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 .
Priority
Applicant’s claim for the benefit of a prior-filed application (CON of 17/953,818, filed 27 September 2022, which is a CON of 16/275,467, filed 14 February 2019, which has PRO 62/631,167, filed 15 February 2018) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Objections
Claim 16 is objected to because of the following informalities:
“wherein the contacting step (5) and the measuring step (6) are continuous”.
Claim 18 is objected to because of the following informalities:
“wherein the contacting step (5) and the measuring step (6) are continuous”.
Appropriate correction is required.
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.
Claim 1-21 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.
Regarding Claim 1, the recitation of “the compositions” at the end of step (a) renders the claim indefinite. A number of compositions based on the reference sample have been introduced, i.e., “a separation composition”, “an elution composition”, “at least a first waste composition”, “a second waste composition”, and “an eluted analyte composition”. It is unclear which compositions are referenced in the phrase “the compositions”. Claims 2-21 are also rejected due to their dependence on Claim 1.
Similarly, regarding Claim 1, the recitation of “the composition” (singular) at the end of step (b) renders the claim indefinite. A number of compositions based on the process sample have been introduced, i.e., “a separation composition”, “the elution composition”, “at least a first waste composition”, and “at least a second waste composition”. It is unclear which composition is referenced in the phrase “the composition”.
Claim Rejections - 35 USC § 103
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 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-6, 8-12, and 18-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over WOLTERS (US 2010/0050737 A1) in view of ZHOU et al. (PLOS One, Vol. 8, Issue 7, July 2013).
Regarding Claim 1, WOLTERS discloses a method for analyzing a sample to determine the performance of a separation and to identify errors (i.e., [a] method for detecting a column malfunction in a chromatography process; abstract; p0004). The analyzed sample includes a mixture of two or more components and includes biological components (i.e., the reference sample [comprises] a plurality of analytes; the process sample [comprises] the plurality of analytes; p0062), such as active pharmaceutical ingredients (p0191). UV/Vis spectra are obtained (p0075) from samples passing through chromatography columns, e.g., HPLC (p0081-0083).
In the method, a sample is measured to obtain a measurement profile data (i.e., step (a) contacting a reference sample… with a chromatography column; generating a reference chromatogram from a chromatography column; p0020). The sample is separated into one or more subsamples, and the subsamples are measured to obtain subsample measurement profile data (i.e., step (b) contacting a process sample… with a chromatography column; generating a process chromatogram from the chromatography column). The subsample measurement profile is generated in real-time (i.e., wherein the plotting occurs continuously as the composition exits the chromatography column; p0174).
In a third step, the sample measurement profile which is compared with the subsample measurement profile data (i.e., step (c) comparing the process chromatogram to the reference chromatogram; p0021-0023). WOLTERS discloses generating a difference spectrum (i.e., detecting an atypical profile in the process chromatogram; p0172) and further discloses that positive or negative signals in the difference spectrum indicate errors or contaminants (i.e., wherein the atypical profile comprises at least one indentation on the process chromatogram having a decreased sharpness or decreased magnitude when compared to an indentation at a comparable position on the reference chromatogram; p0172).
WOLTERS discloses a computer that examines differences between the measured sample and subsample data and notifies a user of potential problems, e.g., with alerts (i.e., step (d) generating a warning signal when the atypical profile is detected; p0124, p0193). The computer automatically “shuts down sample separation or device in event of a potential safety problem” (i.e., step (e) halting the chromatography process when the atypical profile is detected; p0125). Subsequently, the computer attempts corrective actions, e.g., conducting calibrations, applying baseline corrections, running blank samples, subtracting background measurements (p0125, top of first column on pg. 18), determining whether sensors are properly calibrated due to offset sensitivities (p0125, middle of second column on pg. 18), and running reference standards to ensure proper operation of the device (i.e., halting the chromatography process until the column malfunction is resolved; p0125 on pg. 19).
Finally, WOLTERS discloses that WOLTERS further acknowledges that “erroneous results” are possible and can be due to contaminant peaks (p0015, p0076) or any other “slight discrepancy” due to measurement artifacts (p0173).
WOLTERS is deficient in disclosing the reference sample comprises a VEGF-Trap protein or that the process sample comprises the VEGF-Trap protein.
However, as indicated earlier, WOLTERS discloses the sample includes biological components, such as active pharmaceutical ingredients (p0007, p0191). Such pharmaceutical products are commonly known to include small molecule drugs, monoclonal antibodies, and the like, i.e., therapeutic products. As disclosed by ZHOU, therapeutic products, such as VEGF-Trap, are commonly purified, separated, or isolated from other components using chromatography (i.e., the reference sample [comprises] a plurality of analytes and a VEGF-Trap protein; the process sample [comprises] the plurality of analytes and the VEGF-Trap protein; §Mice and Reagents, pg. 2). Prior to the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious that in the chromatographic separation of process samples made obvious by WOLTERS or modified WOLTERS, a commonly separated sample includes therapeutic products, e.g., VEGF-Trap, as disclosed by ZHOU. The nature of the problem to be solved would have led one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective, individual functions, and the combination would have yielded nothing more than predictable results (MPEP §2143.01 A). Furthermore, the composition of the biologic composition does not impact the how the claimed method for detecting a column malfunction in a chromatography process is practiced by one of ordinary skill in the art, i.e., whether the composition is a therapeutic protein, or even further a VEGF-Trap protein, would not significantly alter the way that one of ordinary skill in the art would practice the claimed method.
Regarding Claim 4, modified WOLTERS makes obvious the method of Claim 1. WOLTERS further discloses chromatography, specifically ion chromatography (i.e., wherein the chromatography process comprises ion exchange chromatography; p0088).
Regarding Claim 5, modified WOLTERS makes obvious the method of Claim 1. WOLTERS further discloses the method is applicable for any separation technique, especially chromatography, including ion exchange and bind-elute chromatography (i.e., wherein the chromatography process comprises affinity chromatography; p0088).
Regarding Claim 6, modified WOLTERS makes obvious the method of Claim 1. WOLTERS further discloses the method is applicable for any separation technique, especially chromatography and further cites a C18 chromatographic packing material (p0088), which is widely known to be used in hydrophobic interaction chromatography (i.e., wherein the chromatography process comprises hydrophobic interaction chromatography).
However, the claimed method is directed toward a method for detecting malfunctions in a chromatography process with a chromatography column and not the use of said chromatography column for specific separation techniques. All chromatography processes generate profiles, whether they are ion exchange, affinity, hydrophobic interaction, or other types of processes. The claimed method can be used for any of these chromatography separations. Thus, the claimed limitations to the chromatography process comprising hydrophobic interaction chromatography would have been obvious to one of ordinary skill in the art at the time of the filing of the invention absent showings that such uses of the claimed column would have significance or criticality over any other type of chromatography.
Regarding Claim 7, modified WOLTERS makes obvious the method of Claim 1. WOLTERS further discloses that particulate matter can clog the chromatography column (p0063), thereby decreasing the separation power and efficiency (i.e., wherein the column malfunction is caused by column deterioration).
Furthermore, such a claim is considered an inherent property of a column malfunction. Whether a column malfunction is caused by the column itself, an error in sample preparation or some other issue, the prior art regardless has disclosed the existence of a column malfunction. Because the claimed invention is directed toward a method for detecting a column malfunction, the origination of the malfunction bears no patentable weight so long as the prior art addresses a column malfunction.
Regarding Claim 9, modified WOLTERS makes obvious the method of Claim 1. WOLTERS further discloses that particulate matter can clog the chromatography column (p0063), thereby decreasing the separation power and efficiency (i.e., wherein the column malfunction induces a loss of separation power of the chromatography column).
Furthermore, the limitation “wherein the malfunction of the chromatography process induces a loss of separation power…” is directed toward an intended result of the claimed method. Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. A “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003); MPEP §2111.04). Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, the fact that the reference does not describe the recited effect in haec verba is of no significance because the reference meets the claim under the doctrine of inherency. In this case, no actionable steps are claimed; the limitations only describe the results or desired outcomes resulting from the practice of the steps outlined in Claim 1.
Regarding Claim 10, modified WOLTERS makes obvious the method of Claim 1. WOLTERS further discloses comparing UV/Vis spectra from the subsample and sample (i.e., wherein the measured absorbance intensity is determined at a wavelength corresponding to ultraviolet light; p0075).
Regarding Claim 14, modified WOLTERS makes obvious the method of Claim 1. Modified WOLTERS is deficient in explicitly disclosing an anion exchange resin; however, WOLTERS discloses the use of the columns for ion exchange chromatography (p0088). Depending on the desired separation, one of ordinary skill in the art prior to the effective filing date of the claimed invention would find it obvious to use the appropriate column resin that would afford optimal separation. Absent showings of criticality or unexpected results due to the use of an anionic resin over any other ion exchange resin (i.e., cationic, zwitterionic, and amphoteric) would have been obvious to one of ordinary skill in the art at the time of the filing of the invention.
Regarding Claims 15 and 17, modified WOLTERS makes obvious the method of Claim 1. The instantly claimed method steps of generating reference and process chromatograms are well-known to any one of ordinary skill in the art prior to the effective filing date of the claimed invention. These steps are commonly practiced by an operator of a chromatography system; while not explicitly disclosed by the prior art, WOLTERS nevertheless discloses generating both types of chromatograms based on the separating of one or more components of a mixture (i.e., a plurality of pre-determined analytes or test analytes) via bind-elute mechanisms (p0009, p0062, p0065). UV/Vis detectors are utilized to measure light absorbance at multiple wavelengths (p0091-0092).
Regarding Claims 16 and 18, modified WOLTERS makes obvious the methods of Claims 15 and 17, respectively. WOLTERS further discloses continuous flow operation and measurement of the chromatography columns (i.e., wherein the contacting step and measuring step are continuous; p0083).
Regarding Claim 19, modified WOLTERS makes obvious the method of Claim 1. WOLTERS further discloses a computer (i.e., wherein the warning signal is communicated electronically to a processor and wherein the processor is operably linked to the chromatography column; p0120-0121, p0124, p0189, p0193; Claim 24).
Regarding Claim 20, modified WOLTERS makes obvious the method of Claim 19. WOLTERS further discloses the computer, upon identifying any difference between the measurement profile data of the sample and subsample, automatically re-runs samples, references or blanks to troubleshoot the potential problem (i.e., wherein the processor receives the warning signal and interrupts the chromatography process or prevents the initiation of a further chromatography process until the column malfunction is resolved; p0124).
Claims 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over WOLTERS (US 2010/0050737 A1) in view of ZHOU et al. (PLOS One, Vol. 8, Issue 7, July 2013), as applied to Claim 1 above, and further in view of MAO et al. (US 2018/0113101 A1; effectively filed 25 October 2016).
Regarding Claims 2 and 3, modified WOLTERS makes obvious the method of Claim 1. Modified WOLTERS is deficient in disclosing the at least one indentation on the process chromatogram having a decreased sharpness or decreased magnitude occurs just prior to a collection step (Claim 2) or that the at least one indentation on the process chromatogram having a decreased sharpness or decreased magnitude occurs just prior to a strip peak (Claim 3).
MAO discloses methods for assessing the integrity of a chromatography column (abstract). A chromatography cycle is tracked/recorded using data collected at a UV detector at the outlet of a column during wash, elution, collection, and strip steps of the cycle; as liquid passes through the column during each step, the UV detector measures absorbance as shown in FIG. 2 (p0064). MAO further discloses that the integrity assessment involves “a transition analysis” to determine the quality and integrity of the chromatography column (p0067); such transition analysis includes monitoring measured signals during, e.g., a change from a wash step to an elution step or a change from an elution step to a strip step (i.e., prior to a collection step (Claim 2); prior to a strip peak (Claim 3); p0065). Advantageously, such monitoring allows for precise in-process controls to respond to deviations such that issues with column integrity can be identified and corrected early with minimal waste and expense (p0006). Thus, prior to the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to apply the method of detecting a column malfunction as made obvious by modified WOLTERS to detect potential malfunctions occurring prior to a collection step.
PNG
media_image1.png
200
400
media_image1.png
Greyscale
Furthermore, such recited limitations are considered anticipated or obvious over the prior art. Whether a column malfunction occurs during a wash step, an elution step, or a strip step, the prior art regardless has disclosed the existence of a column malfunction. Because the claimed invention is directed toward a method for detecting a column malfunction, the origination of the malfunction bears no patentable weight so long as the prior art discloses or makes obvious the ability to determine a column malfunction during the recited period. If a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process (In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986); MPEP §2112.02).
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over WOLTERS (US 2010/0050737 A1) in view of ZHOU et al. (PLOS One, Vol. 8, Issue 7, July 2013), as applied to Claim 7 above, and further in view of ZHANG et al. (US PGPub 2004/0249082 A1).
Regarding Claim 8, modified WOLTERS makes obvious the method of Claim 7. Modified WOLTERS is deficient in disclosing the column deterioration comprises column bed fracturing.
However, column bed fracturing is known to be a common issue leading to degraded separation performance as taught by ZHANG (p0008). Absent any showings that such a limitation is of criticality or significance, one of ordinary skill in the art prior to the effective filing date of the claimed invention would find such conditions obvious, if not common, as taught by ZHANG for the method made obvious by modified WOLTERS.
Furthermore, such a recited limitation is considered an inherent property of a column malfunction. Whether a column malfunction is caused by the column itself, an error in sample preparation or some other issue, the prior art regardless has disclosed the existence of a column malfunction. Because the claimed invention is directed toward a method for detecting a column malfunction, the origination of the malfunction bears no patentable weight so long as the prior art addresses a column malfunction.
Claims 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over WOLTERS (US 2010/0050737 A1) in view of ZHOU et al. (PLOS One, Vol. 8, Issue 7, July 2013), as applied to Claim 10 above, and further with evidentiary support from BIOTEK (Application Note, published 06 February 2001; <url: biotek.com/resources/docs/PowerWave200_Nucleic_Acid_Purity_Assessment.pdf>).
Regarding Claims 11-13, modified WOLTERS makes obvious the method of Claim 10. Modified WOLTERS is deficient in disclosing measuring absorbance intensity at wavelengths between 260 and 280 nm or at 260 nm or 280 nm.
However, WOLTERS discloses measuring UV absorbance at specific wavelengths, e.g., FIG. 5B, albeit not at the claimed range of 260-280 nm or at 260 nm or at 280 nm. Further, as evidenced by BIOTEK, absorbances measured at 260 and 280 nm are commonly used especially to determine protein purity in a separation (pg. 1, par. 2). Absent showings that such wavelengths provide criticality or unexpected results to the claimed method, such limitations would have been obvious to one of ordinary skill in the art at the time of the filing of the invention. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation absent unexpected results or evidence indicating such optimum or workable ranges are critical (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP§2144.05).
Claim 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over WOLTERS (US 2010/0050737 A1) in view of ZHOU et al. (PLOS One, Vol. 8, Issue 7, July 2013), as applied to Claim 1 above, and further in view of HOLMAN et al. (US PGPub 2006/0096903 A1).
Regarding Claim 21, modified WOLTERS makes obvious the method of Claim 1. Modified WOLTERS is deficient in disclosing the method further comprises repacking the chromatography column.
However, column repacking is typically practiced after a malfunction or failure has occurred after a separation has rendered the packed column unusable, e.g., by contamination, as taught by HOLMAN (i.e., wherein resolving the column malfunction comprises repacking the chromatography column; p0010-0011). Advantageously, repacking a column will render the column usable again for separations rather than using costly disposable columns (p0012). Thus, at the time of the filing of the invention, one of ordinary skill in the art would have found such a limitation obvious to practice as taught by HOLMAN in the method for detecting malfunction in a chromatography process made obvious by modified WOLTERS.
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 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-6, 10-14, and 21-27 of U.S. Patent No. 12,025,599 in view of WOLTERS (US 2010/0050737 A1) and MAO et al. (US 2018/0113101 A1), singly or in combination.
Regarding Claims 1 and 2, nearly all recited limitations are read upon by Claim 1 of the reference patent ‘599. Reference patent ‘599 fails to disclose the claimed recitation that “the atypical profile comprises at least one indentation on the process chromatogram having a decreased sharpness or decreased magnitude when compared to an indentation at a comparable position on the reference chromatogram”.
However, such a limitation is disclosed by WOLTERS as indicated in the prior art rejection: A difference spectrum shows that positive or negative signals in the difference spectrum indicate errors or contaminants (i.e., wherein the atypical profile comprises at least one indentation on the process chromatogram having a decreased sharpness or decreased magnitude when compared to an indentation at a comparable position on the reference chromatogram; p0172).
Regarding Claim 3, reference patent ‘599 is deficient in disclosing the at least one indentation on the process chromatogram having a decreased sharpness or decreased magnitude occurs just prior to a strip peak.
However, such a limitation is disclosed by MAO as indicated in the prior art rejection. MAO discloses that a column integrity assessment involves “a transition analysis” to determine the quality and integrity of the chromatography column (p0067); such transition analysis includes monitoring measured signals during, e.g., a change from a wash step to an elution step or a change from an elution step to a strip step (i.e., prior to a strip peak); p0065). Advantageously, such monitoring allows for precise in-process controls to respond to deviations such that issues with column integrity can be identified and corrected early with minimal waste and expense (p0006).
Regarding Claims 4, 5, and 6, all recited limitations are respectively read upon by Claims 2, 3, and 4 of the reference patent ‘599.
Regarding Claims 7-13, all recited limitations are respectively read upon by Claims 5, 6, and 10-14 of the reference patent ‘599.
Regarding Claim 14, reference patent ‘599 is deficient in disclosing the chromatography column comprises an anion exchange resin. However, WOLTERS discloses the use of the columns for ion exchange chromatography (p0088). Depending on the desired separation, one of ordinary skill in the art prior to the effective filing date of the claimed invention would find it obvious to use the appropriate column resin that would afford optimal separation. Absent showings of criticality or unexpected results due to the use of an anionic resin over any other ion exchange resin (i.e., cationic, zwitterionic, and amphoteric) would have been obvious to one of ordinary skill in the art at the time of the filing of the invention.
Regarding Claims 15-18, all recited limitations are respectively read upon by Claims 21-24 of the reference patent ‘599.
Regarding Claims 19-21, all recited limitations are respectively read upon by Claims 25-27 of the reference patent ‘599.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-6, 10-14, 21, 22, 25-27, 30, and 31 of U.S. Patent No. 11,499,951 in view of WOLTERS (US 2010/0050737 A1) and MAO et al. (US 2018/0113101 A1), singly or in combination.
Regarding Claims 1 and 2, nearly all recited limitations are read upon by Claims 1 and 30 of the reference patent ‘951. Reference patent ‘951 fails to disclose the claimed recitation that “the atypical profile comprises at least one indentation on the process chromatogram having a decreased sharpness or decreased magnitude when compared to an indentation at a comparable position on the reference chromatogram”.
However, such a limitation is disclosed by WOLTERS as indicated in the prior art rejection: A difference spectrum shows that positive or negative signals in the difference spectrum indicate errors or contaminants (i.e., wherein the atypical profile comprises at least one indentation on the process chromatogram having a decreased sharpness or decreased magnitude when compared to an indentation at a comparable position on the reference chromatogram; p0172).
Regarding Claim 3, reference patent ‘951 is deficient in disclosing the at least one indentation on the process chromatogram having a decreased sharpness or decreased magnitude occurs just prior to a strip peak.
However, such a limitation is disclosed by MAO as indicated in the prior art rejection. MAO discloses that a column integrity assessment involves “a transition analysis” to determine the quality and integrity of the chromatography column (p0067); such transition analysis includes monitoring measured signals during, e.g., a change from a wash step to an elution step or a change from an elution step to a strip step (i.e., prior to a strip peak); p0065). Advantageously, such monitoring allows for precise in-process controls to respond to deviations such that issues with column integrity can be identified and corrected early with minimal waste and expense (p0006).
Regarding Claims 4, 5, and 6, all recited limitations are respectively read upon by Claims 2, 3, and 4 of the reference patent ‘951.
Regarding Claims 7-13, all recited limitations are respectively read upon by Claims 5, 6, and 10-14 of the reference patent ‘951.
Regarding Claim 14, reference patent ‘951 is deficient in disclosing the chromatography column comprises an anion exchange resin. However, WOLTERS discloses the use of the columns for ion exchange chromatography (p0088). Depending on the desired separation, one of ordinary skill in the art prior to the effective filing date of the claimed invention would find it obvious to use the appropriate column resin that would afford optimal separation. Absent showings of criticality or unexpected results due to the use of an anionic resin over any other ion exchange resin (i.e., cationic, zwitterionic, and amphoteric) would have been obvious to one of ordinary skill in the art at the time of the filing of the invention.
Regarding Claims 15-18, all recited limitations are respectively read upon by Claims 21, 22, and 31 of the reference patent ‘951.
Regarding Claims 19-21, all recited limitations are respectively read upon by Claims 25-27 of the reference patent ‘951.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN B HUANG whose telephone number is (571)270-0327. The examiner can normally be reached 9 am-5 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, In Suk Bullock can be reached at 571-272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Ryan B Huang/Primary Examiner, Art Unit 1777
Prosecution Insights