DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office Action is in response to the paper filed 2 July 2025. Claims 29 and 44 have been amended. Claim 36 has been cancelled. Claims 33 and 38-43 remain withdrawn. Claims 29-32, 34, 35, 37, and 44-48 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/US2020/039736, filed June 26, 2020, which claims priority to U.S. Provisional Application No. 62/867184, filed June 26, 2019.
Withdrawal of Rejections:
The rejection of claims 36 and 44 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
The rejection of claims 29-32, 34-37, 45, 47, and 48 under 35 U.S.C. 103 as being unpatentable over Plakas, is withdrawn.
The rejection of claims 29 and 44 under 35 U.S.C. 103 as being unpatentable over Plakas, and further in view of Hygiena, is withdrawn.
The rejection of claims 29, 45, 46, and 48 under 35 U.S.C. 103 as being unpatentable over Plakas, and further in view of Aneja et al. is withdrawn.
New Rejections Necessitated by Amendment:
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.
Claims 29-32, 34, 35, 37, and 44-48 are rejected under 35 U.S.C. 103 as being unpatentable over Picciolo et al. (IDS; US 3,971,703; Published 1976), in view of Swenson et al. (US 2019/0136226; Published May 9, 2019), and further in view of Daly et al. (US 2013/0273582; Published 2013).
With regard to claims 29, 31, 32, and 34, Picciolo et al. teach a method for determining amounts of bacteria in an aqueous physiological fluid including urine (Abs.; Col. 2, line 59-62), which is a liquid sample that is not bovine milk. The method comprising concentrating the liquid sample by centrifuging (Col. 3, line 5-7). Treating the sample with a non-ionic surfactant which lyses non-microbial cells selectively, and puts the ATP from the non-microbial cells in soluble free form (Col. 2, line 65 to Col. 3, line 1). An apyrase, which is an ATPase, is then added to destroy the free non-bacterial ATP (Col. 3, line 7-9). The apyrase is then destroyed (Col. 3, line 17), which is deactivated. The bacterial cells are ruptured with a bacterial releasing agent, such as nitric acid, to provide free bacterial ATP (Col. 3 line 17-20). The free bacterial ATP is then treated with a luciferin/luciferase reagent (Col. 3, line 23-29). The bacteria are then quantified by measurement of bioluminescence (Col. 3, line 30-33). As Picciolo et al. teach these steps, it would have been obvious to an ordinary artisan to utilize each of the expressly taught steps in the method for determining an amount of bacteria in an aqueous physiological fluid sample, as desired.
As noted, the method comprises concentrating the liquid sample by centrifuging (Col. 3, line 5-7). It is further taught that after centrifuging steps, the sample is placed on filter paper to provide a pellet for further treatment (see Example 7). As such, it would have been obvious to one of ordinary still in the art to utilize filter paper to filter the liquid sample following centrifugation, where the porosity of the filter paper is such that the bacterial and somatic cells remain on the filter paper as a pellet, which is a retained residue.
Picciolo et al. teach that the non-ionic surfactant for selective lysis of the non-microbial cells includes TRITON® X-100, however, other detergents that lyse cell membranes but do not rupture bacterial cells walls may be used instead (Col. 3, line 46-51). Picciolo et al. do not teach that the non-ionic surfactant for selective lysis is Nonoxynol-9.
Swenson et al. teach the lysis of biological cells in a biological sample using a lysis buffer containing non-ionic surfactants, including TRITON® X-100 and Nonoxynol-9 (Abs.; Para. 53).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Picciolo et al. and Swenson et al., because both teach selective lysis of biological cells in a biological sample using non-ionic surfactants including TRITON® X-100. The use of Nonoxynol-9 as the non-ionic surfactant in a lysis buffer is known in the art as taught by Swenson et al. The use of Nonoxynol-9 in place of TRITON® X-100 in the method of Picciolo et al. amounts to the simple substitution of one known non-ionic surfactant for another, and would have been expected to predictably and successfully provide a non-ionic surfactant selective lysis agent for use in the method of Picciolo et al.
While Picciolo et al. teach that the apyrase, which is an ATPase, is deactivated after it destroys the free non-bacterial ATP (Col. 3, line 7-9, 17), it is not specifically taught that it is deactivated by treatment with dimethyldioctadecylammonium chloride, DTAB, DBBABr, or CTAB.
Daly et al. teach that ATPase inhibitors include CTAB (Para. 743).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Picciolo et al. and Daly et al., because both teach the inhibition of ATPase. The use of CTAB as an ATPase inhibitor is known in the art as taught by Daly et al. One would have been motivated to utilize CTAB in the method of Picciolo et al., because Daly et al. teach that CTAB is an ATPase inhibitor, and Picciolo et al. desires the inhibition of ATPase. The use of CTAB in the method of Picciolo et al. would have been expected to predictably and successfully provide a composition for deactivation of the ATPase as desired by Picciolo et al. following its use to destroy the free non-bacterial ATP.
With regard to claim 30, as Picciolo et al. teach that the aqueous physiological fluid sample is urine (Col. 2, line 59-62), this liquid sample is necessarily collected in a container from the subject.
With regard to claim 35, Picciolo et al. teach that the aqueous physiological fluid sample is urine (Col. 2, line 59-62). While it is not specifically taught that the urine is human urine, it would have been obvious to one of ordinary skill in the art to utilize the method to quantify bacteria in a urine sample from a patient in need thereof, and where the patient is physiologically capable of providing urine, including a human patient.
With regard to claim 37, Picciolo et al. teach the use of TRITON® X-100 (Col. 3, line 46-48; Ex. 7), which is a non-ionic surfactant that is also a bacterial releasing agent. As such, it would have been obvious to an ordinary artisan to utilize TRITON® X-100 in the method, wherein it is a non-ionic surfactant that is capable of providing the function of a bacterial releasing agent.
With regard to claim 44, Picciolo et al. teach that the luciferase-luciferin mixture is prepared using 1 to 5 mg of luciferase per ml, mixed with 0.01 to 1.0 mg of luciferin per ml (Col. 5, line 51-56). While it is not specifically taught that the luciferase/luciferin reagent comprises 40 pg luciferse and 100 pM luciferin, it would have been routine for an ordinary artisan to determine the appropriate amount of each in the mixture based upon the sample size and expected bacterial species. It is noted that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). Accordingly, it would have been obvious to optimize the amount of the luciferase and luciferin in the luciferase-luciferin mixture to result in the presence of effective amount of each component based upon the sample size and expected bacterial species when practicing the taught method.
With regard to claims 45-48, while Picciolo et al. teach the quantification of bacteria in aqueous physiological fluid including urine, it is not specifically taught that the bacteria to be quantified includes gram positive or negative bacteria, including Staphylococcus spp., Streptococcus spp., Propionibacterium spp., Enterococcus spp., Bacillus spp., Corynebacterium spp., Nocardia spp., Clostridium spp., Actinobacteria spp., Lactococcus spp., or Listeria spp.
Swenson et al. teach that bacterial species found in biological samples include gram positive and negative bacteria, including Staphylococcus spp., Streptococcus spp., Enterococcus spp., Bacillus spp., Corynebacterium spp., Clostridium spp., and Listeria spp., and including specifically Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Streptococcus agalactiae, and Staphylococcus aureus (Para. 70).
The rationale for the combination of Picciolo et al. and Swenson et al. has been set forth previously. As Picciolo et al. teach the detection of bacterial species in biological samples and Swenson et al. teach bacterial species found in biological samples, an ordinary artisan would have been motivated to utilize the combined method to detect bacterial species including gram positive and gram negative bacteria, including Staphylococcus spp., Streptococcus spp., Enterococcus spp., Bacillus spp., Corynebacterium spp., Clostridium spp., and Listeria spp., including specifically Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Streptococcus agalactiae, and Staphylococcus aureus.
Response to Arguments
In view of Applicant’s amendments, all previous rejections have been withdrawn. Therefore, Applicant’s arguments are moot. However, new rejections have been set forth above.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653