DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1 and 3-20 are pending in this application, Claims 9-20 are acknowledged as withdrawn, Claims 1 and 3-8 were examined on their merits.
The rejection of Claim 3 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to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, has been withdrawn due to the Applicant’s amendments to the claims filed 04/15/2026.
The rejection of Claims 1, 3, 5 and 6 under 35 U.S.C. § 102(a)(2) as being anticipated by Liang et al. (CN113450882A), machine translation, cited in the IDS, has been withdrawn due to the Applicant’s submission of a Certified Translation of the Priority Document.
The rejection of Claims 1-8 under 35 U.S.C. § 102(a)(2) as being anticipated by Liang et al. (CN113450868A), machine translation, cited in the IDS, has been withdrawn due to the Applicant’s submission of a Certified Translation of the Priority Document
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.
Claims 1 and 3-8 are newly 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 1 now recites the limitation "the addition amount of each component" in Line 13. There is insufficient antecedent basis for this limitation in the claim as the limitation appears before the limitation in Line 20 of “acquiring an addition range of each component”. Claims 3-8 are rejected as being dependent on Claim 1.
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 and 3-8 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to Judicial Exception(s) without significantly more. The claim(s) recite(s) Abstract Ideas of Mathematical concepts and Mental processes. These judicial exceptions are not integrated into a practical application because they amount to a general linkage of the use of the JEs to a particular technological environment/field of use, that is, optimizing a basal culture medium. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Step 1) The claims are drawn to a process
Step 2A, P1) The claims recite the Judicial Exception of Abstract Ideas. Claim 1
now recites: "selecting and optimizing", "to determine", "for predicting", "acquiring",
"enumerating", "randomly selecting", "predicting", "searching within", "acquiring culture indicator data", "creating a data set" and "selecting";
Claim 5 recites, "creating a training data sample set" and "optimizing the
components";
Claim 7 recites, "acquiring", "enumerating and randomly selecting", "acquiring a
point value", "sorting the value sequences", "constructing a component value matrix",
"obtaining candidate basal culture medium formulations".
Claim 4 recites the Judicial Exception of a mathematical concept. Claim 4
recites, "the step of creating a training sample data set with the addition amount of each
component or its normalized value in the training formulation as an input matrix and the
culture indicator data as an output matrix, comprises
-forming a set of experimental data by input data (x1, x2, Xn) and output data
(y1, y2, Ym); wherein x; is the ith component of the basal culture medium formulation,
used as a feature during model training, verification and testing; y1 represents a cell survival rate, y2 represents a cell density, y3 represents a protein expression level,
and Ym represents the mth output indicator;
the input matrix of the regression model is X matrix, wherein Xij represents the jth
component of the ith formulation; and the output matrix is Y matrix, wherein Yij represents the jth output value of the ith formulation:
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Step 2A, P2) These judicial exceptions are not integrated into a practical
application because they amount to a general linkage of the use of the JEs to a
particular technological environment/field of use, that is, optimizing a basal culture
medium.
Step 2B) The claims do not recite additional elements that amount to significantly
more than the JEs. Claim 1 recites "conducting cell culture experiments by preparing basal culture media" and “culturing target cells with the prepared culture media”, see for example, Biniarz et al. whom recites testing various culture media containing different components and under different conditions to optimize lipopeptide production (Pg. 1, Abstract and Pg. 4, Table 1, Pg. 5, Tables 2-3, Pg. 7, Table 4 and Pg. 9, Table 5) and
which are recited with a high degree of generality, are mere data gathering, and are well-known and routine in the cell culture art.
Claim 3 merely lists culture indicators which can be monitored, Claim 6 recites
multiple alternative regression prediction models (which are themselves abstract
ideas/mathematical processes) and Claim 8 merely delineates the number of possible
candidate basal culture medium formulations.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/05/2026, with respect to the above withdrawn rejection have been fully considered and are persuasive.
Applicant's remaining arguments filed 04/05/2026 have been fully considered but they are not persuasive.
The Applicant argues that amended Claim 1 is not directed to a Judicial Exception but merely involves exceptions, that the claim is not directed to “predicting” in the abstract and does not recite mental processes as it involves “conducting cell culture experiments” as well as “sampling and detecting” that cannot be performed in the human mind (Remarks, Pg. 13, Lines 1-25).
This is not found to be persuasive for the following reasons, as stated above and in the prior action, at least claim 1 recites the Judicial Exception of Abstract Ideas. Claim 1 now recites: "selecting and optimizing", "to determine", "for predicting", "acquiring", "enumerating", "randomly selecting", "predicting", "searching within", "acquiring culture indicator data", "creating a data set" and "selecting" which are mental processes/Abstract Ideas which can be performed in the human mind.
While Claim 1 now recites some general steps of “conducting cell culture experiments” as well as “sampling and detecting” that cannot be performed in the human mind, these do not amount to “significantly more” than the Judicial Exceptions, being recited with a high degree of generality, are mere data gathering, and well-known and routine in the cell culture art.
The Applicant argues that Claim 4 is allegedly not directed to a Mathematical concept but rather is a practical workflow in which the model is used as one step of a physical process leading to cell culture experiments and validation, citing MPEP 2106.04(a)(2). Applicant argues that while Claim 4 includes an equation, the calculation is not executed in the abstract as it is practiced within the claimed workflow requiring physical method steps (Remarks, Pg. 13, Lines 26-30 and Pg. 14, Lines 1-16).
This is not found to be persuasive for the following reasons, the Examiner notes that the MPEP at 2106.04(a)(2) recites:
However, mere recitation of a judicial exception does not mean that the claim is "directed to" that judicial exception under Step 2A Prong Two. Instead, under Prong Two, a claim that recites a judicial exception is not directed to that judicial exception, if the claim as a whole integrates the recited judicial exception into a practical application of that exception
In this instance and as discussed above and in the prior action, the claim as a whole does not integrate the recited Judicial Exception/Mathematical Concept into a practical application of the exception(s) because they amount to a general linkage of the use of the JEs to a particular technological environment/field of use, that is, optimizing a basal culture medium.
The Applicant argues Claims 2 and 7 are directed to technological solutions for optimizing basal culture media based on the claimed workflow providing an alleged improvement over prior art processes (Remarks, Pg. 14, Lines 17-30 and Pg. 15, Lines 1-5).
This is not found to be persuasive for the following reasons, as discussed above and in the prior action, Claims 2 (now incorporated into Claim 1) and 7 are also drawn to Judicial Exceptions/Abstract Ideas and do not include additional elements sufficient to amount to significantly more than the JE.
Thus, the claims do not amount to an inventive concept because they recite Judicial Exceptions in addition to the recited Judicial Exception recited in Claim 1 from which they depend.
See the MPEP at 2106.05, I. which states:
("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). Instead, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
The Specification indicates that the existing technology requires multiple rounds of tests, each test not covering all components, takes a long time and requires professional theoretical scientific knowledge. Further, the resultant formulation may not be the optimal one (See Specification, as filed Paragraph [0004]). The Specification indicates that the claimed invention can recommend a basal culture formulation with the most potential in s short time and “could” solve the technical problems of slow development rate and high development cost (See Specification, as filed Paragraph [0020]). As noted above and in the prior action, both the Specification and the claims recite identified abstract ideas and are recited at a high degree of generality. Further, the Specification sets forth the alleged “improvement” in a conclusory manner using uncertain language without the detail necessary such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. See the MPEP at 2106.05(a).
The Applicant argues that Claim 1 integrates the judicial exception into a practical application because the method uses gathered data from cell culturing for regression prediction models to generate new data thereby providing improvements to the technology of basal media development (Remarks, Pg. 16).
This is not found to be persuasive for the following reasons, as discussed above and in the prior action, the judicial exceptions are not integrated into a practical
application because they amount to a general linkage of the use of the JEs to a
particular technological environment/field of use. That is, the physical method steps amount to mere data gathering (insignificant extra solution activity) using well-known cell culturing techniques to obtain input for a machine learning system and generally linking the use of the JEs to a particular technological environment/field of use, that is, optimizing a basal culture medium, and are not in improvement in the technological field
The Applicant argues the claimed method allegedly “transforms” an article (target cells, basal culture media) into a new and different function (experimentally measured datasets used to train and select regression models to derive improved media formulations) (Remarks, Pg. 17, Lines 1-25).
This is not found to be persuasive for the following reasons: the alleged “articles” are not particular being drawn to generic target cells and media, the alleged “transformation” is not particular being drawn to general datasets and modeling, and the transformation itself is mere extra-solution activity or field of use and would not provide significantly more (or integrate a judicial exception into a practical application) as discussed above.
The Applicant argues that Claims 1 and 3-8 involve other meaningful limitations of tangible collection of data about cell states and biochemical culture indicators) which is analyzed and employed in a tangible way to integrate the judicial exception into a practical application (Remarks, Pg. 18, Lines 1-26).
This is not found to be persuasive for the following reasons, as discussed above and in the prior action, the claim limitations generally link the judicial exceptions to a particular technology and recite physical method steps which are well-understood, routine, conventional activity recited at a high level of generality and therefore do not meaningfully limit. The Examiner notes that in contrast to the generally disclosed instant invention, Classen provided a tangible, physical method (immunization) step determined to be meaningful because it integrated the results of the analysis into a specific and tangible method.
The Applicant argues that Claims 1 and 3-8 as a whole form an inventive concept found in non-conventional arrangement of the components significantly more than the process steps performed in the abstract and recite physical steps which go beyond generic data manipulation. Applicant asserts the claimed method provides a technological improvement and is not routine and conventional (Remarks, Pg. 19, Lines 19-34 and Pg. 20).
This is not found to be persuasive for the reasoning provided in the above response to arguments and in the above rejections. Briefly, the judicial exceptions are not integrated into a practical application because they amount to a general linkage of the use of the JEs to a particular technological environment/field of use. That is, the physical method steps amount to mere data gathering (insignificant extra solution activity) using well-known cell culturing techniques to obtain input for a machine learning system and generally linking the use of the JEs to a particular technological environment/field of use, that is, optimizing a basal culture medium and are not in improvement in the technological field.
The Applicant notes the submission of Certified Translations of the two Chinese Patent Priority Documents in response to the two rejections under 35 U.S.C. § 102(a)(2) in view of Liang et al. (CN 113450882A and (CN113450808A), both cited in the IDS (Remarks, Pg. 21, Lines 9-28).
This is sufficient to remove the two documents as prior art and withdrawal of the rejections.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm 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, Sharmila G Landau can be reached at (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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/PAUL C MARTIN/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
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