DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed 06 April 2026 has been entered. Claim(s) 1-2, 5-8, 14 and 16-18 is/are currently amended. Claim(s) 3, 10-13, 15 and 19-20 has/have been canceled. Claim(s) 1-2, 4-9, 14 and 16-18 is/are pending.
Objections and/or Rejections Withdrawn
Objections to the specification, objections to the claims, rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 6 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 6 and claims dependent thereon, whether the preamble and the limitation "elevated cumulative abundance relative to uninfected control pediatric patients being indicative of a SARS-CoV-2 infection" limit the claim is not clear, such that the scope of the claim is indefinite. Specifically, it is unclear if all that is required by the claim is to calculating the cumulative abundance based on the concentrations for each of the claimed VOCs, with the preamble reciting the purpose of intended use of the analysis step (see MPEP 2111.02(II)), and the latter clause merely expressing the intended result of the analysis (see MPEP 2111.04), or if the method requires the additional, active step of diagnosing a SARS-CoV-2 infection, or monitoring such an infection, when the calculated cumulative abundance is elevated relative to uninfected control pediatric patients.
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.
Claim(s) 1-2, 4-9, 14 and 16-18 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more.
Claims 1-2, 4-9, 14 and 16-18 recite/require the steps of comparing octanal, nonanal, and heptanal levels within a breath sample of a pediatric subject to octanal, nonanal, and heptanal levels observed in uninfected control pediatric subjects to determine if the subject levels are elevated relative to the uninfected control pediatric subjects' levels and/or calculating a cumulative abundance of octanal, nonanal, heptanal, decane, 2-pentyl furan and tridecane (or of octanal, nonanal, heptanal, decane, 2-penthyl furan, tridecane and at least one or all of the remaining markers recited in Table 1A) within a breath sample from the subject; and diagnosing the subject with a SARS-CoV-2 infection if octanal, nonanal, and heptanal levels are elevated and/or based on the cumulative abundance.
These limitations, as drafted, are a process that, under its BRI, cover performance of the limitations in the mind. That is, nothing in the claim elements preclude the steps from practically being performed in the mind. For example, comparing VOC levels of a breath sample of a subject to levels of said VOCs observed in uninfected control pediatric subjects encompasses a user manually or mentally comparing respective pairs of numbers indicative of level/concentration of each VOC as determined by any known/existing technique. Calculating a cumulative abundance of the above-noted VOCs within the breath sample encompasses a user mentally/manually adding concentrations of each VOC determined by any known/existing technique. Lastly, the step of diagnosing/monitoring the subject with a SARS-CoV-2 infection encompasses the user manually or mentally considering the elevated octanal, nonanal, and heptanal levels, and calculated cumulative abundance in any manner he/she desires to form a judgment/opinion of the SARS-CoV-2 infection status of the subject. If claim limitations, under their BRI, cover performance of the limitations in the mind but for the recitation of generic computer components, then they fall within the "mental processes" grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Alternatively/Additionally, said claims recite the naturally-occurring correlation between elevated octanal, nonanal, and heptanal levels in breath of pediatric subjects and/or the cumulative abundance of octanal, nonanal, heptanal, decane, 2-penthyl furan, tridecane (or of octanal, nonanal, heptanal, decane, 2-penthyl furan, tridecane and at least one or all of the remaining markers recited in Table 1A) in breath of pediatric subjects and a SARS-CoV-2 infection comparable to concepts identified by the courts as laws of nature or natural phenomena (see MPEP 2106.04(b)(I)). Accordingly, the claim alternatively/additionally recites a law of nature or natural phenomenon.
The additional elements of the claims include analyzing/assessing levels/concentrations of the above-noted VOCs by use of any one of a plurality of analytical techniques (e.g., GC-MS, PTR-MS, etc.) and/or a hand-held breathalyzer device; a step of condensing or concentrating the sample before said analysis; and a step of administering a pharmaceutical composition comprising a therapeutically effective amount of at least one or a plurality of compound(s) effective against a SARS-CoV-2 infection to the subject. At least the steps of analyzing/assessing levels or concentrations of the above-noted VOCs by use of any one of a plurality of analytical techniques (e.g., GC-MS, PTR-MS, etc.) and/or a hand-held breathalyzer device and condensing or concentrating the sample before said analysis are data gathering steps used to acquire data necessary for performing the abstract idea or relevant to the law of nature (i.e., levels/concentration of the recited VOCs), and are therefore extra-solution activity (see MPEP 2106.05(g), particularly comparable limitations identified in In re Grams and Mayo as insignificant extra-solution activity).
The step of administering the pharmaceutical composition to the subject does not apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. First, the treatment is not particular, but encompasses any one of multiple therapies, or combination of therapies, suitable for SARS-CoV-2 infections. Secondly, there is no indication in the claim that the treatment is administered based on a diagnosis made based on elevated octanal, nonanal, and heptanal levels or the calculated cumulative abundance. Rather, as there is no indication as to when, and/or in response to what, the composition is administered, the claim appears to encompass the administering step being merely part of the data gathering (i.e., a composition is administered and a breath sample acquired after said administration, e.g., to monitor treatment efficacy, etc.). Accordingly, the steps of administering the pharmaceutical composition merely indicates a field of use in which to apply a judicial exception (see MPEP 2106.05(h), particularly comparable limitations identified in Mayo as merely indicating a field of use or technological environment in which to apply a judicial exception) and/or an additional data gathering step. Therefore, the additional elements do not integrate the abstract idea and/or law of nature into a practical application because they do not impose any meaningful limits on practicing the abstract idea and/or law of nature. Accordingly, said claims are directed to an abstract idea and/or law of nature.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. With respect to the data gathering steps, concentrating the sample and the analysis techniques are recited at a high level of generality, encompassing use of at least the commercially-available equipment disclosed as being used by Applicant (e.g., pgs. 11-17, sorbent tubes from Markes International Limited; samples analyzed using GCxGC BenchTOF-MS from SepSolve Analytical; etc.). Alternatively/Additionally, US 2012/0252129 A1 (previously cited, "Fu") discloses at least GC-MS with a pre-concentrator, or concentrating the VOCs before analysis, is well-understood, routine and/or conventional in the field (e.g., ¶ [0003]-[0005]). The "portable, hand-held breathalyzer device" is similarly recited at a high level of generality. Wilson ("Recent progress in the design and clinical development of electronic-nose technologies") indicates that electronic nose (e-nose) instruments, i.e., generally small, portable devices that can detect and discriminate between precise complex VOC mixtures of gas-analyte samples from patients with good precision and reasonable accuracy, have been used in various research studies to detect human diseases via biomarkers in breath (e.g., 18-20), thereby providing sufficient evidence that analyzing the breath samples with portable, hand-held breathalyzer device in a highly-generic manner also encompasses well-understood, routine and/or conventional activities in the field. Lastly, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of administering the pharmaceutical composition to the subject does not apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, but instead at best indicates a field of use in which to apply a judicial exception. Simply appending well-understood, routine and/or conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception and/or generally linking the use of the judicial exception to a particular technological environment or field of use component cannot provide an inventive concept. Therefore, claims 1-2, 4-9, 14 and 16-18 are not patent eligible.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim(s) 1, 4, 9 and 13 is/are rejected under 35 U.S.C. 103 as obvious over WO 2020/186335 A1 (previously cited, "Reddy"), or alternatively, over Reddy in view of "Breath carbonyl levels in a human population of seven hundred participants" (previously cited, "McCartney").
Regarding claim 1, Reddy discloses/suggests a method for diagnosing or monitoring a subject with a SARS-CoV-2 infection (¶¶ [00197]-[00212]), the method comprising:
obtaining a sample of exhaled breath or condensate breath from the subject (¶ [00197] sample of exhaled breath; ¶ [0210] receiving an exhaled breath of a subject into a mouth piece; etc.);
determining levels of volatile organic compounds (VOCs) octanal, nonanal, and heptanal in said sample relative to levels observed in uninfected control subjects (¶ [00197] sensor or sensor module can detect one or more chemicals associated with coronavirus; ¶ [00198] one or more sensors can be tuned to detect any number of alkanes and/or alkane derivatives as well as aldehydes to indicate the presence of one or more viruses causing increased oxidative stress; ¶ [00210] one or more chemicals associated with a virus, such as COVID-19, in the exhaled breath of the subject can be detected) via at least one technique selected from the group consisting of photo ionization detection, flame ionization detection, gas chromatography-mass spectrometry (GC-MS), proton transfer reaction mass spectrometry (PTR-MS), colorimetry, infrared spectroscopy, electrochemical fuel cell sensing, semiconductor gas sensing, quartz tuning fork (QTF) sensors, electronic noses and combinations thereof (e.g., ¶ [0076] analytical techniques, such as gas chromatography, flame and/or combustion reactions detected using characteristic optical emission and/or absorption lines, hydrogen flame ionization, an indirect calorimeter, chemical detection methods, and colorimetry, can analyze the exhaled breath for detecting and/or identifying one or more substances; etc.); and
diagnosing said pediatric subject with a SARS-CoV-2 infection, or monitoring the subject, when the determined levels of said VOCs are elevated compared to those observed in uninfected control pediatric subjects (¶¶ [00197]-[00198] detecting and monitoring COVID-19 based on VOC breath print, which may include indicators of increased oxidative stress; ¶ [00211] specific substances and/or VOCs can be significantly elevated in subjects who have a virus, such as COVID-19, as compared with subjects without a virus, such respective concentrations and/or amounts of these substances and/or VOCs within a predefined threshold or range indicates high likelihood of a subject having a virus, such as COVID-19).
Reddy does not expressly disclose the uninfected control subjects are pediatric uninfected control subjects. However, in diagnosing/monitoring other health conditions (e.g., breast cancer), Reddy discloses a subject and control subjects are age-matched (e.g., ¶ [00148]-[00150]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Reddy with the uninfected control subjects being pediatric uninfected control subjects at least when the subject is a pediatric subject in order to age-match the subject to healthy controls for a more accurate/reliable reference by which to assess if VOCs of the subject are elevated.
As discussed above, Reddy as modified discloses, in diagnosing/monitoring a subject with a SARS-CoV-2 infection, analyzing a breath sample for relatively elevated levels of VOCs aldehydes, as noted above. One of ordinary skill in the art would ready appreciate "aldehydes" encompasses straight-chain aldehydes including octanal, nonanal, and heptanal, particularly as Reddy appears to differentiate between "aldehydes" and "branched aldehydes" (e.g., [00109]). Accordingly, Reddy as modified meets the limitations of claim 1. Alternatively/Additionally, McCartney discloses heptanal, octanal, nonanal are oxidative stress biomarkers (e.g., pg. 11, Conclusion, C4-C10 straight chain aldehyde levels were quantified in human breath to provide typical distributions of certain oxidative stress biomarkers). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Reddy with the aldehydes to include heptanal, octanal and nonanal in order to facilitate identifying and/or analyzing additional markers of oxidative stress that may indicate the presence of one or more viruses, such as SARS-CoV-2/COVID-19 (Reddy, ¶ [00198]; McCartney, pg. 11).
Regarding claim 4, Reddy as modified discloses/suggests analysis of the VOCs is conducted using a portable, hand-held breathalyzer device (e.g., ¶ [00210]; ¶ [0037]; etc.).
Regarding claim 9, Reddy as modified discloses/suggests the sample is exhaled breath (e.g., ¶ [00210]).
Regarding claim 13, Reddy as modified discloses/suggests condensing or concentrating the sample before analysis (e.g., ¶ [0062] concentrating or otherwise retaining one or more substances, for detection and/or identification by the sensor module 108).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reddy (or Reddy in view of McCarthy) as applied to claim(s) 1 above, and further in view of US 2008/0286830 A1 (previously cited, "Scotter").
Regarding claim 2, Reddy as modified discloses/suggests the limitations of claim 1, as discussed above, and further discloses/suggests the method further comprises assessment of decane, tridecane and dodecane levels (e.g., ¶ [0028] example embodiments may be combined; ¶ [00109] decane, tridecane; ¶ [00117] dodecane; ¶ [00146] dodecane, tridecane; etc.). Reddy further discloses VOCs associated with bacterial infections may be analyzed (e.g., ¶¶ [00213]-[00222]), but does not expressly disclose assessment of 2-pentyl furan levels.
Scotter discloses the use of a biomarker pentylfuran, such as 2-pentylfuran, in a breath sample to detect bacterial and/or fungal pathogens (Abstract; ¶ [0011]; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Reddy to further comprise the assessment of additional VOCs, including 2-pentyl furan, as taught and/or suggested by Scotter in order facilitate diagnosing and/or monitoring additional health conditions (e.g., bacterial and/or fungal infections).
Claim(s) 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reddy (or Reddy in view of McCarthy) as applied to claim(s) 1 above, and further in view of US 10,9807,56 B1 (previously cited, "Glick").
Regarding claims 14 and 16, Reddy as modified discloses/suggests the limitations of claim 1 as discussed above, and further discloses/suggests administering to the subject a treatment effective against a SARS-CoV-2 infection (e.g., ¶ [00212] performing a treatment on the subject to address the virus, such as COVID-19). Reddy as modified does not expressly disclose performing the treatment effective against the SARS-CoV-2 infection comprises administering to the subject a therapeutically effective amount of a pharmaceutical composition having at least one compound effective against a SARS-CoV-2 infection.
Glick discloses/suggests treatments effective against a SARS-CoV-2 infection include administering to the subject a therapeutically effective amount of a pharmaceutical composition having at least one compound effective against a SARS-CoV-2 infection (Abstract; col. 2, lines 29-33; col. 28, line 60 - col. 30, line 54; etc.), wherein the compound effective against the SARS-CoV-2 infection comprises at least two compounds selected from the group consisting of convalescent plasma, remdesivir, regeneron, soluble ACE-2 and steroids, and combinations thereof (col. 28, line 60 - col. 30, line 54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Reddy with administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of at least one compound effective against a SARS-CoV-2 infection, wherein the compound effective against the SARS-CoV-2 infection comprises at least two compounds selected from the group consisting of convalescent plasma, remdesivir, regeneron, soluble ACE-2 and steroids, and combinations thereof, as taught/suggested by Glick as a simple substitution of one suitable SARS-CoV-2 infection treatment(s) for another to yield no more than predictable results. See MPEP 2143(I)(B).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to rejections under 35 U.S.C. 112(b), regarding claim 6, Applicant expresses disagreement with an alleged assertion in the prior Office action that "the phrase 'cumulative abundance' renders the scope of claim 6 and claims dependent therefrom unclear" (Remarks, pgs. 8-9). However, no such assertion was made by the examiner in the prior Office action. Rather, as reiterated in the rejections of record above, claim 6 was rejected as indefinite because it is unclear whether the preamble and the limitation "elevated cumulative abundance relative to uninfected control pediatric patients being indicative of a SARS-CoV-2 infection" limit the claim (similar to the prior rejection of claim 1 under 35 U.S.C. 112(b)). Since Applicant's amendments to claim 6 and/or submitted remarks do not address this issue, said rejection has been maintained.
With respect to eligibility under 35 U.S.C. 101, Applicant asserts "it is clear that claims 1-9 and 13-18 as amended do not encompass a judicial exception," contending the recited techniques for detecting a discrete set of VOCs in a breath sample "obviously require more than 'performance of the limitations in the mind'" (Remarks, pg. 9).
The examiner respectfully disagrees. Claim 1 requires comparing detected VOC levels to control VOCs levels, a limitation capable of being practically performed in the mind (mentally comparing two numbers). Claim 6 requires calculating a cumulative abundance of detected VOCs and (presumably) comparing the calculated cumulative abundance to a control cumulative abundance to determine if the calculated cumulative abundance is elevated and indicative of a SARS-CoV-2 infection, also limitations capable of being practically performed in the mind (mentally calculating a sum of concentrations; mentally comparing two numbers; etc.). Accordingly, the pending claims recite mental processes. The claims further employ a natural relationship between levels/concentrations of the recited VOCs in breath and a SARS-CoV-2 infection, such that the pending claims alternatively/additionally recite a law of nature.
The examiner has made no contention that analyzing the sample to detect the VOC levels or concentrations is capable of being performed in the mind. However, these additional steps or elements of the claim amount to the data gathering necessary to perform the above-noted mental processes (e.g., in order to compare the concentration of a VOC(s), said concentration must first be detected), and therefore amount to insignificant extrasolution activity. The limitations merely require a user to detect the relevant VOC levels and/or concentrations using any one of numerous existing analytical techniques for use in the abstract idea and/or applying the natural law, and therefore neither practically apply the judicial exception(s) nor amount to significantly more than said judicial exception(s).
With respect to the prior art rejections, regarding the rejection of claim 1, Applicant contends, "Reddy teaches detection of aldehydes generally in connection with Covid-19 infection but does not identify which aldehyde may be elevated. Reddy is silent regarding the specific VOC combinations encompassed by claims 1, 2 5 and 6 for detection of Covid-19 in pediatric subjects. Indeed, the subjects of Reddy appear to be adults which as taught in the present application have different VOC profiles when compared to pediatric subjects. McCartney's discussion relating elaboration of certain VOCs in response to oxidative stress caused by lung disease and other disorders does make up for this deficiency" (Remarks, pg. 12).
The examiner respectfully disagrees. Reddy discloses levels of aldehydes in breath can be analyzed to identify elevated levels associated with increased oxidative stress and/or those subjects who have a virus, such as COVID-19 (¶ [00198]; ¶ [00211]). "Aldehydes" generally encompasses the specific aldehydes claimed, such that Reddy meets the limitations of claim 1. Alternatively or additionally, Reddy discloses viruses, including COVID-19, may initiate/increase oxidative stress, leading to increased/elevated levels of oxidative stress biomarker in breath, which can be the basis for an early differential diagnosis of viral infections, including COVID-19. Accordingly, Reddy discloses detecting biomarkers indictive of oxidative stress to identify increased oxidative stress associated with COVID-19, expressly disclosing aldehydes may be included in said biomarkers, as noted above. McCartney more expressly discloses straight chain aldehydes, including octanal, nonanal, and heptanal, are known biomarkers of oxidative stress that can be non-invasively measured in exhaled human breath (Abstract). Therefore, it would have been obvious that Reddy suggests including, and/or to modify Reddy to include, straight chain aldehydes such as octanal, nonanal, and heptanal, among the oxidative stress biomarkers detected and analyzed in detection and/or monitoring of COVID-19.
With respect to the rejection of claim 2, "the Examiner has provided no motivation whatsoever that would compel the POSITA to add 2-pentyl furan to the aldehydes of Reddy and oxidative stress VOCs of McCartney absent application of impermissible hindsight reconstruction of the presently claimed invention" (Remarks, pg. 13).
The examiner respectfully disagrees. As noted in the rejection of record, assessing the additional recited biomarkers enables diagnosing and/or monitoring additional health conditions (e.g., bacterial and/or fungal infections). There is no requirement in claim 2 that the assessment of decane, 2-pentyl furan, tridecane and dodecane levels is used in assessing SARS-CoV-2 infection of the subject.
Applicant does not argue the rejection(s) of claims 14 and 16 separately, merely contending the rejection(s) is/are inappropriate because of the claims' dependence on claim 1, which Applicant contends is not taught/suggested by Reddy, or Reddy and McCartney (Remarks, pg. 13). The examiner respectfully disagrees for at least the reasons discussed above.
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 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 Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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