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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“an addition unit” in claim 1. The addition unit will be interpreted to be a pump or syringe or equivalents thereof based on paragraph 0022 of specification.
“a measurement unit” in claim 1. The measurement unit will be interpreted to be a total organic carbon (TOC) analyzer system comprising an oxidizing agent, UV light, and NDIR detector or equivalents thereof based on paragraph 0022, 0025, 0027 of the specification.
“a temperature maintaining unit” in claim 1. The temperature maintaining unit will be interpreted to be a column oven or equivalents thereof based on paragraph 0035-0036 of the specification.
“a pretreatment unit” in claim 4. The pretreatment unit will be interpreted to be a degassing unit or equivalents thereof based on paragraph 0030 of the specification.
“a pressure regulation unit” in claim 8. The pressure regulation unit will be interpreted to be a vacuum pump or equivalents thereof based on paragraph 0031 of the specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Examiner would like to make of note that the “degassing unit” of claim 1 is not interpreted under U.S.C. 112(f) despite the similar structure because of the distinct structures of “a container, and a gas-permeable tube disposed in the container and connected to the channel” in the later part of claim 1.
Claims 6 and 7 recite “a room temperature.” Examiner interprets “room temperature to be between 15-25°C.
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.
Claim 3 is 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.
Claim 3 recites, “the inspection apparatus according to claim 1, further comprising a column oven that houses the temperature maintaining unit and the container.” The analysis of “the temperature maintaining unit” in claim 1 has been interpreted to be a column oven. Therefore, it is unclear how a column oven can house a part that has been interpreted to be a column oven. Examiner recommends amending the claim to read, “the inspection apparatus according to claim 1, wherein the temperature maintaining unit is a column oven and houses the container” or an equivalent thereof. Claims 6 and 7 are rejected based on their dependency to claim 1.
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.
Claims 1-3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Li, et. al. (US 20200173968 A1) in view of Heidorn (“The Role of Temperature and Column Thermostatting in Liquid Chromatography”) and Metrohm (930 Compact IC Flex from Metrohm; citation made with respect to provided copy).
With regards to Claim 1, Li teaches an organic carbon detector that can be used with size exclusion chromatography equipment (Abstract). Li teaches the apparatus is for water quality determination (par. 0001) (for inspecting an aqueous sample). Li teaches the apparatus comprises a size exclusion chromatography (SEC) system including a SEC column (a column that separates a group of substances contained in the aqueous sample by size), a carbon oxidation subsystem and a stripping and CO2 detection subsystem (Fig. 1).
Li teaches the carbon oxidation subsystem comprises an injection module 1 and inorganic carbon removal module 2 (Fig. 1; par. 0051). In the embodiment shown in Figure 4 of the disclosure, Li teaches the injection module 1 comprises acidic agent pump 101 and storing tank 102 (par. 0066) to convert inorganic carbon to CO2 (par. 0005). The injection module is downstream the SEC column and meets at the overlapping outlet region, circled in modified Figure 4 below (an addition unit that adds a reagent into a channel to convert inorganic carbon included in each substance into carbon dioxide, the channel being connected to an outlet of the column, the reagent acidifying the aqueous sample flowing through the channel). Li teaches inorganic carbon removal module 2 is downstream the injection module 1 and comprises an air permeable tube coil 201 and a casing 202 (par. 0054). Gases dissolved in the liquid sample permeate the tube coil 201 and move into casing 202 where the gas is removed by a vacuum system (par. 0054) (a degassing unit provided downstream of the addition unit for degassing the carbon dioxide) (the degassing unit including a container, and a gas-permeable tube disposed in the container and connected to the channel).
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Li teaches downstream the inorganic carbon removal module 2 is ultraviolet oxidation module 3 (Fig. 1). Ultraviolet oxidation module 3 comprises a lamp 301 oxidizes the degassed sample within a microchannel 303 (Fig. 4; par. 0056) (a measurement unit that oxidizes each substance from which the carbon dioxide has been removed by the degassing unit). Further downstream is the CO2 detection subsystem that comprises a detector 12 to determine CO2 concentration from the oxidized sample (Fig. 1, 4; par. 0062) (a measurement unit that… measures organic carbon contained in each substance).
Li further teaches in the embodiment of the apparatus as seen in Figure 4; the SEC system uses a column oven (par. 0069). Li is silent to the column oven (having) a thermostat and heating/cooling elements.
Heidorn teaches the benefits of changing temperatures during chromatographic separation (Introduction). Heidorn teaches chromatography systems commonly comprise column ovens or compartments to hold columns and maintain the temperature of the column with a thermostat and heating/cooling element (pg. 2, section “What Types of Column Compartments Exist on the Market”).(the inspection apparatus further comprising a temperature maintaining unit for maintaining a temperature of each of the column). Heidorn teaches having control over the column oven via a thermostat allows for benefits such as, altering chromatographic run times and improved separation (by altered retention times) ultimately leading to improved resolution (pg. 1, section “Why is Temperature Control so Important in Liquid Chromatography?”).
It would have been obvious to one skilled in the art before the effective filing date of the invention to combine the column oven of Li to include a thermostat and heating/cooling element as taught by Heidorn in order to improve chromatographic resolution. Because both devices discuss an oven to house a chromatography column, combining an oven with a thermostat and heating/cooling element as provided by Heidorn, provides likewise sought functionality in which the combination would yield predictable results. MPEP 2143(I)(A).
Li is silent to a temperature maintaining unit for maintaining a temperature of the container.
Li teaches a stripping module 7 to remove CO2 that is separate from inorganic carbon removal module 2 (Fig. 1; par. 0058). Li teaches within the stripping module, heating mantle 707 keeps casing 701 to help reduce CO2 solubility in the liquid sample making CO2 easier to strip away (Fig. 4; par. 0058).
Metrohm teaches an ion chromatography system for aqueous sample analysis. Metrohm teaches a system in which a column oven is capable of housing degassing units (pg. 1, par. 04) (a temperature maintaining unit for maintaining a temperature of the container). Metrohm teaches the system is designed for ease of use (pg. 1, par. 02) and to be compact (pg. 1, "Features" section).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the inorganic carbon degasser to be heated to like the organic carbon degasser in order to more efficiently remove the formed CO2 as taught by Li and be housed in a column oven in order to keep the system compact and easy to use as taught by Metrohm. Because the systems removing CO2 by means of a degasser and use chromatography systems with an oven and degassing units, modifying the inorganic carbon degassing unit to be heated as provided by Li and housed in a column oven as provided by Metrohm, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
With regards to Claim 2, modified Li further teaches in the embodiment of the apparatus as seen in Figure 4, the SEC system uses a column oven, specifically a LC100 liquid chromatography system (Shanghai Wufeng Scientific Instruments Co., Ltd) (par. 0069). Chromatography column ovens/compartments are designed for the thermostat and heating/cooling elements to bring the column/column wall to a temperature set by the user (Heidorn, pg. 2, section “What Types of Column Compartments Exist on the Market” – pg. 3, section “What Does Thermostatting Principle of a Column Compartment Mean?”). (As seen in claim 1 above, Metrohm teaches housing a degasser in a column oven (wherein the temperature maintaining unit has a function of adjusting the temperature of each of the column and the container).
With regards to Claim 3, modified Li further teaches in the embodiment of the apparatus as seen in Figure 4, the SEC system uses a column oven, specifically a LC100 liquid chromatography system (Shanghai Wufeng Scientific Instruments Co., Ltd) (par. 0069). Chromatography column ovens/compartments are designed for the thermostat and heating/cooling elements to maintain the column/column walls at the set temperature to be isothermal (pg. 3, section “What Does Thermostatting Principle of a Column Compartment Mean?”). As seen in claim 1 above, Metrohm teaches housing a degasser in a column oven (further comprising a column oven that houses the temperature maintaining unit and the container).
With regards to Claim 8, Li teaches inorganic carbon removal module 2 comprises an air permeable tube coil 201 and a casing 202 (par. 0054). Gases dissolved in the liquid sample permeate the tube coil 201 and move into casing 202 where the gas is removed by a vacuum system (par. 0054) due to the outer negative pressure of the casing 202 (par. 0021) (wherein the degassing unit includes a pressure regulation unit that renders a pressure in the container negative with respect to the gas-permeable tube).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Li, et. al. (US 20200173968 A1) in view of Metrohm (930 Compact IC Flex from Metrohm; citation made with respect to provided copy) as applied to claim 1 above, and further in view of Dolan ("Mobile-Phase Degassing: What, Why, and How;" citations made with respect to provided copy).
With regards to Claim 4, modified Li teaches the limitation of claim 1.
Modified Li is silent to a pretreatment unit that is provided upstream of an inlet of the column and degasses gas dissolved in an eluent.
Dolan teaches the history and importance of degassing mobile phases (eluents) in chromatography (pg. 482, col. 1, par. 1). Dolan teaches in-line degassing units are common practice and standard in modern LC systems (pg. 486, col. 2-3, section "In-Line Degasser"). Dolan teaches degassing is performed as an initial step when making the mobile phase it is degasses before being added to the system (pg. 484, col. 3, last paragraph) and as LC systems developed degassing elements (helium sparging) as an initial step in preparing mobile phases before mixing (pg. 486; col. 1, par. 2 – col. 2, par. 1). Dolan teaches in-line degassers are now standard component in LC systems, and knowing degassing must be an initial step in processing mobile phase (as seen above), degassing units are placed in position to degas the mobile phase eluent before it enters the column (a pretreatment unit that is provided upstream of an inlet of the column and degasses gas dissolved in an eluent). Dolan teaches gas in the mobile phase eluent can lead to inconsistent flow rates, gas bubbles, and detection problems especially for optical-based detection units, and therefore degassing remedies those problems (pg. 82, col. 2, lines 24-40).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the SEC system of modified Li to use an in-line degasser as taught by Dolan in order to prevent common problems in chromatography. Because both device use and discuss liquid chromatography and it’s eluents, modify a LC system to include an in-line eluent degasser as provided by Dolan, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Li, et. al. (US 20200173968 A1) and Metrohm (930 Compact IC Flex from Metrohm; citation made with respect to provided copy) as applied to claim 1 above, and further in view of Shimotori, et. al. ("Quantification and characterization of coastal dissolved organic matter by high-performance size exclusion chromatography with ultraviolet absorption, fluorescence, and total organic carbon analyses;" citations made with respect to provided copy).
With regards to Claim 5, modified Li teaches a wide variety of commercially available detectors can be used with this device including a US-Vis absorbance detector and a fluorescence detector (par. 0003).
Li is silent to at least one of an ultraviolet-visible spectrophotometer and a fluorometer in a path from the column to the addition unit.
Shimotori teaches the DOM and TOC analysis of a water sample when paired with high-performance SEC (HPSEC) (Abstract). Shimotori teaches an analysis apparatus that comprises an HPLC unit that pair with a TOC detector with a degassing unit in between the two (Fig. 1). Shimotori teaches the HPLC unit is an HPSEC system that uses an SEC column, and once eluted from the column, the eluent passes through a UV detector and a fluorescence detector before having an acid added and being degassed (Fig. 1; pg. 640, col. 2, lines 7-18) (at least one of an ultraviolet-visible spectrophotometer and a fluorometer in a path from the column to the addition unit). Shimotori teaches the UV and fluorescence detectors provide addition data relating to the size of the DOM which in turn provides further understanding to TOC size and concentration relationships (pg. 638, col. 2, lines 26-47).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the SEC system of modified Li to include UV-Vis and fluorescence detectors as taught by Shimotori in order to provide additional DOM and TOC data for greater understanding of the sample. Because both teach apparatus that combine SEC with TOC analysis, modifying the SEC unit to include additional optical detectors as provided by Shimotori, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Li, et. al. (US 20200173968 A1) and Metrohm (930 Compact IC Flex from Metrohm; citation made with respect to provided copy) as applied to claim 1 above, and further in view of Heidorn (“The Role of Temperature and Column Thermostatting in Liquid Chromatography”).
With regards to Claim 6, modified Li teaches the column oven used is a LC100 liquid chromatography system (Shanghai Wufeng Scientific Instruments Co., Ltd) (par. 0069).
Li is silent to wherein the column oven is set to be not lower than a room temperature.
Heidorn teaches the column oven/compartments of modern LC systems can use Peltier elements to heat and cool a column in tandem with a thermostat to monitor the temperature, reaching temperatures as low at 15°C and up to 130°C (pg. 2, section “What Types of Column Compartments Exist on the Market”). Further, control of the temperature of the column influences retention factors and experimentation must be performed to find the optimum temperature for the selected mobile phases and samples in order to improve separation at a shorter run time (pg. 2, section “When are Temperatures Above Ambient Used in LC?”).
Heidorn teaches wherein the temperature of the column is a result-effective variable. Specifically, Heidorn teaches the type of mobile phase, type of sample, and column material are directly impacted by the column temperature (pg. 5-6, section “Which Limits Exist When Working at Temperatures Above Ambient?” Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention (to set) the column oven to be not lower than a room temperature in order to have a temperature that allows for efficient separation.
With regards to Claim 7, modified Li teaches the column oven used is a LC100 liquid chromatography system (Shanghai Wufeng Scientific Instruments Co., Ltd) (par. 0069). Modified Li is silent to wherein the column oven is set to be not lower than a room temperature and not higher than 30 degrees.
Heidorn teaches the column oven/compartments of modern LC systems can use Peltier elements to heat and cool a column in tandem with a thermostat to monitor the temperature, reaching temperatures as low at 15°C and up to 130°C (pg. 2, section “What Types of Column Compartments Exist on the Market”). Further, control of the temperature of the column influences retention factors and experimentation must be performed to find the optimum temperature for the selected mobile phases and samples in order to improve separation at a shorter run time (pg. 2, section “When are Temperatures Above Ambient Used in LC?”).
Heidorn teaches wherein the temperature of the column is a result-effective variable. Specifically, Heidorn teaches the type of mobile phase, type of sample, and column material are directly impacted by the column temperature (pg. 5-6, section “Which Limits Exist When Working at Temperatures Above Ambient?” Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention (to set) the column oven to be not lower than a room temperature and not higher than 30 degrees in order to have a temperature that allows for efficient separation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris 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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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758