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 .
Request for Continued Examination
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/26/26 has been entered.
Claim Status
3. The amendment, filed 01/26/26, has been entered. Claims 1, 3-10, and 23 are pending. Claims 2, 11-22, and 24 are cancelled. Claim 1 is amended.
Declaration under 37 C.F.R. 1.132
4. The declaration under 37 CFR 1.132 filed 01/26/26 is insufficient to overcome the rejection of claims 1, 3-10, and 23 under 35 U.S.C. 103 as being unpatentable over Galvin et al. 2009 (WO2009/000893) in view of Sutton 2010 (Journal of Validation Technology, Summer 2010, pages 35-38); Woomer et al. 1990 (Agron. J. 82:349-353); and Avineon 2013 (Most Probable Number (MPN) Calculator; User and System Installation and Administration Manual), as set forth in the last Office action because:
It includes statements which amount to an affirmation that the claimed subject matter functions as it was intended to function. This is not relevant to the issue of nonobviousness of the claimed subject matter and provides no objective evidence thereof. Thus, there is no showing that the objective evidence of nonobviousness is commensurate in scope with the claims. See MPEP § 716 and a more detailed discussion following the maintained rejection below.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Withdrawal of Objections/Rejections
5. The following are withdrawn from the Office Action, filed 09/25/25: None.
New Rejection: Claim Rejections - 35 USC § 101
6. 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.
7. Claims 1, 3-10, and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. abstract ideas) without significantly more.
Amended claims recite “A method for detection … comprising the steps of… applying the Most Probable Number analysis method…” wherein the Most Probable Number analysis is a mathematical concept including mathematical relationships and calculations (i.e. see “a statistical estimation method” Remarks, filed 01/26/26, page 6). Thus, the claims are drawn to a statutory category (i.e. methods) and Step 1 of the subject matter eligibility analysis is yes. However, the claims also recite a judicial exception (e.g. mathematical concepts); and accordingly, Step 2A, prong 1, is also yes.
The judicial exception is not integrated into a practical application because the positively recited steps of distributing a liquid sample (step a) and allowing the microorganisms to grow (step b), amount to pre-solution data gathering steps required to subsequently execute the mathematical concepts of the MPN. Further, since there are no other required steps once the mathematical concept is completed, then nothing is actually done with the information gathered and, accordingly, the judicial exception is not integrated into a practical application because the inventive concept encompasses conducting mathematical concepts on routinely gathered data and then thinking about it (i.e. also an abstract idea of concepts performed in the human mind including observation, evaluation, judgement and opinion), as evidenced by Galvin et al. 2009 (WO2009/000893); Sutton 2010 (Journal of Validation Technology, Summer 2010, pages 35-38); Woomer et al. 1990 (Agron. J. 82:349-353); and Avineon 2013; each of record. However, it is also noted that merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea does not integrate an abstract idea into a practical application; see MPEP 2106.05(f). Therefore, Step 2A, prong 2, is no.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception(s) because there are no other elements in claims 1, 3-10, and 23 beyond specifying aspects of the pre-solution data gathering steps (e.g. volumes, sample type, detection reagents). Further, these data gathering steps are each recited at a high level of generality, as evidenced by the state of the art (see above). Consequently, taken alone, the additional elements do not amount to significantly more than the above identified judicial exceptions (i.e. abstract ideas: mathematical concepts). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually because there is nothing significant beyond the sum of their parts taken separately.
Therefore, Step 2B is no and the claims are rejected as ineligible subject matter under 35 U.S.C. 101.
New Rejection: Claim Rejections - 35 USC § 112
8. 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.
9. Claims 1, 3-10, and 23 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The term “appropriate” in newly amended claim 1, is a relative term which renders the claim indefinite. The term “appropriate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In other words, what would be “appropriate” to one skilled artisan might not be appropriate to another, so appropriate to whom and appropriate relative to what? Dependent claims do not clarify; accordingly, clarification is required to ascertain the metes and bounds of this claim.
Claim Rejections - 35 USC § 102
10. 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.
11. 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.
12. Claims 1, 4, 5, and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halverson et al. 1999 (WO 99/06589).
Halverson teaches methods for detecting a microorganism in a liquid test sample, comprising distributing microvolumes of the sample to a plurality of microcompartments of a culture device; incubating for a time sufficient to permit at least one cell division cycle of the microorganism; detecting the presence or absence of the microorganism in the microcompartments using quantitation via the MPN method without the need for serial dilutions and providing narrower 95% confidence intervals (e.g. see page 2, line 29 to page 3, lines 13; page 5, lines 8-28; page 12, lines 12-25; meeting limitations found in instant claims 1 and 9). Halverson teaches the microcompartments may be either uniform in size or vary incrementally including a specific example of volumes of 1, 3, 7, 14, 20 and 50 microliters repeated over a row of at least 10 (i.e. linearly increasing volumes in at least triplicate; e.g. page 13, lines 25-31; Figure 2 and Examples 5 and 10; meeting limitations found in instant claims 1 and 4). Halverson teaches the sample may be any sample containing microorganisms and may be used directly or diluted prior to distribution (e.g. page 9, lines 20-25; Example 6; meeting limitations found in newly amended claim 1). Halverson teaches explicit examples using 50 CFU/ml (e.g. see Examples 7 and 8; meeting limitations found in instant claim 5 and 9 with sufficient specificity; see MPEP 2131.03). Halverson teaches the use of nutrient media with indicator substances (e.g. see page 3, lines 14-22) and detection, with or without, an indicator including visually, microscopically or with the aid of other equipment (e.g. page lines 3-16; meeting limitations found in claims 8 and 10).
Accordingly, Halverson anticipates the invention as claimed.
Maintained Rejection: Claim Rejections - 35 USC § 103
13. 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.
14. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
15. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
16. Claims 1, 3-10, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Galvin et al. 2009 (WO2009/000893) in view of Sutton 2010 (Journal of Validation Technology, Summer 2010, pages 35-38); Woomer et al. 1990 (Agron. J. 82:349-353); and Avineon 2013 (Most Probable Number (MPN) Calculator; User and System Installation and Administration Manual).
Galvin teaches the Most Probable Number (MPN) method is routinely used worldwide in the field of environmental microbiology to detect and enumerate coliform bacteria in water samples including the use of three sets of tubes with 3 to 5 tubes each wherein the first set contains 10 ml of double strength broth and each tube in the set is inoculated with 10 ml of sample; then the second and third sets of tubes contain single strength broth and each tube is these sets is inoculated with 1 ml and 0.1 ml of sample respectively, followed by incubation to allow growth, and then results are compared to statistically determined most probable numbers (e.g. see page 3, lines 27-38; page 5, lines 32-38; page 9, lines 8-15; and Example 1; meeting limitations found in instant claims 1, 4, 8 and 10). Galvin teaches water samples include wastewater, environmental waters, and seawater and that the sample may be diluted first or not (i.e. dilution is a results effective variable; e.g. page 5, lines 25-30; and page 7, lines 11-15; and page 9, lines 25; meeting limitations found in instant claims 1, 6 and 7). Galvin teaches aqueous samples can be prepared by serial dilution so as to give a sample within the working range of the test, including on the order of <2000 MPN/100mls; 1 to 2000 MPN/100mls; preferably 10 to 1500 MPN/100mls, more preferably 500 to 1000 MPN/100mls; see page 7, lines 16-20; meeting limitations found in instant claim 5, with sufficient specificity; see MPEP 2131.03). Galvin teaches an appropriate indicator (i.e. microorganism-specific detection reagents) is added to the sample to facilitate detection (e.g. see page 6, lines 25-35; page 7, lines 21-22; and page 9, lines 12-13; meeting limitations found in instant claim 8).
Therefore, the difference between prior art and the invention is the use of linearly increasing volumes to create a linear dilution sequence (i.e. see independent claim 1 and dependent claims 3 and 23) and the calculation of confidence intervals (see dependent claim 9).
However, with regards to the use of a linear dilution sequence, as opposed to the more traditional exponential dilution sequence, Sutton teaches that the traditional version of the Most Probable Number (MPN) assay uses three replicates and a ten-fold (i.e. exponential) dilution series, but that there is no theoretical reason for these parameters and that it is well known that the accuracy of the method increases dramatically when increasing the number of replicates and decreasing the interval of the dilution series (see page 37, left column). Therefore, Sutton teaches that a person of ordinary skill in the art would (a) recognize that the interval of the dilution series is a results-effective variable (i.e. affects accuracy of results) and (b) have motivation to decrease the interval from exponential to less than that, which is toward linearity.
Further, Woomer teaches similar methods for detecting and quantifying microorganisms in liquid samples comprising analyzing the results of dilutions, including non-traditional dilution series, followed by time for the microorganisms to grow, and then using a computer program to calculate the most probable number of organisms in the original sample using the positive and negative results for the sample diluted to extinction (e.g. MPNES program; see abstract, and page 349, Materials and Methods). Woomer teaches the MPNES program allows adjustments for base dilution ratios and replicate number and combinations to meet specific degrees of accuracy (i.e. dilution is a results-effective variable; e.g. see page 351, left column; Tables 4A and 4B0 including non-standard dilution ratios (e.g. see page 351, right column) ranging from 2 to 5 replicates and dilution ratios of 1 to 14.5 (i.e. page 352, right column). Woomer teaches the ability to generate MPN estimates for nonstandard dilution ratios is important in several regards such as it can be used to further adjust the range of the MPN to the population densities expected by the researcher, fractional decreases in the base dilution ratio result in increased accuracy of MPN procedures through reduction of the confidence interval (see page 351, right column to page 352, right column). Woomer detected less than 100 CFU per 100 mL (i.e. 1 CFU per ml; see Table 5). Woomer teaches calculating the upper and lower 95% confidence intervals (e.g. see Tables 5 and 6). Woomer teaches the MPN technique is widely used to enumerate microorganisms in water (e.g. page 349, introduction).
Similarly, Avineon teaches similar methods for detecting and quantifying microorganisms in liquid samples comprising analyzing the results of dilutions for both standard serial (i.e. exponential) and non-standard (i.e. non-serial; non-exponential) dilutions; and that both options were routinely used with most probable number calculations, such that the number of test tubes and the volumes of sample represented at each dilution is entered by the scientist (i.e. teaches dilution is a results-effective variable; e.g. Section 1.0, Introduction; and section 4.2). Avineon also teaches generating confidence intervals ranging from 50 to 99% even with non-standard dilutions is routine in the field (e.g. see section 4.2; and section 5.1.1).
Therefore, it remains the Office’s position that it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to modify MPN-based methods for detecting and/or quantify microorganisms in water samples, as taught by Galvin, by using an optimized dilution sequence for the sample, including calculating confidence intervals from linearly diluted samples, thereby arriving at the claimed invention, in order to dramatically improve the accuracy of the results obtained, as taught by Sutton, Woomer, and Avineon. Therefore, each and every element is taught in the prior art and the combination has a beneficial result; however, the combination amounts to no more than a predictable use of prior art elements according to their established functions.
The person of ordinary skill in the art would have been motivated to make the modification because there were no theoretical reasons for the traditional parameters (i.e. for requiring an exponential dilution series) but it was well known that the accuracy of the method could be dramatically increased by decreasing the interval of the dilution series, as taught by Sutton. Further Woomer already recognized that the ability to generate MPN estimates for nonstandard dilution ratios was important because it could be used to further adjust the range of the MPN to the population densities expected by the researcher; and because fractional decreases in the base dilution ratio result in increased accuracy of MPN procedures through reduction of the confidence interval. Furthermore, Avineon taught the dilution amount is a user-selected input for the data analysis for MPN. Therefore, it remains the Office' s position that the dilution amount (i.e. linear vs. exponential) is an art-recognized, results-effective variable(s), and thus there is motivation for one of ordinary skill to optimize the dilutions through routine experimentation (see MPEP 2144.05II(B)).
The person of ordinary skill in the art would have had a reasonable expectation of success because Galvin had already taught methods for detection and quantification of microorganisms in water samples using the MPN method; and Sutton already taught that an exponential dilution series was not required and that decreasing the dilution interval (i.e. toward linearity) would dramatically improve accuracy; and Woomer had already demonstrated similar applications of MPN methods using non-traditional dilutions series and already demonstrated reporting results as confidence intervals; and Avineon had already demonstrated similar applications of MPN methods with non-traditional dilution sequences, including calculating the confidence intervals thereof. Therefore, the combination leads to expected results because each element performs the same function as it does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that applying a known technique to a known device, method or product ready for improvement is obvious because a particular known technique is recognized as part of the ordinary capabilities of one skilled in the art. In the instant case, Galvin contains a “base” method of using the most probable number approach to quantify microorganisms in water samples; and Woomer, Sutton, and Avineon all contain similar methods for using most probable number approach wherein the technique of using non-standard (i.e. non-exponential) series was recognized as advantageous (e.g. because decreasing the dilution increased the accuracy). Thus, one of ordinary skill in the art would have recognized that applying the known techniques taught by Avineon, Woomer and Sutton, to the methods taught by Galvin, would have yielded predictable results (i.e. the same advantages) and an improved system.
Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Applicant’s Arguments and Response to Arguments
17. All of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record. For example:
With regards to the argument that “…one having ordinary skill in the art would generally understand the MPN method to be a statistical estimation method, not a method that would inherently require serial dilution” and “… the mere use of the term "MPN method, such as used in claim 1, does not necessarily or unavoidably imply that multiple serial dilutions must be performed as part of the calculation or estimation process” (see Remarks, pages 6 and 7, respectively; and Declaration paragraphs 8-10); the Office agrees and notes these statements support the Office’s position that serial dilutions would not be required and thus the volumes to analyze would be a results effective variable to be optimized by the ordinary artisan. Accordingly, this argument is not persuasive.
With regards to all arguments referring to ISO 9308-2 (see Remarks, page 7 and Declaration, paragraph 9), it is noted that ISO 9308-2 was not part of the 103-rejection of record, so these arguments are not germane. However, in the interest of compact prosecution, it is also noted that ISO 9308-2 focuses on the enumeration of E. coli and coliform bacteria in water, specifically marine waters (see abstract), and thus is not commensurate in scope with the claimed invention which is not so limited. Furthermore, these arguments and this citation are not persuasive because ISO 9308-2 states that serial dilutions are not an essential requirement of an MPN analysis and that the skilled person would understand that (see Declaration, paragraph 9); and accordingly, these arguments support the Office’s position that the skilled artisan would recognize the volume of the sample (i.e. diluted or not) to be a results-effective variable of the prior art of, for example, Galvin et al. 2009 (i.e. the prior art would not be limited to serial dilution sequences) and accordingly the skilled artisan would have motivation to optimize the volumes tested through routine optimization; see MPEP 2144.05.
With regards to the arguments that the use of the MPN method on linearly increasing volumes represents a novel and non-obvious alternative implementation of the conventional MPN analysis, while improving statistical performance and simplifying handling (see Remarks, page 8), the Office disagrees and notes Applicant has not proffered any data or evidence of unexpected results compared to prior art (i.e. Applicant is also reminded that better is not necessarily unexpected; see MPEP 716.02(a) and 716.02(d)). Thus, this argument is not persuasive.
Therefore, all of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record.
Conclusion
18. No claims are allowed.
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. 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, Dan Kolker can be reached on (571)-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY MAILLE LYONS/Examiner, Art Unit 1645
February 20, 2026