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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4, 7, and 13-15 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended independent claim 1 to recite incubating a water sample and measuring the color or darkness of the solution are carried out in the same single-use container, and argued that the combination of Evans et al., in view of Stumbaugh et al., and further in view of Fernando et al., do not teach the amended limitation. After reviewing the prior art, the Examiner agrees that the references do not teach incubating a water sample and measuring a change in color or darkness in a single reaction chamber. However, after performing an updated search, the Examiner has replaced reference to Stumbaugh et al., with reference to Berzofsky (US 5,310,657) wherein a sample is mixed in a cuvette or microplate prior to spectrophotometric determination. Because reference to Berzofsky is newly cited, the Examiner will not argue the merits of its teachings here, but will instead rely on the rejection detailed below. Therefore, in light of the teachings of the prior art, the Examiner contends that the instant claims are not in condition for allowance.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed steps, the process steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
For claims 1 and 13-15, the Examine notes that the claimed “single use” does not provide a limitation on the reaction chamber as any chamber, tube, or container can be single use. Specifically, a user can determine if a reaction chamber is single-use or not as one can choose to discard a reaction chamber, or sterilize a reaction chamber for multiple uses. As such, the Examiner contends that any reaction chamber can reasonably be considered as single use as recited in the claims.
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) 1, 4, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans et al., (Appl. Environ. Microbiol. February 1978, 376-382) in view of Berzofsky (US 5,310,657), and further in view of Fernando et al., (US 2003/0151745).
Regarding claims 1, 4, and 7, Evans et al., teach determining bacteriological water quality comprising placing a water sample in a vial having lyophilized limulus lysate (Endotoxin determination page 377), incubating the sample at 37°C for 1 hour (Endotoxin determination page 378), and determining the presence of endotoxin with a spectrophotometer (Endotoxin determination page 378).The Examiner notes that the reagent taught by Evans et al., is identical to that of the instant claims, thus the properties of the reagent and its reaction with endotoxins would be identical.
Evans et al., do not explicitly teach measuring a change in color of the reaction solution.
Berzofsky teaches an assay for endotoxin using limulus lysate and a chromogenic substrate wherein a change in color is determined to bacterial endotoxin in a sample (column 6 lines 7-11). Berzofsky also teaches mixing (incubating) a sample in a cuvette or microplate, and measuring a color change of the sample in the cuvette or microplate with a spectrophotometer (column 6 lines 11-16). Berzofsky teaches that it is advantageous to utilize a chromogenic substrate as a means of quantifying the amount of activated clotting enzyme (column 2 lines 54-57).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Evans et al., in view of Berzofsky to utilize a chromogenic substrate wherein a color change is determined in order to quantify the amount of activated clotting enzyme as taught by Berzofsky.
Evans in view of Berzofsky do not teach a spectrophotometer comprising a heater, temperature probe, and a control unit.
Fernando et al., teach a sample analysis system comprising an apparatus having a temperature probe (paragraphs 0082-0084), spectrophotometer (paragraphs 0010, 0011), and a computer (paragraph 0086). Fernando et al., teach that it is advantageous to provide a temperature probe as a means of monitoring temperature of a test solution (paragraph 0084). Fernando et al., also teach that it is advantageous to provide a computer as a means of coordinating operation of all the operations of the analysis device (paragraph 0086).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Evans et al., in view of Berzofsky to include a spectrophotometer with a temperature probe and a computer in order to monitor temperature of a test solution, and to coordinate operation of a device as taught by Fernando et al.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans et al., (Appl. Environ. Microbiol. February 1978, 376-382) in view of Berzofsky (US 5,310,657), in view of Fernando et al., (US 2003/0151745) as applied to claim 1 above, and further in view of Khan (US 4,067,776).
Regarding claims 13-15, Evans et al., in view of Berzofsky in view of Fernando et al., do not explicitly teach pre-packaged test tubes.
Khan teaches a limulus lysate test kit wherein the limulus reagent is pre-packaged in a test tube (column 10 lines 55-60). Additionally, Khan teaches performing a limulus lysate test by adding a sample to the pre-packaged test tube (column 10 line 55 column 11 line12). Khan teaches that it is advantageous to provide the reagent and test tube in a kit as a means of providing materials that are inexpensive and disposable (column 9 lines 22-24).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Evans et al., in view of Berzofsky in view of Fernando et al., by providing the reagent in a pre-packaged test tube (as taught by Khan) for the benefit of providing inexpensive and disposable materials for required testing.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
