DETAILED ACTION
Reissue
The present reissue application is directed to US 11,774,287 B2 (“287 Patent”). 287 Patent issued on October 3, 2023 with claims 1-20 from application 17/613,760, which is a 371 of PCT/CN2020/092441 filed on May 27, 2020, and claims priority to PCT/CN2019/088722 filed on May 28, 2019.
This application was filed on October 2, 2025. Since this date is after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions. Furthermore, the present application is being examined under the first inventor to file provisions of the AIA .
This application presents broadened claims, which are permitted because Applicant filed these claims and demonstrated an intent to broaden within two years of the issue date of 287 Patent.
The most recent amendment was filed on October 2, 2025. The status of the claims is:
Claims 1-20: Original
Claims 21-41: New
This is a first, non-final action.
References and Documents Cited in this Action
287 Patent (US 11,774,287 B2)
Angelini (US 2019/0153381 A1)
Moretto (US 2018/0291329 A1)
Webster (US 2019/0137338 A1)
Churchwell (US 2022/0018782 A1)
Summary of Rejections and Objections in this Action
Claims 1-41 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251.
Claim 7 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claims 1-5, 7-22, 24, 25, 27-29, 31, 32, 34-36, 38, 39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Angelini in view of Moretto.
Claims 6, 23, 30, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Angelini in view of Moretto and Webster.
Claims 26, 33, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Angelini in view of Moretto and Churchwell.
Summary of the Claims
287 Patent is directed to a Raman spectroscopy integrated perfusion cell culture system for monitoring and auto-controlling perfusion cell culture. Claims 1, 21, 28, and 35 are the independent claims. Claim 21 is representative:
21. A Raman spectroscopy integrated perfusion cell culture system for monitoring and auto-controlling perfusion cell culture, comprising:
a bioreactor, comprising:
(1) an interior chamber for receiving a cell culture,
(2) a port for feeding nutrient materials from a feed reservoir into the interior chamber,
(3) a port for auto-bleeding from the interior chamber, and
(4) a port for continuously harvesting materials from the interior chamber with the help of a cell retention system;
an analyzer, which is configured to collect Raman spectrum for monitoring perfusion cell culture;
a computer which is configured to receive the Raman spectrum and turn it into biochemical parameter values; and
a controller in communication with the computer, the feed reservoir or an auto-bleeding device, the controller being configured to control the feed reservoir for adjusting the feeding rate of nutrient materials into the bioreactor, or being configured to control the auto-bleeding device for auto-bleeding materials from the bioreactor.
Oath/Declaration
The reissue oath/declaration filed with this application is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following:
The declaration does not sufficiently describe an error upon which this reissue is based. Examiner acknowledges that Applicant states “new claim 21 does not require the use of immerse Raman probes.” However, for an application filed on or after September 16, 2012 that seeks to enlarge the scope of the claims of the patent, the reissue oath or declaration must identify a claim that the application seeks to broaden in the identification of the error that is relied upon to support the reissue application. A general statement, e.g., that all claims are broadened, is not sufficient to satisfy this requirement. For example, Applicant may state that claim 1 is broadened.
Furthermore, in specifically identifying the error as required by 37 CFR 1.175(a), it is sufficient that the reissue oath/declaration identify the claim being broadened and a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid.
Applicant must submit a new reissue declaration (rather than merely correct the error statement in remarks) because no proper reissue declaration has been yet entered in this reissue application.
Claim Rejections - 35 USC § 251
Claims 1-41 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office action.
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.
Claim 7 is 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.
Claim 7 is indefinite because there is insufficient antecedent basis for “the Raman probes.” Parent claim 1 previously recites “one or more Raman probes,” and it is unclear whether claim 7 requires plural Raman probes and not simply one Raman probe.
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 (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 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.
Claims 1-5, 7-22, 24, 25, 27-29, 31, 32, 34-36, 38, 39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Angelini in view of Moretto.
Regarding independent claim 1, Angelini discloses a Raman spectroscopy integrated perfusion cell culture system for monitoring and auto-controlling perfusion cell culture (Figures 1-3), comprising:
a bioreactor, comprising:
(1) an interior chamber for receiving a cell culture (i.e., bioreactor tank 10; paragraph [0068])),
(2) a port for feeding nutrient materials from a feed reservoir 28 into the interior chamber 10 (i.e., cap 12 includes ports, at least one of which connects to feed reservoir 28; paragraphs [0068]-[0073]),
(3) a port for auto-bleeding from the interior chamber 10 (i.e., cap 12 includes ports, at least one of which connects to bleed pump 40 and bleed tank 80; paragraphs [0068]-0073] and [0079]), and
(4) a port for continuously harvesting materials from the interior chamber 10 with the help of a cell retention system (i.e., filter system 100 is a cell retention system and cap 12 includes ports, at least one of which connects to filter system 100, harvest pump 50, and harvest tank 90; paragraphs [0068]-[0073], [0076]-[0077], [0081]-[0084]);
a Raman analyzer, comprising Raman probe 18 which is immersed into the bioreactor and are configured to collect Raman spectrum in the bioreactor (paragraphs [0071], [0074], and [0081]-[0082])
a controller 200 in communication with the Raman analyzer 18, the feed reservoir 28 and an auto-bleeding device (i.e., bleed pump 40), the controller being configured to receive the values from the Raman analyzer and compare them with preset parameters, and the controller further being configured to control the feed reservoir for adjusting the feeding rate of nutrient materials into the bioreactor, and being configured to control the auto-bleeding device for auto-bleeding materials from the bioreactor, based on results from comparing action (i.e., “Controller 200 may be configured to receive raw spectral data from Raman probe 18 to determine process parameters such as, e.g., glucose concentration, glutamine concentration, glutamate concentration, ammonia concentration, lactate concentration, total cell density, titer, and viable cell density. Controller 200 may use these determined process parameters to establish a feedback loop to adjust one or more of the fluid flow through feed pump 30, bleed pump 40, and harvest pump 50”; paragraph [0082]; see also paragraphs [0083]-[0091]).
Angelini discloses that controller 200 may comprise a computer that can turn collected Raman spectrum into biochemical parameter values (paragraphs [0089]-[0090]) but does not specifically disclose that the Raman analyzer itself comprises a host computer which is configured to receive the Raman spectrum collected and transferred by the Raman probe(s) and turn it into biochemical parameter values.
However, Moretto teaches system that is related to the one disclosed by Angelini, including a Raman spectroscopy integrated cell culture system including a Raman analyzer comprising a bioreactor and an immersed Raman probe collecting Raman spectrum from cell culture (Moretto, paragraphs [0008]-[0013]). Moretto further teaches that the Raman analyzer further comprises a host computer which is configured to receive the Raman spectrum collected and transferred by the Raman probe(s) and turn it into biochemical parameter values, while the bioreactor includes its own controller in communication with the Raman analyzer (Figure 4; paragraphs [0246]-[0251]). Moretto particularly teaches that Raman analyzers including a probe and a host computer are commercially available (e.g., from “Kaiser Optical Systems”; Moretto, paragraphs [0238] and [0246]), and Angelini also discloses that Raman analyzers are available from Kaiser Optical Systems (Angelini, paragraph [0075]). Regarding claim 1, it would have been obvious to a person of ordinary skill in the art to include a host computer in the Raman analyzer as taught by Moretto in the system disclosed by Angelini in order to process the Raman spectrum data and effectively provide feedback control to the bioreactor with predictable results using a known, commercially available type of Raman analyzer.
Regarding claim 2, in the system taught by Angelini in view of Moretto, Angelini discloses that the cell retention system (i.e., including filter system 100) is coupled to the bioreactor via the port for continuously harvesting materials from the interior chamber 10 (paragraphs [0076]-[0077] and [0081]-[0084]).
Regarding claim 3, in the system taught by Angelini in view of Moretto, Angelini discloses that the cell retention system 100 is selected from an Alternating Tangential Filtration (ATF) system, a Tangential Flow Filtration (TFF) system, an internal microfiltration system, a dielectrophoresis system, an acoustic resonance system or a gravitation, sedimentation system (e.g., alternating tangential flow filtration; paragraph [0077]).
Regarding claim 4, in the system taught by Angelini in view of Moretto, Angelini discloses that the system further comprises a product harvest reservoir (i.e., harvest tank 90; paragraph [0068]).
Regarding claim 5, in the system taught by Angelini in view of Moretto, Angelini discloses that the bioreactor further comprises a rotatable shaft coupled to an agitator 16 (paragraph [0073]).
Regarding claim 7, in the system taught by Angelini in view of Moretto, Angelini discloses that the Raman probes are configured to collect Raman spectrum in the bioreactor by detecting an intensity of scattered light in the bioreactor after the cell culture is exposed to a beam of light periodically (paragraph [0074]).
Regarding claim 8, in the system taught by Angelini in view of Moretto, Angelini discloses that the Raman analyzer further comprises a laser-emitting module which emits a laser into the bioreactor with excitation wavelength of 785 nm periodically (paragraph [0074]).
Regarding claim 9, in the system taught by Angelini in view of Moretto, Angelini discloses that the system further comprises a cover made of light-impermeable material (i.e., cap 12), and the cover is configured to cover the bioreactor when the laser-emitting module of the Raman analyzer emits a laser into the bioreactor periodically and the Raman probes collect the Raman spectrum by detecting an intensity of scattered light in the bioreactor (paragraphs [0071]-[0075]).
Regarding claim 10, in the system taught by Angelini in view of Moretto, Angelini discloses that the system is configured to incubate mammalian cells (paragraphs [0050]-[0053]).
Regarding claim 11, in the system taught by Angelini in view of Moretto, Angelini discloses that the collected Raman spectrum is correlated to biochemical indices selected from viable cell density (VCD), cell diameter, pH, pCO2, pO2, Na+ ions and K+ ions, glucose, glutamine, glutamate, lactate, ammonium ions and titer, or osmolality (paragraph [0082]).
Regarding claim 12, in the system taught by Angelini in view of Moretto, Angelini discloses that the system is configured to incubate animal cells, plant cells, bacteria cells or fungi cells (paragraphs [0050]-[0053]).
Regarding claim 13, Angelini in view of Moretto teaches a Raman spectroscopy integrated perfusion cell culture system according to claim 1 as discussed above, and Angelini further discloses a process for monitoring and auto-controlling perfusion cell culture by using the system comprising:
(a) culturing a starting amount of cells in a starting volume of basal medium in a bioreactor (Angelini, paragraphs [0010] and [0046]-[0048],
(b) collecting Raman spectrum by one or more Raman probes after exposing the cell culture to a beam of light periodically, and converting the collected Raman spectrum to biochemical indices (Angelini, paragraphs [0074]-[0075], wherein the step is performed by a host computer of a Raman analyzer as taught by Moretto; see Moretto, paragraphs [0246]-[0251]); and
(c) adjusting feeding rate of nutrient materials from a feed reservoir 28 into the bioreactor and auto-bleeding rate of the materials from the bioreactor by a controller based on results from comparing the biochemical indices with corresponding preset parameter values input into the controller (Angelini, paragraphs [0068]-[0084]).
Regarding claim 14, in the process taught by Angelini in view of Moretto, Angelini discloses continuously harvesting a cell product of interest from the bioreactor with the help of a cell retention system, and/or maintaining cells in the bioreactor based on their sizes through a cell retention system (i.e., filter system 100 is a cell retention system that maintains cells based on size; Angelini, paragraphs [0076]-[0078]).
Regarding claim 15, in the process taught by Angelini in view of Moretto, Angelini discloses that the cell retention system is selected from an Alternating Tangential Filtration (ATF) system, a Tangential Flow Filtration (TFF) system, an internal microfiltration system, a dielectrophoresis system, an acoustic resonance system or a gravitation, sedimentation system (e.g., alternating tangential flow filtration; Angelini, paragraph [0077]).
Regarding claim 16, in the process taught by Angelini in view of Moretto, Angelini discloses that the collected Raman spectrum is correlated to biochemical indices selected from viable cell density (VCD), cell diameter, pH, pCO2, pO2, Na+ ions and K+ ions, glucose, glutamine, glutamate, lactate, ammonium ions and titer, or osmolality (Angelini, paragraph [0082]).
Regarding claim 17, in the process taught by Angelini in view of Moretto, Angelini discloses that the process is used to continuously incubate animal cells, plant cells, bacterial cells, or fungi cells (Angelini, paragraphs [0050]-[0053]).
Regarding claim 18, in the process taught by Angelini in view of Moretto, Angelini discloses that the process is used to continuously incubate mammalian cells (Angelini, paragraphs [0050]-[0053]).
Regarding claim 19, in the process taught by Angelini in view of Moretto, Angelini discloses that the process is used to continuously incubate Chinese hamster ovary (CHO) cells, hybridomas, Baby Hamster Kidney (BHK) cells, myeloma cells, HEK-293 cells, human lymphoblastoid cells, E1 immortalized HER cells, NSO cells or SP/20 cells (Angelini, paragraphs [0050]-[0053]).
Regarding claim 20, in the process taught by Angelini in view of Moretto, Angelini discloses that the cells produce products of interest (Angelini, paragraphs [0050]-[0053]).
Regarding independent claim 21 and independent claim 28, Angelini discloses a Raman spectroscopy integrated perfusion cell culture system for monitoring and auto-controlling perfusion cell culture (Figures 1-3), comprising:
a bioreactor, comprising:
(1) an interior chamber for receiving a cell culture (i.e., bioreactor tank 10; paragraph [0068]),
(2) a port for feeding nutrient materials from a feed reservoir 28 into the interior chamber 10 (i.e., cap 12 includes ports, at least one of which connects to feed reservoir 28; paragraphs [0068]-[0073]),
(3) a port for auto-bleeding from the interior chamber 10 (i.e., cap 12 includes ports, at least one of which connects to bleed pump 40 and bleed tank 80; paragraphs [0068]-0073] and [0079]), and
(4) a port for continuously harvesting materials from the interior chamber 10 with the help of a cell retention system (i.e., filter system 100 is a cell retention system and cap 12 includes ports, at least one of which connects to filter system 100, harvest pump 50, and harvest tank 90; paragraphs [0068]-[0073], [0076]-[0077], [0081]-[0084]);
an analyzer, which is configured to collect Raman spectrum (or spectral data) for monitoring perfusion cell culture (i.e., an analyzer including Raman probe 18; paragraphs [0071], [0074], and [0081]-[0082]);
a controller (or controlling device) in communication with the analyzer, the feed reservoir 28 or an auto-bleeding device (i.e., bleed pump 40), the controller being configured to control the feed reservoir for adjusting the feeding rate of nutrient materials into the bioreactor, or being configured to control the auto-bleeding device for auto-bleeding materials from the bioreactor (i.e., “Controller 200 may be configured to receive raw spectral data from Raman probe 18 to determine process parameters such as, e.g., glucose concentration, glutamine concentration, glutamate concentration, ammonia concentration, lactate concentration, total cell density, titer, and viable cell density. Controller 200 may use these determined process parameters to establish a feedback loop to adjust one or more of the fluid flow through feed pump 30, bleed pump 40, and harvest pump 50”; paragraph [0082]; see also paragraphs [0083]-[0091]).
Further regarding claims 21 and 28, Angelini discloses that controller 200 may comprise a computer that can turn collected Raman spectrum/spectral data into biochemical parameter values (paragraphs [0089]-[0090]) but does not specifically disclose a separate computer which is configured to receive the Raman spectrum or spectral data and turn it into biochemical parameter values.
However, Moretto teaches system that is related to the one disclosed by Angelini, including a Raman spectroscopy integrated cell culture system including a Raman analyzer comprising a bioreactor and an immersed Raman probe collecting Raman spectrum (or spectral data) from cell culture (Moretto, paragraphs [0008]-[0013]). Moretto further teaches that the Raman analyzer further comprises a host computer which is configured to receive the Raman spectrum (or spectral data) collected and transferred by the Raman probe(s) and turn it into biochemical parameter values, while the bioreactor includes its own controller in communication with the Raman analyzer (Moretto, Figure 4; paragraphs [0246]-[0251]). Moretto particularly teaches that Raman analyzers including a probe and a host computer are commercially available (e.g., from “Kaiser Optical Systems”; Moretto, paragraphs [0238] and [0246]), and Angelini also discloses that Raman analyzers are available from Kaiser Optical Systems (Angelini, paragraph [0075]). Regarding claims 21 and 28, it would have been obvious to a person of ordinary skill in the art to include a host computer in the Raman analyzer as taught by Moretto in the system disclosed by Angelini in order to process the Raman spectrum data and effectively provide feedback control to the bioreactor with predictable results using a known, commercially available type of Raman analyzer.
Regarding claims 22 and 29, in the system taught by Angelini in view of Moretto, Angelini further discloses that the analyzer comprises Raman probes 18 which is immersed into (1) the bioreactor, (2) a product harvest reservoir that is connected to the bioreactor, and/or (3) a pipe that is connected to the bioreactor (Angelini, paragraphs [0017] and [0071]-[0074]).
Regarding claims 24 and 31, Angelini in view of Moretto teaches a Raman spectroscopy integrated perfusion cell culture system as discussed above with regard to claims 21 and 28 including a controller in communication with a computer as taught by Moretto (Moretto, Figure 4; paragraphs [0246]-[0251]). Angelini further discloses that the controller 200 is in communication with the feed reservoir 28 and the auto-bleeding device (i.e., bleed pump 40), the controller being configured to control the feed reservoir for adjusting the feeding rate of nutrient materials into the bioreactor, and being configured to control the auto-bleeding device for auto-bleeding materials from the bioreactor (Angelini, paragraphs [0083]-[0091).
Regarding claims 25 and 32, Angelini in view of Moretto teaches a Raman spectroscopy integrated perfusion cell culture system as discussed above with regard to claims 21 and 28 including a controller receiving values from a computer as taught by Moretto (Moretto, Figure 4; paragraphs [0246]-[0251]). Angelini further discloses that the controller is configured to compare values with preset parameters (Angelini, paragraphs [0012]-[0018] and [0082]).
Regarding claims 27 and 34, Angelini in view of Moretto teaches a Raman spectroscopy integrated perfusion cell culture system as discussed above with regard to claims 21 and 28 including a controller receiving values from a computer as taught by Moretto (Moretto, Figure 4; paragraphs [0246]-[0251]). Angelini further discloses that the controller is trained based on historical data from the bioreactor (Angelini, paragraphs [0100] and [0106]).
Regarding independent claim 35, Angelini discloses a method for monitoring and auto-controlling a perfusion cell culture, comprising:
(a) culturing a starting amount of cells in a starting volume of basal medium in a bioreactor, (Angelini, paragraphs [0010] and [0046]-[0048]),
(b) collecting spectral data by an analyzer (i.e., an analyzer including Raman probe 18) after exposing the cell culture to a beam of light periodically, and converting the collected spectral data to biochemical indices (Angelini, paragraphs [0074]-[0075]);
(c) adjusting feeding rate of nutrient materials from a feed reservoir into the bioreactor or auto-bleeding rate of the materials from the bioreactor by a controlling device 200 based on the biochemical indices (Angelini, paragraphs [0068]-[0084]); and
(d) continuously harvesting a cell product of interest from the bioreactor with the help of a cell retention system, and/or maintaining cells in the bioreactor based on their sizes through a cell retention system (i.e., filter system 100 is a cell retention system that maintains cells based on size; Angelini, paragraphs [0076]-[0078]).
Further regarding claim 35, Angelini discloses that controlling device 200 may comprise a computer that can convert collected spectral data into biochemical indices (paragraphs [0089]-[0090]) but does not specifically disclose a separate computer which is configured to convert the collected spectral data to biochemical indices.
However, Moretto teaches system that is related to the one disclosed by Angelini, including a Raman spectroscopy integrated cell culture system including a Raman analyzer comprising a bioreactor and an immersed Raman probe collecting spectral data from cell culture (Moretto, paragraphs [0008]-[0013]). Moretto further teaches that the Raman analyzer further comprises a host computer which is configured to receive the spectral data collected and transferred by the Raman probe(s) and convert it into biochemical indices, while the bioreactor includes its own controller in communication with the Raman analyzer (Moretto, Figure 4; paragraphs [0246]-[0251]). Moretto particularly teaches that Raman analyzers including a probe and a host computer are commercially available (e.g., from “Kaiser Optical Systems”; Moretto, paragraphs [0238] and [0246]), and Angelini also discloses that Raman analyzers are available from Kaiser Optical Systems (Angelini, paragraph [0075]). Regarding claim 35, it would have been obvious to a person of ordinary skill in the art to include a host computer in the Raman analyzer as taught by Moretto in the method disclosed by Angelini in order to process the Raman spectrum data and effectively provide feedback control to the bioreactor with predictable results using a known, commercially available type of Raman analyzer.
Regarding claim 36, in the method taught by Angelini in view of Moretto, Angelini further discloses that the analyzer comprises Raman probe 18 which is immersed into (1) the bioreactor, (2) a product harvest reservoir that is connected to the bioreactor, and/or (3) a pipe that is connected to the bioreactor (Angelini, paragraphs [0017] and [0071]-[0074]).
Regarding claim 38, Angelini in view of Moretto teaches a Raman spectroscopy integrated perfusion cell culture method as discussed above with regard to claim 35 including a controlling device in communication with a computer as taught by Moretto (Moretto, Figure 4; paragraphs [0246]-[0251]). Angelini further discloses that the controlling device 200 is in communication with the feed reservoir 28 and the auto-bleeding device (i.e., bleed pump 40), the controller being configured to control the feed reservoir for adjusting the feeding rate of nutrient materials into the bioreactor, and being configured to control the auto-bleeding device for auto-bleeding materials from the bioreactor (Angelini, paragraphs [0083]-[0091).
Regarding claim 39, Angelini in view of Moretto teaches a Raman spectroscopy integrated perfusion cell culture method as discussed above with regard to claim 35 including a controlling device receiving values from a computer as taught by Moretto (Moretto, Figure 4; paragraphs [0246]-[0251]). Angelini further discloses that the controlling device is configured to compare values with preset parameters (Angelini, paragraphs [0012]-[0018] and [0082]).
Regarding claim 41, Angelini in view of Moretto teaches a Raman spectroscopy integrated perfusion cell culture method as discussed above with regard to claim 35 including a controller receiving values from a computer as taught by Moretto (Moretto, Figure 4; paragraphs [0246]-[0251]). Angelini further discloses that the controller is trained based on historical data from the bioreactor (Angelini, paragraphs [0100] and [0106]).
Claims 6, 23, 30, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Angelini in view of Moretto as applied to claims 1, 21, 28, and 35 respectively above, and further in view of Webster.
Regarding claims 6, 23, 30, and 37, Angelini in view of Moretto teach a Raman spectroscopy integrated perfusion cell culture system and method as discussed above with regard to claims 1, 21, 28, and 35, including an analyzer with a Raman probe 18 as disclosed by Angelini, but does not specifically teach that the analyzer comprises two or more Raman probes, which measure different signals relative to each other.
However, Webster teaches a system and method that is related to the one taught by Angelini in view of Moretto, including Raman probes configured to collect Raman spectrum or spectral data (Abstract and paragraph [0060]), and further teaches two or more Raman probes that measure different signals relative to each other (paragraph [0118]). Regarding claims 6, 23, 30, and 37, it would have been obvious to a person of ordinary skill in the art to include two or more Raman probes measuring different signals relative to each other as taught by Webster in the system and method taught by Angelini in view of Moretto, in order to advantageously collect additional types of data and/or provide additional measurements for calibrating the system (Webster, paragraph [0118]).
Claims 26, 33, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Angelini in view of Moretto as applied to claims 21, 28, and 35 respectively above, and further in view of Churchwell.
Regarding claims 26, 33, and 40, Angelini in view of Moretto teach a Raman spectroscopy integrated perfusion cell culture system and method as discussed above with regard to claims 21, 28, and 35, including a computer as taught by Moretto, but does not specifically teach that the computer is configured to apply a second derivative processing to the Raman spectrum.
However, Churchwell teaches a system and method that is related to the one taught by Angelini in view of Moretto, including Raman probes configured to collect Raman spectrum or spectral data (Abstract and paragraph [0207]), and further teaches applying a second derivative processing to the Raman spectrum or spectral data (paragraphs [0016], [0045], and [0121]-[0124]). Regarding claims 26, 33, and 40, it would have been obvious to a person of ordinary skill in the art to apply a second derivative processing to the Raman spectrum or spectral data as taught by Churchwell in the system and method taught by Angelini in view of Moretto in order to advantageously correct the collected Raman spectral data against interfering signals before further processing (Churchwell, paragraphs [0122]-[0123]).
Conclusion
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which this reissue application is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Applicant is notified that any subsequent amendment to the specification and/or claims must comply with 37 CFR 1.173(b).
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 https://www.uspto.gov/patents/laws/interview-practice.
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Any inquiry concerning this communication or earlier communications from the examiner, or as to the status of this proceeding, should be directed to Examiner Christina Leung at telephone number (571) 272-3023; the Examiner’s supervisor, SPE Patricia Engle at (571) 272-6660; or the Central Reexamination Unit at (571) 272-7705.
/CHRISTINA Y. LEUNG/ Primary Examiner, Art Unit 3991
Conferees:
/DEANDRA M HUGHES/Reexamination Specialist, Art Unit 3992
/Patricia L Engle/SPRS, Art Unit 3991
Prosecution Insights