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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 The rejection has been withdrawn.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.
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Claims 23-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 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.
This is a double patenting rejection since the conflicting claims have been patented.
Claims 30-33 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-18 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.
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 16)
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.
This is a double patenting rejection since the conflicting claims have been patented.
Claims 38-42 and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-28 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 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.
This is a double patenting rejection since the conflicting claims have been patented.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 23-33 and 37-45 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Mao; Nathan L. et al. (US Patent #US 11680930 B2; hereinafter Mao).
Regarding claim 23, Mao teaches
A process control method (abstract), comprising:
supplying raw material (par.42 teaches supplying raw materials) to a process unit (par.42 teaches a process controller 108) using a material injection system (par.42 – 43 teaches material injection system 104);
passing the raw material through the process unit to form processed material (par.42 and 45);
detecting characteristics of the processed material using a detector (par.40 teaches detector 112) 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 (par.70), and wherein the raw data corresponds to a conductivity(par.71), a pH (par.71), a salt concentration (par.50), a light absorption (par.50), a fluorescence (par.50), a refractive index (par.50), an electrochemical response (par.50), or mass spectrographic data of the processed material (par.50);
applying a noise reduction technique to the plurality of signals and the plurality of blocks to generate processed data (par.59);
performing a transition analysis on the processed data (par.62), to generate transition data (par.62), wherein performing the transition analysis includes:
generating a curve using the processed data (par.62);
analyzing the curve to generate a performance parameter (par.62); and
generating the transition data based on the performance parameter (par.69); and
performing an action based on the transition data (par.69), wherein performing the action includes generating a notification of an event (par.110), generating an evaluation of the event (par.110), or generating a deviation notification form (par.110),
wherein performing the action based on the transition data further includes discontinuing supplying raw material to the process unit (par.110 teaches stopping a chromatography process, this includes stopping material injection system from process controller 108).
Regarding claim 24, Mao teaches the method of claim 23, wherein applying the noise reduction technique to the plurality of signals and the plurality of blocks includes selecting a combination of a first block and a first signal from the raw data (par.12).
Regarding claim 25, Mao teaches the method of claim 24, wherein selecting the combination of the first block and the first signal includes selecting the combination according to a profile defining a plurality of selection criteria (par.78), wherein the plurality of selection criteria comprises one or more of:
whether blocks occur at regular intervals (par.78);
an extent to which one of the plurality of signals saturates the detector (par.8);
an extent to which the plurality of signals approaches a stationary phase at a distinct level (par.8);
a magnitude of variation in the plurality of signals (par.8);
or a number of inflection points shown by the plurality of signals during a transition phase (par.8).
Regarding claim 26, Mao teaches the method of claim 25, wherein the profile is associated with a drug product (par.73).
Regarding claim 27, Mao teaches the method of claim 26, wherein the transition data is indicative of an integrity of a chromatography column (par.63) used to purify the drug product (par.44).
Regarding claim 28, Mao teaches the method of claim 23, wherein the performance parameter includes two or more of:
a maximum rate of change (par.62);
a number of inflection points (par.62);
a breakthrough volume (par.62);
a cumulative error (par.62);
a curve asymmetry (par.62); and
a height equivalent of a theoretical plate (par.4).
Regarding claim 29, Mao teaches the method of claim 23, wherein the noise reduction technique includes one or more of:
analyzing a portion of raw data for dynamic signal errors (par.4); or
normalizing a portion of raw data to prevent magnitude bias (par.4).
Regarding claim 43, Mao teaches the method of claim 23, wherein performing the action includes generating the evaluation of the event based on the transition data indicating an integrity associated with the process unit is compromised (par.63 and par.117), and wherein the supplying of the raw material to the process unit is discontinued in response to the indication that the integrity associated with the process unit is compromised (par.110 teaches stopping a chromatography process, this includes stopping material injection system from process controller 108; par.117 further teaches displaying notifications to an operator at the time of an analysis completion, advising on continuing or stopping a chromatography process, or advising on other actions.).
Regarding claim 30, Mao teaches
A process control method (abstract), comprising:
supplying raw material (par.42 teaches supplying raw materials) to a process unit using (par.42 teaches a process controller 108) a material injection system (par.42 – 43 teaches material injection system 104);
passing the raw material through the process unit to form processed material (par.42 and 45);
detecting characteristics of the processed material using a detector (par.40 teaches detector 112) to generate raw data associated with the processed material (par.47);
receiving the raw data from the detector, wherein the raw data corresponds to a conductivity (par.71), a pH (par.71), a salt concentration (par.50), a light absorption, a fluorescence (par.50), a refractive index (par.50), an electrochemical response (par.50), or mass spectrographic data (par.50) of the processed material;
generating processed data by selecting smoothed data matching a feature of a transition (par.11);
performing a transition analysis on the processed data (par.62), to generate transition data (par.62), 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 (par.62); and
generating transition data based on the performance parameter (par.89) or generating transition data based on the performance parameter in combination with historical data (par.89 “The transition analysis may include performing one or more mathematical processes on the processed data”); and
performing an action based on the transition data (par.69), wherein performing the action includes generating a notification of an event (par.110), generating an evaluation of the event (par.110), or generating a deviation notification form (par.110),
wherein performing the action based on the transition data further includes discontinuing supplying raw material to the process unit (par.110 teaches stopping a chromatography process, this includes stopping material injection system from process controller 108).
Regarding claim 31, Mao teaches the method of claim 30, wherein the feature of the transition includes:
a derivative duration (par.86);
a maximum intensity (par.86);
a duration from initiation (par.86); or
expected background noise (par.86).
Regarding claim 32, Mao teaches the method of claim 30, further comprising: generating an Individual chart (par.95), Moving Range chart (par.95), or Range chart (par.95).
Regarding claim 33, Mao teaches the method of claim 32, further comprising:
generating performance data by performing a multivariate data analysis to the Individual chart, the Moving Range chart, or the Range chart (par.100);
generating performance data by performing a multivariate data analysis to the Individual chart, the Moving Range chart, or the Range chart, wherein the multivariate data analysis includes principal component analysis, partial least squares, orthogonal partial least squares, multivariate regression, canonical correlation, factor analysis, cluster analysis, graphical procedures, or a combination thereof (par.100);
generating performance data by performing a principal component analysis to the Individual chart, the Moving Range chart, or the Range chart (par.100); and/or
generating performance data by performing a principal component analysis or a multivariate data analysis to the Individual chart, the Moving Range chart, or the Range chart (par.131-132); and
terminating a chromatography process based on the performance data (par.106).
Regarding claim 37, Mao teaches the method of claim 30, wherein the raw data includes a plurality of blocks and plurality of signals (par.12), and the method further comprises selecting a combination of a first block and a first signal from the raw data (par.9) according to a profile defining a plurality of selection criteria, wherein the profile is associated with a drug product (par.73).
Regarding claim 44, Mao teaches the method of claim 30, wherein performing the action includes generating the deviation notification (par.114) form based on the transition data indicating a critical process parameter (par.115) associated with the process unit has deviated beyond an acceptable range (par.113), and wherein the supplying of the raw material to the process unit is discontinued in response to the indication (par.114) that critical process parameter associated with the process unit has deviated beyond the acceptable range (par.110 teaches stopping a chromatography process, this includes stopping material injection system from process controller 108).
Regarding claim 38, Mao teaches
A process control method (abstract), comprising:
supplying raw material (par.42 teaches supplying raw materials) to a process unit using (par.42 teaches a process controller 108) a material injection system (par.42 – 43 teaches material injection system 104);
passing the raw material through the process unit to form processed material (par.42 and 45);
detecting characteristics of the processed material using a detector (par.40 teaches detector 112) to generate raw data associated with the processed material (par.47);
receiving the raw data from the detector, wherein the raw data corresponds to a conductivity (par.71), a pH (par.71), a salt concentration (par.50), a light absorption, a fluorescence (par.50), a refractive index (par.50), an electrochemical response (par.50), or mass spectrographic data (par.50) of the processed material;
generating smoothed data by applying a noise reduction technique to the raw data (par.69),
wherein the noise reduction technique comprises:
selecting a portion of raw data (par.9) using predetermined set points (par.9); and
using a smoothing filter on the portion of raw data to generate smoothed data (par.9);
performing a transition analysis on the smoothed data to generate transition data (par.69); and
performing an action based on the transition data (par.69), wherein performing the action includes generating a notification of an event (par.110), generating an evaluation of the event (par.110), or generating a deviation notification form (par.110),
wherein performing the action based on the transition data further includes discontinuing supplying raw material to the process unit (par.110 teaches stopping a chromatography process, this includes stopping material injection system from process controller 108).
Regarding claim 39, Mao teaches the method of claim 38, wherein the noise reduction technique further includes selecting the portion of the raw data using predetermined set points (par.11).
Regarding claim 40, Mao teaches the method of claim 38, wherein the noise reduction technique further includes:
analyzing the portion of raw data for dynamic signal errors (par.9);
normalizing the portion of raw data to prevent magnitude bias (par.9); or both.
Regarding claim 41, Mao teaches the method of claim 38, further comprising: generating an Individual chart (par.95), Moving Range chart (par.95), or Range chart (par.95); and
generating performance data by performing a principal component analysis or a multivariate data analysis to the Individual chart, the Moving Range chart, or the Range chart (par.131-132).
Regarding claim 42, Mao teaches the method of claim 38, wherein performing the transition analysis includes: generating a performance parameter based on the smoothed 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 (par.62); and
generating transition data based on the performance parameter (par.89) in combination with historical data (par.89 “The transition analysis may include performing one or more mathematical processes on the processed data”).
Regarding claim 45, Mao teaches the method of claim 38, wherein performing the action based on the transition data includes determining a critical process (par.115) parameter associated with the process unit is beyond an acceptable limit (par.113) and wherein the supplying of the raw material to the process unit is discontinued in response to the indication (par.114) that the critical process parameter associated with the process unit is beyond the acceptable limit (par.110 teaches stopping a chromatography process, this includes stopping material injection system from process controller 108).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
US 20120246211 A1; Lytle; Fred E. is a syntactical system and method for chromatographic peak identification.
US 6816789 B2; Excoffier; Jean-Louis is a Method and system for analyzing chromatograms.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARL F.R. TCHATCHOUANG whose telephone number is (571)272-3991. The examiner can normally be reached Monday - Friday 8:00am -5:00am.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Huy Phan can be reached at 571-272-7924. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARL F.R. TCHATCHOUANG/ Examiner, Art Unit 2858
/HUY Q PHAN/ Supervisory Patent Examiner, Art Unit 2858
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