unable to determine if the claim requires the buffer at the concentration and pH ranges recited in the claim, or if the claim only requires using one of the selected buffers regardless of the concentration.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rannikko et al., (US 2004/0180444).
For claim 1, Rannikko et al., teach a control solution comprising a buffer (paragraphs 0007, 0043), a polymer (paragraphs 0007, 0042), EDTA (paragraph 0041), a preservative (paragraph 0040), a blood simulated dye (paragraph 0029), and an analyte (paragraphs 0006, 0011).
For claim 3, Rannikko et al., teach urea and creatinine as suitable analytes (paragraph 0011).
For claim 5, Rannikko et al., teach glycerol as a suitable polymer (paragraph 0042).
For claim 9, Rannikko et al., teach utilizing HEPES buffer (paragraphs 0007, 0043).
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) 2, 4, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rannikko et al., (US 2004/0180444).
Regarding claim 2, Rannikko et al., teach a control solution comprising a buffer (paragraphs 0007, 0043), a polymer (paragraphs 0007, 0042), EDTA (paragraph 0041), a preservative (paragraph 0040), a blood simulated dye (paragraph 0029), and an analyte (paragraphs 0006, 0011), but do not teach the pH and concentrations recited in claim 2. The Examiner is reading the pH and concentration ranges as optimization which would have been obvious to one of ordinary skill in the art. The MPEP states that differences in concentration will not support patentability absent evidence showing the concentration to be critical (MPEP 2144.05 II A). Additionally, the MPEP states that when the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP 2144.05 II A). Reference to Rannikko et al., teach an aqueous control solution for photometric test strips comprising all the elements recited in claim 2, thus one of ordinary skill in the art would have found it obvious to discover the optimum or workable ranges through routine experimentation so as to accurately measure analyte concentrations. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Rannikko et al., wherein the pH ranges from 6.5 to 7.5, polymer concentration ranges from 10% to 40%, EDTA concentration ranges from 0.1% to 1%, preservative concentration ranges from 0.1% to 2%, and blood simulated dye ranges from 0.1% to 2% as optimization of result effective variables require only routine skill in the art.
Regarding claim 4, Rannikko et al., teach creatinine as a suitable analyte (paragraph 0011), but do not teach creatinine at a concentration ranging from 0.0001% to 3%. The Examiner is reading the concentration range as optimization which would have been obvious to one of ordinary skill in the art. The MPEP states that differences in concentration will not support patentability absent evidence showing the concentration to be critical (MPEP 2144.05 II A). Additionally, the MPEP states that when the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP 2144.05 II A). Reference to Rannikko et al., teach a control solution wherein creatinine is a suitable analyte, thus one of ordinary skill in the art would have been motivated to determine the optimal concentration of creatinine in the control solution so as to accurately measure creatinine in a sample. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Rannikko et al., wherein creatinine concentration ranges from 0.0001% to 3% as optimization of result effective variables require only routine skill in the art.
Regarding claim 8, Rannikko et al., teach the control solution comprising a predetermined amount of the analyte (paragraph 0005), and creatinine as a suitable analyte (paragraph 0011).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rannikko et al., (US 2004/0180444) in view of Lin et al., (US 2009/0148875).
Regarding claim 6, Rannikko et al., do not teach a control solution comprising calcium chloride or sodium chloride.
Lin et al., a control solution wherein chloride salts including calcium chloride or sodium chloride are added to the control solution (paragraph 0068). Lin et al., teach that it is advantageous to add a chloride salt as a means of increasing the measured current of a control marker thereby improving the differentiation between the control solution and the sample (paragraph 0067).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Rannikko et al., wherein calcium chloride or sodium chloride are added to the control solution in order to increase the measured current of a control marker to improve differentiation between the control solution and the sample as taught by Lin et al.
Regarding claim 7, Rannikko et al., in view of Lin et al., do not teach calcium chloride at concentrations ranging from 0.02% to 0.5%. With respect to sodium chloride, the Examiner notes that the claim recites 0% sodium chloride, thus the Examiner contends that the presence of sodium chloride is not required. The Examiner is reading the concentration range as optimization which would have been obvious to one of ordinary skill in the art. The MPEP states that differences in concentration will not support patentability absent evidence showing the concentration to be critical (MPEP 2144.05 II A). Additionally, the MPEP states that when the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP 2144.05 II A). Reference to Lin et al., teach a control solution comprising calcium chloride, thus one of ordinary skill in the art would have been motivated to determine the optimal ranges of calcium chloride so as to accurately measure analytes in a sample.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al., (US 2009/0148875) in view of Rannikko et al., (US 2004/0180444).
Regarding claim 10, Lin et al., teach a quality control method comprising inserting a test strip in an electrochemical test meter (paragraph 0037) wherein the test strip is configured to detect urea and creatinine (paragraph 0036), introducing a quality control solution to the test strip (paragraph 0048) wherein the control solution comprises a buffer, a polymer, salts, and a blood simulated dye (paragraph 0061), measuring the concentration of the analytes (paragraphs 0047, 0048), and determining precision of the analyte measurements (paragraphs 0047, 0048). Lin et al., do not teach a control solution comprising EDTA and a preservative.
Rannikko et al., teach a control solution wherein the solution comprises EDTA and a preservative (paragraphs 0040, 0041). Rannikko et al., teach that it is advantageous to provide a control solution having EDTA and a preservative as a means of preventing metals from reacting with the analyte or the dye (paragraph 0041), and to prevent bacterial growth in the solution (paragraph 0040).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Lin et al., to include EDTA and a preservative in the control solution in order to prevent metals from reacting with the analyte and dye, and to prevent bacterial growth in the solution as taught by Rannikko et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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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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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
