DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed August 6, 2025, has been received and entered.
Claims 1-19 are pending. Claims 14-19 are withdrawn.
Claims 1-13 are examined on the merits.
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 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. All claims are directed to a statutory category, i.e. a process (Step 1: YES).
Claim 1: The claim recites three steps of recreating a medical device arranged in a sterilizer in a data structure, recreating an initial state in the data structure, and recreating the sterilization process by entering information about the sterilization process to the data structure, the recreating comprising step by step intervals of changes in temperature and in quantities of media occurring in each cell of the second multiplicity of cells of the data structure. These steps fall within the “Mental processes” grouping of abstract ideas since a data structure is a form of organizing data.
Also, claim 1 recites two final steps of calculating a reduction in a germ loading achieved in each cell of the second multiplicity of cells of the data structure during the sterilization process, and determining the effectiveness of the sterilization process based on the calculating. The last two steps of claim 1 fall within the “Mathematical Concepts” grouping of abstract ideas, since they involve a mathematical calculation. See MPEP 2106.04(a)(2)(I)(C).
Accordingly, claim 1 recites abstract ideas (Step 2A, Prong One: YES).
The judicial exceptions are not integrated into a practical application. The ‘additional elements’ other than the abstract ideas are (1) the limitation of the process being carried out by execution of a program code by a processor, and (2) the initial step of providing a data structure. Regarding the limitation of the process being carried out by execution of a program code by a processor, it does not integrate the judicial exceptions because it merely uses a generic computer element (a processor) as a tool to perform the abstract ideas. The limitation does not improve computer capabilities, and instead, invokes a computer element as a tool. The limitation describes how to generally “apply” the abstract ideas, and is recited at a high-level of generality such that it amounts to no more than mere instructions to apply the abstract ideas using a generic computer element. As indicated in MPEP 2106.05(f), simply adding a general purpose computer or computer components to an abstract idea does not integrate a judicial exception into a practical application. Regarding the step of providing a data structure, it gathers data by providing a data structure, so it is an insignificant pre-solution activity to the abstract ideas (the subsequent steps). Accordingly, the ‘additional elements’ of claim 1 do not integrate the abstract ideas into a practical application because they do not impose meaningful limits on practicing the abstract ideas (Step 2A, Prong Two: NO). Thus, claim 1 is directed to judicial exceptions, specifically abstract ideas (Step 2A: YES).
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exceptions. The additional element of carrying out the process by execution of a program code by a processor does not amount to significantly more than the abstract ideas because it amounts to no more than mere instructions to apply the abstract ideas. Mere instructions to apply a judicial exception using a generic computer component (in this case, a processor) cannot provide an inventive concept. See MPEP 2106.05(f) and MPEP 2106.05(I)(A). Regarding the additional element of the first step of claim 1, it is directed to insignificant pre-solution activity of data gathering in conjunction with the abstract ideas which does not add significantly more than the abstract ideas (the second step to the final step of claim 1). The courts have found that limitations adding insignificant extra-solution activity to the judicial exception, such as mere data gathering in conjunction with a law of nature or abstract idea, are limitations found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception (see MPEP 2106.05(I)(A)). In sum, the additional elements do not add ‘significantly more’ than the recited judicial exceptions (Step 2B: NO). As such, claim 1 is not eligible subject matter under 35 U.S.C. 101.
Claims 2 and 5-11: Claims 2 and 5-11 further limit the data, and further limit the abstract ideas. Thus, the analysis still follows according to the analysis for claim 1. As such, claims 2 and 5-11 are rejected under 35 U.S.C. 101 on the same basis as claim 1.
Claims 3 and 4: Claims 3 and 4 recite calculations. Moreover, claim 3 further limits the calculating step (second-to-last step) of claim 3. The calculations of claims 3 and 4 thus fall within the “Mathematical Concepts” grouping of abstract ideas. See MPEP 2106.04(a)(2)(I)(C). The same analysis with respect to the judicial exceptions of claim 1 apply to the judicial exceptions recited in claims 3 and 4. Thus, claims 3 and 4 are rejected under 35 U.S.C. 101 on the same basis as claim 1.
Claim 12: Claim 12 recites an initial step of stipulating a required reduction in a germ loading to be achieved by the sterilization process. It is drawn to making a judgment which falls within the ‘Mental Processes’ grouping of abstract ideas.
The next step of claim 12 is carrying out the process according to claim 1. As discussed above, claim 1 is not patent eligible subject matter since it is directed to abstract ideas without significantly more.
Then, claim 12 recites a step of comparing the reduction in the germ loading determined in each cell of the second multiplicity of cells of the data structure, and steps of classifying the sterilization process as effective or not effective. These steps are drawn to observations and evaluations which could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas. They fall within the ‘Mental Processes’ grouping of abstract ideas.
As such, claim 12 recites abstract ideas (Step 2A, Prong One: YES).
These judicial exceptions are not integrated into a practical application. The only ‘additional element’ other than the abstract ideas in claim 12 are the ‘additional elements’ of claim 1 (the limitation of the process being carried out by execution of a program code by a processor; the initial step of providing a data structure). For the same reasons as discussed above with respect to claim 1, these additional elements do not integrate the abstract ideas into a practical application (Step 2A, Prong Two: NO). Thus, claim 12 is directed to judicial exceptions, specifically abstract ideas (Step 2A: YES).
Claim 12 does not include additional elements that are sufficient to amount to significantly more than the judicial exceptions. As pointed out above, the ‘additional elements’ of claim 12 are the limitation of the process of claim 1 (incorporated by claim 12) being carried out by execution of a program code by a processor, and the step of providing a data structure of claim 1. For the same reasons as discussed above with respect to claim 1, these additional elements do not add significantly more than the abstracts ideas of claim 12 (Step 2B: NO). As such, claim 12 is not eligible subject matter under 35 U.S.C. 101.
Claim 13: Claim 13 further limits claim 12. In addition to the abstract ideas of claim 12 discussed above, claim 13 recites a final step of classifying the sterilization process as effective according to a comparison of actual reduction in the germ loading at a predefined point and a calculated reduction in the germ loading at a point of a medical device for a corresponding point. This step is drawn to an evaluation which could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas. They fall within the ‘Mental Processes’ grouping of abstract ideas. As such, claim 13 recites abstract ideas (Step 2A, Prong One: YES).
These judicial exceptions are not integrated into a practical application. The ‘additional elements’ other than the abstract ideas in claim 13 are the additional elements of claim 1 (limitation of the process of claim 1 being carried out by execution of a program code by a processor; the step of providing a data structure of claim 1) and the other steps recited in claim 13 of introducing a sample provided with a known germ loading at a predefined point of a medical device to be sterilized, carrying out the sterilization process to be validated with the medical device, and determining the reduction in the germ loading of the sample achieved by the sterilization process. As discussed above with respect to claim 1, the limitation regarding a processor does not integrate the abstract ideas of claim 1 (incorporated by claim 13) into a practical application. The step of providing a data structure of claim 1 and the other steps recited in claim 13 (the steps of introducing a sample, carrying out the sterilization process, and determining the reduction in the germ loading) are performed in order to gather data necessary to perform the steps which are abstract ideas; they are insignificant pre-solution activity. Thus, the additional elements of claim 13 do not add a meaningful limitation to the abstract ideas since the additional elements either merely provide generic computer implementation (the additional element of carrying out the process of claim 1 by execution of a program code by a processor) or are insignificant pre-solution activity (the other additional elements). Accordingly, the ‘additional elements’ of claim 13 do not integrate the abstract ideas into a practical application because they do not impose meaningful limits on practicing the abstract ideas (Step 2A, Prong Two: NO). Thus, claim 13 is directed to judicial exceptions, specifically abstract ideas (Step 2A: YES).
Claim 13 does not include additional elements that are sufficient to amount to significantly more than the judicial exceptions. As discussed above with respect to claim 1, the additional element of carrying out the process of claim 1 by execution of a program code by a processor merely provide generic computer implementation, amounting no more than mere instructions to apply the abstract ideas of claim 1 using a generic computer component. Such mere instructions cannot provide an inventive concept, thereby failing to amount to ‘significantly more’ than the judicial exceptions of claim 1 which are incorporated by claim 13. As pointed out above, the first step of claim 1 of providing a data structure is directed to insignificant pre-solution activity of data gathering in conjunction with the abstract ideas of claim 1. Likewise, the steps of claim 13 of introducing a sample, carrying out the sterilization process, and determining the reduction in the germ loading, are insignificant pre-solution activity of data gathering in conjunction with the abstract idea of claim 13 (the classifying final step) which do not add significantly more to the abstract ideas of claim 13. The courts have found that limitations adding insignificant extra-solution activity to the judicial exception, such as mere data gathering in conjunction with a law of nature or abstract idea, are limitations found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception (see MPEP 2106.05(I)(A)). In sum, the additional elements of claim 13 do not add ‘significantly more’ than the recited judicial exceptions (Step 2B: NO). As such, claim 13 is not eligible subject matter under 35 U.S.C. 101.
Response to Arguments
Applicant’s arguments, filed August 6, 2025, with respect to the rejections under 35 U.S.C. 112(b) and the provisional double patenting rejection over claims 1-10 of Application No. 17/617,952, have been fully considered and are persuasive. The rejections under 35 U.S.C. 112(b) have been overcome by the amendments to claims 1, 2, 4, 5, 7, 8, and 12. The provisional double patenting rejection has been rendered moot by the abandonment of Application No. 17/617,952. Therefore, these rejections have been withdrawn.
However, Applicant’s arguments are unpersuasive with respect to the rejections under 35 U.S.C. 101, which have been modified as necessitated by the amendments to the claims. Applicant asserts that claim 1 provides a dynamic simulation over time which tracks evolving conditions over time, and requires iterative updates and interactions across the grid. Applicant argues that a human mind cannot feasibly manage or manipulate such a large, dynamic grid with numerous cells, each requiring individual assignment and tracking of data, including the temperature and quantities of media. It is further asserted that the human mind does not have the capacity to process and update a large amount of data points in real-time across a three-dimensional grid, and performing such a time-based, multivariable simulation using only the human mind or with the use of a pencil and paper is impractical. However, not all of the abstract ideas recited in the claims fall within the “Mental Processes” grouping of abstract ideas, so Applicant’s argument does not apply to all the abstract ideas recited in the claims. In particular, the last two steps of claim 1 (calculating and determining based on the calculating) fall within the “Mathematical Concepts” grouping of abstract ideas.
While the recreating steps recited in claim 1 fall within the “Mental Processes” grouping of abstract ideas, the Examiner is not persuaded by Applicant’s argument. Claim 1 recites broadly a second multiplicity of cells without any limitation regarding the number of cells that are composed by the second multiplicity. Therefore, the second multiplicity of cells encompasses embodiments of a low number of cells, such as two cells. As such, contrary to Applicant’s assertion, the invention does not involve a large, dynamic grid with numerous cells. For a second multiplicity of cells directed to a low number of cells, it would have been possible for a human to perform the recreating steps in the human mind, or by a human using a physical aid such as pen and paper. As to the claimed step by step intervals of changes in the temperature, in the quantity of the first medium, and in the quantity of the second medium occurring in each cell of the second multiplicity of cells during the sterilization process, the claims provides no limits with respect to the number of intervals of changes in the three variables. The step by step intervals of changes are broadly drawn to any number of intervals and any length of intervals, such that the recreation of the sterilization process includes the embodiment of few instances of change in the variables, such as only a single change in each of the temperature, the quantity of the first medium, and the quantity of the second medium. Given that the recreation of the sterilization process can be for the embodiment of a low number of changes in the variables, then it is feasible for the human to use a physical aid such as pen and paper to perform the step of recreating the sterilization process as claimed.
Additionally, Applicant refers to Example 38 of the guidance for subject matter eligibility provided by the Office. Applicant compares the claim of Example 38 with instant claim 1 by characterizing the recreating steps of instant claim 1 as simulation steps, and comparing those simulation steps with the simulation step of the claim of Example 38. The analysis of Example 38 sets forth that the claim does not recite a mental process because the steps are not practically performed in the human mind. However, the technology of the simulation of Example 38 is different from that of instant claim 1 since an analog circuit for an analog audio mixer is more complex than a plurality of three-dimensional cells of instant claim 1 where there is no limitation regarding the number of cells composed by the second multiplicity of cells (see discussion above in response to Applicant’s arguments). As the Examiner maintains that the recreating steps of claim 1 fall within the “Mental Processes” grouping of abstract ideas, then Applicant’s argument in comparing Example 38 with claim 1 is unpersuasive.
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.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651