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 a chromatographic separation of a sample on said 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 and 10 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 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. 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 and 12-14 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 at least one chromatographic separation under conditions of a first set of aging parameter category values; determining at least one second value of said performance parameter; 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; 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 at least one chromatographic separation under conditions of a first set of aging parameter category values” and “performing at least one chromatographic separation under conditions of a second set of aging parameter category values” are recited at a high level and are directed to generally linking the “determining” 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 “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.
Claim 17 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 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 value 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.
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).
The device claim of Claim 17 is 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 Claim 17 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10, 15, 17, and 19-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With regard to Claim 10, part (iv), it is unclear what the term “onboard aging” means.
With regard to Claims 15 and 17, it is unclear how one of ordinary skill in the art determines “an aging parameter category value”, or what this value represents.
With regard to Claim 19, it is unclear what “released testing” means.
With regard to Claim 20, it is unclear what “column keeping” means.
With regard to Claim 21, the method claim is dependent on device Claim 17. Therefore, it is not clear which claim 21 is supposed to be dependent on.
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, 17, and 19-21 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 a chromatographic separation of a sample on said chromatography column ([0043], gas analyzer data is received by a monitoring component (i.e., indicating a run on a chromatography 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 at least one chromatographic separation under conditions of a first set of aging parameter category values ([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).
Satpute discloses performing 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 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, wherein said aging parameter category value 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).
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).
With regard to Claim 19, Satpute discloses wherein the parameter indicating the initial performance of said chromatography column is determined upon released testing ([0023], memory may be configured to store standard reference data and archived data related to previous gas chromatograph analyses).
With regard to Claim 20, Satpute discloses wherein the parameter indicating onboard aging is indicative of at least one of time or temperature of column keeping ([0023], archive data may comprise data related to previous calibration data).
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.
Claims 3, 12, and 13 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.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN LEBRON whose telephone number is (571)272-0475. The examiner can normally be reached 9 AM - 5:30 PM.
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Benjamin Lebron
Primary Examiner
Art Unit 1777
/BENJAMIN L LEBRON/ Primary Examiner, Art Unit 1777
Prosecution Insights