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 .
Election/Restrictions
Applicant's election with traverse of Fig. 3 species in the reply filed on 01/16/2026 is acknowledged. However, in view of applicant’s arguments filed 01/16/2026 and amended claims, the restriction requirement of 09/11/2025 has been withdrawn. Claims 20-39 remain pending.
Information Disclosure Statement
No IDS was filed for this application. The applicant and/or the assignee of this application are required under 37 CFR 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application (see MPEP §§ 704.10 - 704.13). In response to this requirement, please provide a copy of any related and pertinent information, such as non-patent literature, published application(s) or patent(s) (U.S. or foreign), that was used to assist in the drafting of this application. The applicant is reminded of the duty to disclose information that is material to patentability (see 37 CFR § 1.56). A complete reply to the instant Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the instant Office action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the:
“a diffraction grating element and a charged-coupled device (CCD) array” (claims 21, 27);
“photon dispersive unit and a photon detection unit” (claims 22, 28);
“the laser module further comprises multiple monochromatic lasers, optical elements , and detectors” (claim 30);
“wherein multiple monochromatic lasers of different wavelengths are employed either at the same position or at different locations” (claim 31);
“wherein multiple activation sensors, oriented at different angles with respect to each other, are employed to detect a dispersed droplet moving along the centerline of the device” (claim 35);
“the breath analysis device is employing a fan situated at the outlet of the device and a different mouthpiece with a more restrictive filter used continuously for a longer period of time than a single exhalation” (claim 37); and
“wherein the device is incorporated into airport security full body scanners in order to monitor exhaled breath of travelers during the scanning procedure” (claim 39) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 20 is objected to because of the following informalities: Claim 20 includes the identifier of (New). However, previous claims filed 02/07/2023 includes Claim 20. MPEP 714 and 37 C.F.R. 1.121(c) states amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection. Therefore, since claim 20 has been amended, claim 20 should include proper strike-throughs of the limitations that have been deleted and the claim identifier should be (Currently amended). If applicant intended to cancel previously filed claim 20, claim 20 should be identified as (Canceled) and the current claims should be renumbered. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: It is suggested to recite “TB” in line 1 in an unabbreviated form to establish the acronym. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: “clam” in line 1 should read “claim”. Appropriate correction is required.
Claims 21, 23-25, 27-31, 35, 37-39 is objected to because of the following informalities: It is suggested to recite the instances of “the device” as “the breath analysis device” for improved consistency of terminology. Appropriate correction is required.
Claims 22-26 and 28-39 are objected to because of the following informalities: Claims 22-26 and 28-39 uses dashes and bullet points. Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). There may be plural indentations to further segregate subcombinations or related steps. (MPEP 608.01(m). It is suggested to remove the dashed list and the bullet points and ensure that each element or step is separated by a line indentation. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: It is suggested to recite “the detector” of lines 12 and 19 as “the autofluorescence detector” for improved consistency of terminology. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: In the last line, it is suggested to include a period at the end of the sentence. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: It is suggested to recite “the detector” of lines 11 and 19 as “the autofluorescence detector” for improved consistency of terminology. 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:
“photon dispersive unit” and “photon detection unit” in claims 22 and 28.
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.
In this instant case:
“means of signal transmission and reception” of claim 24 any element capable of signal transmission and reception by WiFi (specification, paragraph [0019]) and equivalents thereof;
“photon dispersive unit” and “photon detection unit” in claims 22 and 28 are interpreted as any element capable of minimizing the effect of scattered photons to achieve resolution of a fluorescent spectrum and equivalents thereof.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20-26, 28-29, and 32-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 20, claim 20 recites “wherein the application is configured to process autofluorescence signal data received from the breath analysis device, generate test results for the user, and communicate the results to the user, and to a server for storing the test results of the user”, which was not described in the disclosure. Originally filed claim 1 recites “A system for detecting TB mycobacteria in droplets dispersed in an air sample exhaled by a user, through a disposable mouthpiece, into a breath analysis device, connected to an App, processing autofluorescence signal data and communicating the results to the user, and a server, storing each subject's test result”. However, the “App” was not recited as “configured to process autofluorescence signal data received from the breath analysis device, generate test results for the user, and communicate the results to the user, and to a server for storing the test results of the user”. The specification, paragraph [0019] discloses “transmitted signals are processed by software and the results are displayed locally on the mobile device and may also be communicated back to the breath analysis device”. However, the disclosure is silent on the specific limitations of: “wherein the application is configured to process autofluorescence signal data received from the breath analysis device, generate test results for the user, and communicate the results to the user, and to a server for storing the test results of the user”. Therefore, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 21-26 and 32-39 are rejected by virtue of their dependency on claim 20.
Regarding claims 23 and 28, claims 23 and 28 recites “ensuring minimal deposition and fouling…” (emphasis added). The disclosure fails to describe “ensuring minimal deposition and fouling…”. The specification, paragraph [0017] describes “preventing exhaled droplets from depositing onto the interior surfaces of the device” and originally filed claim 3 recites “avoid deposition and fouling”. However, the disclosure does not recite ensuring minimal deposition and fouling. Therefore, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 29 is rejected by virtue of its dependency on claim 28.
Regarding claim 24, claim 24 recites “means of signal transmission and reception”. The specification, paragraph [0019], and Fig. 1 merely describes the breath analysis device that transmits autofluorescent spectra by WiFi. However, the disclosure is silent on what structure contributes to the particular “means of signal transmission and reception.” The disclosure is devoid of any structures that performs the functions of the “means of signal transmission and reception” in the claim, and thus the claims were not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 22 and 28, claims 22 and 28 recite “a photon dispersive unit and a photon detection unit”. The disclosure is silent on what structure(s) contribute to the particular “photon dispersive unit” and “photon detection unit”. The written description is devoid of any structures that performs the functions of “a photon dispersive unit and a photon detection unit” in the claim, and fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Thus, the claims were not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 24 and 29 are rejected by virtue of their dependency on claims 22 and 28.
Regarding claim 38, claim 38 recites “within 4m” in line 3. While the disclosure recites monitoring across a desk, for example 1-2m (specification, paragraph [0056]; originally filed claim 19), the disclosure fails to describe “within 4m”. Therefore, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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.
Claims 21-39 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.
Regarding claim 21, claim 21 recites the limitation "the autofluorescence signal” in the last line. There is insufficient antecedent basis for this limitation in the claim. Claims 22-25 and 32-39 are rejected by virtue of their dependency on claim 21.
Regarding claim 22, claim 22 recites “an optical detection system” in line 2. It is unclear if the optical detection system of claim 22 is the same or different from the activation sensor, autofluorescence detector, and optical system established in claim 21. Does the optical detection system of claim 22 comprise the activation sensor, autofluorescence detector, and optical system of claim 21? Or is the optical detection system a separate element? Claim 24 is rejected by virtue of its dependency on claim 22.
Regarding claim 22, claim 22 recites “an autofluorescence signal” in lines 4-5. It is unclear if the autofluorescence signal of claim 22 is the same or different from “the autofluorescence signals” established in claim 21. Claim 24 is rejected by virtue of its dependency on claim 22.
Regarding claim 22, claim 22 recites the limitation "the detection section" in line 6. There is insufficient antecedent basis for this limitation in the claim. Claim 24 is rejected by virtue of its dependency on claim 22.
Regarding claim 22, the term “high-intensity” in line 18 is a relative term which renders the claim indefinite. The term “high-intensity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 24 is rejected by virtue of its dependency on claim 22.
Regarding claim 22, claim 22 recites the limitation "the autofluorescence detector unit" in line 20. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the autofluorescence detector unit is interpreted as the autofluorescence detector established in claim 21. It is suggested to recite “the autofluorescence detector unit” as “the autofluorescence detector”. Claim 24 is rejected by virtue of its dependency on claim 22.
Regarding claim 22, claim 22 recites the limitation "the effect" and “the fluorescent spectrum” in lines 22-23. There is insufficient antecedent basis for this limitation in the claim. Claim 24 is rejected by virtue of its dependency on claim 22.
Regarding claim 23, claim 23 recites “the system of claim 1”. Claim 1 is cancelled. It is unclear which claim that claim 23 is dependent upon. For examination purposes, claim 23 is interpreted as being dependent upon claim 21.
Regarding claim 23, claim 23 recites the limitation "the inhaled air” in line 4,“the air leaving” in line 6, and “the environment” in line 10. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 23, the term “low enough velocity” in line 7, “highly filtered stream” in lines 9-10 , and “minimal deposition and fouling” in line 11 are relative terms which renders the claim indefinite. The terms “low enough”, “highly”, and “minimal” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 24, claim 24 recites “a charged-coupled device (CCD) array”. It is unclear if the CCD array of claim 24 is the same or different from the CCD array established in claim 21. For examination purposes, the CCD arrays of claims 24 and 21 are interpreted as the same.
Regarding claim 24, claim 24 recites the limitation "the status” and “the result of the test” in the last paragraph. There is insufficient antecedent basis for this limitation in the claim. Note that claim 20 establishes “test results”, wherein it is unclear if the “result of the test” is the same or different from “the test results”.
Regarding claim 25, claim 25 recites the limitation "the LED light” in line 8. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 26, claim 26 recites the limitation "the subject” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 26, claim 26 recites the limitation "the location” and “the date” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 27, claim 27 recites the limitation "the user” in line 3. There is insufficient antecedent basis for this limitation in the claim. Claims 28-31 are rejected by virtue of their dependency on claim 27.
Regarding claim 27, claim 27 recites the limitation "the autofluorescence signal” in the last line. There is insufficient antecedent basis for this limitation in the claim. Claims 28-31 are rejected by virtue of their dependency on claim 27.
Regarding claim 28, claim 28 recites “an optical detection system” in line 2. It is unclear if the optical detection system of claim 28 is the same or different from the activation sensor, laser module, autofluorescence detector, and optical system established in claim 27. Does the optical detection system of claim 22 comprise the activation sensor, laser module, autofluorescence detector, and optical system of claim 27? Or is the optical detection system a separate element? Claim 29 is rejected by virtue of its dependency on claim 28.
Regarding claim 28, claim 28 recites “an autofluorescence signal” in lines 3-4. It is unclear if the autofluorescence signal of claim 28 is the same or different from “the autofluorescence signals” established in claim 27. Claim 29 is rejected by virtue of its dependency on claim 28.
Regarding claim 28, claim 28 recites the limitation "the detection section” in the line 5. There is insufficient antecedent basis for this limitation in the claim. Claim 29 is rejected by virtue of its dependency on claim 28.
Regarding claim 28, claim 28 recites the limitation "the monochromatic laser” in the line 10. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the monochromatic laser of claim 28 is interpreted as the same as the laser module established in claim 27. Claim 29 is rejected by virtue of its dependency on claim 28.
Regarding claim 28, claim 28 recites the limitation "the reflecting mirror” in the line 12. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the reflecting mirror of claim 28 is interpreted as the same as the curved reflector mirror established in claim 27. Claim 29 is rejected by virtue of its dependency on claim 28.
Regarding claim 28, the term “high-intensity” in line 17 is a relative term which renders the claim indefinite. The term “high-intensity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 29 is rejected by virtue of its dependency on claim 28.
Regarding claim 28, claim 28 recites the limitation "the effect" and “the fluorescent spectrum” in lines 21-22. There is insufficient antecedent basis for this limitation in the claim. Claim 29 is rejected by virtue of its dependency on claim 28.
Regarding claim 28, claim 28 recites the limitation "the inhaled air” in line 28 and “the air leaving” in line 30. There is insufficient antecedent basis for this limitation in the claim. Claim 29 is rejected by virtue of its dependency on claim 28.
Regarding claim 28, the term “low enough velocity” in line 31, “highly filtered stream” in lines 33-34, and “minimal deposition and fouling” in line 35 are relative terms which renders the claim indefinite. The terms “low enough”, “highly”, and “minimal” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 29 is rejected by virtue of its dependency on claim 28.
Regarding claim 29, claim 29 recites “a charged-coupled device (CCD) array”. It is unclear if the CCD array of claim 29 is the same or different from the CCD array established in claim 27. For examination purposes, the CCD arrays of claims 29 and 27 are interpreted as the same.
Regarding claim 30, claim 30 recites “the device of claim 30” in line 1. Claim 30 is dependent upon itself, and it is unclear which claim that claim 30 is intended to be dependent upon. For examination purposes, claim 30 is interpreted as being dependent upon claim 27. Claim 31 is rejected by virtue of its dependency on claim 30.
Regarding claim 30, claim 30 recites the limitation "the total collected autofluorescence signal" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Claim 31 is rejected by virtue of its dependency on claim 30.
Regarding claim 32, claim 32 recites the limitation "the laser" in lines 2 and 4. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the laser of claim 32 is interpreted as the laser module of claim 21. It is suggested to recite “the laser” of claim 32 as “the laser module” if referring to the same element.
Regarding claim 32, claim 32 recites the limitation "the volume" in line 3 and “the sensitivity” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 33, claim 33 recites “a pulsed laser…”. It is unclear if the pulsed laser is the same or different from the laser module established in claim 21. Does the laser module comprise the pulsed laser?
Regarding claim 34, claim 34 recites “an activation sensor” in line 3. It is unclear if the activation sensor of claim 34 is the same or different from the at least one activation sensor established in claim 21.
Regarding claim 34, claim 34 recites the limitation "the subject” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 35, claim 35 recites “multiple activation sensors…are employed”. It is unclear if the multiple activation sensors of claim 35 is the same or different from the at least one activation sensor established in claim 21. Does the “at least one activation sensor” comprise multiple activation sensors?
Regarding claim 35, claim 35 recites the limitation "the centerline” in lines 3-4, “the maximum autofluorescence signal” in lines 5-6, and “the necessary air flow” in line 8. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 35, the term “low air flow resistance mouthpieces” in line 7 are relative terms which renders the claim indefinite. The terms “low air flow resistance” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 36, claim 36 recites the limitation "the software” in line 1, “the signal analysis” in line 2, “the number of peaks” in line 4, and “the curve” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 37, claim 37 recites the limitation "the tBmb identification software” in lines 1-2, “the autofluorescence spectra” in lines 4-5, and “the outlet” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 37, the term “more restrictive filter” in line 8 are relative terms which renders the claim indefinite. The term “more restrictive” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 39, claim 39 recites the limitation "the scanning procedure”. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 22 and 28, claim limitation “a photon dispersive unit and a photon detection unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The written description is devoid of any structures that performs the functions of “a photon dispersive unit and a photon detection unit” in the claim, and fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claims 24 and 29 are rejected by virtue of their dependency on claims 22 and 28.
Regarding claim 24, claim limitation “means of signal transmission and reception” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification, paragraph [0019], and Fig. 1 merely describes the breath analysis device transmits autofluorescent spectra by WiFi. However, the disclosure is silent on what structure contributes to the particular “means of signal transmission and reception.” The disclosure is devoid of any structures that performs the functions of the “means of signal transmission and reception” in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Takenaka et al. (US 20150377762 A1) in view of Haick et al. (US 20150301021 A1).
Regarding claim 20, Takenaka teaches a system (abstract; Fig. 1) for detecting TB mycobacteria in droplets dispersed in an air sample exhaled by a user (abstract, paragraph [0001] and Fig. 1 teach detection of microparticles in droplets contained in breath; paragraph [0044] teaches detection of specific microbes such as tuberculosis, such as tubercle bacilli, i.e. TB mycobacteria), the system comprising:
a breath analysis device (Fig. 1 breath microbe detection device 1);
an application (Fig. 5 and paragraph [0073] teaches a control section for controlling operation of the breath microbe detection device, therefore implies an application or software in order to control operations) operatively connected to the breath analysis device (Fig. 5 and paragraph [0073]), and
wherein the application is configured to process autofluorescence signal data received from the breath analysis device (paragraph [0073] teaches the control section controls the breath microbe detection device to display the test contents and results; paragraph [0095] teaches the control section processes fluorescence value from the photodetector; therefore, the control section includes an application or software configured to process fluorescence signal data, e.g. autofluorescence, received from the photodetector of the breath microbe detection device), generate test results for the user (paragraph [0073] teaches the control section displays results, therefore includes an application or software to generate the test result for a user), and communicate the results to the user (paragraph [0073] teaches the control section and display section displays the test results).
Takenaka fails to teach: a server for data storage and communication; the application is configured to communicate the results to a server for storing the test results of the user.
Takenaka teaches externally connected devices such as a personal computer can be used (paragraph [0073]).
Haick teaches a sensor with a pattern recognition algorithm for diagnosis of tuberculosis caused by TB bacteria in a subject (abstract). Haick teaches after analysis, resulting information can be displayed, transmitted to a host computer, or stored on a storage device for subsequent retrieval (paragraph [0089]). Haick teaches the sensor is mounted on an electronic chip for signal readout and data storage; the device includes an opening to capture the breath of a subject; the sensor readout and software for data analysis is loaded onto a computer via a USB port; and data can be analyzed on-site or via data-link to a server (paragraph [0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Takenaka to incorporate the teachings of transmitting and storage of resulting information after sample analysis of Haick (paragraphs [0089],[0100]) to provide: a server for data storage and communication; the application is configured to communicate the results to a server for storing the test results of the user. Doing so would have a reasonable expectation of successfully improving transmission and storage of test results for subsequent retrieval and analysis by a user.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable Takenaka in view of Haick as applied to claim 20 above, and further in view of Uribe (US 11915808 B1; effectively filed 07/25/2019).
Regarding claim 26, modified Takenaka fails to teach: wherein the server is configured to collect and organize, in a database, data from each test, the data comprising: information regarding the subject being tested in pseudo-anonymized form; information regarding the user executing the test in pseudo-anonymized form; the location of the test; the date of the test; environmental conditions at the test site; and the test results.
Haick teaches a sensor with a pattern recognition algorithm for diagnosis of tuberculosis caused by TB bacteria in a subject (abstract). Haick teaches after analysis, resulting information can be displayed, transmitted to a host computer, or stored on a storage device for subsequent retrieval (paragraph [0089]). Haick teaches the sensor is mounted on an electronic chip for signal readout and data storage; the device includes an opening to capture the breath of a subject; the sensor readout and software for data analysis is loaded onto a computer via a USB port; and data can be analyzed on-site or via data-link to a server (paragraph [0100]).
Uribe teaches a privacy-preserving biospecimen test kit kiosk and locker that pairs to and stores data in a private digital wallet (abstract). Uribe teaches a unique code that represents a biospecimen and relevant data results, such as date and time at which the user provided the biospecimen (column 9, lines 22-40). Uribe teaches a pseudo-anonymous identifier of the user to protect and preserve the user’s privacy and data (column 10, lines 15-23). Uribe teaches sensor devices that capture environmental data (column 18, lines 1-8). Uribe teaches data provenance includes records of data collected before, during, or after collection of bio-samples that are processed to derive resulting data of interest, such as time and date of securing a biospecimen, air quality, temperature, and humidity measurements (column 3, lines 42-58). Uribe teaches data of interest includes infectious disease data from samples (column 3, lines 60-64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the server of modified Takenaka to incorporate Haicks’ teachings of data analysis, readout, and storage (paragraphs [0089],[0100]) and Uribe’s teachings of preserving a user’s privacy via pseudo-anonymous identifiers and capturing data of interest of a sample including environmental data, date, and time and infectious disease data (column 3, lines 42-58; column 3, lines 60-64; column 9, lines 22-40; column 10, lines 15-23) to provide: wherein the server is configured to collect and organize, in a database, data from each test, the data comprising: information regarding the subject being tested in pseudo-anonymized form; information regarding the user executing the test in pseudo-anonymized form; the location of the test; the date of the test; environmental conditions at the test site; and the test results. Doing so would have a reasonable expectation of successfully improving further characterization of sample data and improving privacy and organization of the collected data.
Prior Art / Allowable Subject Matter
The prior art fails to teach or suggest claims 21-25 and 32-39:
Regarding claim 21, the closest prior art of Takenaka et al. (US 20150377762 A1) in view of Haick et al. (US 20150301021 A1) teaches the system of claim 20 (see above rejection of claim 20 under 35 U.S.C. 103), and further teaches wherein the breath analysis device is configured to detect autofluorescent entities of Mycobacterium tuberculosis in exhaled air of the user (Takenaka, abstract, paragraph [0001] and Fig. 1 teach detection of microparticles in droplets contained in breath; paragraph [0044] teaches fluorescent detection of specific microbes such as tuberculosis, such as tubercle bacilli, i.e. TB mycobacteria; therefore, the optical detector of the breath microbe detection device is capable of detecting autofluorescent entities as claimed since it is capable of detecting fluorescence), the device comprising:
a disposable mouthpiece (Fig. 1 and paragraph [0049] teaches a breath bag 121 that is connected to the breath microbe detection device, wherein the breath bag is interpreted as a disposable mouth piece);
a laser module (paragraph [0093], laser);
an autofluorescence detector (Fig. 1 and paragraph [0109] teaches optical detector 124 detects fluorescence, therefore is capable of detecting autofluorescence) operatively connected downstream of the laser module (Fig. 9 teaches photodetector 144 is operatively connected downstream of light source 143), the autofluorescence detector comprising a charged-coupled device (CCD) array (paragraph [0093], “CCD”) for detecting photons emitted as autofluorescence from entities stimulated by the laser light (interpreted as an intended use, see MPEP 2114; the CCD of paragraph [0093] is structurally capable of detecting photons from autofluorescence from entities stimulated by the laser light);
an optical system (Fig. 9, optical elements 1411, 1422, 1423, 1413) configured to direct autofluorescence light emitted by the entities toward the autofluorescence detector (Fig. 9 teaches optical elements 1411, 1422, 1423, 1413 directing light towards photodetector 144, therefore is structurally capable of directing autofluorescent light as claimed), the optical system comprising:
a collector lens (Fig. 9 condensing lens 1413) arranged to focus the collected light onto an aperture of the autofluorescence detector (interpreted as an intended use, see MPEP 2114; Fig. 9 and paragraph [0092] teaches condensing lens 1413 condenses fluorescence onto the photodetector, therefore is structurally capable of focusing collected light onto an aperture of the photodetector; note that the “aperture” is not positively recited structurally), and
Modified Takenaka fails to teach: at least one activation sensor configured to detect initiation of exhalation by the user and to generate an activation signal; the laser module operatively connected to the activation sensor, the laser module being configured to emit monochromatic laser light at a predetermined wavelength in response to the activation signal; the autofluorescence detector comprising a diffraction grating element; the optical system comprising: a curved reflector mirror arranged to collect the autofluorescence light, and a scattered light filter positioned between the collector lens and the autofluorescence detector, the filter having a wavelength cut-off above the wavelength of the laser light to suppress scattered laser light and enhance sensitivity to the autofluorescence signals.
Takenaka teaches connecting the breath bag activates a pump and automatically detecting fluorescence (paragraph [0049]). Takenaka teaches a valve automatically opens upon attaching the breath bag to the breath microbe detection device (paragraph [0074]). Takenaka teaches mirrors to direct light (Fig. 9, elements 1421 and 1423) and a band-pass filter to pass only wavelengths of the fluorescent light (paragraphs [0091]-[0092]). However Takenaka fails to teach or suggest all of the limitations of claim 21.
A reference Mottram et al. (US 6270462 B1) teaches an apparatus for automatically detecting a sample of an animal’s breath (abstract), the apparatus including a sensor for sensing a flow of breath (abstract). Mottram teaches analysis means for detecting viruses and bacteria (column 5, lines 23-22). Mottram teaches the apparatus comprises an actuation means to initiate collection, conditioning, and analysis of a sample or turn on the apparatus to a stand by mode, the collection, condition, and analysis of the exhalation sample being subsequently initiated by the sensing means of the presence of animal exhalation (column 6, lines 10-16). However, Mottram fails to teach or suggest all of the limitations of claim 21.
None of the prior art teaches or fairly suggests, alone or in combination, all of the limitations of claim 21. Therefore, claim 21 is free from the prior art. Claims 22-25 and 32-39 are free from the prior art due to their dependency and inclusion of all of the limitations of claim 21. It is suggested to incorporate all of claim 21 into claim 20.
Claims 27 and 30-31 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. Note that claims 28-29 are rejected under 35 U.S.C. 112(a).
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 27, the closest prior art of Takenaka et al. (US 20150377762 A1) teaches a breath analysis device is configured to detect autofluorescent entities of Mycobacterium tuberculosis in exhaled air of the user (abstract, paragraph [0001] and Fig. 1 teach detection of microparticles in droplets contained in breath; paragraph [0044] teaches fluorescent detection of specific microbes such as tuberculosis, such as tubercle bacilli, i.e. TB mycobacteria; therefore, the optical detector of the breath microbe detection device is capable of detecting autofluorescent entities as claimed since it is capable of detecting fluorescence), the device comprising:
a disposable mouthpiece (Fig. 1 and paragraph [0049] teaches a breath bag 121 that is connected to the breath microbe detection device, wherein the breath bag is interpreted as a disposable mouth piece);
a laser module (paragraph [0093], laser);
an autofluorescence detector (Fig. 1 and paragraph [0109] teaches optical detector 124 detects fluorescence, therefore is capable of detecting autofluorescence ) operatively connected downstream of the laser module (Fig. 9 teaches photodetector 144 is operatively connected downstream of light source 143), the autofluorescence detector comprising a charged-coupled device (CCD) array (paragraph [0093], “CCD”) for detecting photons emitted as autofluorescence from entities stimulated by the laser light (interpreted as an intended use, see MPEP 2114; the CCD of paragraph [0093] is structurally capable of detecting photons from autofluorescence from entities stimulated by the laser light);
an optical system (Fig. 9, optical elements 1411, 1422, 1423, 1413) configured to direct autofluorescence light emitted by the entities toward the autofluorescence detector (Fig. 9 teaches optical elements 1411, 1422, 1423, 1413 directing light towards photodetector 144, therefore is structurally capable of directing autofluorescent light as claimed), the optical system comprising:
a collector lens (Fig. 9 condensing lens 1413) arranged to focus the collected light onto an aperture of the autofluorescence detector (interpreted as an intended use, see MPEP 2114; Fig. 9 and paragraph [0092] teaches condensing lens 1413 condenses fluorescence onto the photodetector, therefore is structurally capable of focusing collected light onto an aperture of the photodetector; note that the “aperture” is not positively recited structurally).
Takenaka fails to teach: at least one activation sensor configured to detect initiation of exhalation by the user and to generate an activation signal; a laser module operatively connected to the activation sensor, the laser module being configured to emit monochromatic laser light at a predetermined wavelength in response to the activation signal; the autofluorescence detector comprising a diffraction grating element; the optical system comprising: a curved reflector mirror arranged to collect the autofluorescence light, a scattered light filter positioned between the collector lens and the autofluorescence detector, the filter having a wavelength cut-off above the wavelength of the laser light to suppress scattered laser light and enhance sensitivity to the autofluorescence signals.
Takenaka teaches connecting the breath bag activates a pump and automatically detecting fluorescence (paragraph [0049]). Takenaka teaches a valve automatically opens upon attaching the breath bag to the breath microbe detection device (paragraph [0074]). Takenaka teaches mirrors to direct light (Fig. 9, elements 1421 and 1423) and a band-pass filter to pass only wavelengths of the fluorescent light (paragraphs [0091]-[0092]). However Takenaka fails to teach or suggest all of the limitations of claim 27.
A reference Mottram et al. (US 6270462 B1) teaches an apparatus for automatically detecting a sample of an animal’s breath (abstract), the apparatus including a sensor for sensing a flow of breath (abstract). Mottram teaches analysis means for detecting viruses and bacteria (column 5, lines 23-22). Mottram teaches the apparatus comprises an actuation means to initiate collection, conditioning, and analysis of a sample or turn on the apparatus to a stand by mode, the collection, condition, and analysis of the exhalation sample being subsequently initiated by the sensing means of the presence of animal exhalation (column 6, lines 10-16). However, Mottram fails to teach or suggest all of the limitations of claim 27.
None of the prior art teaches or fairly suggests, alone or in combination, all of the limitations of claim 27. Therefore, claim 27 is deemed allowable. Claims 30-31 are deemed allowable based on their dependency on claim 27. Note that claims 28-29 are free from the prior art due to their dependency and inclusion of all of the limitations of claim 27.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mueller et al. (DE 10114141 A1; see machine translation) teaches bacterial infections such as mycobacterium tuberculosis is transmitted through droplet infection in exhaled air (paragraph [0001]). Muller teaches an invention for tuberculosis diagnosis in exhaled air of persons (paragraph [0003]), the invention including a rapid tuberculosis system (Figs. 1-2 and paragraph [0016], element 1), breath inlet (2), mouthpiece (4), ion mobility spectrometer (8), and PC (8).
Patino et al. (Patino et al., “Autofluorescence of Mycobacteria as a Tool for Detection of Mycobacterium tuberculosis”, Journal of Clinical Microbiology, Oct. 2008, p3296-3302, Vol. 46, No. 10) teaches diagnosis of tuberculosis by autofluorescence detection of mycobacterium tuberculosis (abstract).
McLoughlin et al. (US 20220044921 A1) teaches systems for identifying composition of bioaerosol particles (abstract), including a continuous timing laser tightly coupled with a pulse ionization laser is used to index aerosol particles, measure particle properties, and trigger the ionization laser to fire when each particle enters the beam of the trigger laser (abstract). McLoughlin teaches analyte aerosol could include exhaled breath particles in exhaled air of humans, where patients with tuberculosis exhaled mycobacterium tuberculosis when coughing (paragraph [0005]). McLoughlin teaches the continuous laser may be used to determine particle size, fluorescence (autofluorescence) and polarization (particle shape) and identify particles of particular interest (paragraph [0031]).
Bittner et al. (US 20230266222 A1; effectively filed 07/29/2020) teaches a method for detecting aerosol particles in air (abstract). Bittner teaches aerogenic infectious diseases from droplet transmission includes exhalation (paragraph [0067]), wherein the aerosol particles to be detected are bacteria (paragraph [0073]), which can include Mycobacterium tuberculosis (paragraph [0075]). Bittner teaches a laser (paragraph [0095]). Bittner teaches it is known for the detection of biological molecules, it is possible to exploit the fact that the autofluorescence, i.e., intrinsic fluorescence, of some biomolecules can indicate the presence of biological material, while the intensity of most non-biological aerosols is low (paragraph [0015]).
Chen et al. (US 20220034854 A1; effectively filed 08/23/2020) teaches a device for analyzing aerosol particles in exhaled breath for tuberculosis diagnosis (abstract; Figs. 1-2). Chen teaches sample extraction through a mouthpiece (paragraph [0061]).
Wang et al. (US 20100137733 A1) teaches systems for detecting whether a subject has tuberculosis (abstract), wherein exhaled breath is sampled through a disposable mouthpiece (paragraph [0060]). Wang teaches data analysis software (paragraphs [0086],[0091]).
Mohanty et al. (US 20150293057 A1) teaches a rapid electronic TB detection device, wherein a patient blows into the device and the biomarkers in the breath react with functionalized nanotubes that are under a bias voltage (abstract; paragraph [0010]; Fig. 1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758