Prosecution Insights
Last updated: August 16, 2026
Application No. 18/557,492

AN AIR OR BREATH SAMPLING DEVICE CAPTURING BOTH AEROSOL AND VAPOR FRACTIONS

Non-Final OA §102§103§112
Filed
Oct 26, 2023
Priority
Apr 28, 2021 — EU 21171015.7 +1 more
Examiner
MCCORMACK, ERIN KATHLEEN
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Merck Patent GmbH
OA Round
1 (Non-Final)
10%
Grant Probability
At Risk
1-2
OA Rounds
6m
Est. Remaining
60%
With Interview

Examiner Intelligence

Grants only 10% of cases
10%
Career Allowance Rate
3 granted / 31 resolved
-60.3% vs TC avg
Strong +50% interview lift
Without
With
+50.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
53 currently pending
Career history
128
Total Applications
across all art units

Statute-Specific Performance

§101
10.1%
-29.9% vs TC avg
§103
45.6%
+5.6% vs TC avg
§102
11.9%
-28.1% vs TC avg
§112
32.5%
-7.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 31 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION This action is pursuant to claims filed on 01/28/2026. Claims 1-30 are pending, with claims 1, 3-11, and 23-30 withdrawn. A first action on the merits of claims 2 and 12-22 is as follows. 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 Election/Restrictions Claims 1, 3-11, and 23-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups I, III, and IV, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/28/2026. Claim Objections Claims 2 and 12-14 are objected to because of the following informalities: In claim 2, line 3, “human breath” should read “the human breath” In claim 2, lines 4-5, “human breath” should read “the human breath” In claim 2, line 7, “human breath” should read “the human breath” In claim 12, line 1, “human breath” should read “the human breath” In claim 12, line 8, “exhaled human breath aerosols, particles and VOC's” should read “the human breath aerosols, particles and VOC's” In claim 13, line 1, “the presence” should read “a presence” In claim 14, line 1, “the presence” should read “a presence” In claim 14, line 10, “exhaled” should be deleted 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. Regarding the “means for collecting aerosols and particles from human breath” from claim 2, line 3: (A) “means for” is the generic placeholder; (B) The functional language that modified “means for” is the step of “collecting aerosols and particles from human breath”; (C) “means for” is not modified by a sufficient structure for performing the claimed inventions, therefore 35 U.S.C. 112(f) is invoked. The corresponding structure of the “means for collecting aerosols and particles from human breath” from claim 2 is found on page 5, stating that “the means for collecting aerosols and particles comprises a filter to capture such aerosols and particles. Such filter can be an electrostatic filter”. Regarding the “means for collecting Volatile Organic Compounds (VOC’s) from human breath” from claim 2, lines 4-5: (A) “means for” is the generic placeholder; (B) The functional language that modified “means for” is the step of “collecting Volatile Organic Compounds (VOC’s) from human breath”; (C) “means for” is not modified by a sufficient structure for performing the claimed inventions, therefore 35 U.S.C. 112(f) is invoked. The corresponding structure of the “means for collecting Volatile Organic Compounds (VOC’s) from human breath” from claim 2 is found on page 5, stating that “the volatile organic compounds are collected in the device through a means for collecting such VOC's which comprises a thermal desorption tube”. Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 13-14 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 13, the claim recites the limitation “a sample of exhaled human breath” in line 2. It is unclear if this limitation is meant to refer to the sample from human breath from claim 2, line 1, or a different sample of human breath. If it is meant to refer to the sample from claim 2, it needs to refer back to it. If it is meant to refer to a different sample, it needs to be distinguished from the sample from claim 2. For purposes of examination, it is being interpreted as referring to the sample from claim 2. Further regarding claim 13, the claim recites the limitation “aerosols” in line 3. It is unclear if this limitation is meant to refer to the aerosols from claim 2, line 3, or different aerosols. If it is meant to refer to the aerosols from claim 2, it needs to refer back to it. If it is meant to refer to different aerosols, it needs to be distinguished from the aerosols from claim 2. For purposes of examination, it is being interpreted as referring to the aerosols from claim 2. Further regarding claim 13, the claim recites the limitation “particles” in line 3. It is unclear if this limitation is meant to refer to the particles from claim 2, line 3, or different particles. If it is meant to refer to the particles from claim 2, it needs to refer back to it. If it is meant to refer to different particles, it needs to be distinguished from the particles from claim 2. For purposes of examination, it is being interpreted as referring to the particles from claim 2. Further regarding claim 13, the claim recites the limitation “human breath” in lines 3 and 4. It is unclear if this limitation is meant to refer to the human breath from line 1, the human breath from claim 2, line 1, or a different human breath. If it is meant to refer to any of the previously introduced human breath, it needs to refer back to it. If it is meant to refer to a different human breath, it needs to be distinguished from any of the human breath limitations introduced previously. For purposes of examination, it is being interpreted as referring to any of the previously introduced human breath limitations. Further regarding claim 13, the claim recites the limitation “Volatile Organic Compounds (VOC’s)” in line 4. It is unclear if this limitation is meant to refer to the Volatile Organic Compounds (VOC’s) from claim 2, line 4, or different VOC’s. If it is meant to refer to the VOC’s from claim 2, it needs to refer back to it. If it is meant to refer to different VOC’s, it needs to be distinguished from the VOC’s from claim 2. For purposes of examination, it is being interpreted as referring to the VOC’s from claim 2. Further regarding claim 13, the claim recites the limitation “a single device” in line 9. It is unclear if this is meant to refer to the device from claim 2, line 1, or a different device. If it is meant to refer to the device from claim 2, it needs to refer back to it. If it is meant to refer to a different device, it needs to be distinguished from the device from claim 2. For purposes of examination, it is being interpreted as referring to the device from claim 2. Regarding claim 14, the claim recites the limitation “aerosols” in line 4. It is unclear if this limitation is meant to refer to the aerosols from claim 2, line 3, or different aerosols. If it is meant to refer to the aerosols from claim 2, it needs to refer back to it. If it is meant to refer to different aerosols, it needs to be distinguished from the aerosols from claim 2. For purposes of examination, it is being interpreted as referring to the aerosols from claim 2. Further regarding claim 14, the claim recites the limitation “particles” in line 4. It is unclear if this limitation is meant to refer to the particles from claim 2, line 3, or different particles. If it is meant to refer to the particles from claim 2, it needs to refer back to it. If it is meant to refer to different particles, it needs to be distinguished from the particles from claim 2. For purposes of examination, it is being interpreted as referring to the particles from claim 2. Further regarding claim 14, the claim recites the limitation “human breath” in lines 4 and 5. It is unclear if this limitation is meant to refer to the human breath from line 1, the human breath from claim 2, line 1, or a different human breath. If it is meant to refer to any of the previously introduced human breath, it needs to refer back to it. If it is meant to refer to a different human breath, it needs to be distinguished from any of the human breath limitations introduced previously. For purposes of examination, it is being interpreted as referring to any of the previously introduced human breath limitations. Further regarding claim 14, the claim recites the limitation “Volatile Organic Compounds (VOC’s)” in line 5. It is unclear if this limitation is meant to refer to the Volatile Organic Compounds (VOC’s) from claim 2, line 4, or different VOC’s. If it is meant to refer to the VOC’s from claim 2, it needs to refer back to it. If it is meant to refer to different VOC’s, it needs to be distinguished from the VOC’s from claim 2. For purposes of examination, it is being interpreted as referring to the VOC’s from claim 2. Further regarding claim 14, the claim recites the limitation “a single device” in line 11. It is unclear if this is meant to refer to the device from claim 2, line 1, or a different device. If it is meant to refer to the device from claim 2, it needs to refer back to it. If it is meant to refer to a different device, it needs to be distinguished from the device from claim 2. For purposes of examination, it is being interpreted as referring to the device from claim 2. Regarding claim 22, the claim recites the limitation “adsorbent materials” in line 2. It is unclear if this limitation is meant to refer to the adsorbent material from claim 21, line 2, or different adsorbent materials. If it is meant to refer to the adsorbent material from claim 21, it needs to refer back to it. If it is meant to refer to different adsorbent materials, it needs to be distinguished from the adsorbent material from claim 21. For purposes of examination, it is being interpreted as referring to the adsorbent material from claim 21. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 2, 12-13, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (CN 204260747). Citations to CN 204260747 will refer to the English Machine Translation that accompanies this Office Action. Regarding independent claim 2, Li teaches a device for capturing a breath sample from human breath ([0002]: “This utility model relates to the field of medical devices, and in particular to a device for monitoring respiratory dynamics and analyzing exhaled breath components”) comprising: a. a means for collecting aerosols and particles from human breath ([0014]: “This utility model provides a respiratory monitoring and exhalation analysis system that can detect human respiratory dynamic parameters and collect human exhaled aerosol particles and volatile organic compounds during human respiration; Fig. 1 shows the breath analysis system, which is the means for collecting aerosols and particles from human breath.), and b. a means for collecting Volatile Organic Compounds (VOC's) from human breath ([0014]: “This utility model provides a respiratory monitoring and exhalation analysis system that can detect human respiratory dynamic parameters and collect human exhaled aerosol particles and volatile organic compounds during human respiration. Fig. 1 shows the breath analysis system, which is the means for collecting VOCs from human breath.), wherein the means for collecting aerosols and particles and the means for collecting VOC's from human breath are connected to each other such that the device collects from the same volume of exhaled human breath aerosols, particles and VOC's ([0014]: “This utility model provides a respiratory monitoring and exhalation analysis system that can detect human respiratory dynamic parameters and collect human exhaled aerosol particles and volatile organic compounds during human respiration, and analyze them simultaneously (exhaled aerosol particles are analyzed using genomics and proteomics analysis platforms; volatile organic compounds are analyzed using gas analysis sensors or gas chromatography/mass spectrometry analysis stations)”. The device collects the aerosol particles and VOCs from the same exhaled breath, therefore from the same volume.). Regarding claim 12, Li teaches a method of sampling human breath with the device according to claim 2 ([0022]: “This invention enables the collection of human exhaled aerosol particles and the enrichment and analysis of human exhaled VOCs during monitoring expiratory dynamic parameters, normal breathing, and certain pathological processes (such as coughing).”). Regarding claim 13, Li teaches a method to determine the presence of a biomarker of interest in a sample of exhaled human breath ([0002]: “This utility model relates to the field of medical devices, and in particular to a device for monitoring respiratory dynamics and analyzing exhaled breath components” ) comprising a. collecting aerosols and particles from human breath ([0014]: “This utility model provides a respiratory monitoring and exhalation analysis system that can detect human respiratory dynamic parameters and collect human exhaled aerosol particles and volatile organic compounds during human respiration, and analyze them simultaneously (exhaled aerosol particles are analyzed using genomics and proteomics analysis platforms; volatile organic compounds are analyzed using gas analysis sensors or gas chromatography/mass spectrometry analysis stations)”) b. collecting Volatile Organic Compounds (VOC's) from human breath ([0014]: “This utility model provides a respiratory monitoring and exhalation analysis system that can detect human respiratory dynamic parameters and collect human exhaled aerosol particles and volatile organic compounds during human respiration, and analyze them simultaneously (exhaled aerosol particles are analyzed using genomics and proteomics analysis platforms; volatile organic compounds are analyzed using gas analysis sensors or gas chromatography/mass spectrometry analysis stations)”), and c. determining the presence of the biomarker of interest in either one of the collected aerosols, particles or VOC's ([0005]: “Currently, studies have identified more than 3,000 volatile organic compounds (VOCs) in human exhalation, but the vast majority of these gases are present in extremely small amounts. Even those gases that can serve as markers of disease require high-resolution gas chromatography/mass spectrometry for detection. Therefore, in order to conduct certain disease biomarker analysis in clinical practice, the method of enriching exhaled VOCs is urgently needed”; [0014]: “This utility model provides a respiratory monitoring and exhalation analysis system that can detect human respiratory dynamic parameters and collect human exhaled aerosol particles and volatile organic compounds during human respiration, and analyze them simultaneously (exhaled aerosol particles are analyzed using genomics and proteomics analysis platforms; volatile organic compounds are analyzed using gas analysis sensors or gas chromatography/mass spectrometry analysis stations)”; [0027]: “This invention can enrich VOCs in exhaled breath and perform preliminary analysis using an exhaled breath analysis sensor; at the same time, the VOCs enrichment tube can be disassembled for gas chromatography/mass spectrometry analysis to obtain accurate exhaled VOCs composition data.”. The various types of analysis such as gas chromatography or mass spectrometry determine the biomarkers of interest in the VOCs.), wherein the aerosols, particles and VOC's are collecting from the same exhaled human breath and are collected in a single device according to claim 2 ([0014]: “This utility model provides a respiratory monitoring and exhalation analysis system that can detect human respiratory dynamic parameters and collect human exhaled aerosol particles and volatile organic compounds during human respiration, and analyze them simultaneously (exhaled aerosol particles are analyzed using genomics and proteomics analysis platforms; volatile organic compounds are analyzed using gas analysis sensors or gas chromatography/mass spectrometry analysis stations)”. The device collects the aerosol particles and VOCs from the same exhaled breath, therefore from the same volume.). Regarding claim 15, Li teaches the device according to claim 2, wherein the means for collecting aerosols and particles comprises a filter to capture such aerosols and particles ([0015]: “The respiratory monitoring and exhalation analysis system of this utility model includes … a high-efficiency air filter”; [0018]: “The aerosol particle enrichment material of the exhaled aerosol particle enrichment submodule is a gelatin filter membrane or an electrostatic filter.”). Regarding claim 16, Li teaches the device according to claim 15, wherein the filter is an electrostatic filter ([0018]: “The aerosol particle enrichment material of the exhaled aerosol particle enrichment submodule is a gelatin filter membrane or an electrostatic filter.”). 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. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claim 2 above, and further in view of Troudt (US 20220304589). Regarding claim 14, Li teaches a method of diagnosing a patient for having or having a risk of having a disorder comprising determining the presence of a biomarker of interest comprising ([0002]: “This utility model relates to the field of medical devices, and in particular to a device for monitoring respiratory dynamics and analyzing exhaled breath components”) a. collecting aerosols and particles from human breath ([0014]: “This utility model provides a respiratory monitoring and exhalation analysis system that can detect human respiratory dynamic parameters and collect human exhaled aerosol particles and volatile organic compounds during human respiration, and analyze them simultaneously (exhaled aerosol particles are analyzed using genomics and proteomics analysis platforms; volatile organic compounds are analyzed using gas analysis sensors or gas chromatography/mass spectrometry analysis stations)”), b. collecting Volatile Organic Compounds (VOC's) from human breath ([0014]: “This utility model provides a respiratory monitoring and exhalation analysis system that can detect human respiratory dynamic parameters and collect human exhaled aerosol particles and volatile organic compounds during human respiration, and analyze them simultaneously (exhaled aerosol particles are analyzed using genomics and proteomics analysis platforms; volatile organic compounds are analyzed using gas analysis sensors or gas chromatography/mass spectrometry analysis stations)”), c. determining the presence of the biomarker of interest in either one of the collected aerosols, particles or VOC's ([0005]: “Currently, studies have identified more than 3,000 volatile organic compounds (VOCs) in human exhalation, but the vast majority of these gases are present in extremely small amounts. Even those gases that can serve as markers of disease require high-resolution gas chromatography/mass spectrometry for detection. Therefore, in order to conduct certain disease biomarker analysis in clinical practice, the method of enriching exhaled VOCs is urgently needed”; [0014]: “This utility model provides a respiratory monitoring and exhalation analysis system that can detect human respiratory dynamic parameters and collect human exhaled aerosol particles and volatile organic compounds during human respiration, and analyze them simultaneously (exhaled aerosol particles are analyzed using genomics and proteomics analysis platforms; volatile organic compounds are analyzed using gas analysis sensors or gas chromatography/mass spectrometry analysis stations)”; [0027]: “This invention can enrich VOCs in exhaled breath and perform preliminary analysis using an exhaled breath analysis sensor; at the same time, the VOCs enrichment tube can be disassembled for gas chromatography/mass spectrometry analysis to obtain accurate exhaled VOCs composition data.”. The various types of analysis such as gas chromatography or mass spectrometry determine the biomarkers of interest in the VOCs.), wherein the aerosols, particles and VOC's are collecting from the same exhaled human breath in a single device according claim 2 ([0014]: “This utility model provides a respiratory monitoring and exhalation analysis system that can detect human respiratory dynamic parameters and collect human exhaled aerosol particles and volatile organic compounds during human respiration, and analyze them simultaneously (exhaled aerosol particles are analyzed using genomics and proteomics analysis platforms; volatile organic compounds are analyzed using gas analysis sensors or gas chromatography/mass spectrometry analysis stations)”. The device collects the aerosol particles and VOCs from the same exhaled breath, therefore from the same volume.). However, Li does not teach correlating the presence or absence of the biomarker of interest with a disease state. Troudt discloses a device to detect biomarkers of disease in human breath. Specifically, Troudt teaches correlating the presence or absence of the biomarker of interest with a disease state ([0004]: “Some disease states result in the production of specific chemical compounds. In some cases, volatile organic compounds (VOCs) released into a gaseous sample of a patient can be hallmarks of certain diseases. In particular, the volatile organic compounds can include aldehydes and ketones, which are known biomarkers for disease and can be detected in a gaseous sample. The detection of these compounds or differential sensing of the same can allow for the early detection of particular disease states”). Li and Troudt are analogous art as they are both related to devices that analyze VOCs in a user’s breath. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the determination of a disease state from Troudt into the method from Li as it allows the methods to use the detected biomarkers to inform the user of their disease state, which can allow for further analysis and information for the user. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claim 2 above, and further in view of Smith (US 20230337935). Regarding claim 17, Li teaches the device according to claim 2. However, Li does not teach wherein the means for collecting aerosols and particles and the means for collecting VOC's are connected through a gas-tight connection. Smith discloses a breath sample device. Specifically, Smith teaches wherein the means for collecting aerosols and particles and the means for collecting VOC's are connected through a gas-tight connection ([0076]: “the fluidly connecting 520 comprises engaging a valve opener 120 with the breath-sample container 100 in a substantially gas-tight manner such that a part 122 of the adaptor 120 configures the valve 110 to the second open configuration 110b by irreversible deforming the valve 110, and fluidly connecting an outlet 134 of the valve opener 120 with the inlet 142 of the breath sample analyser 138 in a substantially gas-tight manner”). Li and Smith are analogous art as they are both related to devices that analyze VOCs in a user’s breath. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the gas-tight connection from Smith into the device from Li as the device from Li is silent on the connection means, and Smith discloses a gas-tight connection, which ensures that the breath sample does not leak out of the device, ensuring the whole sample can be analyzed. Claims 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claim 2 above, and further in view of Shi (CN 111250066). Citations to CN 111250066 will refer to the English Machine Translation that accompanies this Office Action. Regarding claim 18, Li teaches the device according to claim 2. Li teaches wherein the means for collecting VOCs comprise an enrichment tube ([0027]: “This invention can enrich VOCs in exhaled breath and perform preliminary analysis using an exhaled breath analysis sensor; at the same time, the VOCs enrichment tube can be disassembled for gas chromatography/mass spectrometry analysis to obtain accurate exhaled VOCs composition data”), however Li does not teach the enrichment tube being a thermal desorption tube. Shi discloses an invention for adsorbing VOCs. Specifically, Shi teaches wherein the means for collecting VOC's comprises a thermal desorption tube ([0011]: “The method for preparing the molecular sieve honeycomb carrier for adsorbing volatile organic compounds according to the present invention involves preparing a molecular sieve honeycomb carrier from a composite molecular sieve, additives, and a binder, and then performing a hydrophobic treatment by passing SiCl-NER6 gas under N-NER5 protection conditions to obtain the molecular sieve honeycomb carrier”; [0074]: “All molecular sieve honeycomb carriers have a desorption capacity of no less than 98%”; [0106]: “Weigh the original weight m0 of the honeycomb molecular sieve and the mass m1 of the saturated honeycomb molecular sieve. Place them in a forced-air constant temperature oven at 300℃ for thermal desorption. Weigh them after desorption to obtain m2. Calculate the desorption efficiency”). Li and Shi are analogous art as they are both related to devices used to enrich VOCs. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the thermal desorption structure from Shi into the device from Li as Li is silent on the structure of the VOC enrichment tube, and Shi discloses a suitable structure in an analogous device. Regarding claim 19, the Li/Shi combination teaches the device according to claim 18, wherein the thermal desorption tube comprises a honeycomb structure (Shi, [0011]: “The method for preparing the molecular sieve honeycomb carrier for adsorbing volatile organic compounds according to the present invention involves preparing a molecular sieve honeycomb carrier from a composite molecular sieve, additives, and a binder, and then performing a hydrophobic treatment by passing SiCl-NER6 gas under N-NER5 protection conditions to obtain the molecular sieve honeycomb carrier”). Regarding claim 20, the Li/Shi combination teaches the device according to claim 19. However, the Li/Shi combination does not teach wherein the honeycomb structure is made from any material which is capable of resisting temperatures of 450℃ or more. Shi teaches wherein the honeycomb structure is made from any material which is capable of resisting temperatures of 450℃ or more ([0063]: “The dried molecular sieve honeycomb carrier was calcined in a programmable calcination furnace at a temperature of 700℃ for 4 hours”. The material was treated at a temperature of 700℃, therefore it is capable of withstanding a temperature greater than 450℃). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the temperature threshold from Shi into the Li/Shi combination as the combination is silent on the temperature the honeycomb structure can withstand, and Shi discloses a suitable temperature threshold in an analogous device. Regarding claim 21, the Li/Shi combination teaches the device according to claim 19. However, the Li/Shi combination is silent on the material of the honeycomb structure. Shi teaches wherein the honeycomb structure comprises adsorbent material ([0027]: “This invention directly synthesizes molecular sieves by in-situ crystallization on calcined kaolin. Compared with mixing NaY molecular sieves with kaolin during the mixing process, kaolin exists in a layered structure. Directly growing NaY molecular sieves on kaolin results in richer pores, larger pore size, relatively higher specific surface area, and greater contact with volatile organic compounds”; [0007]: “NaY molecular sieves have a large specific surface area and well-developed microporous structure, and exhibit good adsorption performance for different VOCs under dry conditions”. The NaY is formed by crystallization, which forms a coating on the honeycomb structure and is an adsorbent material.). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the material from Shi into the Li/Shi combination as the combination is silent on the material and Shi discloses a suitable material in an analogous device. Regarding claim 22, the Li/Shi combination teaches the device according to claim 21, wherein the honeycomb structure is coated with one or more adsorbent materials (Shi, [0027]: “This invention directly synthesizes molecular sieves by in-situ crystallization on calcined kaolin. Compared with mixing NaY molecular sieves with kaolin during the mixing process, kaolin exists in a layered structure. Directly growing NaY molecular sieves on kaolin results in richer pores, larger pore size, relatively higher specific surface area, and greater contact with volatile organic compounds”; [0007]: “NaY molecular sieves have a large specific surface area and well-developed microporous structure, and exhibit good adsorption performance for different VOCs under dry conditions”. The NaY is formed by crystallization, which forms a coating on the honeycomb structure and is an adsorbent material.). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN K MCCORMACK whose telephone number is (703)756-1886. The examiner can normally be reached Mon-Fri 7:30-5. 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 Sims can be reached at 5712727540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /E.K.M./Examiner, Art Unit 3791 /MATTHEW KREMER/Primary Examiner, Art Unit 3791
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Prosecution Timeline

Oct 26, 2023
Application Filed
Apr 21, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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SENSOR DEVICE MONITORS FOR CALIBRATION
4y 3m to grant Granted Feb 24, 2026
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Study what changed to get past this examiner. Based on 3 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
10%
Grant Probability
60%
With Interview (+50.0%)
3y 4m (~6m remaining)
Median Time to Grant
Low
PTA Risk
Based on 31 resolved cases by this examiner. Grant probability derived from career allowance rate.

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