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 .
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 02 January 2026.
CLAIMS UNDER EXAMINATION
Claims 1, 3 and 6-11 have been examined on their merits.
PRIORITY
The earliest priority is to the Provisional Applications filed on 18 October 2019.
WITHDRAWN REJECTIONS
The previous grounds of rejection have been withdrawn due to claim amendment.
REJECTIONS
New grounds of rejection have been necessitated by claim amendment.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3 and 6-11 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to nonstatutory subject matter as evidenced by the specification, Tsang et al. (20100068693) and Moretto et al. (cited as prior art below).
Based on the claims as a whole, claims 1, 3 and 6-11 are determined to be directed to a law of nature/natural principle. The rationale for the determination is explained below.
Question 1: Is the claim to a process, machine manufacture or composition of matter? Yes, the invention recited in claim 1 is a process.
Question 2A Prong 1: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions) ? Yes, claim 1 is directed to an abstract idea.
(a) The limitations in the claim that set forth the law of nature are:
The 2019 PEG explains that the abstract idea exception includes the following groupings of subject matter:
Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations;
Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
Claim 1 is directed to an abstract idea. The abstract idea is:
Calculating a daily nutrient feeding target based on viable cell density and a residual nutrient measurement such that the cell culture is expected to achieve a daily residual nutrient concentration within a predetermined range when measured one-day post-feeding. A mathematical calculation is a judicial exception. The PG Pub of the specification discloses the use of an algorithm ([0085][0086]). The algorithm concept originated from taking the thought process human operators used ([0088]). A thought is a mental process (a judicial exception).
Question 2A Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? No.
The claim recites receiving a sample from the bioreactor comprising a cell culture. This is an insignificant extrasolution activity required to gather data for the calculation step (the judicial exception). Claim 1 recites feeding the nutrient to the bioreactor according to the calculated daily feeding target. Feeding a cell culture is well known, routine and conventional. As evidenced by the specification (PG Pub), nutrient feeding is an important parameter for cell culture (see [0002]). As evidenced by Moretto, cell cultures are fed nutrients ([0025]). As evidenced by Tsang et al., nutrients are added to cell cultures ([0010]). The nutrient feeding does not amount to more than a recitation of the words “apply it” (or an equivalent) with the abstract idea.
Question 2B: Do the claims recite any additional elements? Yes.
With respect to Step 2B, limitations that were found to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
Improvements to another technology or technical field.
Improvements to the functioning of the computer itself.
Applying the judicial exception with, or by use of, a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application.
Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
With respect to Step 2B, limitations that were found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer
Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well understood, routine and conventional activities previously known to the industry
Adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea
Generally linking the use of the judicial exception to a particular technological environment or field of use.
Do the additional elements result in the claim amounting to significantly more?
No.
Regarding claim 1: Claim 1 recites the nutrient is glucose, glutamate or glutamine. Specifying the type of nutrient does not add significantly more to the recited judicial exceptions. While claim 1 recites feeding the nutrient according to the calculated daily nutrient feeding target, adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception does not amount to significantly more than the abstract idea.
Claim 3 further comprises recalculating the daily nutrient feeding target. A mathematical calculation is a judicial exception.
Claim 6 recites assaying a nutrient concentration in the bioreactor. The assay is recited at a high level of generality, and does not result in something significantly more than the recited judicial exceptions.
Claim 7 recites an inline or offline measurement. The measurements are recited at a high level of generality, and does not result in something significantly more than the recited judicial exceptions.
Claim 8 recites devices. The devices do not result in something significantly more than the recited judicial exceptions.
Claims 9-11 are directed to the cells being cultured. The cells do not result in something significantly more than the recited judicial exceptions.
Therefore claims 1, 3 and 6-11 are not eligible subject matter under 35 USC 101.
RESPONSE TO APPLICANT’S ARGUMENTS
The arguments made in the response filed on 02 January 2026 are acknowledged.
Argument 1: The arguments state the feeding step applies the calculated target to physically control nutrient delivery to a cell culture in a bioreactor. The Applicant argues this constitutes applying the judicial exception in a meaningful way.
Response to Argument 1: As set forth above, adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, does not amount to significantly more. As disclosed by the evidentiary references cited above, nutrient feeding is well known in cell culture. Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, does not add significantly more to the judicial exception.
Argument 2: The Applicant argues the physical step of feeding as recited in claim 1 “effects a transformation of the cell culture by adding nutrients based on the calculated target”. The Applicant argues provide a specific technical improvement to cell culture processes.
Response to Argument 2: “Transformation" of an article means that the "article" has changed to a different state or thing. A new or different function or use can be evidence that an article has been transformed. See MPEP 2106.05 (c). The cell culture contains cells and nutrient (e.g. glucose) before and after the calculation step is performed. The cell culture has the same function and use: cell growth. Therefore the argument is not persuasive.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3 and 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moretto et al. (previously cited; Cell Culture methods and systems. 20180291329 11 October 2018).
Moretto teaches methods and systems for improving cell culture performance by controlling a level of glucose being supplied to the cell culture based on one or more measured parameters, e.g. a level of glucose in the culture ([0005]). The art teaches the desired level of glucose depends on additional cell culture parameters, and both the level of glucose and the level of the additional parameter (“e.g., viable cell density”) are evaluated prior to making a decision on the adjustment of the level of glucose ([0188]-[0189]).
The art teaches a system comprising a bioreactor containing a culture of CHO cells ([0030]).The system comprises a probe that measures the amount of glucose in the bioreactor ([0030]). The amount of glucose present in a sample is evaluated ([0084]).The system comprises a controller which regulates the amount and/or frequency of glucose supplied to the bioreactor to maintain glucose at or below a set-point ([0030]).
The “desired level of glucose” to be added to the system is interpreted to read on calculation of a nutrient feeding target. The art teaches it is based on viable cell density and the level of glucose present in the cell culture (i.e., residual nutrient).
The art teaches a cell culture in a bioreactor ([0235]). Bolus nutrient feed additions proportional to the integral of viable cells (IVC) were supplied to cultures every 24 hours starting on day 2 ([0234]). In addition to nutrient feed, a 400 g/L glucose stock was administered to the production culture. When glucose is bolus fed, the 400 g/L stock was supplied daily to target a culture concentration of 2 g/L on the following day ([0235]). Glucose and viable cell density are measured ([0237]). Therefore samples are received, and viable cell density and residual nutrient is measured. Supplying bolus feed as recited is interpreted to read on calculating a daily nutrient feed target to achieve a residual concentration of 2 g/L on the following day (hence, the day after feeding). Because the art teaches the limitations recited in claim 1, the claimed method is anticipated.
Moretto teaches maintaining glucose at low levels (a predetermined range) in a cell culture ([0005]). Therefore claim 2 is included in this rejection.
Monitoring on a continuing basis includes continuous monitoring and/or monitoring at regular intervals (e.g., daily). ([0190]). Therefore claim 3 is included in this rejection.
Moretto teaches a Cedex Bio HT was used to measure (hence, assay) glucose ([0237]). Therefore claim 6 is included in this rejection.
The art teaches offline measurements at ([0237]). Therefore claim 7 is included in this rejection. Moretto uses a Ramen probe ([0239]). Therefore claim 8 is included in this rejection.
The art teaches bench scale production bioreactor studies were performed using light shielded 5 L glass Applikon bioreactors ([0235]). Therefore claim 9 is rejected.
CHO cells read on claims 10-11.
Claim 12 recites the daily nutrient feeding target is calculated based on a global average consumption and a growth profile. This is a product by process limitation. The art teaches the use of a historical process average obtained from glucose profiles for four controlled cultures ([0062] ([0063]). Therefore claim 12 is included in this rejection.
Therefore Applicant’s Invention is anticipated as claimed.
RESPONSE TO APPLICANT’S ARGUMENTS
The arguments made in the response filed on 02 January 2026 are acknowledged.
Argument 1: The Applicant argues Moretto teaches maintaining glucose at a target set-point or around a given set-point. See Moretto at paragraphs [0005] and [0189]. Moretto does not teach or suggest calculating a feeding target based on an expectation of what the residual nutrient concentration will be one day after feeding. The arguments state the claimed method requires a forward-looking calculation that accounts for anticipated
nutrient consumption over a one-day period to achieve "a daily residual nutrient concentration, of the nutrient, within a predetermined range when measured one-day post-feeding."
Response to Argument: As set forth above, Moretto teaches the level of glucose and viable cell density are evaluated prior to making a decision on the adjustment of the level of glucose. The art teaches samples from a cell culture in a bioreactor are analyzed. Moretto teaches bolus nutrient feed additions proportional to the integral of viable cells were supplied to cultures every 24 hours. In addition to the nutrient feed, a 400 g/L glucose stock was administered to the production culture. “When glucose is bolus fed, the 400 g/L stock was supplied daily to target a culture concentration of 2 g/L on the following day ([0235]). Therefore the art adds an amount of glucose to target 2 g/L glucose (a residual amount of glucose in the culture) on the following day. The arguments are not persuasive.
CONCLUSION
No Claims Are Allowed
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
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