DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicants’ pre appeal brief of 5/27/2025 has been acknowledged. A pre-appeal conference was held on 7/23/2025 with SPEs Gary Nickol and quality review specialist Soren Harward. The appeal conference result was mailed on 7/24/2025 and was decided to reopen the prosecution.
Status of the Claims
3. Claims 1-6 and 21-22 are pending in this application. Claims 7-20 have been canceled by previous amendment. Claims 1-6 are under consideration. Newly submitted claims 21-22 were withdrawn from further consideration. Upon reconsideration claims 21-22 are going to be examined together with elected claims 1-6.
Claim Objections Withdrawn
4. Objection of claim 6 for reciting abbreviation qPCR, full name of said abbreviation is withdrawn in view of applicants’ amendment of 3/26/2025.
Rejection Withdrawn
Double Patenting
5. Rejection of claims 1-6 are provisionally rejected on the ground of non-statutory double patenting as being un-patentable over claims 1-3, 7-8 and 13-16 of co-pending Application No. 17/747,928 is withdrawn in view of amendment of claim 1 of application 17/747,928.
Rejection Withdrawn
Double Patenting
6. Rejection of claims 1-6 on the ground of non-statutory double patenting as being unpatentable over claims 1-3, 7-8, 13, 16, 17 of U.S. Patent No.US 10,935, 535, B2 is withdrawn in view of applicant’s arguments in the pre appeal brief of 5/27/2025.
Rejection Withdrawn
Claim Rejections - 35 USC § 103
7. Rejection of claims 1-6 under 35 U.S.C. 103 as being un-patentable over Alverez Martin et al. (WO2017186907 published Nov 2017; priority to April 29, 2016) as mentioned on claim 1 above, in view of Wilhelmsen et al. (US 2019/0049419 A1 published Feb 2019; priority to 62/543,220 filed Aug 2017) and Taylor et al. (Microbiology Insights, vol.7, pp.-15-24, 2014), is withdrawn in view of applicants arguments in the pre appeal brief of 5/27/2025.
New Rejection
Claim Rejections - 35 USC § 101
8. 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.
9. Claim 1-6 and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
"Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I). Abstract ideas include mathematical concepts, and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)). The claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than the abstract idea of “comparing the measured longitudinal changes with the immune response signature of the disease” and “identifying the antigen that elicits the immune perturbation”.
Step 1: The Four Categories of Statutory Subject Matter (MPEP 2106.03)
The claims are directed to a method, which is one of the categories of statutory subject matter.
Step 2A, Prong One: Whether the Claims Set Forth or Describe a Judicial Exception (MPEP 2106.04 § II.A.1)
Steps of measuring, obtaining or reporting information recited in the claims include “reporting the log of ratios of abundance as the lethality”.
Hence, calculating a log ratio is a mathematical operation. The claims must therefore be examined further to determine whether they integrate that abstract idea into a practical application (MPEP 2106.04(d)).
Step 2A, Prong Two: Whether the Claims Contain Additional Elements that Integrate the Judicial Exception(s) into a Practical Application (MPEP 2106.04 § II.A.2)
Claim 1 recites additional elements that are not abstract ideas: Measuring microbe abundances are insignificant extrasolution activity because they are only data gathering and are insufficient to constitute inventive steps that would render the claims significantly more than an abstract idea. (See MPEP 2106.05(g)). Hence, this step constitutes insignificant extrasolution activity, and does not integrate the abstract idea into a practical application (see MPEP 2106.04(d) § I; and MPEP 2106.05(g)).
Claim 4 is also directed to nothing more than abstract ideas (such as measuring metagenomic levels and a referenced enumeration is used to measure before and after microbial load), therefore such natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I).
Claim 21 is also directed to nothing more than abstract ideas (such as (such as a mathematical formula or equation), therefore such natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I).
None of the dependent claims recite any additional non-abstract elements; they are all directed to further aspects of the information being analyzed or the manner in which that analysis is performed. Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are directed to that abstract idea. Claims that are directed to abstract ideas must be examined further to determine whether the additional elements besides the abstract idea render the claims significantly more than the abstract idea. Claims that are directed to abstract ideas
and that raise a concern of preemption of those abstract ideas must be examined to determine what elements, if any, they recite besides the abstract idea, and whether these additional elements constitute inventive concepts that are sufficient to render the claims significantly more than the abstract idea
(MPEP 2106.05).
Step 2B: Whether the Claims Contain Additional Elements that Amount to an Inventive Concept (MPEP 2106.05)
As explained above, the steps when considered individually, are insufficient to constitute inventive concepts that would render the claims significantly more than an abstract idea (see MPEP 2106.05(g)).
Conclusion: Claims are Directed to Non-statutory Subject Matter
For these reasons, the claims, when the limitations are considered individually and as a whole, the claims are not significantly more than mathematical operations.
Claim Rejections - 35 USC § 102
10. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
11. Claims 1-3, 5 and 21 is rejected under 35 U.S.C. 102(a) (1) as being anticipated by Dull et al. US 20160021903.
Claim 1 recites:
A method for measuring a lethality of a process that is compatible with use during commercial food processing operations, the method comprising:
obtaining a before measure of microbial load of one or more genera or species of abundant wild type bacteria selected to serve as surrogates for one or more target organisms; obtaining an after measure of microbial load of the same abundant wild type bacteria; and reporting the log of the ratios of abundance as the lethality.
As to claims 1 and 21, Dull et al. teach methods and process in food processing operations (see abstract). Dull et al. para [0340] recites: Microbial load analysis was performed for lettuce both before ("Initial Micro") and after each wash treatment step. Microbial load reduction (expressed as a reduction: "Micro Red") was calculated by subtracting the microbial load after each wash treatment step from the microbial load before each wash treatment step ("Initial Micro"). Microbial load analysis was performed by APC testing as described in Example 1. Initial and post-treatment microbial loads are given in log units. The differences between experimental and corresponding control microbial reductions are expressed as log units. Dull et al. teach wild and pathogenic bacteria (see para 0331, 0332, 0362). The prior art anticipates the claimed invention.
As for claims 2 and 3 aggregating samples and wild-type bacteria, dull et al. para [0396] recites: Romaine lettuce was purchased from a local grocery store and prepared by removing all the leaves from five heads of lettuce. The leaves were then taken apart and chopped to mimic cutting for processed bag salads. The chopped leaves were mixed to obtain a random sample of multiple heads, as well as inner and outer leaves to obtain water that contained natural lettuce background microflora, 200 g of lettuce was dipped into 2 L of the treatment solution (water and pH 10 catholyte) for 20 seconds. The lettuce was removed, discarded, and 100 ml of solution was collected into sterile water sampling bottles containing sodium thiosulfate as a neutralizer (i.e. aggregating sample). After 60 seconds, an additional 100 ml of solution was collected in sterile water sample bottles containing sodium thiosulfate. An additional 200 g of lettuce was then added to the same treatment.
As to claim 5, Dull et al. para [0037] recites: As used herein, "sanitize" refers to reducing the microbial load on produce by treating with a sanitizer solution, such as a catholyte solution, a FAC solution, and/or a PAA solution, as compared to produce that has not been treated with the sanitizer solution. The reduction in microbial load may be determined by any method known in the art, for example by measuring total aerobic plate counts in colony forming units per gram (CFU/g) or by measuring total log unit reduction in microbial load. solution and sampled as described. This sampling protocol was repeated for a total of3 dips of lettuce and collection of water samples both following dipping the lettuce and waiting for 60 seconds. The water samples were serially diluted using PB as the diluent and plated on Total Plate Count Agar. The plates were incubated at 30° C. for 48 hours for enumeration of the bacteria that were present in the treatment water.
Claim Rejections - 35 USC § 103
12. The following is a quotation of 35 U.S.C. 103, which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
13. Claims 1-6 and 21-22 are rejected under 35 U.S.C. 103 as being un-patentable over Dull et al. US 20160021903, in view of Wilhelmsen et al. (US 2019/0049419 A1 published Feb 2019; priority to 62/543,220 filed Aug 2017).
The teachings of claim 1 has been mentioned above.
Regarding claim 2, Dull et al. teach where an aggregating sampler is used to collect sample of the abundant wild type bacteria for enumeration from which the after and/or the before measures are obtained. Additionally, in similar invention, Wilhelmsen et al. teach an aggregating sampler is used to collect sample (Wilhelmsen et al. abstract, "Certain aspects of the present disclosure relate to methods and apparatus for microbial sampling of foods. For example, a method may include providing at least one aggregating sampler al one or more sampling locations, and sampling a production lot of produce or other food items such as meat using the al least one aggregating sampler to create one or more samples that makes up a microbial sampling"). Therefore, it would 'lave been obvious to one of ordinary skill in the art to combine these references and incorporate the aggregating sampler by routine experimentation to optimize obtaining samples in Dull et al.., wherein used to collect sample of the abundant wild type bacteria for enumeration from which the after and/or the before measures are obtained (Dull et al. para (0340); because both references teach measuring microbials in food processing (Dull et al. para (abstract); Wilhelmsen et al. abstract).
Regarding claim 3, Dull et al. in view of Wilhelmsen et al. teaches the method of measuring lethality of claim 2. Wilhelmsen et al. further teaches where the aggregating sampler is one or more fixed catchers (Wilhelmsen et al. para (0034), "In one or more cases, sampling may include using a sampling sheet or swab that collects a sample"; see instant specification para (0027), "... a fixed catcher (e.g., swab) ..."),
Regarding claim 4, Dull et al. teach the method of claim 1, but does not teach where relative metagenomic levels and a reference numeration are used to measure either or both of the before and after measures of microbial load. However, in similar invention, Wilhelmsen et al. teaches measuring metagenomic levels (Wilhelmsen et al. abstract, "Certain aspects of the present disclosure relate to methods and apparatus for microbial sampling of foods..."; Wilhelmsen et al. para [0064), "In one or more cases, the sample may be analyzed with metagenomics ..."). Therefore, it would have been obvious to one of ordinary skill in the art to combine these references and incorporate measuring metagenomic levels wherein relative metagenomic levels and a reference enumeration are used to measure either or both of
the before and after measures of microbial load by routine experimentation to obtain microbial data (Wilhelmsen et al. para [0064], "... the sample nay be analyzed with metagenomics, allowing for the whole population to be studied yielding a large and in some cases a maximum amount of data which can be determined in various ways to gain knowledge and understanding of positive and negative deviations") because both references teach measuring microbials in food processing (Dull et al. para (0340); Wilhelmsen et al. abstract).
Regarding claim 5, Dull et al. teach the method of claim 1, where thiosulfate is used to quench as a neutralizer (see para 0386 and 0401).
Regarding claim 6, Dull et al. teach the method of claim 1, but does not teach where metagenomic studies are used to identify targets
which are then enumerated by direct qPCR. However, in similar invention, Wilhelmsen et al. teaches measuring microbials using metagenomic and qPCR (Wilhelmsen et al. abstract, "Certain aspects of the present disclosure relate to methods and apparatus for microbial sampling of food..."; Wilhelmsen et al. para [0034). "The targets are analyzed from the filter which may include for example, DNA purified and qPCR being run for Index elements including pathogen intensity, Enteric status, and/or positive control"; Wilhelmsen et al. para [0064), "In one or more cases, the samples may be analyzed with metagenomics..."). Therefore, it would have been obvious to one of ordinary skill in the art to combine these references and incorporate measuring microbials using metagenomic and qPCR wherein identifying targets which are then enumerated by routine experimentation to obtain microbial data (Wilhelmsen et al. para [0064). "... the sample may be analyzed with metagenomics. allowing for the whole population to be studied yielding a large and in some cases a maximum amount of data which can be determined in various ways to gain knowledge and understanding of positive and negative deviations") because both references teach measuring microbials in food processing (Dull et al. para [0340); Wilhelmsen et al. abstract).
Regarding claims 21 and 22, Dull et al. teach the method of claim 1, Additionally, Wilhelmsen et al. teach wild type bacteria (para 0066) as surrogate (para 0107 and claim 15) for pathogenic bacteria (para 0034, 0035, 0067, 0068, 0105, 0106) measuring before and after (para 0068) and measuring sensitivity (para 0031).
It would be obvious to one skill in the time the invention was made to combine the teachings as taught by the above references to obtain the claimed invention with a reasonable expectation of success, because all prior art references and the instant claims use methods and apparatus for microbial sampling of food and qPCR (See KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007). From the combined teaching of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing a method for measuring lethality of a process during food processing. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary
Conclusion
14. No claims are allowed.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHATOL S SHAHNAN SHAH whose telephone number is (571)272-0863. The examiner can normally be reached on Mon-Tue, Thu-Fri 12pm-8pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Nickol can be reached on 571-272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Khatol S Shahnan-Shah/
Examiner, Art Unit 1645
October 25, 2025
/GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645