DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 02/18/2026 in which claims 49, 50, 53, 59, 60, 62-64, were amended, new claims 69-70 were added, and claims 51, 68 were canceled, has been entered. Claims 65-67 were previously withdrawn. Claims 1-48 were previously canceled.
It is noted that new claim 69 depends on withdrawn claim 65. Accordingly, claim 69 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Claims 49, 50, 52-64, 70 are under examination on the merits.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 02/18/2026 have overcome the objection previously set forth in the Non-Final Office Action mailed on 12/17/2025.
Claim Objections
(Previous objections, withdrawn as to claims 51). Applicant’s cancelation of claim 51 has overcome previous objections to this claim. Applicant’s amendments to claims 1 and 50 have overcome previous objections to those claims.
(New objections, necessitated by amendment) Claim 49, is objected to because of the following informalities:
The recitation on claim 49 of “wherein each of the plurality of sensing regions are associated…” should read “wherein each of the plurality of sensing regions is associated…”; “sensing regions are associated with same or different” should read “sensing regions being associated with the same or different”; “by comparing signal or signals to information related to presence of VOCs” should read “by comparing the signal or signals to information related to the presence of VOCs”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(Previous rejection, withdrawn as to claims 59, 60, 64 68) Claims 59, 60, 64, 68 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
See claims 59, 60, 64, 68 as submitted on 02/18/2026.
The previous rejections of claim 68 is moot in view of Applicant’s cancelation of this claim.
Applicant’s amendment to the instant claims has overcome previous rejection to claims 59, 60, and 64.
(New rejection, necessitated by amendment as to claims 49, 50, 52-64, 70) Claims 49, 50, 52-64, 70 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
See claims 49, 50, 52-64, 70 as submitted on 02/18/2026.
Claim 49 recites “a) obtaining a breath sample from a subject, said breath sample being contained in a sample collection chamber detachably connected to a sensor device having a sensor surface, said sensor surface comprising one or a plurality of sensing regions responsive to the interaction with volatile compounds present in a breath sample, wherein each of the plurality of sensing regions are associated with same or different populations of nanoparticles that are surface-associated with a ligand selected from dodecanethiol, hexanethiol, decanethiol, tert-dodecanethiol, butanethiol, 2- ethylhexanethiol, dibutyl disulfide, 2-nitro-4-trifluoromethylbenzenethiol, benzylmercaptane, 4-chlorobenzenemethanethiol, 3-ethoxythiolphenol, 4-tert- methylbenzenethiol and 1-heptanethiol, wherein a signal is independently derived from each of the sensing regions, which signal is indicative of the interaction or lack thereof between the volatile compounds and the nanoparticles on the sensing regions”. This recitation appears to have at least two independent clauses without proper punctuation or appropriate conjunctions. The absence of proper punctuation or appropriate conjunctions renders the indicated recitation unascertainable. Further, it is not clear what the term “responsive” meas. It is further noted that the indicated recitation appears to describe a step of detecting an analyte in a breath sample. Accordingly, it is unclear if step “a)” of obtaining a breath sample encompasses a step of detecting or not. The dependent claims do not add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution and applying prior art, claim 49 was interpreted herein as referring to obtaining a breath sample from a subject, said breath sample being contained in a sample collection chamber detachably connected to a sensor device having a sensor surface.
Further, claim 49 recites “by circulating the sample in a closed loop channel assembly equipped with a pump configured for directing said sample from the sample collection chamber over the sensor surface over a period of time”. It is unclear what is meant by this recitation because neither the claim nor the Specification define or explain what the term “configured for directing” means in the context of the method of claim 49. For instance, it is not clear if the term “configured for directing” refers to a step of circulating the sample or not. The dependent claims do not add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution and applying prior art, claim 49 was interpreted herein as referring to circulating the sample in a closed loop.
Claim 70 recites “The method according to claim 49 for determining the viral load or stage of a viral infection in a subject”. However, claim 49 recites “A method of identifying the presence of a viral infection in a subject”. It is unclear if claim 70 refers to the method of claim 49 or another method. The claim language lacks consistency. For purposes of compact prosecution and applying prior art, claim 70 was interpreted herein as referring to the method of claim 49.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
(Previous rejection, withdrawn as to claims 51 and 68, maintained and modified as necessitated by amendment as to claims 49, 50, 52-64, expanded as to claim 70) Claims 49, 50, 52-64, and 70 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
See claims 49, 50, 52-64, and 70 as submitted on 02/18/2026.
The previous rejections of claims 51 and 68 are moot in view of Applicant’s cancelation of these claims.
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes and the Steps cited below (See flowchart at pages 10-11 at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf ).
The claims are directed to a process, which is one of the four statutory categories of invention (Step 1: YES).
The amended claims remain directed to the natural correlation between the binding of a ligand to a volatile organic compound (VOC) in a breath sample of a subject, as recited in claim 49. The instant claims are further directed to the mental step of appreciating the natural correlation to determine the presence of the VOC in the breath sample based on an output signal, and further to the mental step of appreciating the natural correlation to compare between the VOC profile of the subject with a VOC profile control signal or signals. Further, the instant claims are directed to the mental step of determining and comparing an output based on the natural correlation between the VOC profile of the subject with a VOC profile control signal or signals. As such, the instant claims still recite judicial exceptions (JEs) in the form of a law of nature and abstract idea (Step 2A, Prong One: YES).
The crux of the claimed method is the appreciation of the natural correlation between the binding of a ligand to a volatile organic compound (VOC) in a breath sample of a subject. These steps of determining and comparing can be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). Obtaining and detecting the natural correlation in a biological sample would constitute insignificant extra-solution activities.
It is noted that the claims further require “obtaining a breath sample” and “exposing a breath sample to the sensor surface of the sensor device.” These are not a particular field of use, but, rather, a generic way to obtain a read out from the natural correlation in a biological sample. Hence, amended claim 49 does not recite additional elements that integrate the judicial exception (abstract idea) into a practical application. Integration into a practical application requires an additional element(s) or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception (See for example, Slide 18 of 2019 PEG training at http://ptoweb.uspto.gov/patents/exTrain/101.html). Further, the steps of “determining” and “comparing” in claim 49 are performed separately from the steps of “obtaining a breath sample” and “exposing a breath sample to the sensor surface.” There is no improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a). Further, generally linking of the use of the judicial exception to a particular technological environment or field of use is not indicative of integration into a practical application – see MPEP 2106.05(h)”.
As such, the instant claims do not recite additional elements that integrate the JEs into a practical application (Step 2A, Prong Two: NO).
It was well-understood, routine, and conventional (WURC) at the time of filing to expose a breath sample obtained from the subject to a sensor surface comprising a ligand, as evidenced by the art cited below (see rejections under 35 USC § 102 and 103). As such, beyond the JEs, the instant claims only recite WURC data-gathering steps and generic instructions to apply the JE. These constitute insignificant extra-solution activities, which do not reasonably provide an inventive concept.
As such, the instant claims do not recite significantly more than the JE (Step 2B: NO).
Accordingly, the amended claims do not constitute patent eligible subject matter under 35 U.S.C § 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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.
(Previous rejection, withdrawn as to claims 49-51, 64) Claims 49-51, 64, were rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bhatia et al. (prior art of record).
See claims 49-51, 64, as submitted on 02/18/2026.
The previous rejections of claim 51 is moot in view of Applicant’s cancelation of this claim.
Applicant’s amendment to the instant claims has overcome previous rejection to claims 59-50, and 64.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(New rejection, necessitated by amendment as to claims 49-50, 64, 70) Claims 49-50, 64, 70 are rejected under 35 U.S.C. 103 as being unpatentable over Bhatia et al. (prior art of record).
See claims 49-50, 64, 70 as submitted on 02/18/2026.
Regarding amended claim 49, it is noted that the claim recites new limitations. As noted above, the recitations in claim 49 regarding specific features of a device are indefinite (see rejections under 35 USC § 112(b) above). However, the teachings of Bhatia et al. already teach limitations regarding specific features of a device as follows:
Bhatia et al. disclose a method of identifying the presence of a pathogenic infection including a viral infection in breath sample of a subject (Abstract, ¶¶ [0004]-[0017]). The method of Bhatia et al. comprises:
Obtaining a breath sample from a subject by direct exhalation into a device or into a collecting tube comprising a collection chamber comprising an ExetainerTM vial detachably connected to a nanosensor (¶¶ [0024], [0028], [0114], Figs. 1, 8); said nanosensor comprising a scaffold structure comprising multiple regions associated with nanoparticles the same or different volatile reporters (¶¶ [0038], [0046], [0061], Fig. 2A). In one embodiment, the nanoparticles comprise different volatile reporters including butanethiol and other thiol-containing compounds (¶¶ [0038], [0046]).
exposing a breadth sample to the nanosensor over a period of time by circulating the sample in a closed loop channel assembly comprising a pump in the form of a syringe (Fig 4A), wherein the nanosensor on its surface a plurality of nanoparticles attached to volatile reporters including butanethiol and other thiol-containing compounds (¶¶ [0004]-[0017], [0038], [0057], [0093]; Figs. 1, 13).
determining the presence of one or more volatile reporters or volatile organic compounds (VOCs) indicative of presence one of more VOCs in the breath sample (¶¶ [0016]-[0017])
comparing the one or more volatile reporters to control measurements from healthy subjects thereby determining the presence of a viral infection (¶¶ [0016]-[0019])
determining the presence or absence of a viral infection (¶¶ [0016]-[0019])
Accordingly, the limitations of claim 49 were prima facie obvious to one of ordinary skill in the art before the effective filing date especially in the absence of evidence to the contrary.
It is noted that the recitations regarding specific features of a device in claim 49, do not impart additional method steps to be performed to the method of claim 49, but rather, these recitations refer to a device intended to be used in the method of claim 49. It is also noted that a device constitutes a non-elected invention per Applicant’s response to the election requirement mailed on 08/01/2025. Therefore, the recitations regarding specific features of a device in claim 49 are considered to flow from the step of “obtaining” already present in the method of claim 49. Further, these recitations do not add any distinct meaning or purpose to the manipulative step of “obtaining”. Further, it is noted that any method in the prior art having all of the step limitations recited in claim 49 would be capable of identifying the presence of a viral infection in a subject. Nonetheless, as explained above in detail, the new limitations regarding specific features of the device are already taught by Bhatia et al.
Regarding claim 50, as discussed above, Bhatia et al. further disclose a scaffold structure comprising multiple regions associated with nanoparticles the same or different volatile reporters (¶¶ [0038], [0046], [0061], Fig. 2A). In one embodiment, the nanoparticles comprise different classes of VOCs (surface decoration, as recited in claim 50) (¶¶ [0038], [0046]).
Regarding claim 64, as noted above Bhatia et al. disclose wherein the breath sample is obtained from the subject by direct exhalation into a device or into a collecting tube (¶¶ [0028], [0114], Figs. 1, 8).
Regarding claim 70, Bhatia et al. disclose wherein the levels of reporter measured are quantified such as the pathogen load in the sample can be determined (¶¶ [0023]-[0029], Figs. 3C, 4E, 6, 9).
(Previous rejection, withdrawn as to claim 68, maintained and modified as necessitated by amendment as to claims 52-60) Claims 52-60 are rejected under 35 U.S.C. 103 as being unpatentable over Bhatia et al. (previously cited), as applied to claims 49-51, 64 above, in view of Haick et al. (prior art of record).
See claims 52-60 as submitted on 02/18/2026.
The previous rejections of claim 68 is moot in view of Applicant’s cancelation of this claim.
Regarding claims 52-54, the method of claim 49 was anticipated by the disclosure of Bhatia et al. The disclosure of Bhatia et al. does not teach wherein the nanoparticles are metallic gold nanoparticles.
However, Haick et al. teach methods of detection of VOCs associated with a pathogenic infection comprising sensor technology comprising a single nano-material gold nanoparticles (Abstract, ¶¶ [0047], [0049]). Haick et al. further teach the use of conductive or semi-conductive material such as gold nanoparticles allows for a change in structural configuration which can be translated into an electrical signal, thereby providing a particularly sensitive and selective signal to at least one VOC (¶ [0050]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the gold nanoparticles as taught by Haick et al. into the method taught by Bhatia et al. for the benefit of generating a particularly sensitive and selective signal to at least one VOC with gold nanoparticles. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in incorporating the gold nanoparticles taught by Haick et al. into the method of Bhatia et al. given that the methods of assembling systems of VOC detection are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claims 55-58, Haick et al. further teach wherein the ligand molecules comprise tert-dodecanethiol (¶¶ [0049], [0121], Table 3).
Regarding claims 59-60, the method of claim 49 was anticipated by the disclosure of Bhatia et al. Bhatia et al. further teach a scaffold structure comprising multiple regions associated with nanoparticles the same or different volatile reporters (¶¶ [0038], [0046], [0061], Fig. 2A). Haick et al. also teach these limitations in addition of the specific ligands recited in claim 59. Specifically, Haick et al. teach a sensor surface comprising one or more sensing regions, each of the sensing regions is in the form of a plurality of gold nanoparticles each of the nanoparticles being associated with a ligand molecule, for example dodecanethiol, and tert-dodecanethiol, (¶¶ [0028], [0029], [0083], [0121], Table 3).
Accordingly, claims 52-60 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 02/18/2026 have been fully considered but they are not persuasive.
Applicant contends on page 17 of the Remarks submitted on 02/18/2026:
“Method claim 49 has now been amended to recite specific features of the device to be used in the method. For example, the breath sample must be contained in a sample collection chamber detachably connected to a sensor device having a sensor surface. Furthermore, claim 49 requires that the sensor surface comprise one or a plurality of sensing regions, which sensing regions are associated with populations of nanoparticles that are surface-associated with a specified ligand, and a signal is independently derived from each of the sensing regions, which signal is indicative of the interaction or lack thereof between the volatile compounds and the nanoparticles…”
In response:
The claims as amended are still directed to the natural correlation between the binding of a ligand to a volatile organic compound (VOC) in a breath sample of a subject and to the mental step of appreciating the natural correlation to determine the presence of the VOC in the breath sample, and further to the mental step of appreciating the natural correlation to compare between the VOC profile of the subject with a VOC profile control and/or with a VOC profile obtained from the subject at an earlier time point. As such, the instant claims recite judicial exceptions (JEs) in the form of a law of nature and abstract idea. Further, as indicated above, the limitations in relation to specific features of a device to be used in the method are unclear (see rejections under 35 USC § 112 above) and do not impart additional method steps to be performed to the method of claim 49, but rather, these recitations refer to a device intended to be used in the method of claim 49.
Applicant contends on page 19 of the Remarks submitted on 02/18/2026:
“Bhatia discloses none of these features. Bhatia does not disclose a detachable sample collection chamber, does not disclose exposing an exhaled breath sample to a surface-based sensor at all, and does not disclose nanoparticle sensors functionalized with thiol ligands of any kind…Amended claim 49 further requires determining a VOC profile indicative of one or more VOCs in the breath sample and comparing the resulting signal or pattern to information relating to VOC presence or patterns in order to determine not only the presence or absence of viral infection, but also recurrence, type, viral load, or stage. Bhatia does not disclose VOC profile determination, pattern analysis, or comparative analysis against stored VOC information”
In response:
The specific method steps taught by Bhatia et al. are explained in detail above. The instant rejection is in view of instant claim language. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is noted that the instant claims merely recite a method of identifying the presence of a viral infection in a subject. As amended, the instant claims are still encompassed by the teachings of Bhatia et al. See above a detailed explanation on the teachings of Bhatia et al. in reference to the specific features of a device. Further, as explained above and previously, the steps of determining and comparing, are already taught by Bhatia et al.
Applicant contends on page 21 of the Remarks submitted on 02/18/2026:
“Bhatia and Haick are directed to incompatible diagnostic paradigms. As detailed above, Bhatia teaches that endogenous breath VOCs are insufficiently reliable and must be bypassed through engineered in vivo reporter release, whereas Haick relies on direct interaction between endogenous VOCs and surface-bound nanoparticle sensors. A person of ordinary skill in the art would not have been motivated to combine these references because doing so would require abandoning the core teaching of Bhatia, namely, that in vivo biochemical amplification is necessary, in favor of the very approach that Bhatia implicitly rejects. Even if one were to attempt such a combination, there would have been no reasonable expectation of success. At the relevant priority date, diagnosing viral infections via breath VOC analysis was widely regarded as unpredictable due to inter-subject variability, environmental noise, and lack of unique viral biomarkers…”
In response:
To reiterate, the instant rejection is in view of the instant claims merely reciting or reading on an immunogenic composition. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Both Bhatia et al. and Haick et al. teach methods of identifying the presence of a pathogenic infection including a viral infection in breath sample of a subject. Applicant’s argument that a person of ordinary skill in the art would not have been motivated to combine these references because doing so would require abandoning the core teaching of Bhatia, namely, that in vivo biochemical amplification is necessary, in favor of the very approach that Bhatia implicitly rejects, is not persuasive because as explained above in detail both references teach key elements of VOC detection and analysis comprising sensors as required by instant claims. While Bhatia et al. teach inhalable nanosensors and measurement of reporters, these features are not required, see Bhatia et al.’s independent claim 1. Accordingly, it is herein maintained that it would have been obvious to a person skilled in the art to have combined the elements taught by these two references with reasonable expectation of success to arrive at the claimed invention.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-R 8:00 AM - 5:00 PM.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/ Primary Examiner, Art Unit 1672
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