Prosecution Insights
Last updated: April 19, 2026
Application No. 18/344,501

EVALUATION METHOD OF PATHOGEN INACTIVATION EFFECT

Non-Final OA §101§102§112
Filed
Jun 29, 2023
Examiner
MCKNIGHT, CIARA A
Art Unit
1656
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Institute Of Blood Transfusion Cams
OA Round
1 (Non-Final)
65%
Grant Probability
Favorable
1-2
OA Rounds
3y 0m
To Grant
99%
With Interview

Examiner Intelligence

Grants 65% — above average
65%
Career Allow Rate
41 granted / 63 resolved
+5.1% vs TC avg
Strong +42% interview lift
Without
With
+41.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
23 currently pending
Career history
86
Total Applications
across all art units

Statute-Specific Performance

§101
3.5%
-36.5% vs TC avg
§103
35.4%
-4.6% vs TC avg
§102
16.7%
-23.3% vs TC avg
§112
35.2%
-4.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 63 resolved cases

Office Action

§101 §102 §112
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. Status of the Application 1. Claims 1-11 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. Drawings 3. The drawings are objected to because the Y-axis of Fig. 3A has an apparent typographical error, where “ grouth ” should be amended to “growth.” Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Objections 4. Claims 2 and 8-9 because of the following informalities: “lg” should be amended to “log” to conform with the rest of the claim limitation (log RF) and the drawings. Appropriate correction is required. 5. Claim 3 is objected to because “detected by counting…” in line 2 should be amended to “detected by a method selected from the group consisting of counting or calculating the number of pathogens in an in vitro cell culture, PCR , thermal curve analysis of terahertz (THz) metamaterial, and other pathogen detection methods” to improve grammar. 6. Claim 6 is objected to because “is marked” should be amended to “is labeled” to improve grammar. 7. Claim 7 is objected to because “conducting linear fitting” in lines 2, 5, and 8 should be amended to “conducting a linear fitting” to improve grammar. 8. Claim 8 is objected to because “(2) conducting pathogen inactivation according to a same inactivation method on each of the pathogen solutions prepared in step (1)” should be amended to “(2) conducting the same pathogen inactivation methods on each of the pathogen solutions prepared in step (1)” to improve grammar. 9. Claim 8 is objected to because “taking a part having a linear function” should be amended to “taking the linear function” to improve grammar. 10. Claim 8 is objected to because “conducting calculation” should be amended to “conducting a calculation” to improve grammar. 11. Claim 9 is objected to because “(2’) conducting pathogen inactivation according to a same inactivation method on each of the pathogen solutions prepared in step (1’)” should be amended to “(2’) conducting the same pathogen inactivation methods on each of the pathogen solutions prepared in step (1’)” to improve grammar. 12. Claim 9 is objected to because “taking a part having a linear function” should be amended to “taking the linear function” to improve grammar. 1 3 . Claim 9 is objected to because “conducting calculation” should be amended to “conducting a calculation” to improve grammar. 1 4 . Claim 10 is objected to because “(2) to pathogen culture under same conditions for a same time, and comparing a growth rate” should be amended to “(2) to pathogen culture under the same conditions for the same time, and comparing the growth rate” to improve grammar. 1 5 . Claim 11 is objected to because “(2) to pathogen culture under same conditions for a same time, and comparing a growth rate” should be amended to “(2) to pathogen culture under the same conditions for the same time, and comparing the growth rate” to improve grammar. Claim Rejections - 35 USC § 112(b) 16. 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. 17. Claims 10-11 are 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. 18. Claim 10 is indefinite for the recitation of “m parts.” “m parts” is not defined by the claim or specification. For examination purposes, the broad but reasonable interpretation of “m parts” will be treated as the colloquial “x parts” to mean any number of parts. 19. Claim 11 is indefinite for the recitation of “m parts.” “m parts” is not defined by the claim or specification. For examination purposes, the broad but reasonable interpretation of “m parts” will be treated as the colloquial “x parts” to mean any number of parts. Claim Rejections - 35 USC § 101 20. 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. 21. Claims 1 -11 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 a n 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 claim s 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. T his 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, a s 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. Accordingly, the claim as a whole does not amount to significantly more than the a b stract idea of comparing information Claim Rejections - 35 USC § 10 2 22. 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. 23. Claims 1- 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- 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 = l o g(N/N o ), where log RF is the log reduction factor (claims 7-11), N is the pathogen concentration before inactivation, and N o is the pathogen concentration after inaction (claim 2), 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/N o ) 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. Conclusion 2 4 . All claims are rejected. Any inquiry concerning this communication or earlier communications from the examiner s hould be directed to FILLIN "Examiner name" \* MERGEFORMAT CIARA A MCKNIGHT whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-4791 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8:00am-4:30pm . 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, 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CIARA A MCKNIGHT/ Examiner, Art Unit 1656 /SUZANNE M NOAKES/ Primary Examiner, Art Unit 1656
Read full office action

Prosecution Timeline

Jun 29, 2023
Application Filed
Dec 21, 2025
Non-Final Rejection — §101, §102, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
65%
Grant Probability
99%
With Interview (+41.7%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 63 resolved cases by this examiner. Grant probability derived from career allow rate.

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