DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-6 and 8-18 are pending in the application.
Applicant’s amendment to the claims, filed February 5, 2026, is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s remarks filed February 5, 2026 in response to the non-final rejection filed November 5, 2025 have been fully considered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Objections
The objection to claims 1-6 for reciting “20oC or more and 30oC” is withdrawn in view of applicant’s amendment to replace “20oC or more and 30oC” with “20oC to 30oC.”
Claim Rejections - 35 USC § 103
Claims 1, 3, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Itagaki et al. (JP 2017093358 A; cited on the IDS filed on October 22, 2021; hereafter “Itagaki”) in view of Loesche et al. (J. Clin. Periodontol. 24:718-726, 1997; cited on Form PTO-892 mailed May 9, 2025; hereafter “Loesche”). Reference is made to a machine translation of Itagaki (filed February 26, 2024; hereafter “machine translation”).
The rejection is modified from its previous version in order to address applicant’s amendment to the claims.
As amended, claims 1 and 8 are drawn to a method for detecting periodontopathic bacteria in which periodontopathic bacteria are detected in a sample at 20oC to 30oC and in 2 minutes, wherein:
a first compound having an antioxidant effect or a second compound having action of protecting SH groups and cleaving disulfide bonds is added to a water absorbent material together with N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride, the sample is contacted with the water absorbent material at 20oC to 30oC and is allowed to stand at 20oC to 30oC for 2 minutes, and is immediately subjected to coloration analysis with a coloring reagent,
the first compound is 25mM to 100 mM glutathione, and
the second compound is 25 mM to S0 mM DTT or 25 mM to 50 mM thioglycolic acid.
As amended, claims 3 and 10 are drawn to a method for detecting periodontopathic bacteria in which periodontopathic bacteria are detected in a sample at 20oC to 30oC and in 5 minutes, wherein:
a first compound having an antioxidant effect or a second compound having action of protecting SH groups and cleaving disulfide bonds is added to a water absorbent material together with N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride, the sample is contacted with the water absorbent material at 20oC to 30oC and is allowed to stand at 20oC to 30oC for 5 minutes, and is immediately subjected to coloration analysis with a coloring reagent,
the first compound is 6.25 mM to 50 mM L-ascorbic acid, 6.25 mM to 100 mM L-cysteine hydrochloride, or 6.25 mM to 100 mM glutathione, and
the second compound is 6.25 mM to 100 mM DTT, 12.5 mM to 100 mM thioglycolic acid, 6.25 mM to 100 mM thioglycerol, 6.25 mM to 100 mM mercaptoethanol, or 6.25 mM to 25 mM TCEP.
Itagaki teaches a method for detecting periodontopathic bacteria in which periodontopathic bacteria are detected in a sample at room temperature (machine translation of Itagaki at paragraph [0001]) by analyzing trypsin-like protease activity specific to periodontal disease-causing bacteria (machine translation of Itagaki at p. 3, paragraph [0008]). Itagaki teaches that “room temperature” is approximately 20°C to 30°C (machine translation at paragraph [0010]). Itagaki teaches the method uses a first or second compound (machine translation of Itagaki at p. 3, paragraph [0008]), and teaches an exemplary first compound is glutathione and an exemplary second compound is DTT or thioglycolic acid (machine translation of Itagaki at p. 3, paragraph [0009]). Itagaki teaches the concentration of each of the first and second compounds is 1 mM to 100 mM (machine translation of Itagaki at p. 5, paragraph [0015]). Itagaki teaches the first and second compound can be included in a water-absorbing substance together with a substrate for the periodontal disease-causing bacteria (machine translation of Itagaki at p. 4, paragraph [0013]). Itagaki teaches using N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride as the substrate (machine translation of Itagaki at p. 7, paragraph [0023]). N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride is commonly abbreviated as “BANA.” Itagaki teaches the sample to be analyzed and the water-absorbing substance are brought into direct contact, and the presence or absence of a colored substance is analyzed, a coloring reagent can be used if necessary (machine translation of Itagaki at p. 4, paragraph [0013]). Itagaki teaches a 10 minute time period between the step of contacting the sample with the water-absorbing substance and the step of adding a coloring reagent (e.g., machine translation of Itagaki at p. 8, paragraph [0028]).
Example 1 of Itagaki teaches mixing a first or second compound with the substrate and soaked into a paper disk (machine translation of Itagaki at paragraph [0026]). Itagaki teaches the substrate of the examples is N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride (machine translation of Itagaki at paragraph [0023]). Itagaki teaches the first compound includes glutathione (グルタチオン) at a concentration of 62.5 mM. Itagaki teaches the second compound includes DTT or thioglycol (チオグリセロール) at a concentration of 62.6 mM (machine translation of Itagaki at paragraph [0022]) and Example 3 of Itagaki teaches concentrations of the second compounds being 25 mM each (machine translation of Itagaki at paragraph [0039]). Itagaki teaches the paper disk with the first or second compound and substrate is coated with a bacterial solution and was left standing at room temperature for 10 minutes followed by addition of a coloring liquid (machine translation of Itagaki at paragraph [0028]).
The difference between Itagaki and claims 1 and 3 is that while Itagaki teaches a 10 minute time period before coloration with a coloring reagent, Itagaki does not teach a 2 minute or a 5 minute time period as recited in claims 1 and 3, respectively.
Loesche is directed to optimizing the BANA test to screen for gingivitis (title). Loesche teaches compares the performances of the BANA test with incubation protocols of 5 minutes/35oC, 5 minutes/55oC, and 15 minutes/55oC (p. 718, Abstract). According to Loesche, the BANA test performance is dependent upon the length and temperature of incubation and – of the three incubation protocols tested – the performance of the BANA test is best using a 5 minute/35oC incubation period (p. 718, Abstract).
In view of the combined teachings of Itagaki and Loesche, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Itagaki with a 2 minute or a 5 minute time period between the step of contacting the sample with the water-absorbing substance and the step of adding a coloring reagent.
According to MPEP 2144.05.II.A, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In this case, the general conditions of claims 1 and 3 are disclosed by Itagaki with the exception that Itagaki teaches a 10 minute time period before coloration with a coloring reagent while claims 1 and 3 recites a 2 minute and a 5 minute time period, respectively, before coloration with a coloring reagent. According to MPEP 2144.05.1I.B, the presence of a known result-effective variable would be motivation for a person of ordinary skill in the art to experiment to reach another workable process. In view of teachings of Loesche that the BANA test performance is dependent upon the length and temperature of incubation, one of ordinary skill would have recognized that the combination of time and temperature of incubation for a BANA test are result-effective variables and one of ordinary skill in the art would have been motivated to experiment to discover the optimum or workable ranges of the time period before coloration with a coloring reagent in the BANA test of Itagaki. Moreover, of the three incubation protocols tested, the performance of the BANA test was best for the least amount of time and the lowest temperature incubation protocol.
One would have expected success to modify the method of Itagaki with a 2 minute or a 5 minute time period between the step of contacting the sample with the water-absorbing substance and the step of adding a coloring reagent because, in view of the combined teachings of Itagaki and Loesche, no more than routine experimentation would have been required for such a modification.
Regarding claims 8 and 10, Figure 1 of Itagaki shows that adding the first or second compound alone, e.g., adding 62.5 mM glutathione (グルタチオン) alone, as taught in Example 1 of Itagaki achieved a detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium.
Therefore, the methods of claims 1, 3, 8, and 10 would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 2, 5, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Itagaki in view of Loesche. Reference is made to a machine translation of Itagaki (filed February 26, 2024; hereafter “machine translation”).
The rejection is modified from its previous version in order to address applicant’s amendment to the claims.
As amended, claims 2 and 9 are drawn to a method for detecting periodontopathic bacteria in which periodontopathic bacteria are detected in a sample at 20oC to 30oC and in 2 minutes, wherein:
a first compound having an antioxidant effect and a second compound having action of protecting SH groups and cleaving disulfide bonds is added to a water absorbent material together with N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride, the sample is contacted with the water absorbent material at 20oC to 30oC and is allowed to stand at 20oC to 30oC for 2 minutes, and is immediately subjected to coloration analysis with a coloring reagent,
the first compound is 25 mM L-ascorbic acid, 25 mM L-cysteine hydrochloride, or 25 mM glutathione, and
the second compound is 25 mM DTT, 25 mM thioglycolic acid, 25 mM thioglycerol, or 25 mM mercaptoethanol.
As amended, claims 5 and 12 are drawn to a method for detecting periodontopathic bacteria in which periodontopathic bacteria are detected in a sample at 20oC to 30oC and in 5 minutes, wherein:
a first compound having an antioxidant effect and a second compound having action of protecting SH groups and cleaving disulfide bonds is added to a water absorbent material together with N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride, the sample is contacted with the water absorbent material at 20oC to 30oC and is allowed to stand at 20oC to 30oC for 5 minutes, and is immediately subjected to coloration analysis with a coloring reagent,
the first compound is 25 mM L-ascorbic acid, 25 mM L-cysteine hydrochloride, or 25 mM glutathione, and
the second compound is 25 mM DTT, 25 mM thioglycolic acid, 25 mM thioglycerol, or 25 mM mercaptoethanol.
Itagaki teaches a method for detecting periodontopathic bacteria in which periodontopathic bacteria are detected in a sample at room temperature (machine translation of Itagaki at paragraph [0001]) by analyzing trypsin-like protease activity specific to periodontal disease-causing bacteria (machine translation of Itagaki at p. 3, paragraph [0008]). Itagaki teaches that “room temperature” is approximately 20°C to 30°C (machine translation at paragraph [0010]). Itagaki teaches the method uses first and second compounds (machine translation of Itagaki at p. 3, paragraph [0008]), teaches the first and second compounds may be mixed (machine translation of Itagaki at p. 3, paragraph [0009]), and teaches the first compound including glutathione and the second compound including DTT or thioglycolic acid (machine translation of Itagaki at p. 3, paragraph [0009]). Itagaki teaches the concentration of each of the first and second compounds is 1 mM to 100 mM (machine translation of Itagaki at p. 5, paragraph [0015]). Itagaki teaches the first and second compounds can be included in a water-absorbing substance together with a substrate for the periodontal disease-causing bacteria (machine translation of Itagaki at p. 4, paragraph [0013]). Itagaki teaches using N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride as the substrate (machine translation of Itagaki at p. 7, paragraph [0023]). Itagaki teaches the sample to be analyzed and the water-absorbing substance are brought into direct contact, and the presence or absence of a colored substance is analyzed, a coloring reagent can be used if necessary (machine translation of Itagaki at p. 4, paragraph [0013]). Itagaki teaches a 10 minute time period between the step of contacting the sample with the water-absorbing substance and the step of adding a coloring reagent (e.g., machine translation of Itagaki at p. 8, paragraph [0028]).
Example 3 of Itagaki teaches mixing the first and second compounds (machine translation of Itagaki at paragraph [0037]) and the solution of the first and second compounds is mixed with the substrate and a paper disk is soaked with the concentrations of the first and second compounds being 25 mM each (machine translation of Itagaki at paragraph [0039]). Itagaki teaches the substrate of the examples is N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride (machine translation of Itagaki at paragraph [0023]). Example 3 of Itagaki teaches that the first and second compounds were added according to Table 3 (machine translation of Itagaki at p. 10, paragraph [0037]), which shows combinations of, e.g., glutathione (グルタチオン) as first compound and DTT as second compound, glutathione as first compound and thioglycolic acid (チオグリコール酸) as second compound, glutathione as first compound and thioglycerol (チオグリセロール) as second compound, and glutathione as first compound and mercaptoethanol (メルカプトエタノール) as second compound (Itagaki at Table 3). Itagaki teaches the paper disk with a mixture of the first compound, second compound, and substrate is coated with a bacterial solution and was left standing at room temperature for 10 minutes followed by addition of a coloring liquid (machine translation of Itagaki at paragraph [0041]).
The difference between Itagaki and claims 2 and 5 is that while Itagaki teaches a 10 minute time period before coloration with a coloring reagent, Itagaki does not teach a 2 minute or a 5 minute time period as recited in claims 2 and 5, respectively.
Loesche is directed to optimizing the BANA test to screen for gingivitis (title). Loesche teaches compares the performances of the BANA test with incubation protocols of 5 minutes/35oC, 5 minutes/55oC, and 15 minutes/55oC (p. 718, Abstract). According to Loesche, the BANA test performance is dependent upon the length and temperature of incubation and – of the three incubation protocols tested – the performance of the BANA test is best using a 5 minute/35oC incubation period (p. 718, Abstract).
In view of the combined teachings of Itagaki and Loesche, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Itagaki with a 2 minute or 5 minute time period between the step of contacting the sample with the water-absorbing substance and the step of adding a coloring reagent.
According to MPEP 2144.05.II.A, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In this case, the general conditions of claims 2 and 5 are disclosed by Itagaki with the exception that Itagaki teaches a 10 minute time period before coloration with a coloring reagent while claims 2 and 5 recite a 2 minute and 5 minute time period, respectively, before coloration with a coloring reagent. According to MPEP 2144.05.1I.B, the presence of a known result-effective variable would be motivation for a person of ordinary skill in the art to experiment to reach another workable process. In view of teachings of Loesche that the BANA test performance is dependent upon the length and temperature of incubation, one of ordinary skill would have recognized that the combination of time and temperature of incubation for a BANA test are result-effective variables and one of ordinary skill in the art would have been motivated to experiment to discover the optimum or workable ranges of the time period before coloration with a coloring reagent in the BANA test of Itagaki. Moreover, of the three incubation protocols tested, the performance of the BANA test was best for the least amount of time and the lowest temperature incubation protocol.
One would have expected success to modify the method of Itagaki with a 2 minute or 5 minute time period between the step of contacting the sample with the water-absorbing substance and the step of adding a coloring reagent because, in view of the combined teachings of Itagaki and Loesche, no more than routine experimentation would have been required for such a modification.
Regarding claims 9 and 12, Figure 3 of Itagaki shows that adding combinations of the first and second compounds, e.g., adding a combination of 25 mM glutathione (グルタチオン) and 25 mM DTT, as taught in Example 3 of Itagaki achieved a detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium.
Therefore, the methods of claims 2, 5, 9, and 12 would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 4, 6, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Itagaki in view of Loesche. Reference is made to machine translations of Itagaki (filed in the instant application on February 26, 2024; hereafter “machine translation”).
The rejection is modified from its previous version in order to address applicant’s amendment to the claims.
As amended, claim 4 is drawn to a method for detecting periodontopathic bacteria in which periodontopathic bacteria are detected in a sample at 20oC to 30oC and in 5 minutes, wherein:
a sample containing a first compound having an antioxidant effect or a second compound having action of protecting SH groups and cleaving disulfide bonds is added to a water absorbent material that contains N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride is allowed to stand at 20oC to 30oC for 5 minutes, and is immediately subjected to coloration analysis with a coloring reagent,
the first compound is 6.25 mM to 100 mM L-ascorbic acid, 6.25 mM to 100 mM L-cysteine hydrochloride, or 6.25 mM to 100 mM glutathione, and
the second compound is 6.25 mM to 100 mM thioglycerol or 6.25 mM to 100 mM mercaptoethanol.
As amended, claim 6 is drawn to a method for detecting periodontopathic bacteria in which periodontopathic bacteria are detected in a sample at 20oC to 30oC and in 5 minutes, wherein:
a sample containing a first compound having an antioxidant effect or a second compound having action of protecting SH groups and cleaving disulfide bonds is added to a water absorbent material that contains N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride is allowed to stand at 20oC to 30oC for 5 minutes, and is immediately subjected to coloration analysis with a coloring reagent,
the first compound is 25 mM L-ascorbic acid, 25 mM L-cysteine hydrochloride, or 25 mM glutathione, and
the second compound is 25 mM thioglycolic acid, 25 mM thioglycerol, or 25 mM mercaptoethanol.
Itagaki teaches a method for detecting periodontopathic bacteria in which periodontopathic bacteria are detected in a sample at room temperature (machine translation of Itagaki at paragraph [0001]) by analyzing trypsin-like protease activity specific to periodontal disease-causing bacteria (machine translation of Itagaki at p. 3, paragraph [0008]). Itagaki teaches that “room temperature” is approximately 20°C to 30°C (machine translation at paragraph [0010]). Itagaki teaches the method uses first and second compounds (machine translation of Itagaki at p. 3, paragraph [0008]), teaches the first and second compounds may be mixed (machine translation of Itagaki at p. 3, paragraph [0009]), and teaches the first compound including glutathione and the second compound including DTT or thioglycolic acid (machine translation of Itagaki at p. 3, paragraph [0009]). Itagaki teaches the concentration of each of the first and second compounds is 1 mM to 100 mM (machine translation of Itagaki at p. 5, paragraph [0015]). Itagaki teaches the first and second compounds can be included in a water-absorbing substance together with a substrate for the periodontal disease-causing bacteria (machine translation of Itagaki at p. 4, paragraph [0013]). Itagaki teaches using N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride as the substrate (machine translation of Itagaki at p. 7, paragraph [0023]). Itagaki teaches the sample to be analyzed and the water-absorbing substance are brought into direct contact, and the presence or absence of a colored substance is analyzed, a coloring reagent can be used if necessary (machine translation of Itagaki at p. 4, paragraph [0013]). Itagaki teaches a 10 minute time period between the step of contacting the sample with the water-absorbing substance and the step of adding a coloring reagent (e.g., machine translation of Itagaki at p. 8, paragraph [0028]).
Regarding claim 4, Example 1 of Itagaki teaches mixing a first or second compound with the substrate and soaked into a paper disk (machine translation of Itagaki at paragraph [0026]). Itagaki teaches the substrate of the examples is N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride (machine translation of Itagaki at paragraph [0023]). Itagaki teaches the first compound includes glutathione at a concentration of 62.5 mM and the second compound includes DTT, thioglycol, thioglycerol, mercaptoethanol, or TCEP at a concentration of 62.6 mM (machine translation of Itagaki at paragraph [0022]). Itagaki teaches the paper disk with the first or second compound and substrate is coated with a bacterial solution and was left standing at room temperature for 10 minutes followed by addition of a coloring liquid (machine translation of Itagaki at paragraph [0028]).
Regarding claim 6, Example 3 of Itagaki teaches mixing the first and second compounds (machine translation of Itagaki at paragraph [0037]) and the solution of the first and second compounds is mixed with the substrate and a paper disk is soaked with the concentrations of the first and second compounds being 25 mM each (machine translation of Itagaki at paragraph [0039]). Itagaki teaches the substrate of the examples is N-α-benzoyl-DL-arginine-2-naphthylamide hydrochloride (machine translation of Itagaki at paragraph [0023]). Example 3 of Itagaki teaches that the first and second compounds were added according to Table 3 (machine translation of Itagaki at p. 10, paragraph [0037]), which shows combinations of, e.g., glutathione (グルタチオン) as first compound and DTT as second compound, glutathione as first compound and thioglycolic acid (チオグリコール酸) as second compound, glutathione as first compound and thioglycerol (チオグリセロール) as second compound, and glutathione as first compound and mercaptoethanol (メルカプトエタノール) as second compound (Itagaki at Table 3). Itagaki teaches the paper disk with a mixture of the first compound, second compound, and substrate is coated with a bacterial solution and was left standing at room temperature for 10 minutes followed by addition of a coloring liquid (machine translation of Itagaki at paragraph [0041]).
The difference between Itagaki and claims 4 and 6 is that while Itagaki teaches a 10 minute time period before coloration with a coloring reagent, Itagaki does not teach a 5 minute time period as recited in claims 4 and 6.
Loesche is directed to optimizing the BANA test to screen for gingivitis (title). Loesche teaches compares the performances of the BANA test with incubation protocols of 5 minutes/35oC, 5 minutes/55oC, and 15 minutes/55oC (p. 718, Abstract). According to Loesche, the BANA test performance is dependent upon the length and temperature of incubation and – of the three incubation protocols tested – the performance of the BANA test is best using a 5 minute/35oC incubation period (p. 718, Abstract).
In view of the combined teachings of Itagaki and Loesche, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Itagaki with a 5 minute time period between the step of contacting the sample with the water-absorbing substance and the step of adding a coloring reagent.
According to MPEP 2144.05.II.A, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In this case, the general conditions of claims 4 and 6 are disclosed by Itagaki with the exception that Itagaki teaches a 10 minute time period before coloration with a coloring reagent while claims 4 and 6 recite a 5 minute time period before coloration with a coloring reagent. According to MPEP 2144.05.1I.B, the presence of a known result-effective variable would be motivation for a person of ordinary skill in the art to experiment to reach another workable process. In view of teachings of Loesche that the BANA test performance is dependent upon the length and temperature of incubation, one of ordinary skill would have recognized that the combination of time and temperature of incubation for a BANA test are result-effective variables and one of ordinary skill in the art would have been motivated to experiment to discover the optimum or workable ranges of the time period before coloration with a coloring reagent in the BANA test of Itagaki. Moreover, of the three incubation protocols tested, the performance of the BANA test was best for the least amount of time and the lowest temperature incubation protocol.
One would have expected success to modify the method of Itagaki with a 5 minute time period between the step of contacting the sample with the water-absorbing substance and the step of adding a coloring reagent because, in view of the combined teachings of Itagaki and Loesche, no more than routine experimentation would have been required for such a modification.
The combination of Itagaki and Loesche does not teach the order of adding components as recited in claims 4 and 6. However, according to MPEP 2144.04.IV.C, the selection of any order of mixing ingredients or performing process steps is prima facie obvious in the absence of new or unexpected results. There are no unexpected results that are achieved by the order of mixing ingredients or performing process steps of claims 4 and 6 and in accordance with MPEP 2144.04.IV.C, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the order of adding the components of Itagaki’s method according to the order recited in claims 4 and 6.
Regarding claim 11, Figure 1 of Itagaki shows that adding the first or second compound alone, e.g., adding 62.5 mM glutathione (グルタチオン) alone, as taught in Example 1 of Itagaki achieved a detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium.
Regarding claim 13, Figure 3 of Itagaki shows that adding combinations of the first and second compounds, e.g., adding a combination of 25 mM glutathione (グルタチオン) and 25 mM DTT, as taught in Example 3 of Itagaki achieved a detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium.
Therefore, the methods of claims 4, 6, 11, and 13 would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Applicant argues the combination of Itagaki and Loesche does not provide motivation to reduce the reaction time from 10 minutes to 2 minutes. Applicant further argues that reducing the reaction time would not have been the optimum or workable ranges by routine experimentation because it is expected that the enzyme reaction rate would decrease at room temperature, there would have been no articulated reasoning with some rational underpinning to expect a color development can be achieved at room temperature if the reaction time as taught by Itagaki is shortened to be 2 minutes or 5 minutes, and only the subject specification describes that a color development can be achieved in short time such as 2 minutes or 5 minutes due to the specific combination of the chemical compositions and the concentration ranges.
Applicant’s argument is not found persuasive. Itagaki already taught a reaction temperature of room temperature and there is nothing in the prior art of record that teaches or suggests that color development would not occur if the reaction time of Itagaki were shortened from 10 minutes to 2 minutes or 5 minutes. Rather, in view of the combined teachings of Itagaki and Loesche, particularly Loesche’s teachings that the BANA test performance is dependent upon the length of time and temperature of incubation and the performance of the BANA test was best for the least amount of time and the lowest temperature incubation protocol, one would have been motivated to experiment to discover the optimum or workable ranges of the time period before coloration with a coloring reagent in the BANA test of Itagaki, and would have arrived at a 2 minute or 5 minute time period before coloration with a coloring reagent by no more than routine experimentation.
Applicant addresses claims 1 and 3 arguing that in the presence of the first or second compound at the recited concentration, a detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium was achieved with a 5 minute reaction time, which is an unexpectedly superior result compared to the detection sensitivity at 10 minutes taught by Itagaki.
Applicant’s arguments are not found persuasive. Contrary to applicant’s position, applicant’s results fail to establish an unexpectedly superior detection sensitivity that is commensurate in scope with the claimed invention as required by MPEP 716.02(d). Applicant’s table at p. 15 of the instant remarks shows that adding the first or second compound alone achieved a detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium with a 5 minute reaction time, however, Itagaki’s Figure 1 shows that, with the exceptions of L-ascorbic acid and mercaptoethanol, adding glutathione, DTT, or thioglycolic acid alone achieved the same detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium. Given that the detection sensitivity of Itagaki is the same as applicant’s detection sensitivity, applicant’s results fail to establish an unexpectedly superior detection sensitivity and consequently, applicant’s results fail to rebut a prima facie case of obviousness.
Applicant addresses claims 2 and 5 arguing that in the presence of the first and second compound at the recited concentrations, a detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium was achieved with a 2 minute reaction time, which is an unexpectedly superior result compared to the detection sensitivity at 10 minutes as taught by Itagaki.
Applicant’s arguments are not found persuasive. Applicant’s results fail to compare the claimed subject matter with the closest prior art as required by MPEP 716.02(e). For example, applicant’s comparisons at the paragraph bridging pp. 11-12 of the instant remarks include references to combinations with TCEP as a second compound, however, claims 2 and 5 do not recite TCEP as a second compound. Also, even when applicant’s comparisons are between combinations recited in claims 2 and 5 and the same combinations disclosed in Itagaki, applicant’s results fail to establish an unexpectedly superior detection sensitivity that is commensurate in scope with the claimed invention as required by MPEP 716.02(d). For example, applicant’s tables at pp. 12-14 of the instant remarks show that adding glutathione as the first compound and DTT, thioglycolic acid, thioglycerol, or mercaptoethanol as the second compound achieved a detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium with a 2 minute reaction time, however, Itagaki’s Figure 3 shows that that adding glutathione as the first compound and DTT, thioglycolic acid, thioglycerol, or mercaptoethanol also achieved the same detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium. Given that the detection sensitivity of Itagaki is the same as applicant’s detection sensitivity for at least some of the combinations of first and second compounds recited in claims 2 and 5, applicant’s results fail to establish an unexpectedly superior detection sensitivity and consequently, applicant’s results fail to rebut a prima facie case of obviousness.
Applicant addresses claim 4 arguing that in the presence of the first or second compound at the recited concentration, a detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium was achieved with a 5 minute reaction time, which is an unexpectedly superior result compared to the detection sensitivity at 10 minutes as taught by Itagaki.
Applicant’s arguments are not found persuasive. Contrary to applicant’s position, applicant’s results fail to establish an unexpectedly superior detection sensitivity that is commensurate in scope with the claimed invention as required by MPEP 716.02(d). Applicant’s table at p. 16 of the instant remarks shows that adding the first or second compound alone achieved a detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium with a 5 minute reaction time, however, Itagaki’s Figure 2 shows that, with the exception of L-ascorbic acid, adding L-cysteine hydrochloride, glutathione, thioglycerol, or mercaptoethanol alone achieved the same detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium. Given that the detection sensitivity of Itagaki is the same as applicant’s detection sensitivity, applicant’s results fail to establish an unexpectedly superior detection sensitivity and consequently, applicant’s results fail to rebut a prima facie case of obviousness.
Applicant addresses claim 6 arguing that in the presence of the first and second compound at the recited concentrations, a detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium was achieved with a 5 minute reaction time, which is an unexpectedly superior result compared to the detection sensitivity at 10 minutes as taught by Itagaki.
Applicant’s arguments are not found persuasive. Contrary to applicant’s position, applicant’s results fail to establish an unexpectedly superior detection sensitivity that is commensurate in scope with the claimed invention as required by MPEP 716.02(d). For example, applicant’s table at p. 17 of the instant remarks shows that adding glutathione as the first compound and thioglycolic acid, thioglycerol, or mercaptoethanol as the second compound achieved a detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium with a 5 minute reaction time, however, Itagaki’s Figure 4 shows that that adding glutathione as the first compound and thioglycolic acid, thioglycerol, or mercaptoethanol as the second compound achieved the same detection sensitivity of 1 x 104 cfu/mL of P. g. bacterium. Given that the detection sensitivity of Itagaki is the same as applicant’s detection sensitivity for at least some of the combinations of first and second compounds recited in claim 6, applicant’s results fail to establish an unexpectedly superior detection sensitivity and consequently, applicant’s results fail to rebut a prima facie case of obviousness.
Applicant argues these differences would not have been predictable by one of ordinary skill in the art because it is not generally expected that simply shortening the reaction time would improve detection sensitivity; rather, according to applicant, shortening the reaction time typically leads to a decrease in sensitivity; and the synergistic effect of specific chemical compositions and concentration ranges enables both shortened reaction time and enhanced sensitivity to be achieved simultaneously. Applicant argues these effects are the unexpected results, and it would not have been possible to predict such results based on Itagaki in view of Loesche.
Applicant’s arguments are not found persuasive. There is no evidence of record that before the effective filing date one would have expected that shortening the reaction time would decrease sensitivity of Itagaki’s methods and arguments presented by applicant cannot take the place of evidence in the record (MPEP 716.01(c)). Moreover, as stated above, shortening the reaction time of Itagaki’s methods does not improve reaction sensitivity for all first and/or second compounds in the methods of claims 1-13. Consequently, applicant’s results fail to rebut a prima facie case of obviousness.
For these reasons, it is the examiner’s position that the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date.
Allowable Subject Matter
Applicant’s remarks provide convincing evidence of an unexpected 1 x 104 cfu/ml detection sensitivity for the methods of claims 14-18 as compared to a 1 x 105 cfu/ml detection sensitivity for the 10 minute reaction time of Itagaki, which rebuts a prima facie case of obviousness. As such, claims 14-18 are allowable over the prior art of record.
Conclusion
Status of the claims:
Claims 1-6 and 8-18 are pending.
Claims 1-6 and 8-13 are rejected.
Claims 14-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
No claim is in condition for allowance.
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.
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/David Steadman/Primary Examiner, Art Unit 1656