DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/30/2026 has been entered.
Claims 1, 7, 10, 16-19, 22-23, 27 and 29 are pending in this application.
Applicant’s amendment to the claims filed 01/30/2026 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s remarks filed on 01/30/2026 in response to the final rejection mailed on 10/30/2025 are acknowledged and have been fully considered.
The rejections to claim 8 are withdrawn in view of the cancelation of the claim.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election
The elected subject matter is
Group I, corresponding to claims 1, 7, 10, 16-19, 22-23, 27 and 29, drawn to the technical feature of a method for fingerprinting a cell culture media and/or identifying optimal storage conditions for a cell culture media using Raman spectroscopy, comprising: collecting a Raman spectrum of the cell culture media, the cell culture media containing a mixture of one or more components, wherein the Raman spectrum of the cell culture media is compared to one or more reference spectra associated with each of the one or more components or a reference spectra associated with a reference media composition, wherein the collecting a Raman spectrum of the cell culture media is conducted about every hour, about every two hours, about every three hours, about every four hours, about every five hours, about every six hours, about every seven hours, about every eight hours, about every nine hours, about every ten hours, about every 11 hours, about every 12 hours, about every 13 hours, about every 14 hours, about every 15 hours, about every 16 hours, about every 17 hours, about every 18 hours, about every19 hours, about every 20 hours, about every 21 hours, about every 22 hours, about every 23 hours, or about every 24 hours; and wherein the Raman spectrum is an average of at least 5 data point,
elected without traverse in the reply filed 07/16/2024, and
Group IA, claims 1, 7-8, 10, 16-19, 22-23, 27 and 29, drawn to the technical feature of a method for detecting degradation in fingerprinting a cell culture media, comprising:
(i) collecting an average of at least five data points of a Raman spectrum of the cell culture media comprising a mixture of one or more components,
(ii) comparing the Raman spectrum of the cell culture media or more reference spectra associated with each of the one or more components or a reference spectrum associated with a reference media composition, and
(iii) discarding the cell culture media,
wherein the collecting of the Raman spectrum of the cell culture media is conducted every hour, every two hours, every three hours, every four hours, every five hours, every six hours, every seven hours, every eight hours, every nine hours, every ten hours, every 11 hours, every 12 hours, every 13 hours, every 14 hours, every 15 hours, every 16 hours, every 17 hours, every 18 hours, every 19 hours, every 20 hours, every 21 hours, every 22 hours, every 23 hours, or every 24 hours;
wherein each data point of the Raman spectrum is measured every 10 seconds, every 15 seconds, every 20 seconds, every 25 seconds, every 30 seconds, every 35 seconds, every 40 seconds, every 45 seconds, every 50 seconds, every 55 seconds, or every 60 seconds, and wherein a principle component (PC) score of the collected spectrum of the cell culture media is different from a reference PC score of a reference spectrum by 10 or higher.
elected without traverse in the reply filed 07/09/2025.
Claims 1, 7, 10, 16-19, 22-23, 27 and 29 are being examined on the merits.
Claim Objections
The objection to claim 8 is withdrawn in view of the cancelation of the claim.
Claim Rejections - 35 USC § 112(b)
Claims 1, 7, 10, 16-19, 22-23, 27 and 29 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 (claims 7, 10, 16-19, 22-23, 27 and 29 dependent therefrom) is indefinite for the phrase “wherein the PC score of the collected spectrum of the cell culture media is different from a reference PC score of a reference spectrum by 10 or higher”. It is unclear whether the reference spectrum recited in the limitation is the same reference spectra recited in part (ii) of the claim. If Applicant intends for the reference spectrum of the limitation to be the same reference spectra recited in part (ii) of the claim, it is unclear which reference spectrum is being used to determine the difference in PC score, as part (ii) of the claim recites multiple reference spectra.
Claim 7 (claim 10 dependent therefrom) is indefinite for the phrase “wherein the PC score is determined by analyzing the with a multivariate analysis”, as it is unclear what is being analyzed.
Response to remarks: Beginning on page 8 of Applicant’s response to rejections under 35 USC 112(b); Applicant in summary contends the amendments to the claims overcome the 112(b) rejections of record.
Applicant’s remarks are considered and found not convincing, as the limitation in claim 1 is indefinite as to which reference spectrum is being used to determine the difference in PC score.
Claim Rejections - 35 USC § 101
Claims 1, 7, 10, 16-19, 22-23, 27 and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims below were evaluated using “Subject Matter Eligibility Test for Products and Processes” as shown in MPEP 2016 III.
The instant rejection is maintained from the previous Office Action and any newly recited portions are necessitated by claim amendment.
Patent Eligibility Analysis Step 1: The claims are drawn to a process (method) which is one of the four statutory categories.
Patent Eligibility Analysis Step 2A Prong 1: The claims are directed towards the abstract idea of “comparing spectra” and “determining a principle component score” recited in claim 1. In the broadest reasonable interpretation of the claim, “comparing” requires the mental activity of analyzing at least two data values to reach a conclusion, and “determining a principle component score” encompasses the use of the abstract idea of math. Claim 7 is further directed towards the abstract idea of “analyzing”, and in the broadest reasonable interpretation “analyzing” is the mental action of evaluating data based on some criteria. Accordingly, claims 1, 7, 10, 16-19, 22-23, 27 and 29 are directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2: Claim 1 includes the additional elements regarding when to collect the spectrum, how many data points comprise each spectrum, the time for data to be measured, that the media contain a mixture of components. However these additional elements are directed to data gathering needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application as they are considered insignificant extra-solution activity (MPEP 2106.05(g)). Claim 1 also includes the additional element of discarding the cell culture media, however there is no connection between the judicial exception and the discarding, and there is no apparent requirement that the discarding step uses the information obtained by the judicial exception of “comparing” as recited in claim 1. The step of “discarding the cell culture media” is therefore considered to be a mere instruction to apply the judicial exception, as the recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more (MPEP 2106.05(f)).
Claims 7 and 10 recite additional elements regarding the method for analyzing the Raman spectrum, but these additional elements do not integrate the abstract idea for the reasons stated above.
Claims 16-18 recite additional elements regarding the effect of cell media on viability of cells and antibody titer, but this additional element does not integrate the abstract idea for the reasons stated above as they limit the culture media on which the abstract idea is being carried out.
Claim 29 recites an additional element regarding the comparison time of cell media, but the additional element does not integrate the abstract idea for the reasons stated above.
There are no additional elements recited in claims 19, 22-23, and 27.
Patent Eligibility Analysis Step 2B: Mulvaney et al. (Analytical Chem, 2000, 72:145R; cited on the attached Form PTO-892; herein referred to as Mulvaney) reviews Raman spectroscopy [title] and discloses that Raman spectroscopy can be used to obtain information such as hydrogen bonding and the time dependence of molecular structure in large macromolecules [p 146R, col 1, para 5], corresponding to the additional element regarding collecting spectrum at different times and for different intervals of time. Carey et al. (J Raman Spectroscopy, 1998, 29:7; cited on the attached Form PTO-892; herein referred to as Carey) reviews Raman spectroscopy used in enzymology [title] and discloses a Raman spectrum comprised of no less than 7 data points [Figure 1], corresponding to the additional element regarding the number of data comprising a Raman spectrum. Jolliffe et al. (Philosophical Transactions A, 2016, 374:20150202; cited on the attached Form PTO-892; herein referred to as Jolliffe) reviews principal component analysis [title] and discloses the data analysis technique of PCA to reduce dimensionality of large datasets to increase interpretability and minimize data loss [abstract], corresponding to the additional element regarding the method for analyzing the Raman spectrum. Poole et al. (J Biol Chem, 1973, 248:6221; cited on the attached Form PTO-892; herein referred to as Poole) discusses protein degradation in cultured cells [title] and discloses an additive to fresh culture medium that inhibits breakdown of proteins [abstract], indicating that spent media is associated with increased protein breakdown, corresponding to the effect of cell media on viability of cells and antibody titer. The disclosure of Poole to allow an additive to prevent breakdown of proteins associated with spent media is considered an implicit disclosure not to use certain media, or in other words, discard certain media that would negatively affect protein stability and cell viability. Hossain et al. (Middle East Fertility Society J, 2010, 15:179; cited on the attached Form PTO-892; herein referred to as Hossain) discusses shelf life for culture media [title] and discloses the relationship between media storage times relative to expiration dates and the effects on pH and time-dependent nutrient depletion [abstract], corresponding to the additional element of storage time for cell media. Hossain additionally discloses that manufacturers indirectly force media users to discard a considerable amount of unused media based on existing regulations that prevent the use of expired media [p 180, col 1, final paragraph].
In view of Mulvaney, Carey, Jolliffe, Poole and Hossain, the additional elements of collecting Raman spectrum at different times comprised of at least 5 data points, using PCA to analyzing the Raman spectrum, the effect of cell media on viability of cells and antibody titer, the use of Raman for different intervals of time, the effects of times on the viability of cell media, and the discarding of cell culture media are considered to be well-understood, routine and conventional activities previously known to the industry (MPEP 2106.05(d)), and therefore the judicial exception is recited without additional limitations amounting to significantly more than the exception. All of the signified additional elements to the judicial exceptions are considered to be required data collection steps of the judicial exceptions that are well-understood, routine and conventional, and, therefore, do not amount to significantly more than the judicial exception that is claimed.
As the instant claims recite judicial exceptions that are not integrated into practical application, and no elements that amount to significantly more than the judicial exception as recited, the claims were found not to be drawn to eligible subject matter under 35 U.S.C. 101.
Response to remarks: beginning on page 9 of Applicant’s response to rejections under 35 USC 101; Applicant in summary contends the amended claims are eligible as the judicial exception is integrated into practical application in light of the additional elements to establish the method as a whole as an improves another technology or technical field (MPEP 2106.04.d.1), as the method provides advantages to assess the quality of cell culture media compared to the standard at the time of the effective filing date regarding measuring sodium phosphate concentration in cell culture media.
Applicant’s remarks are considered and found not convincing, as the claims do not require the determination of sodium phosphate concentration through the recited steps. Additionally, while the claims recite (in relevant portion):
(i) collecting Raman spectra of cell culture media comprising a mixture of one or more components, wherein the one or more components comprise sodium phosphate,
(ii) comparing the spectra of the media to one or more reference spectra associated with each of the one of more components or a reference spectrum associate with a reference media composition,
the conjunction “or” underlined above indicates (a) the comparison to a spectrum from a reference media composition and (b) the comparison to spectra associated with each of the one or more components (e.g., sodium phosphate) to be alternatives for carrying out the method. Therefore the determination of sodium phosphate quality or concentration are not required in order to carry out the claimed method. The additional elements required by the method are discussed in Step 2B above, and are considered to be well-understood, routine and conventional, and therefore do not amount to significantly more than the JEs being claimed.
Claim Rejections - 35 USC § 103
The rejection of claims 1, 7, 10, 16-19, 22-23, 27 and 29 under 35 U.S.C. 103 as being unpatentable over Biogen et al. (WO 2016/004322 A2; cited on the IDS submitted 07/16/2024; herein referred to as Biogen) in view of Langdon et al. (Cell Culture Contamination, In: Langdon, S.P. (eds) Cancer Cell Culture. Methods in Molecular Medicine, 2004, 88:309, Humana Press; cited on the Form PTO-892 mailed 10/30/2025; herein referred to as Langdon) is withdrawn in view of the amendment to claim 1 to recite “wherein the one or more components comprise sodium phosphate”, as Biogen does not explicitly teach a cell culture media comprising sodium phosphate.
Claims 1, 7, 10, 16-19, 22-23, 27 and 29 are newly rejected under 35 U.S.C. 103 as being unpatentable over Biogen in view of Langdon and Ritacco et al. (Biotechnol Prog, 2018, 36: 1407; cited on the attached Form PTO-892; herein Ritacco).
The instant rejection is newly stated and necessitated by claim amendment.
Claim 1 is drawn a method for detecting degradation in cell culture media, comprising:
(i) collecting an average of at least five data points of a Raman spectrum of the cell culture media, comprising a mixture of one or more components,
(ii) comparing the Raman spectrum of the cell culture media to one or more reference spectra associated with each of the one or more components or a reference spectrum associated with a reference media composition, and
(iii) determining a PC score of the collected spectrum of the cell culture media,
(iv) discarding the cell culture media,
wherein the collecting of the Raman spectrum of the cell culture media is conducted every hour, every two hours, every three hours, every four hours, every five hours, every six hours, every seven hours, every eight hours, every nine hours, every ten hours, every 11 hours, every 12 hours, every 13 hours, every 14 hours, every 15 hours, every 16 hours, every 17 hours, every 18 hours, every 19 hours, every 20 hours, every 21 hours, every 22 hours, every 23 hours, or every 24 hours;
wherein each data point of the Raman spectrum is measured every 10 seconds, every 15 seconds, every 20 seconds, every 25 seconds, every 30 seconds, every 35 seconds, every 40 seconds, every 45 seconds, every 50 seconds, every 55 seconds, or every 60 seconds, and
wherein the PC score of the collected spectrum of the cell culture media is different from a reference PC score of a reference spectrum by 10 or higher, and
wherein the one or more components comprise sodium phosphate.
Biogen discusses cross-scale modeling of bioreactor cultures using Raman spectroscopy [title].
Regarding claim 1, Biogen discloses a method of defining a Raman signature of a culture component and using the Raman signature to establish the level of the culture component within the bioreactor culture [p 17, lines 7-10], wherein a Raman spectrum [Fig. 2A-2C] of cell culture media comprised of multiple components [shown in Table 1] is comprised of at least 5 data points [Figures 2A and 2B] and can be parsed with a generated reference library of Raman signatures of culture components that are associated with sample with a particular outcome, e.g. if a particular component is not aggregated or oxidized [p 34, lines 6-14], and wherein cell culture samples taken 24 hours a day at an interval of 6 hours before collection of Raman spectra [p 40, lines 26 to p 41, line 3].
Regarding claim 1 and the limitation of collecting data points for the Raman spectrum at specific times, Biogen discloses that monitoring on a continuous basis includes continuous monitoring at regular intervals including once per minute [p 30, lines 24-26].
Regarding claim 1 and the limitation of determining PC scores of collected spectrum, Biogen discloses the use of multivariate models to predict a molecular parameter that include PCA [p 12, line 11-26]. Therefore, Biogen teaches the generation of Raman spectra from collected cell culture media and the building of a reference library of cell culture media for comparison as described above, and additionally teaches the assessment of culture parameters using multivariate models developed from Raman spectral data obtained from bioreactor cultures [p 1, line 31 to p 2 line 3], and the use of multivariate PLS methods to build correlations into predictive models [p 30, lines 13-14] as well as any appropriate statistical model such as PCA [p 12, lns 19-25], which is understood to generate principle component (PC) scores.
As Biogen teaches the comparison of reference and collected Raman spectra, and the generation of multivariate models from Raman spectra, one of skill in the art would be motivated to further compare the scores of the multivariate models of the Raman spectra to achieve the assessment of culture parameters. Therefore Biogen is considered to suggest the comparing of scores of the multivariate models of the Raman spectra from reference and from collected samples to achieve the assessment of culture parameters.
As Biogen discloses culture parameters to be assessed include total cell density, viable cell density, protein production and cell metabolism components including amino acids, growth nutrients, and cell waste products in order to create real-time control of quality assurance [p 1, lns 9-28], the method of Biogen is considered to encompass the monitoring of media components via Ramen spectroscopy to determine the quality of cell culture media for use in or during cell culture applications.
In view of this interpretation, one of skill in the art would reasonably be expected to deduce that if the score derived from collected sample data was similar to the score derived from reference data, that the collected sample data would be considered similar to the reference data, corresponding to the determination of the collected sample data coming from stable cell culture media. While Biogen does not explicitly teach the similarity of PC score being 10 or above as determinative that a collected sample is considered dissimilar to stable culture media, one of skill in the art would be able to implement the method of Biogen at the claimed threshold that accounts for 10% difference as a common threshold in the art, as according to MPEP 2144.05.II.A, 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. Therefore the method of Biogen encompasses the limitation of collecting a Raman spectrum with a PC score that is different from a reference PC score by 10 or higher as recited in the claim.
Biogen does not teach the discarding of media and that the media comprises sodium phosphate.
Langdon relates to cell culture contamination [title], and discusses that contamination of cell cultures with biological organisms requires constant vigilance [p 309, para 1], and discusses general indications of such contaminations include changes in pH, turbidity and precipitation in the cell media [Table 1].
Regarding claim 1 and the limitation of discarding media, Langdon discloses that when contamination is recognized, contaminated flasks of cell culture media and cells should be discarded immediately and cell culture should be regenerated [p 312, final paragraph], as the consequences of proceeding with contamination can range from the minor inconvenience of a sample being contaminated to a major disaster of publishing invalid results that are due to such contaminations [p 309, para 1].
Ritacco relates to cell culture media for recombinant protein expression in Chinese hamster ovary (CHO) cells [title] and describes media that must support high viable cell densities while stimulating the synthesis of extracellular transport of biologic products [abstract].
Regarding claim 1, Biogen teaches the method described above carried out on cell culture media used in the culture of Chinese hamster ovary (CHO) cells to produce a monoclonal antibody [p 39, Example 1, para 1] which is considered to correspond to recombinant protein expression, however Biogen does not disclose sodium phosphate as a medium component. Ritacco teaches all cell culture requires the essential element phosphorous [p 1408, col 1, final paragraph], bulk ions added to CHO media include sodium and phosphate [p 1414, col 1, para 2], phosphate ions included in the medium can provide a major source of buffering capacity [p 1415, col 1, penultimate paragraph], and provides a list of media components that include sodium phosphate that is present in MEM and D-MEM media [Table 1].
In view of Biogen and Langdon, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Biogen by discarding media, as taught by Langdon, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the method of Biogen by discarding media, because Biogen discloses the comparison of reference and collected Raman spectra, and the generation of multivariate models from Raman spectra, to assess cell culture media parameters including total cell density, viable cell density, protein production and cell metabolism components including amino acids, growth nutrients, and cell waste products in order to create real-time control of quality assurance regarding the cell culture media, and Langdon discloses the discarding of cell culture media upon evidence of contamination to prevent the consequences of collecting data using poor quality cell culture media. One of skill in the art would have had a reasonable expectation of success, because Biogen relates to the assessment of the quality of cell culture media, and Langdon relates to the consequences of utilizing poor quality cell culture media caused by contamination.
In view of Ritacco, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined method of Biogen and Langdon by replacing the CHO cell culture media with the MEM or D-MEM of Ritacco to arrive at the claimed invention, since the simple substitution of one known element for another results in a predictable result. One of ordinary skill in the art would have recognized that the culture medium of Biogen and the MEM or D-MEM of Ritacco all are culture media used in the culture of CHO cells, and as such are capable of being incorporated into such methods as described by Biogen and Langdon. Thus it would have been obvious to one of ordinary skill in the art to replace the culture medium of Biogen with the MEM or D-MEM of Ritacco, as one of ordinary skill in the art would have been able to carry out such a substitution with a reasonable expectation of success because Biogen and Ritacco relate to culture media used for the production of recombinant proteins in CHO cells.
Regarding claims 7, Biogen discloses the use of multivariate models to predict a molecular parameter that include PCA [p 12, line 11-26].
Regarding claim 10, Biogen discloses the use of multivariate analysis such as PLS to produce predictive models for various nutrient, metabolic waste and cell growth parameters [p 12, lines 28-31].
Regarding claim 16, Biogen discloses the Raman spectra comparison to a reference wherein the media is degraded and reduces the viability of cells by approximately 10% or less in [Fig. 3A, comparison of actual vs. predicted, wherein error bars represent 10% for reference as disclosed in p 43, lines 24-25].
Regarding claim 17, Biogen discloses the Raman spectra comparison to a reference wherein the media is degraded and reduces the viability of cells by approximately 10% or less in [Fig. 3A, comparison of actual vs. predicted, wherein error bars represent 10% as disclosed in p 43, lines 24-25]. While Biogen does not disclose cell counts ranging from 1 x 106 cells/ml to 12 x 106 cells/ml as recited in the claims, Biogen does disclose the sampling of degraded culture media wherein VCD is decreased up to 10% as described above. One of skill in the art would be able to implement the method of Biogen at the claimed ranges of cell density, as according to MPEP 2144.05.II.A, 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.
Regarding claim 18, Biogen discloses the Raman spectra comparison to a reference wherein the media is degraded and reduces the viability of cells by approximately 10% or less in [Fig. 3A, comparison of actual vs. predicted, wherein error bars represent 10% for reference as disclosed in p 43, lines 24-25], and discloses the experiments used to generate the data involve a 13 day fed-batch process producing a monoclonal antibody via CHO cell line [p 39, final para]. The observed reduction in VCD of up to 10% in [Fig. 3A] is interpreted to correspond to the loss of a comparable amount of antibody titer of up to 10% as a mass percent, which corresponds to a loss of up to 1.0 g/L as recited in the claim.
Regarding claim 19, Biogen discloses Raman spectra of chemically defined media spiked with lactate [Fig. 6A].
Regarding claims 22-23, Biogen discloses the addition of lactate as a marker to the reference as described in the rejection of claim 19 above. Biogen further teaches that the disclosed method can be used for real time prediction of parameters including glucose, lactate, glutamate and ammonia [p 39, lines 15-19]. It would have been prima facie obvious for one of skill in the art to replace lactate with glutamate as a marker in a reference spectrum, since the simple substitution of one known element for another results in a predictable result. One of ordinary skill in the art would have recognized that both lactate and glutamate are components or parameters that can be used for real time assessment of cell media via Raman spectroscopy, and as such both are capable of being incorporated into the method of Biogen. Thus it would have been obvious for one of ordinary skill in the art to replace lactate with glutamate, as one of skill in the art would have been able to carry out such a substitution with reasonable expectation of success because Biogen names both lactate and glutamate as components of cell media.
Regarding claim 27, Biogen discloses Raman spectra measured in the range of 500 cm-1 to 3000 cm-1 [Fig. 2A].
Regarding claim 29, Biogen discloses Raman spectra of culture media for up to 13 days [Fig. 3A].
Therefore the invention of claims 1, 7, 10, 16-19, 22-23, 27 and 29 would have been obvious to one of ordinary skill in the art before the effective filing date.
Response to remarks: beginning on page 10 of Applicant’s response to rejections 35 USC 103; Applicant in summary contends the amendments to the claims to require sodium phosphate as a component of the analyzed cell culture media is a feature that is not taught or suggested by Biogen and Langdon, and therefore the claims as amended overcome the prior art rejection.
Applicant’s remarks are considered and found not convincing.
As Biogen and Langdon do not teach the feature of analyzing sodium phosphate media as stated by Applicant, the rejection of record has been withdrawn. However, new grounds of rejection are raised above as a result of these amendments. Briefly, Biogen teaches the method described above that is carried out on cell culture media from the culture of CHO cells to produce a monoclonal antibody [p 39, Example 1, para 1] which is considered to correspond to recombinant protein expression. Ritacco describes media used for recombinant protein expression on CHO cells that must support high viable cell densities while stimulating the synthesis of extracellular transport of biologic products, wherein examples of such a medium are MEM and D-MEM which comprise sodium phosphate. Thus it would have been obvious to one of ordinary skill in the art before the effective filing date to replace the cell culture medium of Biogen with that of Ritacco, as stated above.
As pointed out in the response section of 101 rejections above, the recitation of the media comprising sodium phosphate is stated in the claim such that the media is only required to comprise sodium phosphate, but the method of analyzing the media and determining PC scores does not require the analysis of or comparison to the sodium phosphate in view of the claim 1 limitation
“(ii) comparing the Raman spectrum of the media to one or more reference spectra associated with each of the one of more components or a reference spectrum associate with a reference media composition”
wherein the references being compared to the collected Raman spectrum are recited in the alternative.
Conclusion
Status of the Application:
Claims 1, 7, 10, 16-19, 22-23, 27 and 29 are pending.
Claims 1, 7, 10, 16-19, 22-23, 27 and 29 are rejected.
No claim is in condition for allowance.
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/JOSEPH R SPANGLER/
Examiner
Art Unit 1656
/David Steadman/Primary Examiner, Art Unit 1656
Prosecution Insights