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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10, 12-14, and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 – The claims are directed to a process, which is one of the statutory categories of invention.
Step 2A, Prong One - Claim 1 recites a method for operating a chromatography column, the method comprising: providing a first value of a lifetime of said chromatography column; performing, with a chromatography analysis system, a chromatographic separation of a sample on said chromatography column, including subjecting the chromatography column to one or more conditions that cause wear on the chromatography column; providing a value of a weighted aging factor determined based on at least one aging parameter selected from sample type, sample dilution, and sample volume; and determining a second value of said lifetime of said chromatography column based on said first value and said value of the weighted aging factor.
The limitations of “determining a second value of said lifetime of said chromatography column” is a process that, under broadest reasonable interpretation, covers performance of the limitation in the mind. This limitation falls under the abstract idea category of (c) mental processes as set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, pages 50-57), such that this recitation is directed to a judicial exception. See MPEP § 2106.04(a)(2)(III).
A user may “determin[e] a second value of said lifetime of said chromatography column” by viewing and comparing new and historical chromatogram data for a chromatography column. Claims 2-4, 9, and 12-14 are directed to further identifying weighted aging factors and values. Claims 5, 10, 19, and 20 are directed to a further comparisons and determinations that may take place in the mind. Claims 7 and 8 are directed to calculations that may be done using paper and pencil.
Step 2A, Prong Two - These judicial exceptions are not integrated into a practical application. The limitation in Claim 1 of “performing, with a chromatographic analysis system, a chromatographic separation of a sample on said chromatography column” is recited at a high level and is directed to generally linking the “determining” judicial exception to a particular technological environment or field of use. Furthermore, a wide array of conditions such as pH, temperature, solvents, mobile phase additives, etc. can cause wear on the chromatography column, such that this limitation does not correspond to a particular application. See MPEP § 2106.05(h).
Step 2B - The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. With regard to Claim 6, the change in the status of the chromatography column from being operational to being discontinued is not a particular transformation, as the transformation does not result in a different function or use. See MPEP § 2106.05(c).
In addition, with regard to Claim 6, the claimed modified use is recited at a high level, and does not amount to more than well-understood, routine, or conventional activity. See MPEP § 2106.05(d). See e.g., Machtejevas, “How to extend liquid chromatography column life: regenerate or use guard columns”; Dolan et al, “Peak fronting, column life and column conditioning”, and Geng et al (US 2004/0195161, [0017]). Claims 1-10, 12-14, and 19-20 are not patent eligible.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 – The claim is directed to a process, which is one of the statutory categories of invention.
Step 2A, Prong One - Claim 15 recites a method of generating annotated aging parameter categories and aging parameter factors for a chromatography column, the method comprising: determining at least one first value of a performance parameter of the chromatography column; performing, with a chromatographic analysis system, at least one chromatographic separation under conditions of a first set of aging parameter category values, wherein each again parameter category value is a numerical value representative of an impact of the aging parameter category on a lifetime of the chromatography column; determining at least one second value of said performance parameter; performing, with the chromatographic system, at least one chromatographic separation under conditions of a second set of aging parameter category values; wherein said second set of aging parameter category values is non-identical to said first set of aging parameter category values; determining at least one third value of said performance parameter; and, determining based on said first, second, third performance parameters and on said first and second set of aging parameter category values, a value of an aging parameter factor for at least one aging parameter category and annotating the values of said at least one aging parameter category and said aging parameter factor into a data collection.
The limitations of “determining at least one first value”, “determining at least one second value”, “determining at least one third value”, and “determining, based on said first, second, and third performance parameters and on said first and second set of aging parameter category values, a value of an aging parameter factor for at least one aging parameter category” are processes that, under broadest reasonable interpretation, cover performance of the limitations in the mind. These limitations fall under the abstract idea category of (c) mental processes as set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, pages 50-57), such that this recitation is directed to a judicial exception. See MPEP § 2106.04(a)(2)(III).
A user may determine a first, second, or third value of said performance parameter or a value of an aging parameter factor for a chromatography column by viewing and comparing chromatogram data for a chromatography column and performing any calculations using paper and pencil.
Step 2A, Prong Two - These judicial exceptions are not integrated into a practical application. The limitations in Claim 15 of “performing, with a chromatographic analysis system, at least one chromatographic separation under conditions of a first set of aging parameter category values, wherein each aging parameter category value is a numerical value representative of an impact of the aging parameter category on a lifetime of the chromatography column” and “performing, with the chromatography system, at least one chromatographic separation under conditions of a second set of aging parameter category values” are recited at a high level. The aging parameter category could be any aging parameter category, and Claim 15 is not limited to sample type, sample dilution, or sample volume. Furthermore, the type of chromatography system could be any system (e.g., packed column, capillary column, size exclusion, affinity, ion exchange, etc). As a result, the judicial exception is not integrated into a practical application. See MPEP § 2106.04(d).
Step 2B - The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitation of “annotating the values of said at least one aging parameter category and said aging parameter factor into a data collection” is an example of mere data gathering, which is an insignificant extra-solution activity. See MPEP § 2106.05(g). Claim 15 is not patent eligible.
Claims 17 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 – The claim is directed to a device or apparatus, which is one of the statutory categories of invention.
Step 2A, Prong One - Claim 17 recites a device for determining a second lifetime value of a chromatography column, comprising: a storage medium comprising a data collection tangibly embedded therein, said data collection comprising: at least one set of an aging parameter factor value annotated to an aging parameter category value, wherein said aging parameter category factor value is representative of an impact of a corresponding aging parameter category on a lifetime of the chromatography column and comprises at least one category value of an aging parameter selected from sample type, sample dilution, and sample volume; and at least one of a first lifetime value of said chromatography column or an initial lifetime value of said chromatography column, an input unit that receives input data indicative of at least one aging parameter factor value; and a data processing unit that calculates a second lifetime value of said chromatography column based on at least one of said input data indicative of at least one aging parameter factor value, said first lifetime value of said chromatography column, or said initial lifetime value of said chromatography column, wherein the device is configured to adjust, based on the calculated second lifetime of the chromatography column, a mode of operation for performing chromatographic separations to reduce wear on the chromatography column in the chromatographic separations..
The limitation of “a data processing unit that calculates a second lifetime value” is an apparatus that, under broadest reasonable interpretation, covers performance of the limitations in the mind. This limitation falls under the abstract idea category of (c) mental processes as set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, pages 50-57), such that this recitation is directed to a judicial exception. See MPEP § 2106.04(a)(2)(III). Furthermore, the instant specification does not indicate that the claimed “data processing unit” is anything more than a generic computer, such that the claimed invention is described as a concept that is performed in the human mind and Applicant is merely claiming that concept performed on a generic computer. See MPEP § 2106.04(a)(2)(III)(C).
A user may determine a second lifetime value of said chromatography column using a data processing unit by viewing and comparing chromatogram data for a chromatography column.
Step 2A, Prong Two - The judicial exception is not integrated into a practical application. The limitation in Claim 17 of a storage medium comprising a data collection comprising various data are recited at a high level and are directed to generally linking the “calculates” judicial exception to a particular technological environment or field of use. See MPEP § 2106.05(h).
Step 2B - The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitation of “an input unit that receives input data indicative of at least one aging parameter factor value” is an example of mere data gathering, which is an insignificant extra-solution activity. See MPEP § 2106.05(g).
Furthermore, the limitations directed to “wherein the device is configured to adjust, based on the calculated second lifetime of the chromatography column, a mode of operation for performing chromatographic separations to reduce wear on the chromatography column in the chromatographic separations” are very broad. A wide array of conditions such as pH, temperature, solvents, mobile phase additives, etc. can cause wear on the chromatography column. Furthermore, adjusting a mode of operation could involve any one or multiple of the array of conditions mentioned above, such that the judicial exception is not integrated into a practical application. See MPEP § 2106.05(h).
The device claims of Claims 17 and 21 are no different in substance from the method of Claims 1-10, 12-14, and 19-20. The method claims recite the abstract idea (Claim 1, “determining a second value of a said lifetime of said chromatography column”); the device Claim 17 recites a handful of generic components configured to implement the same idea. Since Applicant’s system claims add nothing of substance to the underlying abstract idea, they too are patent ineligible under 35 USC §101. See Alice Corp. Pty. Ltd. v. CLS bank Int’l, 573 U.S. _, 16-17 (2014).
In particular, Claim 17 does not appear to be directed to more than well-understood, routine, conventional activities previously known to the industry, and which are specified at a high level of generality.
A chromatography device as claimed in Claims 17 and 21 is a well-understood, routine, and conventional device known from at least DeWitte (US 2013/0295597, [0203]). Instead, Claim 17 appears to be directed to the application of a judicial exception by a generic machine, which the Supreme Court has determined to be an example of a claim that does not recite significantly more than a judicial exception. See MPEP § 2106.05(b) and (d). Claim 17 is not patent eligible.
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 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, 2, 5, 6, 9, 10, 13-15, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Satpute (US 2018/0128797).
With regard to Claim 1, Satpute et al (Satpute) discloses a monitoring component configured to provide a diagnostic indication regarding at least one component of the gas analyzer (Abstract). Satpute discloses a method for operating a chromatography column, the method comprising providing a first value of a lifetime of said chromatography column ([0044], historic gas analyzer data provides a first value of a lifetime of said chromatography column). Satpute discloses performing, with a chromatographic analysis system, a chromatographic separation of a sample on said chromatography column, including subjecting the chromatography column to one or more conditions that cause wear on the chromatography column ([0043], gas analyzer data is received by a monitoring component (i.e., indicating a run on a chromatography column); [0003], contamination in the flow path as a result of column use over an extended period of time (i.e., conditions that cause wear on the chromatography column) can affect the time required for a component to exit the column).
Satpute discloses providing a value of a weighted aging factor determined based on at least one aging parameter selected from sample type, sample dilution, and sample volume ([0045], identifying trends or observed deviations away from an average; once an identified trend reaches a significant deviation, the trend is classified as a potential symptom, and the severity of the symptom is calculated such as calculating a slope (weighted aging factor); [0039], the monitoring component determines an age of one or more gas analyzer components; different components may age faster or slower based on several factors, for example based on a number or type of sample tested).
Satpute discloses determining a second value of said lifetime of said chromatography column based on said first value and said value of the weighted aging factor ([0025], determining the slope (weighted aging factor that includes first value) of an identified trend may indicate how fast a parameter is deviating over time, which can provide an indication of when an anticipated fault condition may occur (determining second value of said lifetime)).
If Satpute is silent to determining a second value of said lifetime of said chromatography column based on said first value and said value of the weighted aging factor, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to do so in order to predict when the chromatography column will need to be replaced.
With regard to Claim 2, Satpute discloses wherein said sample type is defined by sample matrix and/or pre-purification state of said sample ([0013], types of failures may include column contamination, suggesting that lack of pre-purification of the sample matrix contributes to column failure).
With regard to Claim 5, Satpute discloses further comprising comparing said second value to a reference value ([0043], [0044], recent calibration or chromatogram data is compared to historic data, which will include a first data set (reference value)).
With regard to Claim 6, Satpute discloses wherein a use of said chromatography column is discontinued based on the result of comparing said second value to said reference value ([0025], determining the slope of an identified trend (i.e., that includes information from second value and reference value) will provide an indication of when an anticipated fault condition may occur (i.e., when use of a column will need to be discontinued) which may provide sufficient time to order replacement parts).
With regard to Claim 9, Satpute discloses wherein providing said first value of said column is based on an initial value of said lifetime and the weighted aging factors of any preceding uses of said chromatography column ([0044], [0045], comparison of historical to current data and determination of slope).
With regard to Claim 10, Satpute discloses wherein determining the second value is further based on i) a parameter indicating the initial performance of said chromatography column ([0044], comparison between known-good (initial performance) and recently obtained data).
With regard to Claim 15, Satpute et al (Satpute) discloses a monitoring component configured to provide a diagnostic indication regarding at least one component of the gas analyzer (Abstract). Satpute discloses a method of generating annotated aging parameter categories and aging parameter factors for a chromatography column ([0045], identifying trends or observed deviations away from an average; once an identified trend reaches a significant deviation, the trend is classified as a potential symptom, and the severity of the symptom is calculated such as calculating a slope (weighted aging factor); [0013], types of failures may include column contamination, column deterioration).
Satpute discloses the method comprising determining at least one first value of a performance parameter of the chromatography column ([0044], historic gas analyzer data provides a first value of a lifetime of said chromatography column; [0039], the monitoring component determines an age of one or more gas analyzer components; different components may age faster or slower based on several factors, for example based on a number or type of sample tested).
Satpute discloses performing, with a chromatographic analysis system, at least one chromatographic separation under conditions of a first set of aging parameter category values, wherein each aging parameter category value is a numerical value representative of an impact of the aging parameter category on a lifetime of the chromatography column ([0043], gas analyzer data is received by a monitoring component (i.e., indicating a run on a chromatography column); [0013], [0039], number or type of sample tested, column contamination, or column deterioration are all examples of aging parameter categories; [0045], identifying trends or observed deviations away from an average (i.e., numerical values corresponding to deviations away from an average, representative of an impact of the aging parameter category on a lifetime of the chromatography column); once an identified trend reaches a significant deviation, the trend is classified as a potential symptom).
Satpute discloses performing, with the chromatography system, at least one chromatographic separation under conditions of a second set of aging parameter category values ([0043], gas analyzer data is received by a monitoring component; [0013], [0039], number or type of sample tested, column contamination, or column deterioration are all examples of aging parameter categories). Satpute discloses determining at least one second value of said performance parameter ([0044], [0045], if aging parameter values follow a trend, then second value will be different from first value).
Satpute discloses performing at least one chromatographic separation under conditions of a second set of aging parameter category values, wherein said second set of aging parameter category values is non-identical to said first set of aging parameter category values ([0043], gas analyzer data is received by a monitoring component; ([0044], [0045], if aging parameter values follow a trend, then second parameter category values will be different from first parameter category values).
Satpute discloses determining at least one third value of said performance parameter ([0043], gas analyzer data is received by a monitoring component). Satpute discloses determining, based on said first, second, and third performance parameters and one said first and second set of aging parameter category values a value of an aging parameter factor for at least one aging parameter category value and annotating the values of said at least one aging parameter category and said aging parameter factor into a data collection ([0023], data acquisition component may serve to aggregate incoming information about the gas chromatograph; data acquisition may be coupled to a memory, which stores archived data related to previous gas chromatograph analyses or runs as well as previous calibration data; [0045], identifying trends or observed deviations away from an average; once an identified trend reaches a significant deviation, the trend is classified as a potential symptom, and the severity of the symptom is calculated such as calculating a slope (aging factor)).
With regard to Claim 19, Satpute discloses wherein the parameter indicating the initial performance of said chromatography column is determined upon release testing ([0023], memory may be configured to store standard reference data and archived data related to previous gas chromatograph analyses).
Claims 3, 12, 13, 17, 20, and 21 are rejected under 35 U.S.C. 103 as obvious over Satpute (US 2018/0128797), as applied to the claims above, in view of E-Separation Solutions (“GC Column Degradation”).
With regard to Claim 3, Satpute discloses all the limitations in the claims as set forth above. However, Satpute is silent to wherein said value of the weighted aging factor is calculated based on at least one further aging parameter selected from time since a preceding use, storage conditions since a preceding use, and set of chromatography conditions applied.
E-Separation Solutions discloses that there are four main causes of GC column degradation and performance decline (Page 1). The article discloses that high operating or conditioning temperatures will age a column prematurely (Page 2) (set of chromatography conditions applied).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein said value of the weighted aging factor of Satpute is calculated based on at least one further aging parameter selected from time since a preceding use, storage conditions since a preceding use, and set of chromatography conditions applied, as taught by E-Separation Solutions, since high operating or conditioning temperatures, which are a set of chromatography conditions applied, will age a column prematurely.
With regard to Claims 12 and 13, Satpute discloses all the limitations in the claims as set forth above.
Satpute discloses wherein providing the value of said weighted aging factor comprises providing a value of a weighted aging factor determined based on i) at least one sample specific aging parameter selected from sample type, sample dilution, and sample volume ([0025], determining the slope (weighted aging factor) of an identified trend will provide an indication of when an anticipated fault condition may occur; [0013], types of failures may include column contamination, suggesting that lack of pre-purification of the sample matrix contributes to column failure (sample type)).
However, Satpute is silent to the value of a weighted aging factor being determined based on ii) at least one operation specific aging parameter (Claim 12), and wherein said operation specific aging parameter is at least one of an assay specific parameter (Claim 13).
E-Separation Solutions discloses that there are four main causes of GC column degradation and performance decline (Page 1). The article discloses that high operating or conditioning temperatures will age a column prematurely (Page 2) (assay specific aging parameter of high operating temperature).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the value of a weighted aging factor of modified Satpute to be determined based on ii) at least one operation specific aging parameter (Claim 12), wherein said operation specific aging parameter is at least one of an assay specific parameter (Claim 13), as taught by E-Separation Solutions, since high operating temperatures (assay specific parameter) will age a column prematurely.
With regard to Claim 17, Satpute et al (Satpute) discloses a monitoring component configured to provide a diagnostic indication regarding at least one component of the gas analyzer (Abstract). Satpute discloses a device for determining a second lifetime value of a chromatography column ([0023], monitoring component, data acquisition component, memory).
Satpute discloses a storage medium comprising a data collection tangibly embedded therein ([0023], memory may be configured to store standard reference data and/or archived data related to previous gas chromatograph analyses). Satpute discloses said data collection comprising at least one set of an aging parameter factor value annotated to an aging parameter category value, wherein said aging parameter category factor value is representative of an impact of a corresponding aging parameter category on a lifetime of the chromatography column and comprises at least one category value of an aging parameter selected from sample type, sample dilution, and sample volume ([0013], [0039], number or type of sample tested, column contamination, or column deterioration are all examples of aging parameter categories; [0023], data acquisition component may serve to aggregate incoming information about the gas chromatograph; data acquisition may be coupled to a memory, which stores archived data related to previous gas chromatograph analyses or runs as well as previous calibration data; [0045], identifying trends or observed deviations away from an average; once an identified trend reaches a significant deviation, the trend is classified as a potential symptom, and the severity of the symptom is calculated such as calculating a slope (aging factor)).
Satpute discloses the data collection comprising at least one of a first lifetime value of said chromatography column or an initial lifetime value of said chromatography column ([0023], memory may be configured to store standard reference data and/or archived data comprising data related to previous gas chromatograph analyses).
Satpute discloses an input unit that receives input data indicative of at least one aging parameter factor value ([0023], gas chromatograph inlet data and calibration data stream are provided to data acquisition component).
Satpute discloses a data processing unit that calculates a second lifetime value of said chromatography column based on at least one of said input data indicative of at least one aging parameter factor value, said first lifetime value of said chromatography column, or said initial lifetime value of said chromatography column ([0024], monitoring component comprises a data processing component which analyzes incoming data regarding current status of received analyzer parameters, and compare current parameters to previously taken data).
However, Satpute is silent to wherein the device is configured to adjust, based on the calculated second lifetime of the chromatography column, a mode of operation for performing chromatographic separations to reduce wear on the chromatography column in the chromatographic separations.
E-Separation Solutions discloses that there are four main causes of GC column degradation and performance decline (Page 1). The article discloses that high operating or conditioning temperatures will age a column prematurely (Page 2) (assay specific aging parameter of high operating temperature).
It would have been obvious to one of ordinary skill before the effective filing date of the invention for wherein the device of Satpute is configured to adjust, based on the calculated second lifetime of the chromatography column, a mode of operation for performing chromatographic separations to reduce wear on the chromatography column in the chromatographic separations, as taught by E-Separation Solutions, in order to prevent premature aging of a column by reducing high operating or conditioning temperatures.
With regard to Claim 20, Satpute is silent to wherein the parameter indicating onboard aging is indicative of at least one of time that the column is not utilized in a chromatographic separation or temperature at which the column is maintained when the column is not utilized in chromatographic separation.
E-Separation Solutions discloses that there are four main causes of GC column degradation and performance decline (Page 1). The article discloses that high operating or conditioning temperatures will age a column prematurely (Page 2) (assay specific aging parameter of high operating temperature).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the parameter indicating onboard aging is indicative of at least one of time that the column of Satpute is not utilized in a chromatographic separation or temperature at which the column is maintained when the column is not utilized in chromatographic separation, as taught by E-Separation Solutions, in order to document in a column is held at a high conditioning temperature that may contribute to premature aging of the column.
With regard to Claim 21, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the aging parameter factor value is further annotated to a chromatographic protocol, in order to account for which protocols cause the most aging of the chromatography column when analyzing trends away from an average. See [0045] of Satpute.
Claim 4 is rejected under 35 U.S.C. 103 as obvious over Satpute (US 2018/0128797), as applied to the claims above, in view of E-Separation Solutions (“GC Column Degradation”) and Machtejevas et al (“How to extend liquid chromatography column life: regenerate or use guard columns”).
With regard to Claim 4, Satpute discloses all the limitations in the claims as set forth above. Satpute discloses identifying trends or observed deviations away from an average; once an identified trend reaches a significant deviation, the trend is classified as a potential symptom, and the severity of the symptom is calculated such as calculating a slope (weighted aging factor) ([0045]).
However, Satpute is silent to wherein said aging parameters are combined into a single, assay-specific weighted aging factor.
E-Separation Solutions discloses that there are four main causes of GC column degradation and performance decline (Page 1). The article discloses that proper sample preparation (i.e., sample type) will help alleviate the problem of build-up of non-volatile sample residues that interact with target analytes to cause peak tailing, catalytic decomposition, and ultimately loss of separation (Page 1).
Furthermore, Machtejevas discloses that the total number of injections is inversely proportional to the volume of the sample injected, e.g., if 10 microliter sample is applied per injected and this results in a column lifetime of 5000 injections, then an increased sample load of 100 microliters per injection would typically shorten column lifetime to approximately 500 injections (Page 30) (i.e., sample dilution and sample volume).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to wherein said aging parameters of Satpute are combined into a single, assay-specific weighted aging factor, as taught by Machtejevas and E-Separation Solutions, in order to predict what the overall severity of the symptoms will be for a particular assay and how the trends will affect column life.
Claim 14 is rejected under 35 U.S.C. 103 as obvious over Satpute (US 2018/0128797) in view of E-Separation Solutions (“GC Column Degradation”), as applied to the claims above, and in further view of McCann (“Go with the flow: thinking about carrier gas flow in GC”).
With regard to Claim 14, modified Satpute discloses all the limitations in the claims as set forth above. However, modified Satpute is silent to wherein said assay specific parameter is at least one of an eluent pH or a pressure condition.
As in Claims 12 and 13, E-Separation Solutions disclosed that high operating or conditioning temperatures will age a column prematurely (Page 2) (assay specific aging parameter of high operating temperature).
Furthermore, McCann discloses that in constant flow operation, the electronic flow controller increases the head pressure as the temperature is increased, to maintain a constant flow rate (Page 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein said assay specific parameter of modified Satpute is at least one of an eluent pH or a pressure condition, as taught by McCann, since high operating temperature will lead to high pressure, which will age a column prematurely.
Response to Arguments
Applicant’s arguments filed 12 November 2025, with respect to the rejections under 35 USC 112(b) have been fully considered and are persuasive. The 35 USC 112(b) rejections of Claims 10, 15, 17, and 19-21 have been withdrawn.
Applicant's arguments filed 12 November 2025 with regard to the 35 USC 101, 102, and 103 rejections have been fully considered but they are not persuasive.
Applicant argues on Page 11 of the filing that claims do not recite a mental process when they do not contain limitations that can practically be performed in the human mind, and respectfully submits that is the case with at least the limitations of independent Claim 1.
In response, the Examiner respectfully disagrees. The Examiner maintains that a user may “determine a second value of said lifetime of said chromatography column” by viewing and comparing new and historical chromatogram data for a chromatography column. The judicial exception is recited at a high level, such that the claim limitation fits the definition of (c) mental processes of “concepts performed in the human mind (including an observation, evaluation, judgment, opinion)” as provided by Applicant.
Applicant argues on Page 12 of the filing that amended Claim 1 includes “subjecting the chromatography column to one or more conditions that cause wear on the chromatography column”, which clarify that the operation is performed with a particular machine (i.e., a chromatographic analysis system) and represent a transformation of an article to a different physical state (i.e., a transformation of the chromatography column to a more physically worn state).
In response, a wide array of conditions such as pH, temperature, solvents, mobile phase additives, etc. can cause wear on the chromatography column, such that this limitation does not correspond to a particular application. With regard to Applicant’s arguments that a chromatography analysis system is a particular machine, MPEP § 2106.05(b) provides an example of a particular machine from Mackay Radio & Tel. Co. v. Radio Corp. of America, 306 U.S. 86, 40 USPQ 199 (1939). “The claim recited the particular type of antenna and included details as to the shape of the antenna and the conductors, particularly the length and angel at which they were arranged”. This is a particular machine.
With regard to Applicant’s arguments that the wear on the chromatography column is a particular transformation, based on MPEP § 2106.05(c), the Examiner suggests that since a wide array of conditions can cause such wear, that the transformation is not particular, but general. See factor #2: “A transformation applied to a generically recited article or to any and all articles would likely not provide significantly more than the judicial exception”.
Applicant argues on pages 14 and 15 of the filing that the features of Claim 1 are recited with specificity and impose meaningful limits. Applicant contrasts the as argued specific features of Claim 1 with Parker v. Flook and MPEP § 2106.04(d).
In response, Claim 1 does not purport to do anything with the determination of a second value of said lifetime of said chromatography column, such that Claim 1 is missing even mere instructions to apply an exception. See MPEP § 2106.05(f). Therefore, the Examiner respectfully disagrees that the features of Claim 1 are recited with specificity and impose meaningful limits.
Applicant argues on pages 16 and 17 of the filing that the recitations of amended Claim 17 are representative of an improvement in the technological field of chromatography, because the feature enables continued use of a chromatography column that may otherwise be discarded and increase the likelihood that the chromatography column, in the continued use, will still provide accurate results.
In response, “wherein the device is configured to adjust, based on the calculated second lifetime of the chromatography column, a mode of operation for performing chromatographic separations to reduce wear on the chromatography column in the chromatographic separations” is a very broad limitation. A wide array of conditions such as pH, temperature, solvents, mobile phase additives, etc. can cause wear on the chromatography column. Furthermore, adjusting a mode of operation could involve any one or multiple of the array of conditions mentioned above, such that the judicial exception is not integrated into a practical application. See MPEP § 2106.05(h).
Applicant argues on page 22 of the filing that Satpute does not disclose or suggest determining column age based on sample type, sample dilution, and/or sample volume as required by Claim 1. Rather, Applicant argues, Satpute describes column age based on control measures. Applicant points to [0045] of Satpute. Applicant argues that none of the parameters recited in Claim 1 are represented in the matrix of Fig. 3 of Satpute. Finally, Applicant argues that [0039] does not disclose providing a value of a weighted aging factor determined based on sample type, sample dilution, or sample volume.
In response, the Examiner respectfully disagrees. The Examiner interprets the disclosed trend slope, indicating the severity of the symptom, as a weighted aging factor, as disclosed in [0045]. Furthermore, Satpute discloses that the symptom (aging parameter) may be based on the number or type of samples tested ([0039]). Therefore, Satpute discloses providing a value of a weighted aging factor determined based on at least one aging parameter selected from sample type.
Applicant argues that Satpute does not teach all of the features of amended Claim 15, nor does the office assert that it does.
In response, Satpute teaches all the limitations of Claim 15 as set forth above, and Applicant has not identified how Satpute fails to teach the limitations of Claim 15.
Applicant argues that Satpute does not disclose at least one set of an aging parameter category factor value is representative of an impact of a corresponding aging parameter category on a lifetime of the chromatography column and comprises at least one category value of an aging parameter selected from sample type, sample dilution, and sample volume.
In response, Satpute teaches the above limitation, as set forth in the rejection of Claim 17 above.
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.
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Benjamin Lebron
Supervisory Primary Examiner
Art Unit 1773
/BENJAMIN L LEBRON/Supervisory Patent Examiner, Art Unit 1773
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