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 .
Response to Amendment
This Office Action is in response to the Amendment filed 01/08/2026. As directed by the Amendment, claims 73, 76, 78-80, and 85 have been amended, claims 81-83, 89, and 90 have been cancelled, and claim 93 has been added. Claims 73-80, 84-88, and 91-93 are pending in the application.
The rejections made under 35 USC § 112(b) to claims 79, 80, and 89 have been withdrawn in light of Applicant’s amendments and cancellation of claim 89.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/08/2026, with respect to claims 73-84 under 35 USC § 101 have been fully considered and are persuasive. The rejections of claims 73-84 under 35 USC § 101 have been withdrawn.
Applicant’s arguments, see Remarks, filed 01/08/2026, with respect to claims 73-84 under 35 USC § 101 have been fully considered and are persuasive. The rejections of claims 73-84 under 35 USC § 101 have been withdrawn.
Applicant's arguments, see Remarks, filed 01/08/2026, with respect to claims 73-75 and 77-84 have been fully considered and are persuasive. Therefore, the rejections under 35 USC § 102(a)(1) have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Haick et al. (US 20230337934 A1), hereinafter ‘934. Applicant claims that prior art reference Haick fails to teach use of a detachable collection chamber nor a closed loop circulation of the gaseous sample. However, prior art ‘934 explicitly discloses the option to comprise a detachable collection chamber [a device of the invention optionally comprises at least two detachable parts wherein a first part comprises a sample collection chamber and a second part comprises at least one sensor assembly, see in ¶ 0008] as well as a closed loop circulation of the gaseous sample [the gaseous sample is allowed to continuously circulate back to and from the collection chamber and over the sensor assembly in order to maintain a stable and continuous measurement. This closed loop circulation mode permits increased exposure of the sensor assembly to the VC or analyte to be detected, see in ¶ 0023]. As such, claim rejections to pending claims 73-75, 77-80, and 84 have been updated in light of Amendments (see below under Claim Rejections - 35 USC § 103). Examiner notes that Applicant states on page 11 of Remarks that claims 81-83 have been cancelled and thus the rejection remains relevant only against claims 73-75 and 77-80, but Applicant fails to include that the rejection is also relevant against claim 84.
Applicant's arguments, see Remarks, filed 01/08/2026, with respect to claims 85, 86, 89, and 90 under 35 USC § 102(a)(1) have been fully considered and are persuasive. Therefore, the rejections to claims 85, 86, 89, and 90 under 35 USC § 102(a)(1) have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of ‘934 (US 20230337934 A1) (see below under Claim Rejections - 35 USC § 102).
Applicant's arguments, see Remarks, filed 01/08/2026, with respect to claim 76 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection to claim 76 under 35 USC § 103 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of ‘934 (US 20230337934 A1) (see below under Claim Rejections - 35 USC § 103).
Applicant's arguments, see Remarks, filed 01/08/2026, with respect to claims 87 and 88 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection to claims 87 and 88 under 35 USC § 103 have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of ‘934 (US 20230337934 A1) (see below under Claim Rejections - 35 USC § 102).
Examiner notes that Applicant references the specification and points out the determination of bacterial infections by looking at the VC profile or VC pattern as the novel aspect of the invention that is not able to be taught by the combination of Haick and Burch. However, Examiner notes that the claims, as currently written, do not disclose limitations that involve VC profiles or VC patterns. Although the combination of Haick and Burch are no longer applied in the claim rejections of this Office Action, Applicant’s argument involving VC profiles and VC patterns does not impact the interpretation of the claims in the instant application.
Applicant's arguments, see Remarks, filed 01/08/2026, with respect to claims 91 and 92 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection to claims 91 and 92 under 35 USC § 103 have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of ‘934 (US 20230337934 A1) (see below under Claim Rejections - 35 USC § 102).
Claim Objections
Claim 76 and 85 is objected to because of the following informalities:
In Claim 76, Examiner notes that “breathsample” may be mistakenly written as one word while “breath sample” was intended;
In both claims 76 and 85, redundant use of the term “and” is suggested to be fixed, particularly towards the end of the claims.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“data processing unit” in claims 76 and 85;
“data user interface unit” in claims 76 and 85; and
“processing unit” in claim 87.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 85-88 and 91-93 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Haick et al. (US 20230337934 A1), hereinafter ‘934.
The applied reference has a common Applicant and at least one common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 85, ‘934 discloses a device being optionally a hand-held device for determining presence of a bacterial infection in a subject [The device is configured as a handheld device, as a partially disposable device and/or as a device for immediate or on-the-spot real-time analysis of VC sample content, see in ¶ 0015; the VCs are compounds that are associated with the metabolism, presence and/or growth of at least one pathogen (e.g. bacteria or virus) or involved in the pathogenesis of another disease or disorder, see in ¶ 0060], the device comprising
a detachable sample collecting chamber configured to receive and hold a breath sample from the subject, wherein the collecting chamber receives the breath sample when detached from the device [device of the invention optionally comprises at least two detachable parts wherein a first part comprises a sample collection chamber and a second part comprises at least one sensor assembly, see in ¶ 0008; the sample may be collected into the chamber while the chamber is disconnected from the sensing region, see in ¶ 0014; sample collection chamber 110, see in Fig. 1];
at least one sensor assembly comprising one or a plurality of sensing regions responsive to interaction with volatile compounds present in a sample obtained from the subject [Sensor assembly 120, see in Fig. 1; see in ¶ 0051], wherein each of the plurality of the sensing regions is associated with same or different population of nanoparticles, wherein a signal independently derived from each of the sensing areas is indicative of an interaction or lack thereof between volatile compounds present in the sample and the nanoparticles on the sensing regions [see in ¶ 0051], and wherein the at least one sensor assembly is in gaseous communication with said sample collection chamber [the sample collecting chamber and the at least one sensor assembly are in gaseous communication, see in ¶ 0103];
such that upon attachment of the collecting sample to the device the sample is flown in a closed loop channel assembly equipped with a pump from the sample collecting chamber to the at least one sensor assembly and for circulating said sample continuously from the sample collecting chamber over the at least one sensor assembly over a period of time [see in Fig. 2B; see in ¶ 0104];
an analyzer configured for real-time analysis of volatile compounds present in the sample [see in ¶ 0105]; and
a data processing unit for data communication with the sensor assembly [data processing unit, see in ¶ 0112]; and
a data user interface unit being in data communication with the data processing unit [data user interface unit, see in ¶ 0112];
wherein the data processing unit comprises data relating to a control data set and is adapted to receive information relating to the presence of the volatile compounds or pattern thereof and provide an indication of presence or absence of one or more volatile compound [see in ¶ 0112].
Regarding claim 86, ‘934 discloses the device according to claim 85, wherein the at least one sensor assembly comprises a sensor in the form of a functionalized surface region, a sensor having a functionalized nanowire or a nanotube, a polymer-coated surface acoustic wave (SAW) sensors, sensor employing a semiconductor gas sensor technology, aptamer biosensors, or amplifying fluorescent polymer (AFP) sensor [see in ¶ 0114].
Regarding claim 87, ‘934 discloses the device according to claim 85, wherein the at least one sensor assembly comprises one or more chemically sensitive sensors and a processing unit comprising a learning and pattern recognition analyzer configured for receiving sensor output signals and comparing the signals to a stored data [see in ¶ 0048].
Regarding claim 88, ‘934 discloses the device according to claim 85, wherein the at least one sensor assembly is provided in the form of a plurality of nanoparticles associated to a surface [see in ¶ 0051].
Regarding claim 91, ‘934 discloses the device according to claim 85, wherein the device comprises two or more sample collecting chambers [Where multiple (two or more) chambers are present, see in ¶ 0029], wherein one or more of the sample collecting chambers is an environment testing chamber adapted with one or more sensors providing an initial reading of environmental parameters [environment testing chambers are adapted with one or more sensors that provide an initial reading of various environmental parameters relating to the breath/room sample, see in ¶ 0029].
Regarding claim 92, ‘934 discloses the device according to claim 85, wherein the closed loop channel assembly having at least one outlet operable to exhaust the sample upon demand [see in ¶ 0131].
Regarding claim 93, ‘934 discloses the device according to claim 85 that is a hand-held device [hand-held device, see in ¶ 0038].
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 73-80 and 84 are rejected under 35 U.S.C. 103 as being anticipated by Haick et al. (US 20150301021 A1 – Cited by Applicant), hereinafter Haick, in view of ‘934 (US 20230337934 A1).
The applied reference has a common Applicant and at least one common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 73, Haick discloses a method of determining a respiratory tract bacterial infection in a subject [diagnosing tuberculosis, see in ¶ 0015], the method comprising:
a) obtaining a breath sample comprising volatile compounds (VCs) from a subject and exposing the breath sample to a sensor responsive to interaction with the volatile compounds [exposing the sensor to a test sample selected from exhaled breath, see in ¶ 0025];
b) detecting/measuring an output signal received from the sensor correlating with an interaction between the VCs and the sensor [measuring an electrical signal upon exposure of the sensor, see in ¶ 0025];
c) comparing the signal to information relating to presence of VCs or pattern thereof to determine a result [using a pattern recognition algorithm to analyze the response pattern by comparing it to stored data obtained from a control sample whereby significantly different response pattern of the test sample as compared the control sample is indicative of tuberculosis caused by M. tuberculosis bacteria, see in ¶ 0029]; and
d) providing an output indicating the presence or absence of one or more VCs indicative of the respiratory tract bacterial infection in response and in accordance with the result [obtain an identification of the presence of tuberculosis caused by M. tuberculosis bacteria, see in ¶ 0082], wherein the presence of the one or more VCs indicative of bacterial infection is determined using a learning and pattern recognition algorithm enabling learning, dimensionality reduction, classification, regression, optimization and pattern recognition [learning and pattern recognition analyzer, see in ¶ 0028; see in ¶ 0034, ¶ 0087, and ¶ 0088; Examiner notes that learning, dimensionality reduction, classification, regression, optimization and pattern recognition are inherent functions of using learning and pattern recognition algorithms].
Haick fails to disclose that said breath sample is being contained in a sample collection chamber detachably connected to said sensor, said sensor comprising one or a plurality of sensing regions responsive to the interaction with the volatile compounds, wherein each of the plurality of the sensing regions is associated with same or different population of nanoparticles, wherein a signal independently derived from each of the sensing areas is indicative of the interaction or lack thereof between the volatile compounds and the nanoparticles on the sensing regions, wherein said exposing comprises circulating the sample in a closed loop channel assembly equipped with a pump configured for directing said sample from the sample collecting chamber over the sensor over a period of time.
However, ‘934 discloses that said breath sample is being contained in a sample collection chamber detachably connected to said sensor [device of the invention optionally comprises at least two detachable parts wherein a first part comprises a sample collection chamber and a second part comprises at least one sensor assembly, see in ¶ 0008; the sample may be collected into the chamber while the chamber is disconnected from the sensing region, see in ¶ 0014; sample collection chamber 110, see in Fig. 1], said sensor comprising one or a plurality of sensing regions responsive to the interaction with the volatile compounds [Sensor assembly 120, see in Fig. 1; see in ¶ 0051], wherein each of the plurality of the sensing regions is associated with same or different population of nanoparticles [see in ¶ 0051], wherein a signal independently derived from each of the sensing areas is indicative of the interaction or lack thereof between the volatile compounds and the nanoparticles on the sensing regions [see in ¶ 0051], wherein said exposing comprises circulating the sample in a closed loop channel assembly equipped with a pump configured for directing said sample from the sample collecting chamber over the sensor over a period of time [see in Fig. 2B; see in ¶ 0104].
Haick and ‘934 are both analogous to the claimed invention because they are in the same field of analyzing breath samples. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Haick to incorporate the teachings of ‘934 and include that said breath sample is being contained in a sample collection chamber detachably connected to said sensor, said sensor comprising one or a plurality of sensing regions responsive to the interaction with the volatile compounds, wherein each of the plurality of the sensing regions is associated with same or different population of nanoparticles, wherein a signal independently derived from each of the sensing areas is indicative of the interaction or lack thereof between the volatile compounds and the nanoparticles on the sensing regions, wherein said exposing comprises circulating the sample in a closed loop channel assembly equipped with a pump configured for directing said sample from the sample collecting chamber over the sensor over a period of time, with the motivations being to efficiently deliver breath samples to the sensor assembly with the use of a typical circulating pump system and to dispose the detachable sample collection chambers after each subject’s use for sanitary purposes.
Regarding claim 74, Haick, as modified, discloses the method according to claim 73, wherein the algorithm is selected from artificial neural network algorithms (ANN), gradient descent, spike timing dependent plasticity (STDP), principal component analysis (PCA), multi-layer perception (MLP), generalized regression neural network (GRNN), convolutional neural networks (CNN), spiking neural networks (SNN), fuzzy inference systems (FIS), self- organizing map (SOM), radial bias function (RBF), genetic algorithms (GAS), neuro- fuzzy systems (NFS), adaptive resonance theory (ART), partial least squares (PLS), multiple linear regression (MLR), principal component regression (PCR), discriminant function analysis (DFA), linear discriminant analysis (LDA), cluster analysis, k nearest neighbors (KNN), k means clustering (K means), spectral clustering, support vector machine (SVM), logistic regression, random forest and naive Bayes [see in ¶ 0034].
Regarding claim 75, Haick, as modified, discloses the method according to claim 74, wherein the algorithm is LDA [see in ¶ 0034].
Regarding claim 76, Haick, as modified, discloses the method according to claim 73.
Haick fails to disclose that the method is carried out on a device comprising a sample collecting chamber configured to receive and hold a breathsample obtained from the subject; at least one sensor assembly comprising one or a plurality of sensing regions responsive to interaction with volatile compounds present in a sample obtained from the subject, wherein each of the plurality of the sensing regions is associated with a same or different population of nanoparticles, wherein a signal independently derived from each of the sensing areas is indicative of an interaction or lack thereof between volatile compounds present in the sample and the nanoparticles on the sensing regions, and wherein the at least one sensor assembly is in gaseous communication with said sample collection chamber; a closed loop channel assembly equipped with a pump configured for directing said sample from the sample collecting chamber to the at least one sensor assembly and for circulating said sample continuously from the sample collecting chamber over the at least one sensor assembly over a period of time; and an analyzer configured for real-time analysis of volatile compounds present in the sample: a data processing unit for data communication with the sensor assembly; and a data user interface unit being in data communication with the data processing unit; wherein the data processing unit comprises data relating to a control data set and is adapted to receive information relating to the presence of the volatile compounds or pattern thereof and to provide an indication of presence or absence of one or more volatile compound.
However, ‘934 discloses a device comprising a sample collecting chamber [sample collection chamber 110, see in Fig. 1] configured to receive and hold a breathsample obtained from the subject [see in ¶ 0008]; at least one sensor assembly comprising one or a plurality of sensing regions responsive to interaction with volatile compounds present in a sample obtained from the subject [Sensor assembly 120, see in Fig. 1; see in ¶ 0051], wherein each of the plurality of the sensing regions is associated with same or different population of nanoparticles, wherein a signal independently derived from each of the sensing areas is indicative of an interaction or lack thereof between volatile compounds present in the sample and the nanoparticles on the sensing regions [see in ¶ 0051], and wherein the at least one sensor assembly is in gaseous communication with said sample collection chamber [the sample collecting chamber and the at least one sensor assembly are in gaseous communication, see in ¶ 0103]; a closed loop channel assembly equipped with a pump configured for directing said sample from the sample collecting chamber to the at least one sensor assembly and for circulating said sample continuously from the sample collecting chamber over the at least one sensor assembly over a period of time [see in Fig. 2B; see in ¶ 0104]; an analyzer configured for real-time analysis of volatile compounds present in the sample [see in ¶ 0105]; a data processing unit for data communication with the sensor assembly [data processing unit, see in ¶ 0112]; and a data user interface unit being in data communication with the data processing unit [data user interface unit, see in ¶ 0112]; wherein the data processing unit comprises data relating to a control data set and is adapted to receive information relating to the presence of the volatile compounds or pattern thereof and provide an indication of presence or absence of one or more volatile compound [see in ¶ 0112].
Haick and ‘934 are both analogous to the claimed invention because they are in the same field of breath sample analysis. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified the teachings of Haick to incorporate the device disclosed by ‘934 and utilize it for the method disclosed by Haick, as the structure and functionality of the device align with the disclosed diagnostic method to obtain the aligned and intended result.
Regarding claim 77, Haick, as modified, discloses the method according to claim 73, wherein the sensor is at least one sensor assembly [see in ¶ 0016; system comprising an array of sensors, see in ¶ 0049].
Regarding claim 78, Haick, as modified, discloses the method according to claim 73, wherein the sensor comprises one or more chemically sensitive metallic nanoparticles [gold nanoparticles coated with dodecanethiol, see in ¶ 0028].
Regarding claim 79, Haick, as modified, discloses the method according to claim 73, wherein the sensor is selected to be responsive and interact with VCs characteristic of bacterial infections of the respiratory tract [wherein the sensor is configured to detect the presence of at least one volatile organic compound indicative of tuberculosis caused by M. tuberculosis bacteria in a sample thereby affording TB diagnosis, see in ¶ 0051].
Regarding claim 80, Haick, as modified, discloses the method according to claim 79, wherein the sensor or sensor assembly is selected to be responsive to and interact with VCs characteristic of bacterial infections of the respiratory tract and substantially unresponsive or less or differently responsive to VCs characteristic of viral infections [The cluster of HIV positive TB patients completely overlaps with the cluster of HIV negative TB patients (FIG. 6D), showing that the sensor is not sensitive to HIV co-infection of the patients, see in ¶ 0126].
Regarding claim 84, Haick, as modified, discloses the method according to claim 73, for determining onset, presence or evolution of at least one bacterial infection of the upper respiratory tract or the lower respiratory tract, or for determining onset, presence or evolution of at least one bacterial infection induced by Streptococcal pyogenes [a single sensor comprising single walled carbon nanotubes coated with 2-methyl-2-butene provide enhanced sensitivity and selectivity for volatile biomarkers which are indicative of the presence of active tuberculosis caused by M. tuberculosis bacteria in a subject, see in ¶ 0016].
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HY KHANH DOAN whose telephone number is (703)756-5434. The examiner can normally be reached Monday - Friday 8:00 a.m. - 5 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HY KHANH DOAN/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791