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 .
Applicant’s amendment filed on December 17, 2025 is acknowledged and has been entered. Claims 1-21 are pending.
Claims 1-21 are discussed in this Office action.
All of the amendments and arguments have been thoroughly reviewed and considered but are not found persuasive for the reasons discussed below. Any rejection not reiterated in this action has been withdrawn as being obviated by the amendment of the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is made FINAL.
Previous Grounds of Rejection
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 3-26 of copending Application No. 16729422 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the difference is minimal. The claims of the instant application and the claims of the ‘422 application are nearly identical. The instant claims are focused more broadly on enriched samples while the claims of the ‘422 application are drawn specifically to bacterial samples. Compare the steps of the ’422 application and the steps of the ‘139 application. Further, compare instant claims 1-8 to claims 1 and 3-7 where the dependent claims encompass dependent limitations including specific reducing agents (6-7 of ‘422 and instant claims) and cutoff values for further analysis (3-4 of ‘422 and instant claims).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments – rejection maintained
Applicant's arguments filed December 17, 2025 have been fully considered but they are not persuasive.
In response to the rejection under Obviousness type double patenting, Applicant notes “The non-statutory double patenting rejection is noted. A suitable terminal disclaimer will be submitted once allowable subject matter is indicated.” (p 7 of remarks).
Allowable subject matter has been indicated. However, the rejection under obviousness type double patenting is maintained in the absence of a terminal disclaimer.
Response to Arguments – arguments persuasive
Applicant’s arguments, see p 7-14, filed December 17, 2025, with respect to the rejection under 103 have been fully considered and are persuasive. The ground of rejection has been withdrawn.
Applicant’s arguments against the rejection over the combination of Pitkanen and Brinker were persuasive. In particular, Applicant’s arguments were persuasive in pointing out “Even if the references were combined, the combination would not achieve the claimed invention” (p 10 of remarks) and further that “For example, Brinker does not disclose analyzing a DNA extract with real-time PCR. Brinker does not determine a cycle threshold. Brinker does not analyze a difference in values to determine the presence of viable non-culturable cells. No qualitative assessment is performed”. Additionally, Applicant notes the teaching of Brinker has a “substantially different purpose than the present invention. The present claimed invention is intended to detect the presence of viable non-culturable waterborne pathogens” and that the step of the method focused on delta Ct analysis is needed to detect viable pathogens (p 12 of remarks).
While Pitkanen teaches analysis and comparison of amplification and cultures of extracts taken at multiple time points, Pitkanen does not teach the final step of the method (J) which requires an analysis of a difference in Ct (or delta Ct) between the extracts taken at specific time points and does not make a qualitative assessment of the presence of viable cells. Furthermore while Pitkanen calculates Ct using a standard curve, Pitkanen does not focus on the cycle threshold of the samples taken at specific time points as required by the instant claims in steps (G) and (H). Instead, the method of Pitkanen is focused on the enrichment of samples and using real time PCR alongside cultures of samples to achieve detection of Campylobacter more quickly. While the steps of Pitkanen are similar to the method as claimed, the goal is different, as Pitkanen is only focused on detection of bacteria in the samples and not particularly on identification of viable bacteria.
While there are many references that include analysis of delta Ct as part of analyzing results, none of the prior art teaches analyzing the difference in Ct between extracts taken at two separate time points following enrichment to determine the presence of viable but not culturable cells of the targeted waterborne pathogens in the liquid sample, as claimed.
While Kim et al. (Ann Lab Med, 2014, 34:203-209) and the instant method include a focus on the viability of bacteria present in the samples of interest and the culture status of the samples, the approach to determine viable and culturable samples was very different.
The method of Kim is focused on diagnosis of tuberculosis and evaluation of treatment response. Kim notes “The ability to determine the viability of AFB found in smear-positive sputum specimens would improve the monitoring of pa-tients and assist decisions regarding the clinical course”. In the method of Kim, the difference in Ct (or delta Ct) was compared between samples treated with PMA (propidium monoazide) as compared to untreated samples and in culture positive or negative samples (see Abstract and p 206). While the delta Ct comparison within Kim is connected to a measure of viability, as including a focus on bacteria that are either live or dead and includes a cutoff determination, the delta Ct comparison is not a comparison between extracts collected or incubated following time points, as in the instant method, or a measure of viability of cells present in either T0 or T2 extract, as claimed.
Most importantly, even if Kim were combined with Pitkanen, every step of the method would not be anticipated or rendered obvious by the combination of references as neither reference teaches a determination of cycle threshold for To or T2 or a comparison of Ct values between the extracts to determine the presence of viable but not culturable cells.
Finally, there is an additional reference Nocker et al. (J of Microbiol Methods, 2007, 70:252-260) which, like Kim, uses treatment with propidium monoazide combined with real time PCR to monitor the effectiveness of disinfection (Abstract). Nocker, like Kim, does not render the claimed method anticipated or obvious because while it does teach a comparison of Ct values, the comparison (or delta Ct) is not between samples taken at specific time points or to determine the presence of viable but not culturable cells.
As none of the prior art, alone or in combination, teaches all of the steps of the method, as claimed, the claims are novel and non-obvious over the prior art.
While claims 1-21 are free of the art, they are not in condition for allowance because they also stand rejected under obviousness type double patenting.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE KANE MUMMERT whose telephone number is (571)272-8503. The examiner can normally be reached M-F 9:00-5:30.
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/STEPHANIE K MUMMERT/Primary Examiner, Art Unit 1681