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 .
Status of the Application
1. Claims 1 and 3-13 are pending and subject to examination on the merits.
Priority
2. Acknowledgement is made of applicant’s claim for foreign priority based on an application filed in CN (CN202210779876.5) on 04 July 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Withdrawn Objections/Rejections
3. The objection to the drawings, specifically Fig. 3A for reciting “grouth” instead of “growth” is withdrawn, since the drawings were amended to recite “growth.”
4. The objection to claims 8-9 for reciting “lg” instead of “log” is withdrawn, since the claims were amended to recite “log.”
5. The objection to claim 6 for reciting “is marked” is withdrawn, since the claim was amended to recite “is labeled.”
6. The objection to claim 7 for reciting “conducting linear fitting” is withdrawn, since the claim was amended to recite “conducting a linear fitting.”
7. The objections to claim 8 are withdrawn, since the claim was amended to delete the objected elements.
8. The objection to claim 9 for reciting “(2’) conducting pathogen inactivation according to a same inactivation method on each of the pathogen solutions prepared in step (1’)” is withdrawn, since the claim was amended to recited “(2’) conducting the same pathogen inactivation methods on each of the pathogen solutions prepared in step (1’).”
9. The objection to claim 9 for reciting “taking a part having a linear function” is withdrawn, since the claim was amended to recite “taking the linear function.”
10. The objection to claim 9 for reciting “conducting calculation” is withdrawn, since the claim was amended to recite “conducting a calculation.”
11. The objection to claim 10 for reciting “(2) to pathogen culture under same conditions for a same time, and comparing a growth rate” is withdrawn, since the claim was amended to recite “(2) to pathogen culture under the same conditions for the same time, and comparing the growth rate.”
12. The objection to claim 11 for reciting “(2) to pathogen culture under same conditions for a same time, and comparing a growth rate” is withdrawn, since the claim was amended to recite “(2) to pathogen culture under the same conditions for the same time, and comparing the growth rate.”
13. The 35 U.S.C. 112(b) indefinite rejection of claim 10 for reciting “m parts” is withdrawn, since the claim was amended to recite “x parts.”
14. The 35 U.S.C. 112(b) indefinite rejection of claim 11 for reciting “m parts” is withdrawn, since the claim was amended to recite “x parts.”
Maintained/Modified Rejections—Necessitated by Amendments
Claim Rejections - 35 USC § 101
15. 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.
16. Claims 1 and 3-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a process) without additional elements that integrate the judicial exception into a practical application. An analysis with respect to the claims as a whole reveals that they do not include additional elements that integrate the judicial exception into a practical application. See MPEP 2106.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of the following steps:
Step (1) whether the claim is directed to one of the four categories recited in §101 (process, machine, manufacture or composition of matter);
Step (Revised 2A - Prong 1) do the claims recite an abstract idea (mathematical concepts, mental processes or method of organizing human activity), law of nature or natural phenomenon;
Step (Revised 2A - Prong 2) do the claims recite additional elements that integrate the judicial exception into a practical application; and
Step (2B) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. (See 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG)).
Step 1: Yes; the claims are directed to a process.
Step 2A – Prong 1: Yes, the claims recite an abstract idea, or mental process, where the pathogen inactivation effect is a calculated number that is compared to the maximum value of effective pathogen inactivation (MBEPI) as a standard reference index.
Step 2A – Prong 2: No, the claims do not recite any additional elements that integrate the judicial exception into a practical application because the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed aside from a comparison of a calculated logarithmic reduction factor with that of a calculated maximum value of effective pathogen inactivation (MBEPI), wherein this step can be an entirely mental step (e.g. abstract idea). The specific information that is being compared merely narrows the abstract idea, which does not make the comparison step less abstract and is not sufficient to provide eligibility on its own. In addition, the preparation of different concentrations and inactivation steps are recited at such a high level of generality as to not transform the judicial exception. This type of comparison of information has been held by the courts to be an abstract idea and that limits on the type of information being compared merely narrow the abstract idea.
Step 2B: No, as noted in answering that of 2A – This judicial exception is not integrated into a practical application because the comparison of the calculated log reduction factor and maximum value of effective pathogen inaction (MVEPI) because the claim recites a single step of comparing, which was identified as the abstract idea explained above. There are no other elements/steps recited in the claim utilizing this method, where specifically the claims were amended to recite high level steps for acquiring the MVEPI; however, there are no additional steps in the utilization thereof only a comparison. Accordingly, the claim as a whole does not amount to significantly more than the abstract idea of comparing information,
Claim Rejections - 35 USC § 102
17. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
18. Claims 1, 3-5 and 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quintero-Ramos et al. (Quintero-Ramos et al., 2004, Journal of Food Production—cited herein). Regarding claims 1, 3-5 and 7-11, drawn to an evaluation of pathogen inactivation effect, comprising: evaluating an inactivation effect as a log reduction factor after pathogen solutions have been inactivated by the equation logRF=log(N/No), where log RF is the log reduction factor (claims 7-11), N is the pathogen concentration before inactivation, and No is the pathogen concentration after inaction, where the concentration is detected by counting a cell culture (claim 3) of bacteria (claim 4), specifically E. coli (claim 5), Quintero-Ramos et al. teaches a log reduction factor calculated by log(N/No) and a subsequent graphing of the calculated reduction factors versus the doses of UV (p. 1154, equation (1); p. 1155, Table 1, Fig. 1). The pathogen concentrations of E. coli were determined from the cell cultures before and after exposure to UV irradiation (p. 1154, Experimental design.). The derivation of the data being compared does not necessarily matter.
Applicant’s Arguments and Examiner’s Rebuttal:
The Applicant traverses the previous 35 U.S.C. 101 and 35 U.S.C. 102 rejections of record. Specifically, the applicant argues that there is significantly more than an abstract idea or mental process recited in the claims due to the methodology of collecting the data and that the claims also recite additional features not recited in the anticipation rejection.
First, the applicant argues that claim 1 does not recite a mental process, and further, Applicant argues that the claim is directed to a concrete evaluation method for assessing pathogen inactivation effectiveness by reciting laboratory steps that cannot be performed in the human mind. Additionally, Applicant recites the laboratory steps necessary for calculating the data/MVEPI as a standardized reference to evaluate pathogen inactivation performance. However, the examiner respectfully disagrees. As claimed, claim 1 recites basic, high-level steps necessary to derive the data necessary to calculate an MVEPI. It does not subsequently utilize this data in a substantial manner to a practical application and is merely a comparison then of a calculated numerical value to a standard.
Second, the applicant continues to argue that the amended claims combine an element of physical preparation and treatment of biological samples and then use that data to formulate a MVEPI. However, again, this is a calculation and subsequent comparison to a pre-determined standard. There is no practical application after the calculation to determine inactivation efficiency. While the raw data may be collected empirically, the steps of collection are generic, not specific, and the calculations therefore are simply a mental process of calculation and subsequent comparison.
Third, the applicant argues that Quintero-Ramos fails to recite the specific evaluation method of data collection; however, the examiner respectfully disagrees, since Quintero
-Ramos discloses a method of calculating reduction values from samples exposed to UV inactivation, i.e. the same inactivation method. Again, the derivation of the data does not matter (as stated in the instant rejection above).
The examiner does not find the arguments presented by the Applicant persuasive, and for these reasons, the rejections of record above apply.
Conclusion
19. THIS ACTION IS MADE FINAL. 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.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571) 272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656
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