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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6, and 7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “wherein the TOC and the conductivity are measured at the same time”. This limitation is considered to contain new subject matter since applicant’s specification fails to disclose that the measurements occur at the exact same time.
Applicant’s specification discloses that the verification and calibrations are performed “at the same time” (see e.g., [0028], [0031]. However, Applicant’s original disclosure reads that the TOC and conductivity are measured at “substantially the same time” [0008] and “approximately the same time” Abstract; [0005], [0010], [0030], [0039],0046]. In Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1370, 73 USPQ2d 1641, 1646 (Fed. Cir. 2005), the Federal Circuit reversed the district court’s construction of the claim term "about" as "exactly." The appellate court held that "about" should instead be given its plain and ordinary meaning of "approximately."). See MPEP 2111.01(IV)(A).
Claims 2-4, 6, and 7 stand rejected as dependent on claim 1.
Claim Interpretation
For purposes of examination, “at the same time” in reference to measuring the TOC and conductivity will be interpreted as a time frame/period that extends between when an analyzer initiates analysis and produces the analysis results.
Claim Rejections - 35 USC § 102
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 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.
1. Claims 1 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GE SIEVERS 900 SERIES OPERATION AND MAINTENANCE MANUAL (2009) (hereafter GE Sievers”).
GE Sievers teaches an analyzer that measures TOC and conductivity using a single sample. (page 56)
Therefore, GE Sievers anticipates claims 1 and 6.
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.
2. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over GE Seivers.
I.) Regarding applicant’s claim 2, as noted above, GE Seivers anticipates claim 1 from which claim 2 depends.
Claim 2 recites that the instructions further comprise instructions that cause the one or more processor to: verify the TOC and conductivity measuring capability of the TOC analyzer using the measured TOC, measured conductivity, known TOC, and known conductivity of the sample.
GE Seivers teaches verification of TOC in the instructions on page 223, but not verification of conductivity.
It would have been obvious to one of ordinary to modify GE Seivers to provide for verification of conductivity in addition to verification of TOC for purposes of ensuring accurate conductivity measurements.
Therefore, GE Seivers renders claim 2 obvious.
2. Claims 1, 2, 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over International Patent No. WO2013/079755 to Osorio et al. (cited by applicant) in view of International Patent No. WO2007/053515 to Brunk (cited by applicant).
Osorio et al. teaches measuring TOC and conductivity of a sample (see claim 1).
Osorio et al. teaches using a processor to process measured values (page 5, line 18-20 of English translation). Providing the processor with instructions to operate would have been obvious.
Osorio et al. does not teach measuring the TOC and conductivity of a sample having a known TOC and conductivity which sample includes an organic acid.
Brunk teaches “calibrating and/or validating a TOC analysis system,” (Abstract) and “To assure the reliability of the analyzer unit, it is common practice to periodically calibrate the analyzer against one or more known standards. Calibration standards for testing TOC analyzer accuracy may be packaged in either glass or plastic containers or vials, and those standards may either be acidified or not acidified. There is the potential, however, for the standards themselves to become contaminated from contact with the insides of the containers in which they are stored prior to use.” (page 2, lines 16-20).
It would have been obvious to one of ordinary skill in the art to modify Osorio et al. to calibrate the analysis system by measuring the TOC and conductivity of a sample having a known TOC and conductivity which sample includes an organic acid, in view of Brunk teaching calibrating and/or validating TOC analysis systems.
Claim 1 has been amended to recite that the process receives a sample having a known conductivity. Using a sample with a known conductivity and measuring the conductivity is an obvious method of calibrating the conductivity measurement and/or determining the accuracy of the conductivity measurement.
Claim 1 has further been amended to recite that the TOC and the conductivity are measured at the same time.
As noted by applicant Brunk teaches determining the conductivity and selecting an algorithm to determine the carbon concentration.
It would have been obvious to, while determining the carbon concentration, using an algorithm to measure carbon concentration “at the same time” (as interpreted above), since the algorithm would be executed rapidly by the computerized system taught by Brunk once analysis of a sample begins. (paragraph bridging pages 11-12)
Alternatively, since Brunk teaches determining both conductivity and carbon concentration, it would have been obvious to perform these measurements at the same time for purposes of expediting the analysis.
I.) Regarding applicant’s claim 1, as noted above, Osorio et al. in view of Brunk teaches all the elements of claim 1.
Therefore, Osorio et al. in view of Brunk renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Osorio et al. in view of Brunk renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that instructions further comprise instructions that cause the one or more processor to: verify the TOC and conductivity measuring capability of the TOC analyzer using the measured TOC, measured conductivity, known TOC, and known conductivity of the sample.
Osorio, et al. as modified by Brunk does not teach that the instructions further comprise instructions that cause the one or more processor to: verify the TOC and conductivity measuring capability of the TOC analyzer using the measured TOC, measured conductivity, known TOC, and known conductivity of the sample.
It would have been obvious in Osorio et al. in view of Brunk to provide instructions to the processor to verify the TOC and conductivity measuring capability of the TOC analyzer using the measured TOC, measured conductivity, known TOC, and known conductivity of the sample for purposes of calibrating and/or verifying the TOC analysis system.
Therefore, Osorio et al. in view of Brunk renders claim 2 obvious.
III.) Regarding applicant’s claim 6, as noted above Osorio et al. in view of Brunk renders claim 1 obvious from which claim 6 depends.
Claim 6 recites that the TOC and the conductivity are measured using the same sample.
Osorio et a. in view of Brunk does not teach that the TOC and the conductivity are measured using the same sample.
It would have been obvious in Osorio et al. in view of Brunk to measure the TOC and using the same sample to avoid any variations between different samples
Therefore, Osorio et al. in view of Brunk renders claim 6 obvious.
IV.) Regarding applicant’s claim 7, as noted above Osorio et al. in view of Brunk renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that the sample comprises a single vial containing the organic acid.
Osorio et al. in view of Brunk does not teach that the sample comprises a single vial containing the organic acid.
It would have been obvious in Osorio et al. in view of Brunk to use single vial containing the sample with the organic acid for purpose of avoiding any variations in measurement of TOC and conductivity potentially caused by using multiple vials.
Therefore, Osorio et al. in view of Brunk renders claim 7 obvious.
2. Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Osorio et al. in view of Brunk as applied to claim 1 above, and further in view of Japanese Published Patent Application No. JP 2000356631 to Yamanaka et al.
I.) Regarding applicant’s claim 3, as noted above Osorio et al. in view of Brunk renders claim 1 obvious from which claim 3 depends.
Claim 3 recites that the organic acid comprises citric acid.
Osorio et al. in view of Brunk does not teach that the organic acid comprises citric acid.
Yamanaka et al. teaches measuring TOC and conductivity using citric acid. (page 7, line 32)
It would have been obvious to one of ordinary skill in the art to modify Osorio et al. in view of Brunk to use citric acid for the acid taught by Osorio et al. in view of Yamanaka et al. teaching that the use of citric acid is compatible with measuring TOC and conductivity.
II.) Regarding applicant’s claim 4, as noted above Osorio et al. in view of Brunk renders claim 1 obvious from which claim 4 depends.
Claim 4 recites that the organic acid comprises lactic acid.
Osorio et al. in view of Brunk does not teach that the organic caid comprises lactic acid.
Yamanaka et al. teaches measuring TOC and conductivity using lactic acid. (page 7, line 31)
It would have been obvious to one of ordinary skill in the art to modify Osorio et al. in view of Brunk to use Lactic acid for the acid taught by Osorio et al. in view of Yamanaka et al. teaching that the use of lactic acid is compatible with measuring TOC and conductivity.
Response to Arguments
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive.
Applicant argues that both the Brunk and Osorio references teach away from the feature that "the TOC and the conductivity are measured at the same time." First, with respect to Brunk, to the extent that Brunk teaches that TOC and conductivity are measured, it clearly teaches measuring TOC (carbon concentration) after measuring the conductivity and not "at the same time" as claimed.
As noted above, in Brunk in view of Osorio et al. it would have been obvious to, while determining the carbon concentration, using an algorithm to measure carbon concentration “at the same time” (as interpreted above), since the algorithm would be executed rapidly by the computerized system taught by Brunk once analysis of a sample begins. (paragraph bridging pages 11-12)
Alternatively, since Brunk teaches determining both conductivity and carbon concentration, it would have been obvious to perform these measurements at the same time for purposes of expediting the analysis.
Applicant argues that claim 15 of Brunk teaches:
A method for conducting a calibration or validation procedure as part of TOC analysis comprising the steps of:
(a) determining the conductivity and/or pH of a calibration standard;
(c) selecting an algorithm from a plurality of algorithms to determine the carbon concentration of the standard from the derivative solution temperature/conductivity data according to whether the conductivity and/or pH of the standard is above a predetermined conductivity threshold or below a predetermined pH threshold.
Which clearly teaches that the conductivity of the sample is measured first (i.e., step (a)) and then used to select which TOC algorithm is used to measure the TOC (i.e., step (c)). Because the conductivity measurement is first used to select how the TOC is measured.
Brunk has been relied upon to modify Osorio et al. to calibrate the analysis system by measuring the TOC and conductivity of a sample having a known TOC and conductivity which sample includes an organic acid, in view of Brunk teaching calibrating and/or validating TOC analysis systems.
Claim 15 of Brunk does not exclude Osorio et al. as modified above from measuring TOC and conductivity at the same time (as interpreted above).
Applicant’s arguments with respect to claims 1, 2 and 6 have been considered but are moot because the new ground of rejection that relied upon GE Seivers.
Conclusion
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798