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 .
Note: This corrected office action will replace the non-final rejection mailed out on 5/14/2026
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/22/2026 has been entered.
Response to Amendment
Claims 23-33 and 37-45 are pending
Claims 23, 30, 33, 38 and 41 have been amended
Claims 34-36 are cancelled
Claims 43-45 are new
Response to Arguments
Applicant’s arguments, see pages 1-3, filed 4/22/2026, with respect to the rejection of claims 23-42 under U.S.C. 101 have been fully considered and are persuasive. The rejection has been withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 23 is rejected on the ground of non-statutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 10613063 B2 respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims cover the same subject matter.
Both independent claims’ features of the instant application and the co-pending application can be compared as:
Instant Application: 18313745 (Claim 23)
US Patent: US 10,613,063 (Claim 1)
A process control method, comprising:
A process control method, comprising:
supplying raw material to a process unit using a material injection system;
passing the raw material through the process unit to form processed material;
detecting characteristics of the processed material using a detector to generate raw data associated with the processed material;
receiving the raw data from the detector, wherein the raw data includes a plurality of signals and plurality of blocks, and wherein the raw data corresponds to a conductivity, a pH, a salt concentration, a light absorption, a fluorescence, a refractive index, an electrochemical response, or mass spectrographic data of the processed material;
receiving raw chromatography data including a plurality of signals, wherein each signal of the plurality of signals is associated with one of a plurality of blocks;
obtaining a subset of data by selecting a combination of a first block and a first signal from the raw chromatography data;
applying a noise reduction technique to the plurality of signals and the plurality of blocks to generate processed data;
generating processed chromatography data by applying a noise reduction technique to the subset of data, wherein applying the noise reduction technique includes:
selecting a portion of the subset of data to analyze using predetermined set points;
normalizing the portion to prevent magnitude bias:
using at least one smoothing filter on the portion to generate smoothed data; and
analyzing the portion for dynamic signal errors;
performing a transition analysis on the processed data, to generate transition data, wherein performing the transition analysis includes:
generating a curve using the processed data;
analyzing the curve to generate a performance parameter; and
generating the transition data based on the performance parameter; and
generating transition data by performing a transition analysis on the processed chromatography data, wherein performing the transition analysis includes:
generating a curve using the processed chromatography data: and
analyzing the curve to generate performance parameters; and
performing an action based on the transition data, wherein performing the action includes generating a notification of an event, generating an evaluation of the event, or generating a deviation notification form,
wherein performing the action based on the transition data further includes discontinuing supplying raw material to the process unit.
performing an action based on the transition data, wherein performing the action includes generating a notification of an event, generating an evaluation of the event, or generating a deviation notification form.
US patent US 10613063 B2 (Mao) does not specifically disclose supplying raw material to a process unit using a material injection system; passing the raw material through the process unit to form processed material; detecting characteristics of the processed material using a detector to generate raw data associated with the processed material; wherein performing the action based on the transition data further includes discontinuing supplying raw material to the process unit.
However, Cunnien; Paul et al. US 20140067308 A1 does teach
supplying raw material to a process unit using a material injection system (par.44 “drive raw materials injected by material injection system 104”);
passing the raw material through the process unit to form processed material (fig.1 shows the process of passing raw material through process controller 108);
detecting characteristics of the processed material using a detector to generate raw data associated with the processed material (par.47);
wherein performing the action based on the transition data further includes discontinuing supplying raw material to the process unit (par.45 “Process controller 108 and operator's station/computer 110, for example, react to operator inputs and control operation of the various components of system 100 such as, for example, pumps and valves.”; the operator inputs and control operation of the components such as pumps and valves involve discontinuation of the supply of raw materials).
It would have been prima facie obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have modified Mao to include the teachings of Cunnien; which would provide an improved embodiment that can directly measure chromatography column efficiency and/or packing quality while a monitored column is being used to manufacture product as disclosed by Cunnien (par.13).
Both sets of claims’ features of the instant application (Claims 23-29) and the US Patent (claims 1, 6, 7, 11, 16) can be compared by using the table shown above.
Note: although some features of the instant application are found in a different claim set of the US patent, the features are, nevertheless, still present in the US patent.
Claims 24-29 are also rejected on the ground of non-statutory double patenting as they are dependent on claim 23.
This is a double patenting rejection since the conflicting claims have been patented.
Claims 30 is rejected on the ground of non-statutory double patenting as being unpatentable over claim 13 of U.S. Patent No. US 10613063 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims cover the same subject matter.
Regarding claim 30, Both independent claims’ features of the instant application and the co-pending application can be compared as:
Instant Application: 18313745 (Claim 30)
US Patent: US 10,613,063 (Claim 13)
A process control method, comprising:
A process control method, comprising:
supplying raw material to a process unit using a material injection system;
passing the raw material through the process unit to form processed material;
detecting characteristics of the processed material using a detector to generate raw data associated with the processed material;
receiving the raw data from the detector, wherein the raw data includes a plurality of signals and plurality of blocks, and wherein the raw data corresponds to a conductivity, a pH, a salt concentration, a light absorption, a fluorescence, a refractive index, an electrochemical response, or mass spectrographic data of the processed material;
receiving a selection of raw chromatography data;
generating processed data by selecting smoothed data matching a feature of a transition;
generating processed chromatography data by selecting smoothed data matching a feature of a chromatogram transition,
performing a transition analysis on the processed data, to generate transition data, wherein performing the transition analysis includes:
generating a performance parameter based on the processed data, the performance parameter including a maximum rate of change, a number of inflection points, a breakthrough volume, a cumulative error, a curve asymmetry, or a combination thereof; and
generating transition data based on the performance parameter or generating transition data based on the performance parameter in combination with historical data; and
wherein the feature of the chromatogram transition includes:
a derivative duration;
a maximum intensity;
a duration from initiation; or expected background noise; and
performing an action based on the transition data, wherein performing the action includes generating a notification of an event, generating an evaluation of the event, or generating a deviation notification form,
performing an action based on the processed chromatography data, wherein performing the action includes:
generating a notification of an event;
generating an evaluation of the event; or generating a deviation notification form.
wherein performing the action based on the transition data further includes discontinuing supplying raw material to the process unit.
US patent US 10613063 B2 (Mao) does not specifically disclose supplying raw material to a process unit using a material injection system; passing the raw material through the process unit to form processed material; detecting characteristics of the processed material using a detector to generate raw data associated with the processed material; wherein the raw data includes a plurality of signals and plurality of blocks, and wherein the raw data corresponds to a conductivity, a pH, a salt concentration, a light absorption, a fluorescence, a refractive index, an electrochemical response, or mass spectrographic data of the processed material; generating transition data based on the performance parameter or generating transition data based on the performance parameter in combination with historical data; and wherein performing the action based on the transition data further includes discontinuing supplying raw material to the process unit.
However, Cunnien; Paul et al. US 20140067308 A1 does teach
supplying raw material to a process unit using a material injection system (par.44 “drive raw materials injected by material injection system 104”);
passing the raw material through the process unit to form processed material (fig.1 shows the process of passing raw material through process controller 108);
detecting characteristics of the processed material using a detector to generate raw data associated with the processed material (par.47);
wherein the raw data includes a plurality of signals and plurality of blocks, and wherein the raw data corresponds to a conductivity, a pH, a salt concentration, a light absorption, a fluorescence, a refractive index, an electrochemical response, or mass spectrographic data of the processed material (par.16);
generating transition data based on the performance parameter or generating transition data based on the performance parameter in combination with historical data (par.90 “directly calculate column dispersion parameters from a step transition without converting the transition data into a peak, new techniques for reducing noise present in process data, and using skewness to describe the asymmetry of a transition. These features of the present invention, as well as other features, enable one to calculate values of N, HETP, and skewness accurately from step transition datasets.”); and
wherein performing the action based on the transition data further includes discontinuing supplying raw material to the process unit (par.45 “Process controller 108 and operator's station/computer 110, for example, react to operator inputs and control operation of the various components of system 100 such as, for example, pumps and valves.”; the operator inputs and control operation of the components such as pumps and valves involve discontinuation of the supply of raw materials).
It would have been prima facie obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have modified Mao to include the teachings of Cunnien; which would provide an improved embodiment that can directly measure chromatography column efficiency and/or packing quality while a monitored column is being used to manufacture product as disclosed by Cunnien (par.13).
Both sets of claims’ features of the instant application (Claims 30-33, 37 and 44) and the US Patent (claims 9, 13, 14, 15) can be compared by using the table shown above.
Note: although some features of the instant application are found in a different claim set of the US patent, the features are, nevertheless, still present in the US patent.
Claims 31-33, 37 and 44are also rejected on the ground of non-statutory double patenting as they are dependent on claim 30.
This is a double patenting rejection since the conflicting claims have been patented.
Claims 38 is rejected on the ground of non-statutory double patenting as being unpatentable over claim 17 of U.S. Patent No. US 11680930 B2 respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims cover the same subject matter.
Instant Application: 18313745 (Claim 38)
US Patent: US 11680930 B2 (Claim 17)
A process control method, comprising:
A process control method, comprising:
supplying raw material to a process unit using a material injection system;
passing the raw material through the process unit to form processed material;
detecting characteristics of the processed material using a detector to generate raw data associated with the processed material;
receiving the raw data from the detector, wherein the raw data includes a plurality of signals and plurality of blocks, and wherein the raw data corresponds to a conductivity, a pH, a salt concentration, a light absorption, a fluorescence, a refractive index, an electrochemical response, or mass spectrographic data of the processed material;
generating smoothed data by applying a noise reduction technique to the raw data, wherein the noise reduction technique comprises:
selecting a portion of raw data using predetermined set points; and
using a smoothing filter on the portion of raw data to generate smoothed data;
performing a transition analysis on the smoothed data to generate transition data; and
generating smoothed data by applying a noise reduction technique to raw chromatography data, wherein the noise reduction technique comprises:
selecting a portion of raw chromatography data using predetermined set points; and
using a smoothing filter on the portion of raw chromatography data to generate smoothed data;
performing a transition analysis to generate transition data
performing an action based on the transition data, wherein performing the action includes generating a notification of an event, generating an evaluation of the event, or generating a deviation notification form,
wherein performing the action based on the transition data further includes discontinuing supplying raw material to the process unit.
performing an action based on the processed chromatography data, wherein performing the action includes:
generating a notification of an event;
generating an evaluation of the event; or generating a deviation notification form.
US patent US 10613063 B2 (Mao) does not specifically disclose supplying raw material to a process unit using a material injection system; passing the raw material through the process unit to form processed material; detecting characteristics of the processed material using a detector to generate raw data associated with the processed material; receiving the raw data from the detector, wherein the raw data includes a plurality of signals and plurality of blocks, and wherein the raw data corresponds to a conductivity, a pH, a salt concentration, a light absorption, a fluorescence, a refractive index, an electrochemical response, or mass spectrographic data of the processed material;
However, Cunnien; Paul et al. US 20140067308 A1 does teach
supplying raw material to a process unit using a material injection system (par.44 “drive raw materials injected by material injection system 104”);
passing the raw material through the process unit to form processed material (fig.1 shows the process of passing raw material through process controller 108);
detecting characteristics of the processed material using a detector to generate raw data associated with the processed material (par.47);
receiving the raw data from the detector, wherein the raw data includes a plurality of signals and plurality of blocks, and wherein the raw data corresponds to a conductivity, a pH, a salt concentration, a light absorption, a fluorescence, a refractive index, an electrochemical response, or mass spectrographic data of the processed material (par.16);
It would have been prima facie obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have modified Mao to include the teachings of Cunnien; which would provide an improved embodiment that can directly measure chromatography column efficiency and/or packing quality while a monitored column is being used to manufacture product as disclosed by Cunnien (par.13).
Both sets of claims’ features of the instant application (Claims 38-42 and 45) and the US Patent (claims 1, 4, 8, 17) can be compared by using the table shown above.
Note: although some features of the instant application are found in a different claim set of the US patent, the features are, nevertheless, still present in the US patent.
Claims 39-42 and 45are also rejected on the ground of non-statutory double patenting as they are dependent on claim 38.
This is a double patenting rejection since the conflicting claims have been patented.
Conclusion
The Prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
US 8410928 B2; Ganguly; Joydeep et al. are Systems and methods for evaluating chromatography column performance
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/CARL F.R. TCHATCHOUANG/Examiner, Art Unit 2858
/RAUL J RIOS RUSSO/Examiner, Art Unit 2858
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