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 .
Claims 1-18, 20 and 22 are pending. Claims 1-13 are being examined on the merits. Claims 14-18, 20 and 22 are withdrawn.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-13), and the species of (a) molecular/nucleic acid-based method for detecting nucleic acid; (b) oxidizing biocides; and (c) zinc ions, without traverse in the reply filed on February 13, 2026 is acknowledged.
Claims 14-18, 20 and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 13, 2026.
Information Disclosure Statement
The Information Disclosure Statements submitted November 30, 2022 and June 17, 2025 have each been considered.
Claim Rejections - 35 USC § 112
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.
Claims 7 is 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.
Regarding claim 7, the phrase "preferably alkali and alkaline earth hypochlorite salts …" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d), which states that description of examples or preferences is properly set forth in the specification rather than in the claims so as not to lead to confusion over the intended scope of the claim. Claim 7 additionally recites five instances of “such as [a biocide]”, the meaning of which is unclear for the same reasons. Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite.
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 a judicial exception without significantly more.
Eligibility is considered in light of MPEP 2106 III, which incorporates the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG) published on January 17, 2019 (84 Fed. Reg. 50) and clarified in the October 2019 Update.
As can be seen in the MPEP 2106 III Figure, eligibility analysis requires one to address the following questions: (i) Step 1 – Is the claim directed to one of the four statutory categories (i.e., process, machine, manufacture or composition of matter); (ii) Step 2A – Is the claim directed to a judicial exception (i.e., a natural phenomenon, law of nature or abstract idea); and (iii) Step 2B – does the claim recite additional elements that amount to significantly more than the judicial exception. In addition, as can be seen in the MPEP 2106.04 II Figure, Step 2A is a two-prong inquiry, with Prong One asking whether the claims recite a judicial exception (i.e., an abstract idea, natural phenomenon or law of nature) and Prong Two asking whether the claims recite additional elements that integrate the judicial exception into a practical application.
In this case, as to Step 1, claims 1-13 are directed to one of the four statutory categories since they are drawn to a process.
The analysis cannot be streamlined, so the claims are considered with respect to Step 2A.
With respect to Prong One of Step 2A, claims 1-13 recite two judicial exceptions. Specifically, the correlation between the presence of nucleic acid from an organism in a sample and the generation of an amplification product using a primer pair, is a law of nature. In addition, the step of correlating amplification data with the presence of an organism in a sample is an abstract idea, specifically a mental process.
With respect to Prong Two of Step 2A, the claims do not recite additional elements that integrate the judicial exceptions into a practical application for the following reason. In particular, the claims do not recite additional elements that integrate the judicial exceptions into a practical application because the elements in the claims other than the judicial exceptions (i.e., obtaining a sample, performing PCR or qPCR) constitute insignificant extra-solution activity as described in the 2019 PEG and MPEP 2106.05(g).
In addition, in claims 1-8, the step of controlling bacteria by treating the suspension or process water with biocides and/or enzyme inhibitors is merely reciting an idea of a solution, but fails to recite details of how the solution is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application. MPEP 2106.05(f).
Thus, the answer to step 2A is “Yes, the claims are directed to a judicial exception,” and the analysis moves to Step 2B, which asks if the additional elements in the claim amount to significantly more than the judicial exception.
In this case, claims 1-13 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only routine and conventional elements are recited in combination with the judicial exceptions. As evidenced by Riihinen and Goessner (cited below in conjunction with the prior art rejections), obtaining a sample and conducting PCR were performed routinely prior to the effective filing date of the claimed invention. Riihinen also teaches treating a sample by administering a biocide (p. 11, ll. 16-20). Therefore, the additional elements in claims 1-13 are not non-routine or unconventional.
In view of the foregoing, claims 1-13 are rejected under 35 U.S.C. 101 as being drawn to a judicial exception without significantly more.
Claim Rejections - 35 USC § 102
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.
Claims 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goessner1 (Thermicanus aegyptius gen. nov., sp. nov., Isolated from Oxic Soil, a Fermentative Microaerophile That Grows Commensally with the Thermophilic Acetogen Moorella thermoacetica, Applied and Environmental Microbiology, 65(11): 5124-5133, 1999), as evidenced by GenBank Accession No. AJ242495.12 (Thermicanus aegyptius 16S rRNA gene, strain ET-5b, 2003).
Regarding independent claim 9 and dependent claims 10-12, Goessner teaches …
A method for determining a bacterium belonging to the family Thermicanaceae in a
sample, wherein the method comprises allowing a primer or probe, which is capable of specific hybridization with a polynucleotide, optionally an rRNA gene or rRNA polynucleotide, of a bacterium belonging to the family Thermicanaceae, and optionally the genus Thermicanus, to hybridize with said polynucleotide of a sample, optionally with PCR, and thereby determining the presence or absence of the bacterium or the level of the bacteria belonging to the family Thermicanaceae in said sample (abstract; p. 5125, left col., para. 6: PCR amplified 16S rRNA genes – the ordinary artisan understands this requires specifically hybridizing a primer to the 16S rRNA gene).
Further, regarding the optional limitation that the “one or more primers or probes is/are capable of hybridizing with an rRNA gene … of the bacterium belonging to the genus Thermicanus, within SEQ ID NO: 1”, Goessner teaches that PCR was performed on the Thermicanus aegyptius 16S rRNA gene with the EMBL/GenBank Accession No. AJ242295 (p. 5125, left col., para. 9). Instant SEQ ID NO: 1 is identical to the sequence in EMBL/GenBank Accession No. AJ242295.1. Thus, the primers used by Goessner in the PCR meet the limitation of being capable of hybridizing with instant SEQ ID NO: 1.
Claim Rejections - 35 USC § 103
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.
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Goessner (Thermicanus aegyptius gen. nov., sp. nov., Isolated from Oxic Soil, a Fermentative Microaerophile That Grows Commensally with the Thermophilic Acetogen Moorella thermoacetica, Applied and Environmental Microbiology, 65(11): 5124-5133, 1999), as evidenced by GenBank Accession No. AJ242495.1 (Thermicanus aegyptius 16S rRNA gene, strain ET-5b, 2003), as applied to claim 9 above, and further in view of An (US Patent App. Pub. No. 2003/0050470 A1).
Regarding dependent claim 13, Goessner does not teach any particular primer
sequences for detecting the Thermicanus aegyptius 16S rRNA gene. However, instant SEQ ID NO: 2 matches GenBank Accession No. AJ242495.1 nucleotides 638 to 659 with 100% homology, and instant SEQ ID NO: 3 matches the reverse complement of GenBank Accession No. AJ242495.1 nucleotides 853 to 873 with 100% homology.
Further, An teaches “[v]arious probes and primers can be designed around the disclosed nucleotide sequences. Primers can be of any length, but, typically, are 10-20 bases in length. By assigning numeric values to a sequence, for example, the first residue is 1, the residue is 2, etc., an algorithm defining all primers can be proposed:
n to n+y
where n is an integer from 1 to the last number of the sequence and y is the length of the primer minus 1 (9 to 19), where n+y does not exceed the last number of the sequence. Thus, for a 10-mer, the probes correspond to bases 1 to 10, 2 to 11, 3 to 12 … and so on. For a 15-mer, the probes correspond to bases 1 to 15, 2 to 16, 3 to 17 … and so on” (paras. 65-67).
Therefore, An not only teaches designing primers or probes based on a known sequence, but also teaches an algorithm for defining all possible primers and probes of a given length based on a known sequence. In this respect, An teaches that all possible subsequences of a known sequence could be considered as a primer or probe for that sequence. While An is discussing sequences having to do with prostate, bladder and breast cancer (e.g., abstract), the ordinary artisan would have recognized that the principles of designing primers and probes based on a disclosed nucleotide sequence would have applied to any nucleotide sequence under study.
Thus, Goessner teaches using PCR to detect the Thermicanus aegyptius 16S rRNA gene, while An teaches how to generate every possible primer to do so.
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to modify the method of Goessner using a primer pair that is specific to the Thermicanus aegyptius 16S rRNA gene in order to optimize the primers for the particular assay described in Goessner. The ordinary artisan would have had an expectation of success because primer design and optimization is well-known in the art, as described in An.
Claims 1-4 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Riihinen3 (WO 2016/135387 A1) in view of McDaniel (US Patent App. Pub. No. 2004/0175407 A1).
Regarding independent claim 1 and dependent claims 2-4 and 7-8, Riihinen teaches …
A method of determining bacteria in a cellulose fiber suspension, process water for a production method of a fibrous web, a fibrous web or a machine for producing a fibrous web, and controlling said bacteria, wherein the method comprises: determining bacteria in a sample obtained from cellulose fiber suspension, process water for a production method of a fibrous web, a fibrous web or a machine for producing a fibrous web, using a nucleic-acid based method utilizing one or more primers and/or probes (p. 1, ll. 8-16; p. 2, ll. 18-33; p. 3, ll. 17-31; p.8, ll. 10-16);
and controlling bacteria by treating the cellulose fiber suspension or process water for a production method of a fibrous web with one or more biocides one or more times, where the bacteria is controlled to a level of 0 – 1x104 bacteria/mL of process water (p. 4, ll. 1-22; p. 7, ll. 16-26; p. 8, ll. 4-8; Table 3: biocide treated broke sample has no detectable bacteria or spores).
McDaniel teaches that the bacteria belong to the family Thermicanaceae, specifically belonging to the genus Thermicanus (para. 21). McDaniel additionally teaches an oxidizing biocide of an ammonium salt (para. 77: ammonium benzoate), and an enzyme inhibitor comprising zinc ions derived from a zinc salt (para. 73: zinc pyrithione).
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to modify the Riihinen method to incorporate the McDaniel target. Riihinen and McDaniel both teach the importance of monitoring manufacturing processes, including for the production of various paper products, for the presence of contaminating bacteria. It would have been obvious for the ordinary artisan to try the McDaniel target in the Riihinen method in order to optimize the Riihinen method through routine experimentation in order to detect all relevant bacterial pathogens. The ordinary artisan would have had an expectation of success as substituting targets in nucleic acid assays is well-known in the art, and because Riihinen does not limit the method to any particular target(s).
It would have been additionally obvious to try the various biocide and enzyme inhibitor treatments in the modified Riihinen method, as such treatments are known in the art for being suitable for the purpose of controlling bacteria. MPEP 2144.07. Thus, it would have been obvious for the ordinary artisan to try the McDaniel treatments in the Riihinen method in order to optimize the Riihinen method through routine experimentation to achieve the intended result of controlling bacteria levels in the manufacturing process. The ordinary artisan would have had an expectation of success because Riihinen does not limit the method to any particular treatments.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Riihinen (WO 2016/135387 A1) in view of McDaniel (US Patent App. Pub. No. 2004/0175407 A1) as applied to claim 1 above, and further in view of Jerusik (Fungi and paper manufacture, Fungal Biology Reviews, 24, 68-72, 2010).
Regarding dependent claim 5, Jerusik teaches that the fiber suspension comprises
recycled fibers (p. 69, right col., para. 3).
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to try the Jerusik recycled fiber suspension in the modified Riihinen method, discussed above. Riihinen teaches that fiber suspensions are often contaminated with bacteria, while Jerusik teaches that this is particularly true of recycled products, which are often stored in less than optimal conditions. It would have been obvious for the ordinary artisan to try the Jerusik material in the Riihinen method with the expectation that doing so would result in the advantage of a method that can detect bacterial contamination in recycled products. The ordinary artisan would have had an expectation of success because Riihinen does not limit the method to any particular material.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Riihinen (WO 2016/135387 A1) in view of McDaniel (US Patent App. Pub. No. 2004/0175407 A1) as applied to claim 1 above, and further in view of Botta4 (Microbial community analyses by high-throughput sequencing of rumen microorganisms fermenting office paper in mesophilic and thermophilic lysimeters, Process Safety and Environmental Protection, 136, 182-193, 2020).
Regarding dependent claim 6, Botta teaches that the temperature of the cellulose fiber
suspension is at least 40°C (e.g., abstract: 55°C). Botta also teaches that Thermicanus aegyptius has optimal growth at 55-60°C (p. 190, left col., para. 1).
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to try the Botta sample in the modified Riihinen method, discussed above. Botta teaches that Thermicanus aegyptius has optimal growth at 55-60°C. Thus, it would have been obvious to try the cellulose fiber suspension sample of at a temperature of at least 40°C with the expectation that doing so would result in an assay that is optimized for detecting Thermicanus aegyptius when present in the sample. The ordinary artisan would have had an expectation of success as substituting samples in nucleic acid assays is well-known in the art, and because Riihinen does not limit the method to any particular sample.
Conclusion
Claims 1-13 are being examined and are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
1 Goessner was cited in the Information Disclosure Statement submitted November 30, 2022.
2 GenBank Accession No. AJ242495.1 was cited in the Information Disclosure Statement submitted November 30, 2022.
3 Riihinen was cited in the Information Disclosure Statement submitted November 30, 2022.
4 Botta was cited in the Information Disclosure Statement submitted November 30, 2022.