DETAILED ACTION
Status of the Claims
1. Claims 49-68 are pending.
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.
2. Claim(s) 49, 51, 55-61, 63 and 65-67 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soleymani et al. (WO2020/186362).
Claims 49 and 51. Soleymani et al. teach a method of detecting an infection in a subject (method of detecting urinary tract infection (UTI); [0094]), the method comprising
(i) contacting urine from the subject with a device for detecting an infection, wherein the device comprises an electrochemical sensor array, wherein the electrochemical sensor array comprises one or more electrochemical sensors, each electrochemical sensor comprising a working electrode, a reference electrode and a counter electrode and is capable of independently performing an electrochemical measurement, and wherein the working electrode comprises an oxidizing working electrode or a reducing working electrode (contacting biosensor comprising working electrode, counter electrode and reference electrode, with urine sample, wherein the working electrode is reducing electrode; [00104][00113][00110], Soleymani et al. further teach the system can be engineered to target and identify multiple bacteria in parallel for performing rapid multiplexed bacterial analysis [00121], thus it is apparent array of biosensors could be formed, each comprising working, counter and reference electrodes); and
(ii) measuring a presence, absence or amount of one or more target molecule and/or a metabolic activity within the urine sample, wherein the target molecule and/or the metabolic activity is associated with the infection, wherein the electrochemical sensor array performs the measuring and wherein the one or more electrochemical sensors measures the presence, absence or amount of one or more target molecule and/or metabolic activity as current flow through the working electrode from the detection of binding to aptamer (measuring presence of bacteria in urine sample with electrochemical sensor as current flow from the detection of binding to DNA probe to detect UTI; [00110][0012][0089] and Fig 4).
Claim 53. Sun et al. teach administering the appropriate antibiotic for the infection upon the positive test for infection (early detection of UTI, the patient can start on antibiotic treatment; see page 5, ll. 33-36).
Claim 55. Soleymani et al. teach the electrochemical measurement is selected as square wave voltammetry ([0044] and Fig 12).
Claim 56. Soleymani et al. teach the electrochemical measurement is square wave voltammetry and the current flow is measured in response to one or more square wave potentials (see Fig 12 and [0044]).
Claim 57. Soleymani et al. teach the electrochemical sensor array detects a change in pH, a change in temperature, an electrochemical reaction, binding to an aptamer, a change in color, and the combination of any two or more thereof (biosensor detects change in electrochemical reaction current; [00101]).
Claim 58. Soleymani et al. teach the electrochemical sensor comprises: a working electrode, wherein the working electrode is one of an oxidizing electrode and a reducing electrode, (first working electrode undergoes redox process under applied potential with cyclic voltammetry; see Fig 12)
Claim 59. Soleymani et al. teach the electrochemical sensor comprises a reference electrode and/or wherein the reference electrode is comprised of Ag/AgCl) (potential vs Ag/AgCl; see Fig 12).
Claim 60. Soleymani et al. teach the infection is caused by a pathogen Escherichia Coli [00105].
Claim 61. Soleymani et al. teach the device is capable of identifying multiple bacteria in parallel for performing rapid multiplexed bacterial analysis [00121].
Claim 63. Soleymani et al. teach wherein the presence, absence or amount of the target molecule and/or the metabolic activity is measured as current flow through a working electrode [00111].
Claim 65. Sun et al. teach detecting presence of viable cells of E. coli [00113].
Claim 66. Soleymani et al. teach the device is electrically connected or connectable to a reader (electrochemical cell connected to reader; Fig 12).
Claim 67. Soleymani et al. teach the device detects the infection in 30 minutes [00118].
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.
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.
Claim(s) 50, 52-54, 62 and 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soleymani et al. as applied to claim 49 above, and further in view of Elbadry et al. (US2019/0358387).
Claim 50. Soleymani et al. do not teach urine is collected in a catheter bag. However, Elbadry et al. teach method of detecting urinary tract infection with a sensor in a catheter bag [0104][0107].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Elbadry et al. teaching to attach/ dispose biosensor of Soleymani et al. in a urine catheter bag because it would lead sample results of detecting UTI in a urine sample.
Claim 52. Soleymani et al. do not teach estimating a number of viable cells of a pathogen associated with the infection based on the presence, absence or amount of the target molecule and/or the metabolic activity. However, Elbadry et al. teach method of detecting urinary tract infection based on counting cells i.e. WBC’s associated with infection based on the presence of common marker of infections [0421].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Elbadry et al. teaching to further add the method step of counting WBC’s because observing several/different parameters causing the infection would allow to detect infection early in the infection cycle and would thereby alert the healthcare provider to start the treatment.
Claim 53. Soleymani et al. do not teach method inform administering the appropriate antibiotic for the infection upon the positive test for infection. Elbadry et al. teach method of detecting urinary tract infection and administering antibiotic course to prevent patient hospitalization [0010].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Elbadry et al. teaching to further add the method step of administering antibiotic upon detection of UTI because it would prevent patient from being admitted to hospital and start treatment early.
Claim 54. Soleymani et al. do not teach the electrochemical sensor array further comprises a sensor selected from a pH sensor and a temperature sensor. However, Elbadry et al. teach method of detecting urinary tract infection based on employing different types of sensors such as conductivity sensor, pH sensor and temperature sensor to monitor different parameters caused by the infection [0008][0009][0421].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Elbadry et al. teaching to further add different types of sensors such as temperature and pH because it would allow to observe different parameters causing the infection early in the infection cycle and would thereby alert the healthcare provider to start the treatment.
Claims 62 and 64. Soleymani et al. do not teach the device is capable of contemporaneously detecting at least two, or at least three, or at least 4 signals. However, Elbadry et al. teach method of detecting urinary tract infection based on employing different types of sensors such as conductivity sensor, pH sensor, urea sensor and temperature sensor to monitor different parameters/signals caused by the infection [0008][0009][0421].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Elbadry et al. teaching to further add different types of sensors such as temperature and pH because it would allow to observe different parameters causing the infection early in the infection cycle and would thereby alert the healthcare provider to start the treatment.
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goluch et al. (US 2017/047739) in view of Braga et al. (US 2019/0001030).
Claim 68. Goluch et al. teach a method of detecting a wound infection in a subject (method for detecting bacterial infection in wound sample form a bodily fluid; see abstract and [0115]), the method comprising:
(i) administering a dressing to a wound (wound dressing; [0084])
(iii) collecting wound exudate in a wound exudate collection container (collecting wound exudate in a pipette; [0123]),
(iv) contacting wound exudate from a wound dressing or a wound exudate collection container with a device for detecting an infection, wherein the device comprises an electrochemical sensor array, wherein the electrochemical sensor array comprises one electrochemical sensor comprising working electrode, a reference electrode and a counter electrode and is capable of independently performing an electrochemical measurement and wherein the working electrode comprises an oxidizing working electrode or a reducing working electrode (contact wound exudate sample with electrochemical cell comprising working electrode, a reference electrode and a counter electrode, wherein the working electrode conducts redox reaction; see Fig 9A and [0076]); and
(v) measuring a presence, absence or amount of one or more target molecule within the wound exudate, wherein the target molecule is associated with the infection, wherein the electrochemical sensor array performs the measuring and wherein the electrochemical sensor measures the target molecule as current flow through the working electrodes from the detection of binding to an aptamer (measuring presence of pyocyanin with electrochemical sensor using 16SrRNA as probe, wherein wound exudate is associated with infection [0122][0123][0167] and Table 1).
Goluch et al. do not explicitly teach method step of and (ii) applying a negative pressure to the wound. However, Braga et al. teach method of treating wound by applying negative pressure to the wound to inhibit bacterial growth by drawing fluid/exudate from the wound [0010].
Therefore, it would be obvious to one of ordinary skill in the art in view of Braga et al. teaching to add the step of applying negative pressure to the wound of Goluch et al. in order to draw exudate from the wound and thereby inhibit bacterial growth.
Response to Arguments
Applicant’s arguments with respect to claim(s) 49 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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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/GURPREET KAUR/
Primary Examiner
Art Unit 1759
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