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 .
Status of Claims
Applicant's arguments, filed 06/09/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 06/09/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1-2, 5-9, 11-12, and 14-16.
Applicants have left claims 4, 10, 13, and 17 as originally filed/previously presented.
Applicants have canceled/previously canceled claim 3.
Applicants have introduced new claim 18.
Claims 1-2 and 4-18 are the current claims hereby under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification - Withdrawn
Response to Arguments
Applicant’s arguments, see page 6 of Remarks, filed 06/09/2026, with respect to the specification have been fully considered and are persuasive. Applicants have amended the specification, rendering the objection moot. The objection of the specification has been withdrawn.
Claim Objections - Withdrawn
Response to Arguments
Applicant’s arguments, see page 6 of Remarks, filed 06/09/2026, with respect to the objections of claims 5-7, 11, 14, and 15 have been fully considered and are persuasive. Applicants have amended the claims, rendering the objections moot. The objections of claims 5-7, 11, 14, and 15 has been withdrawn.
Claim Interpretation - 35 USC § 112(f) - Withdrawn and Maintained
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:
Claim 1: The claim limitation “a processing unit for determining said respiratory system infection …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “for determining said respiratory system infection …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“processing unit or data processing device may be implemented by special-purpose software (or firmware) run on one or more general-purpose or special-purpose computing devices … one or more processing units, e.g., a CPU …”, or equivalents thereof, as described on pages 9-10 of the disclosure filed on 04/30/2024.
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.
Response to Arguments
Applicant’s arguments, see page 6 of Remarks, filed 06/09/2026, with respect to the 112(f) interpretation of “particle detecting unit” have been fully considered and are persuasive. Applicants have amended the claims to recite sufficient structure. The 112(f) interpretation of “particle detecting unit” has been withdrawn. Applicants arguments/amendments did not address “a processing unit”, therefore the Examiner cannot find a reason to withdraw the interpretation.
Claim Rejections - 35 USC § 112 - Withdrawn
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.
Response to Arguments
Applicant’s arguments, see pages 6-7 of Remarks, filed 06/09/2026, with respect to claims 2, 8-10, and 12 have been fully considered and are persuasive. Applicants have amended the claims, rendering the rejections moot. The 112(b) rejections of claims 2, 8-10, and 12 has been withdrawn.
Claim Rejections - 35 USC § 102 - Modified/Newly Applied Necessitated by Applicant’s Amendments
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-6, 8-9, and 11-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bryden et al. (US 20220322963 A1) (previously cited), hereinafter referred to as Bryden.
The claims are generally directed towards a diagnostic device for detection of a respiratory system infection of a subject, comprising: a particle detecting unit comprising a particle counter or sizer, said particle detecting unit configured for obtaining data related to particles being exhaled from said subject's airways, wherein said data includes at least one of number of particles, mass, size, size distribution, or mass distribution of said particles; a processing unit for determining said respiratory system infection based on analyzing a pattern in said data from said particle detecting unit and subject related properties.
Regarding claim 1, Bryden discloses a diagnostic device for detection of a respiratory system infection of a subject (Abstract, “devices for analyzing exhaled breath aerosols … point of care assays for several diseases including respiratory tract diseases …”), comprising:
a particle detecting unit (Fig. 2, element 100, para. [0037], “diagnosis system …”) comprising a particle counter or size (Fig. 2, element 112, para. [0041], “sensors include … particle sizer/counter …”), said particle detecting unit configured for obtaining data related to particles being exhaled from said subject's airways (Fig. 5, para. [0016], para. [0037], “exhaled breath analysis … EBA sample collection subsystem and an analysis subsystem …”, para. [0041], “sensors include … CO2 sensor and a particle sizer/counter …”, para. [0051-0052], “analysis subsystem … spectral analysis such as mass spectrometry …”), wherein said data includes at least one of number of particles, mass, size, size distribution, or mass distribution of said particles (para. [0041], “particle size/counter …”, para. [0056], “particle size distribution …”);
a processing unit for determining said respiratory system infection based on analyzing a pattern in said data from said particle detecting unit and subject related properties (Fig. 5, para. [0054-0056], “individual is instructed to perform one or more predetermined maneuvers … spectrum obtained is compared to spectra samples that were known positives … spectra samples from patients known to be healthy … diagnosis of the patient is generated … particle size distribution … helps to determine if the sample collected is sufficient for analysis …”).
Regarding claim 2, Bryden discloses the diagnostic device of claim 1, wherein said particle counter or sizer is an optical based particle counter or sizer (para. [0016], “optical particle size counter …”, para. [0055-0056]).
Regarding claim 4, Bryden discloses the diagnostic device of claim 1, wherein said particles are aerosols derived from said subject's respiratory system (para. [0016], “sample extraction component configured to receive an individual’s face for extracting breath aerosol particles …”).
Regarding claim 5, Bryden discloses the diagnostic device of claim 1, wherein said pattern is characteristic of a type of said respiratory system infection (para. [0055], “spectrum obtained is compared … diagnosis of the patient is generated …”).
Regarding claim 6, Bryden discloses the diagnostic device of claim 1, wherein said subject related properties are information related to the respiratory system of said subject, including, exhaled volume, number of exhalations, flow velocity of the exhaled breath, relative moisture in the exhaled breath, temperature of the exhaled breath and/or oxygen saturation (para. [0016], “one or more sensors … CO2 sensor, an oxygen sensor, a humidity sensor … number of exhaled breath maneuvers …”, para. [0041], “sensors provide an indication of the volume of exhaled breath …”, para. [0054], “predetermined maneuvers …”).
Regarding claim 8, Bryden discloses the diagnostic device of claim 1, wherein said data is compared with a reference database of healthy subjects to determine said respiratory system infection (para. [0055], “spectrum obtained is compared to … spectra of samples from patients known to be healthy …”).
Regarding claim 9, Bryden discloses the diagnostic device of claim 1, wherein said data is compared with a reference database of subjects with a respiratory system infection to determine said respiratory system infection (para. [0055], “spectrum obtained is compared to spectra from samples that were known positives to specific respiratory infections”).
Regarding claim 11, Bryden discloses the diagnostic device of claim 1, wherein said processing unit is configured to determine said respiratory system infections, qualitatively or quantitatively (Fig. 5, para. [0054-0056], “individual is instructed to perform one or more predetermined maneuvers … spectrum obtained is compared to spectra samples that were known positives … spectra samples from patients known to be healthy … diagnosis of the patient is generated … particle size distribution … helps to determine if the sample collected is sufficient for analysis …” - the spectrum is compared quantitatively).
Regarding claim 12, Bryden discloses the diagnostic device of claim 1, wherein said determination is based on a pre-defined number of particles (Fig. 5, para. [0054-0056], “individual is instructed to perform one or more predetermined maneuvers … spectrum obtained is compared to spectra samples that were known positives … spectra samples from patients known to be healthy … diagnosis of the patient is generated … particle size distribution … helps to determine if the sample collected is sufficient for analysis …”).
Regarding claim 13, Bryden discloses the diagnostic device of claim 1, wherein said data is collected during a predefined screening process (para. [0019], “predetermined set of breathing maneuvers to expel EBA particles from exhaled breath … performing a deep exhale … repeating the above sequence up to 10 times …”).
Regarding claim 14, Bryden discloses the diagnostic device of claim 13, wherein the predefined screening process includes at least one of, a pre-determined number of exhales, a predetermine inhalation and exhalation routine, or exhalation after inhalation of pure air (para. [0019], “predetermined set of breathing maneuvers to expel EBA particles from exhaled breath … performing a deep exhale … repeating the above sequence up to 10 times …”).
Regarding claim 15, Bryden discloses the diagnostic device of claim 1, wherein thresholds are used to reduce the impact of too large particles and/or too small particles (para. [0042], “virtual impactors may be used to concentrate aerosols of a certain “cut size” and those larger than the cut size …”).
Regarding claim 16, Bryden discloses a computer implemented method for detection of a respiratory system infection of a subject (Abstract, “method … for analyzing exhaled breath aerosols … point of care assays for several diseases including respiratory tract diseases …”, para. [0051], “diagnostic devices …”), comprising:
receiving particle data from a particle detecting unit comprising a particle counter or sizer, wherein said particle data is related to particles being exhaled from said subject's airways (Fig. 2, element 100, element 112, para. [0037], “diagnosis system …”, para. [0041], “sensors include … particle sizer/counter …”, Fig. 5, para. [0016], para. [0037], “exhaled breath analysis … EBA sample collection subsystem and an analysis subsystem …”, para. [0041], “sensors include … CO2 sensor and a particle sizer/counter …”, para. [0051-0052], “analysis subsystem … spectral analysis such as mass spectrometry …”), and wherein said particle data includes at least one of number of particles, mass, size, size distribution, or mass distribution of said particles (para. [0041], “particle size/counter …”, para. [0056], “particle size distribution …”); and
determining said respiratory system infection based on analyzing a pattern in said particle data from said particle detecting unit and subject related properties (Fig. 5, para. [0054-0056], “individual is instructed to perform one or more predetermined maneuvers … spectrum obtained is compared to spectra samples that were known positives … spectra samples from patients known to be healthy … diagnosis of the patient is generated … particle size distribution … helps to determine if the sample collected is sufficient for analysis …”).
Regarding claim 17, Bryden discloses a computer program comprising instructions which, when the program is executed by a computer, cause the computer to carry out the method of claim 16 (para. [0051], “diagnostic devices … spectrometer …”, para. [0054-0055], - the diagnostic method and the generated diagnosis of the patient is generated by a MALDI-MS which inherently includes computer programs).
Regarding claim 18, Bryden discloses the diagnostic device of claim 12, wherein said pre-defined number of particles is a predetermined number of particles, or a predetermined total mass of counted particles (Fig. 5, para. [0054-0056], “individual is instructed to perform one or more predetermined maneuvers … spectrum obtained is compared to spectra samples that were known positives … spectra samples from patients known to be healthy … diagnosis of the patient is generated … particle size distribution … helps to determine if the sample collected is sufficient for analysis …”).
Response to Arguments
Applicant's arguments filed 06/09/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 7-8 of Remarks, filed 06/09/2026, that “claims 1 and 16, as amended, require the respiratory system infection be determined ‘based on analyzing a pattern in said data from said particle detecting unit’ where said data includes ‘at least one of number of particles, mass, size, size distribution, or mass distribution of said particles’ … Bryden does not disclose determining a respiratory system infection based on analyzing a pattern in particle count, size, or mass distribution data from a particle counter or sizer …”.
The Examiner respectfully disagrees. Applicants arguments are not commensurate in scope with the claimed invention. Amended claims 1 and 16 do not limit “said particle data” from explicitly being from the particle counter or sizer and/or limit how the particle data is analyzed to determine said respiratory system infection. As recited above, Bryden teaches a particle detecting unit, which comprises a particle counter or sizer, and other sensing elements to determine a respiratory system infection. The particle detecting unit receives particle data from a plurality of different sensors and/or sensing elements. At least one of a number of particles, mass, size, size distribution, or mass distribution is utilized when determining the respiratory system infection.
Claim Rejections - 35 USC § 103 - Maintained
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.
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bryden et al. (US 20220322963 A1) (previously cited), hereinafter referred to as Bryden as applied to claims 6 and 8 above, and further in view of Haick et al. (US 20150301021 A1) (previously cited), hereinafter referred to as Haick.
Regarding claim 7, Bryden discloses the diagnostic device of claim 6.
However, Bryden does not explicitly disclose wherein said information related to the respiratory system of said subject further include information related to a physical condition and/or a health condition of said subject, including weight, height, sex, age, medical records, smoker/non-smoker, or heart frequency.
Haick teaches of an analogous diagnostic device for detecting a respiratory system infection (Abstract, para. [0099-0100]), and determining a respiratory system infection based on data and subject related properties (para. [0081-0082]). Haick further teaches subject related properties further include information related to a physical condition and/or a health condition of said subject, including weight, height, sex, age, medical records, smoker/non-smoker, or heart frequency (para. [0082]). 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 information related to the respiratory system of said subject to further include information related to a physical condition and/or a health condition of said subject, including weight, height, sex, age, medical records, smoker/non-smoker, or heart frequency, as taught by Haick. This is because Haick teaches references values can be further be specified based on the subjects age, sex, heigh, and weight, which allows for the diagnosis to be more accurate (para. [0082]).
Regarding claim 10, Bryden discloses the diagnostic device of claim 8.
However, Bryden does not explicitly disclose wherein said data is filtered using said subject related properties before comparing said data with said reference database.
Haick teaches of an analogous diagnostic device for detecting a respiratory system infection (Abstract, para. [0099-0100]), and determining a respiratory system infection based on data and subject related properties (para. [0081-0082]). Haick further teaches data is filtered using said subject related properties before comparing said data with said reference database (para. [0082]). 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 data to additionally be filtered using said subject related properties before comparing said data with said reference database, as taught by Haick. This is because Haick teaches filtering the data prior to making a comparison allows for the data to be compared to similar reference values, which allows for the diagnosis to be more accurate (para. [0082]).
Response to Arguments
Applicants arguments, filed 06/09/2026, do not directly address the rejections of claims 7 and 10. Therefore, the Examiner cannot find a reason to withdraw the rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wurie et al. (“Bioaerosol production by patients with tuberculosis during normal tidal breathing: implications for transmission risk”) - discloses patients with TB are more likely to produce a greater concentration of bioaerosols in the 1-5 µm range, when compared to healthy patients (Discussion, pg. 551-554)
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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