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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/30/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
The program and method of claims 1 and 2 are drawn to a system and method for cultivating biological cells that uses a program stored in a memory to operate and move plate carriers within the system between different incubators. The program discloses various applications/programs (A1-3) stored in the memory with a specific treatment for a cell culture/carrier that it has been assigned to by the control module. Each of these applications have workflows/sub-programs (W1.1-1.3, etc…) that are specific instructions carried out on each cell culture ([0015], page 10; Fig. 1). These applications and workflows are performed in parallel with each other and the controller calculates a start time for each application (assigns a function to each workflow and sums the workflow active functions for each application).
It should be noted that the claimed invention are drawn to the statutory categories of a process and machine (i.e. a system) and would satisfy step 1 of the subject matter eligibility test.
For the Step 2A analysis, prong one, the specification describes that the workflows include steps such as a confluence scan, the addition of a detachment agent and cell removal ([0044], page 20). The controller also applies a value to each workflow and determines a start time for each Application (i.e. when to cultivate the cells in each carrier). This seems to support that the program executed by the controller is not an Abstract Idea, Law of Nature or Natural Phenomenon and thus this follows pathway B as not directed to a judicial exception.
Therefore the claims qualify as eligible subject matter under 35 U.S.C. 101.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification does not provide antecedent basis for the term “active function”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Both claims 1 and 2 reference the term “active function, W(t)” where this function is used calculate the start time for each of the work flows of an application. While an equation for the sum of these functions is provided, the specification does not discuss or provide an equation for calculating and using the active function.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The Nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 7331, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). With regards to factor (A), the breadth of the claims are such the disclosure is not commensurate with the scope of protection sought by the claims. Specifically, the scope of the claim limitations of “active function” is broader than the specification as any function can be used to determine the start time for each workflow. Furthermore, to achieve the timing of each workflow would require undue experimentation on one of ordinary skill in the art in order to make and use the claimed invention. For factor (B) regarding the Nature of the Invention, the prior art uses different method for determining the start times of each work flow. For example, Chao et al. (US 2019/0033819 A1) applies a time interval to each process and then starts the next operation at the indicated time ([0016]). This is different from the function used by the instant application as this requires undue experimentation in order to provide a function and value to each process step in order to calculate the start time. For Factor (C), the state of the prior art as indicated b Chao et al. (US 2019/0033819 A1) requires imposing a start time with a time interval for each process that is not dynamically determined like the active function of the instant application. The specific function used in the instant application would require undue experimentation for one of ordinary skill in the art based on the state of the art and how start times where determined at the time of filing. For Factor (D), the level of skill of one of ordinary skill in the art of this field is that of a PhD student, Post-Doctoral fellow or PhD level researcher. While this level of skill is high, the instant specification does not provide the guidance necessary nor does the field and prior art use these specific terms and functions in the automation of biological laboratory equipment. To make or use the claimed invention by the skilled artisan in this field requires undue experimentation that may require more time than simply programing the active function into a computer. For Wands factor (E), the level of predictability in the biological arts can be high depending on the manner in which the cells are cultured or processed based on time and cell growth. The instant application claims a function without providing sufficient guidance to one of ordinary skill in the art to determine how to schedule each of the workflows. Moreover, the unpredictable nature of assigning the active function to each workflow requires undue experimentation to one of ordinary skill in the art as this function is not described or provided in a manner that one of ordinary skill in the art could make or use this invention. Moreover, the active function is an unpredictable factor that requires further guidance and is not reasonably predictable. For that amount of guidance (Factor (F)) provided by the inventor, the instant specification lacks a working example ,either broad or narrow, that would provide some guidance or example that one of ordinary skill in the art could extrapolate from in a manner to make or use the claimed invention. Barring a discussion of how the active function is assigned to each workflow in an application, a data table, a working example or an equation of the active function that would provide some guidance, the process of using the claimed invention would require undue experimentation in order to reconstruct the active function as a means for scheduling the workflow in each application. For Wands Factor (G), the specification, as discussed for Factor (F), lacks a working example and therefore does not provide any guidance to one of ordinary skill in the art or a means to extrapolate the data from the specification in order to develop and use the active function. In order to do so, it would require undue experimentation on the part of one of ordinary skill in the art in order to make or use the claimed invention. Finally, the amount of undue experimentation (Factor (G)) that would be required by one of ordinary skill in the art is insufficient to enable a person skilled in the art to practice the claimed invention to a reasonable degree of experimentation. While some experimentation may be required in the practice of any claimed invention, it should be noted that a person skilled in the art would have to develop, test and implement the active function without any guidance or instruction from the instant specification or the inventor. As it currently stands, the active function is an unknown and unpredictable factor that is used within the claimed invention in such a manner that a person skilled in the cannot make or use the claimed invention.
Appropriate corrective action and clarification is required.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Abraham et al. (US 2022/0290091 A1) discloses a system for the automated process control that includes a generalized cell manufacturing process ([0042]; Fig. 1). However, Abraham does not teach or fairly suggest the method of calculating the start times based on a using an active function applied to each workflow/instruction implemented by the processor. Chao et al. (US 2019/0033819 A1) discloses a system for the automated workflow for a first set of targets within a set of process modules and each workflow consists of a number of instructions that are implemented within each module. However, Chao does not teach or fairly suggest the method of calculating the start times based on a using an active function applied to each workflow/instruction implemented by the processor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit
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